A Phase 2 interventional study of ARRY-438162, MEK inhibitor; oral and Placebo; oral in Rheumatoid Arthritis, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer. Completed at 35 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Treatment
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 201 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Array Biopharma, now a wholly owned subsidiary of Pfizer is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: ARRY-438162, MEK inhibitor; oral
Drug: ARRY-438162, MEK inhibitor; oral
Drug: ARRY-438162, MEK inhibitor; oral
Drug: Placebo; oral
multiple dose, single schedule
matching placebo
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 12
American College of Rheumatology 20% (ACR20) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 1
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 2
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 4
American College of Rheumatology 20% (ACR20) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 8
American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Time frame: Week 16 (Follow-up)
American College of Rheumatology 50% (ACR50) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 1
American College of Rheumatology 50% (ACR50) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 2
American College of Rheumatology 50% (ACR50) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 4
American College of Rheumatology 50% (ACR50) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 8
American College of Rheumatology 50% (ACR50) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 12
American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Time frame: Week 16 (Follow-up)
American College of Rheumatology 70% (ACR70) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 1
American College of Rheumatology 70% (ACR70) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 2
American College of Rheumatology 70% (ACR70) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 4
American College of Rheumatology 70% (ACR70) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 8
American College of Rheumatology 70% (ACR70) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 12
American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Time frame: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Baseline
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 1
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 2
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 4
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 8
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 12
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Time frame: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Baseline
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 1
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 2
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 4
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 8
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 12
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Time frame: Week 16 (Follow-up)
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Baseline
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 1
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 2
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 4
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 8
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 12
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Time frame: Week 16 (Follow-up)
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Baseline
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 1
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 2
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 4
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 8
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 12
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Time frame: Week 16 (Follow-up)
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Baseline
