A Phase 4 interventional study of Etanercept and Etanercept in Rheumatoid Arthritis, sponsored by Pfizer. Terminated at 15 sites in 7 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-01-06.
Sponsored by Pfizer · Phase 4, Interventional, and Treatment
The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.
This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 16 is below the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Subjects who are mAb ADA positive
Drug: Etanercept
Subjects who are mAb ADA negative
Drug: Etanercept
Subjects who are mAb ADA positive
Drug: Placebo
Subjects who are mAb ADA negative
Drug: Placebo
Etanercept 50 mg once-weekly
Etanercept 50 mg once-weekly
Etanercept placebo once-weekly
Etanercept placebo once-weekly
Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
Time frame: Baseline, 12 weeks
Change From Baseline in the DAS28 at Week 24
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
Time frame: Baseline, 24 weeks
Number of Participants With DAS28 <3.2
Number of participants with DAS28 \<3.2. A score of \< 3.2 implied low disease activity.
Time frame: 12 weeks, 24 weeks
Number of Participants With DAS28 <2.6
Number of Participants with DAS28 \<2.6. A DAS28 \< 2.6 implies remission.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.
The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)
The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: 12 weeks, 24 weeks
Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).
The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: 12 weeks, 24 weeks
Change From Baseline in CDAI
Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in SDAI.
Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Number of Tender/Painful Joints
Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Number of Swollen Joints
Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Physician Global Assessment of Disease Activity
Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Subject Global Assessment of Disease Activity
Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Subject General Health VAS.
Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Subject Pain
Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in CRP
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)
The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the "worst imaginable health state" and 100 represented the "best imaginable health state." In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score \>82.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Short Form-36 Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to "Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?" The participant indicated a response of either "acceptable" or "unacceptable".
Time frame: Baseline, 12 weeks, 24 weeks
Change From Baseline in Vectra Disease Activity Levels
The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.
Time frame: Baseline, 12 weeks, 24 weeks
Number of Participants With Positive Etanercept Anti-drug Antibody Status
Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
Time frame: Baseline, 12 weeks, 24 weeks
Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status
Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
Time frame: Baseline, 12 weeks, 24 weeks
In this 24 week, multicenter, randomized, double-blind, placebo-controlled (Period 1), 2 period study, a total of 20 participants were screened, out of which 16 participants were randomized. Due to delayed enrollment and an insufficient number of participants, recruitment was terminated.
| Milestone | Period I - Blinded Treatment - Etanercept | Period I - Blinded Treatment - Placebo | Period 2 - Open Label Treatment |
|---|---|---|---|
| Started | 11 | 5 | 0 |
| Treated | 11 | 5 | 0 |
| Completed | 9 | 2 | 0 |
| Not completed | 2 | 3 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Study terminated by sponsor | 2 | 0 | 0 |
| Milestone | Period I - Blinded Treatment - Etanercept | Period I - Blinded Treatment - Placebo | Period 2 - Open Label Treatment |
|---|---|---|---|
| Started | 0 | 0 | 11 |
| Completed | 0 | 0 | 5 |
| Not completed | 0 | 0 | 6 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 6 |
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
No measurements were reported for this outcome.
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
No measurements were reported for this outcome.
Number of participants with DAS28 \<3.2. A score of \< 3.2 implied low disease activity.
No measurements were reported for this outcome.
Number of Participants with DAS28 \<2.6. A DAS28 \< 2.6 implies remission.
No measurements were reported for this outcome.
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
No measurements were reported for this outcome.
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
No measurements were reported for this outcome.
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
No measurements were reported for this outcome.
ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
No measurements were reported for this outcome.
The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
No measurements were reported for this outcome.
The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
No measurements were reported for this outcome.
The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
No measurements were reported for this outcome.
Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
No measurements were reported for this outcome.
Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
No measurements were reported for this outcome.
Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
No measurements were reported for this outcome.
Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
No measurements were reported for this outcome.
Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
No measurements were reported for this outcome.
Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
No measurements were reported for this outcome.
Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
No measurements were reported for this outcome.
Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.
No measurements were reported for this outcome.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
No measurements were reported for this outcome.
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
No measurements were reported for this outcome.
The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the "worst imaginable health state" and 100 represented the "best imaginable health state." In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score \>82.
No measurements were reported for this outcome.
The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.
No measurements were reported for this outcome.
The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to "Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?" The participant indicated a response of either "acceptable" or "unacceptable".
No measurements were reported for this outcome.
The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.
No measurements were reported for this outcome.
Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
No measurements were reported for this outcome.
Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
No measurements were reported for this outcome.
Collected over From the day the first dose of the investigational product was administered up to 28 days after last dose was administered.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period I - Blinded Treatment - Etanercept | — | 0/11 (0%) | 5/11 (45.5%) |
| Period I - Blinded Treatment - Placebo | — | 0/5 (0%) | 3/5 (60%) |
| Period 2 - Open Label Treatment | — | 0/11 (0%) | 4/11 (36.4%) |
| Event | Period I - Blinded Treatment - Etanercept | Period I - Blinded Treatment - Placebo | Period 2 - Open Label Treatment |
|---|---|---|---|
| ANAEMIABlood and lymphatic system disorders | 0/11 | 1/5 | 0/11 |
| TINNITUSEar and labyrinth disorders | 0/11 | 1/5 | 0/11 |
| DYSPEPSIAGastrointestinal disorders | 0/11 | 1/5 | 0/11 |
| NAUSEAGastrointestinal disorders | 0/11 | 1/5 | 0/11 |
| RHINITISInfections and infestations | 0/11 | 1/5 | 1/11 |
| DERMATITISSkin and subcutaneous tissue disorders | 0/11 | 1/5 | 0/11 |
| RHINORRHOEARespiratory, thoracic and mediastinal disorders | 2/11 | 0/5 | 0/11 |
| GASTROINTESTINAL DISORDERGastrointestinal disorders | 1/11 | 0/5 | 0/11 |
| INJECTION SITE ERYTHEMAGeneral disorders | 1/11 | 0/5 | 1/11 |
| INJECTION SITE REACTIONGeneral disorders | 1/11 | 0/5 | 0/11 |
| Age, Continuous(Years) | Period I - Blinded Treatment - Etanercept | Period I - Blinded Treatment - Placebo | Total |
|---|---|---|---|
| Mean | 54.5 ± 13.43 | 54.8 ± 19.56 | 54.6 ± 14.91 |
| Sex: Female, Male(Participants) | Period I - Blinded Treatment - Etanercept | Period I - Blinded Treatment - Placebo | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 3 | 1 | 4 |
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etanercept