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 1
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 2
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 4
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 8
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 12
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Time frame: Week 16 (Follow-up)
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 1
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 2
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 4
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 8
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 12
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Time frame: Week 16 (Follow-up)
C-Reactive Protein (CRP) at Baseline
Time frame: Baseline
C-Reactive Protein (CRP) at Week 1
Time frame: Week 1
C-Reactive Protein (CRP) at Week 2
Time frame: Week 2
C-Reactive Protein (CRP) at Week 4
Time frame: Week 4
C-Reactive Protein (CRP) at Week 8
Time frame: Week 8
C-Reactive Protein (CRP) at Week 12
Time frame: Week 12
C-Reactive Protein (CRP) at Week 16 (Follow-up)
Time frame: Week 16 (Follow-up)
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Baseline
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 1
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 2
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 4
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 8
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 12
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Time frame: Week 16 (Follow-up)
The ARRAY-162-201 study began recruitment on 04-April-2008 (First Patient First Visit) and concluded on 07-July-2009 (Last Patient Last Visit). This study was conducted at 36 sites in the United States, Europe and South America.
| Milestone | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Started | 51 | 50 | 50 | 50 |
| Completed | 46 | 41 | 36 | 39 |
| Not completed | 5 | 9 | 14 | 11 |
| Withdrew: Adverse event | 0 | 3 | 10 | 8 |
| Withdrew: Death | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 4 | 3 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 0 |
| Withdrew: Other | 1 | 1 | 0 | 0 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 12 | 45.1 (31.1 to 59.7) | 58.0 (43.2 to 71.8) | 60.0 (45.2 to 73.6) | 54.0 (39.3 to 68.2) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 1 | 12.2 (4.6 to 24.8) | 20.8 (10.5 to 35.0) | 32.7 (19.9 to 47.5) | 46.0 (31.8 to 60.7) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 2 | 18.4 (8.8 to 32.0) | 31.3 (18.7 to 46.3) | 32.7 (19.9 to 47.5) | 50.0 (35.5 to 64.5) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 4 | 44.9 (30.7 to 59.8) | 54.2 (39.2 to 68.6) | 44.9 (30.7 to 59.8) | 58.0 (43.2 to 71.8) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 8 | 49.0 (34.4 to 63.7) | 56.3 (41.2 to 70.5) | 53.1 (38.3 to 67.5) | 48.0 (33.7 to 62.6) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up) | 40.8 (27.0 to 55.8) | 52.1 (37.2 to 66.7) | 49.0 (34.4 to 63.7) | 46.0 (31.8 to 60.7) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 1 | 2.0 (0.1 to 10.9) | 6.3 (1.3 to 17.2) | 2.0 (0.1 to 10.9) | 4.0 (0.5 to 13.7) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 2 | 6.1 (1.3 to 16.9) | 8.3 (2.3 to 20.0) | 10.2 (3.4 to 22.2) | 16.0 (7.2 to 29.1) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 4 | 10.2 (3.4 to 22.2) | 8.3 (2.3 to 20.0) | 12.2 (4.6 to 24.8) | 16.0 (7.2 to 29.1) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 8 | 16.3 (7.3 to 29.7) | 27.1 (15.3 to 41.8) | 16.3 (7.3 to 29.7) | 22.0 (11.5 to 36.0) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 12 | 24.5 (13.3 to 38.9) | 25.0 (13.6 to 39.6) | 22.4 (11.8 to 36.6) | 22.0 (11.5 to 36.0) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up) | 16.3 (7.3 to 29.7) | 27.1 (15.3 to 41.8) | 30.6 (18.3 to 45.4) | 14.0 (5.8 to 26.7) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 1 | 0.0 (0.0 to 7.3) | 2.1 (0.1 to 11.1) | 0.0 (0.0 to 7.3) | 2.0 (0.1 to 10.6) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 2 | 2.0 (0.1 to 10.9) | 4.2 (0.5 to 14.3) | 0.0 (0.0 to 7.3) | 2.0 (0.1 to 10.6) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 4 | 0.0 (0.0 to 7.3) | 4.2 (0.5 to 14.3) | 2.0 (0.1 to 10.9) | 2.0 (0.1 to 10.6) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 8 | 4.1 (0.5 to 14.0) | 4.2 (0.5 to 14.3) | 4.1 (0.5 to 14.0) | 4.0 (0.5 to 13.7) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 12 | 8.2 (2.3 to 19.6) | 12.5 (4.7 to 25.2) | 8.2 (2.3 to 19.6) | 6.0 (1.3 to 16.5) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
| percentage of participants | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up) | 6.1 (1.3 to 16.9) | 6.3 (1.3 to 17.2) | 6.1 (1.3 to 16.9) | 10.0 (3.3 to 21.8) |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 16.8 ± 6.44 | 14.8 ± 5.49 | 15.0 ± 5.98 | 17.0 ± 5.95 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 14.9 ± 6.81 | 11.6 ± 6.24 | 11.6 ± 6.46 | 11.1 ± 5.84 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 12.3 ± 6.50 | 10.2 ± 6.49 | 11.4 ± 6.31 | 10.0 ± 6.00 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 11.6 ± 7.46 | 9.0 ± 6.31 | 9.6 ± 6.84 | 8.9 ± 6.02 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 9.9 ± 7.21 | 8.1 ± 7.04 | 8.3 ± 6.27 | 7.5 ± 5.50 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 9.4 ± 7.09 | 7.1 ± 7.05 | 7.8 ± 7.50 | 7.8 ± 6.57 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28) | 9.1 ± 7.13 | 7.4 ± 7.15 | 9.2 ± 7.37 | 8.9 ± 6.97 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 12.7 ± 4.45 | 11.4 ± 4.10 | 12.3 ± 4.96 | 13.0 ± 5.31 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 11.3 ± 5.72 | 8.0 ± 4.65 | 9.6 ± 4.80 | 9.1 ± 4.96 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 9.4 ± 5.45 | 6.9 ± 4.98 | 8.7 ± 4.58 | 7.3 ± 5.76 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 7.9 ± 5.14 | 5.8 ± 4.00 | 7.0 ± 4.70 | 7.1 ± 6.03 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 6.7 ± 5.25 | 5.5 ± 4.64 | 6.9 ± 5.51 | 6.5 ± 5.96 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 6.3 ± 5.67 | 5.3 ± 4.86 | 6.3 ± 5.54 | 6.3 ± 5.92 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28) | 6.5 ± 5.69 | 4.8 ± 4.63 | 6.9 ± 5.72 | 6.5 ± 5.96 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 68.7 ± 18.94 | 61.9 ± 20.32 | 62.4 ± 21.42 | 63.0 ± 18.95 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 61.5 ± 25.16 | 47.9 ± 22.94 | 48.4 ± 22.53 | 42.6 ± 20.62 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 56.5 ± 23.89 | 46.4 ± 22.61 | 47.7 ± 25.20 | 39.6 ± 22.60 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 50.3 ± 23.78 | 44.5 ± 25.23 | 44.8 ± 24.48 | 39.0 ± 19.75 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 49.7 ± 26.53 | 46.1 ± 24.97 | 46.4 ± 25.42 | 41.5 ± 23.39 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 45.9 ± 28.15 | 43.9 ± 27.39 | 43.8 ± 26.93 | 42.3 ± 21.46 |
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) | 50.7 ± 27.93 | 47.1 ± 26.32 | 48.7 ± 27.09 | 48.5 ± 23.93 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 65.2 ± 20.59 | 60.1 ± 20.80 | 63.4 ± 19.25 | 55.4 ± 20.34 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 57.2 ± 24.52 | 45.8 ± 22.65 | 48.3 ± 22.82 | 42.3 ± 20.66 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 57.6 ± 21.74 | 46.3 ± 23.62 | 49.4 ± 22.61 | 40.3 ± 22.33 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 50.5 ± 23.96 | 43.5 ± 24.57 | 46.7 ± 23.70 | 40.0 ± 20.55 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 48.7 ± 26.34 | 42.9 ± 24.69 | 45.5 ± 22.95 | 41.8 ± 21.60 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 45.5 ± 26.71 | 40.6 ± 23.24 | 43.4 ± 24.82 | 41.1 ± 19.75 |
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS). Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Patient's Global Assessment of Arthritis - Visual Analog Score (VAS) | 46.9 ± 26.69 | 42.6 ± 22.99 | 47.5 ± 27.18 | 44.8 ± 21.95 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 61.2 ± 16.71 | 66.0 ± 13.80 | 61.0 ± 15.23 | 59.7 ± 13.26 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 53.7 ± 17.80 | 47.7 ± 19.55 | 46.8 ± 18.21 | 41.1 ± 17.14 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 47.9 ± 18.61 | 41.8 ± 18.67 | 43.9 ± 19.45 | 35.3 ± 18.27 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 42.0 ± 19.83 | 39.9 ± 21.55 | 38.8 ± 18.40 | 34.7 ± 19.20 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 39.5 ± 20.96 | 37.0 ± 21.21 | 36.8 ± 18.88 | 32.7 ± 22.50 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 35.8 ± 21.96 | 34.9 ± 22.19 | 35.7 ± 21.06 | 31.2 ± 21.64 |
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS). The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Physician's Global Assessment of Arthritis - Visual Analog Score (VAS) | 36.7 ± 20.86 | 33.2 ± 19.22 | 40.7 ± 21.92 | 34.6 ± 20.37 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.6 ± 0.59 | 1.5 ± 0.52 | 1.5 ± 0.53 | 1.5 ± 0.65 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.6 ± 0.66 | 1.3 ± 0.58 | 1.3 ± 0.63 | 1.2 ± 0.68 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.5 ± 0.59 | 1.3 ± 0.59 | 1.3 ± 0.62 | 1.0 ± 0.62 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.4 ± 0.63 | 1.3 ± 0.68 | 1.2 ± 0.63 | 1.1 ± 0.60 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.4 ± 0.70 | 1.2 ± 0.72 | 1.2 ± 0.62 | 1.1 ± 0.66 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.3 ± 0.72 | 1.1 ± 0.66 | 1.1 ± 0.68 | 1.1 ± 0.64 |
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 1.3 ± 0.76 | 1.2 ± 0.70 | 1.2 ± 0.64 | 1.1 ± 0.62 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Baseline | 1.9 ± 1.42 | 1.8 ± 1.18 | 2.4 ± 1.86 | 2.4 ± 1.95 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 1 | 2.2 ± 2.20 | 1.9 ± 2.85 | 2.0 ± 2.17 | 1.4 ± 1.58 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 2 | 1.9 ± 1.70 | 1.9 ± 1.70 | 2.5 ± 2.36 | 2.1 ± 2.07 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 4 | 1.9 ± 1.55 | 2.2 ± 3.18 | 2.6 ± 3.02 | 2.2 ± 2.25 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 8 | 2.1 ± 2.24 | 2.0 ± 1.88 | 2.6 ± 2.39 | 3.0 ± 3.34 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 12 | 2.1 ± 2.14 | 1.8 ± 1.87 | 2.5 ± 2.51 | 2.9 ± 2.91 |
| mg/dL | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| C-Reactive Protein (CRP) at Week 16 (Follow-up) | 1.9 ± 1.79 | 2.3 ± 3.33 | 2.0 ± 1.68 | 2.3 ± 2.50 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 6.1 ± 0.77 | 5.9 ± 0.61 | 6.0 ± 0.79 | 6.1 ± 0.77 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 5.8 ± 1.01 | 5.0 ± 1.03 | 5.2 ± 1.08 | 5.0 ± 0.97 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 5.4 ± 0.94 | 4.9 ± 1.17 | 5.3 ± 1.06 | 4.8 ± 1.14 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 5.2 ± 1.13 | 4.7 ± 1.28 | 5.0 ± 1.19 | 4.7 ± 1.24 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 4.9 ± 1.23 | 4.6 ± 1.34 | 4.8 ± 1.15 | 4.6 ± 1.40 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 4.8 ± 1.26 | 4.3 ± 1.39 | 4.6 ± 1.42 | 4.6 ± 1.43 |
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP]) | 4.8 ± 1.20 | 4.4 ± 1.27 | 4.8 ± 1.42 | 4.7 ± 1.42 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | 29.8 ± 8.45 | 31.4 ± 7.78 | 31.6 ± 8.29 | 33.8 ± 9.58 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | 33.8 ± 9.05 | 36.0 ± 9.10 | 34.3 ± 9.73 | 38.7 ± 8.74 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | 34.2 ± 9.86 | 37.2 ± 9.25 | 34.9 ± 10.32 | 38.2 ± 10.36 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | 34.5 ± 11.08 | 37.2 ± 9.83 | 36.4 ± 10.91 | 38.8 ± 9.63 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning | 35.4 ± 11.10 | 36.0 ± 9.75 | 35.5 ± 8.99 | 37.8 ± 9.84 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | 30.3 ± 8.47 | 32.7 ± 8.07 | 32.3 ± 7.68 | 32.9 ± 8.49 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | 34.8 ± 8.20 | 37.1 ± 9.69 | 37.1 ± 7.89 | 38.6 ± 7.88 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | 34.6 ± 9.17 | 39.2 ± 9.70 | 36.5 ± 8.09 | 39.2 ± 9.20 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | 35.1 ± 9.65 | 39.7 ± 10.36 | 37.9 ± 9.46 | 39.3 ± 8.12 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical | 36.4 ± 10.45 | 38.9 ± 8.50 | 36.9 ± 9.48 | 38.7 ± 9.21 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | 32.5 ± 6.39 | 33.1 ± 6.22 | 32.4 ± 7.18 | 33.0 ± 6.50 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | 37.3 ± 8.49 | 38.1 ± 9.22 | 38.0 ± 8.58 | 41.0 ± 9.22 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | 37.2 ± 9.05 | 39.1 ± 9.73 | 38.7 ± 8.27 | 40.8 ± 10.11 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | 38.1 ± 10.01 | 39.3 ± 9.21 | 38.7 ± 9.61 | 40.9 ± 9.62 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain | 37.9 ± 10.62 | 38.1 ± 9.89 | 37.0 ± 9.73 | 38.1 ± 9.19 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | 34.1 ± 6.65 | 33.6 ± 8.05 | 34.0 ± 7.85 | 36.1 ± 7.44 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | 36.4 ± 6.00 | 36.9 ± 9.10 | 36.9 ± 9.11 | 38.9 ± 9.07 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | 36.8 ± 7.96 | 37.8 ± 9.10 | 36.9 ± 8.21 | 39.7 ± 9.29 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | 37.8 ± 6.93 | 37.1 ± 9.13 | 36.7 ± 9.28 | 39.2 ± 8.74 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health | 37.4 ± 8.60 | 36.8 ± 9.02 | 36.4 ± 8.53 | 38.3 ± 9.25 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | 40.1 ± 10.10 | 41.5 ± 7.79 | 41.3 ± 9.17 | 44.5 ± 8.30 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | 44.3 ± 8.75 | 46.3 ± 10.31 | 44.7 ± 9.16 | 47.3 ± 9.64 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | 43.9 ± 9.76 | 47.2 ± 11.08 | 45.3 ± 10.03 | 49.0 ± 9.30 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | 45.5 ± 9.73 | 47.8 ± 10.20 | 46.3 ± 10.56 | 47.5 ± 9.41 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality | 45.1 ± 10.55 | 47.4 ± 11.67 | 44.4 ± 9.91 | 46.9 ± 9.93 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | 32.7 ± 10.97 | 34.1 ± 9.28 | 34.7 ± 9.50 | 36.7 ± 10.62 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | 36.9 ± 9.74 | 39.9 ± 10.07 | 38.3 ± 10.04 | 38.9 ± 9.71 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | 37.1 ± 10.41 | 40.0 ± 9.60 | 39.0 ± 10.09 | 40.2 ± 9.44 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | 37.3 ± 10.93 | 38.9 ± 10.01 | 40.2 ± 10.15 | 39.6 ± 8.67 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning | 37.1 ± 11.97 | 39.0 ± 10.77 | 37.2 ± 10.18 | 38.8 ± 10.70 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | 29.3 ± 12.17 | 31.2 ± 11.66 | 31.1 ± 9.96 | 32.7 ± 13.03 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | 34.8 ± 10.88 | 36.2 ± 12.69 | 34.1 ± 10.32 | 34.6 ± 10.96 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | 33.3 ± 12.19 | 38.3 ± 11.79 | 34.5 ± 11.09 | 36.5 ± 10.91 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | 33.4 ± 12.14 | 37.4 ± 12.38 | 35.0 ± 11.46 | 36.5 ± 11.17 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional | 34.4 ± 13.11 | 36.4 ± 10.77 | 35.2 ± 10.73 | 36.1 ± 12.46 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | 35.3 ± 12.54 | 37.4 ± 10.99 | 36.1 ± 11.39 | 38.9 ± 12.06 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | 40.6 ± 11.13 | 43.3 ± 12.95 | 38.9 ± 12.64 | 40.9 ± 10.80 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | 40.5 ± 11.70 | 42.9 ± 12.44 | 39.7 ± 12.63 | 42.7 ± 11.43 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | 41.0 ± 11.23 | 43.1 ± 11.58 | 39.7 ± 12.14 | 41.7 ± 11.66 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health | 40.5 ± 12.27 | 41.4 ± 13.00 | 37.7 ± 11.70 | 40.4 ± 12.11 |
SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | 35.9 ± 12.47 | 37.8 ± 10.91 | 37.3 ± 10.11 | 40.0 ± 11.86 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | 41.1 ± 11.01 | 43.3 ± 12.95 | 39.9 ± 11.52 | 40.4 ± 10.79 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | 40.2 ± 11.36 | 43.7 ± 11.41 | 40.6 ± 12.35 | 42.8 ± 10.82 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | 40.7 ± 11.06 | 43.1 ± 11.31 | 40.9 ± 11.66 | 41.7 ± 11.35 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score | 40.4 ± 11.98 | 42.3 ± 12.10 | 39.3 ± 11.14 | 41.1 ± 11.92 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | 32.1 ± 6.06 | 32.8 ± 5.91 | 32.9 ± 6.30 | 33.9 ± 6.98 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | 35.3 ± 7.47 | 36.6 ± 7.73 | 37.1 ± 7.08 | 40.5 ± 7.57 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | 35.8 ± 7.59 | 38.1 ± 8.12 | 37.2 ± 6.73 | 40.0 ± 8.78 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | 36.5 ± 8.26 | 38.3 ± 8.82 | 38.2 ± 8.65 | 40.3 ± 8.16 |
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
| units on a scale | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score | 37.1 ± 9.50 | 37.6 ± 7.34 | 37.2 ± 7.95 | 39.0 ± 7.96 |
Collected over Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/49 (2%) | 20/49 (40.8%) |
| ARRY-438162: 10 mg Bid | — | 1/49 (2%) | 25/49 (51%) |
| ARRY-438162: 40 mg qd | — | 1/50 (2%) | 39/50 (78%) |
| ARRY-438162: 20 mg Bid | — | 0/50 (0%) | 42/50 (84%) |
| Event | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| BRONCHOPNEUMONIAInfections and infestations | 0/49 | 1/49 | 0/50 | 0/50 |
| MYOCARDIAL INFARCTIONCardiac disorders | 1/49 | 0/49 | 0/50 | 0/50 |
| ABDOMINAL INJURYInjury, poisoning and procedural complications | 0/49 | 1/49 | 0/50 | 0/50 |
| CHEST INJURYInjury, poisoning and procedural complications | 0/49 | 1/49 | 0/50 | 0/50 |
| PNEUMONIAInfections and infestations | 0/49 | 0/49 | 1/50 | 0/50 |
| ATRIAL FIBRILLATIONCardiac disorders | 0/49 | 0/49 | 1/50 | 0/50 |
| EROSIVE OESOPHAGITISGastrointestinal disorders | 0/49 | 0/49 | 1/50 | 0/50 |
| GASTRITIS EROSIVEGastrointestinal disorders | 0/49 | 0/49 | 1/50 | 0/50 |
| THROMBOPHLEBITISVascular disorders | 0/49 | 0/49 | 1/50 | 0/50 |
| Event | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid |
|---|---|---|---|---|
| DIARRHOEAGastrointestinal disorders | 5/49 | 3/49 | 15/50 | 12/50 |
| RASHSkin and subcutaneous tissue disorders | 2/49 | 1/49 | 7/50 | 5/50 |
| NAUSEAGastrointestinal disorders | 0/49 | 0/49 | 6/50 | 2/50 |
| RHEUMATOID ARTHRITISMusculoskeletal and connective tissue disorders | 5/49 | 2/49 | 5/50 | 2/50 |
| DERMATITIS ACNEIFORMSkin and subcutaneous tissue disorders | 0/49 | 0/49 | 1/50 | 5/50 |
| URINARY TRACT INFECTIONInfections and infestations | 4/49 | 4/49 | 2/50 | 5/50 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 0/49 | 4/49 | 5/50 | 5/50 |
| NASOPHARYNGITISInfections and infestations | 4/49 | 0/49 | 0/50 | 1/50 |
| BRONCHITISInfections and infestations | 2/49 | 2/49 | 1/50 | 4/50 |
| FOLLICULITISInfections and infestations | 0/49 | 3/49 | 1/50 | 2/50 |
Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.
| Age, Categorical(Participants) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 43 | 45 | 41 | 45 | 174 |
| >=65 years | 8 | 5 | 9 | 5 | 27 |
| Age, Continuous(years) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Mean | 52.0 ± 12.67 | 51.6 ± 11.98 | 54.8 ± 11.88 | 51.4 ± 11.74 | 52.6 ± 11.89 |
| Sex: Female, Male(Participants) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Female | 43 | 42 | 43 | 44 | 172 |
| Male | 8 | 8 | 7 | 6 | 29 |
| Race/Ethnicity, Customized(participants) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Hispanic Or Latino | 24 | 21 | 23 | 24 | 92 |
| Not Hispanic Or Latino | 27 | 29 | 27 | 26 | 109 |
| Weight(kilogram) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Mean | 74.1 ± 18.26 | 68.2 ± 14.17 | 72.1 ± 17.95 | 67.2 ± 13.86 | 69.2 ± 15.49 |
| Height(centimeters) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Mean | 160.2 ± 8.63 | 159.5 ± 8.11 | 158.6 ± 9.22 | 158.0 ± 7.44 | 158.7 ± 8.25 |
| Smoking Status(participants) | Placebo | ARRY-438162: 10 mg Bid | ARRY-438162: 40 mg qd | ARRY-438162: 20 mg Bid | Total |
|---|---|---|---|---|---|
| Current Smoker | 6 | 10 | 9 | 12 | 37 |
| Never Smoked | 38 | 39 | 36 | 36 | 149 |
| Past Smoker | 7 | 1 | 5 | 2 | 15 |
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