A Phase 4 interventional study of Etanercept and Methotrexate in Rheumatoid Arthritis, sponsored by Amgen. Completed at 28 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-23.
Sponsored by Amgen · Phase 4, Interventional, and Treatment
The purpose of the study is to evaluate the use of etanercept in the treatment of rheumatoid arthritis with or without methotrexate treatment over a 24 month period
This noninferiority study was a multicenter, open-label, randomized trial of patients with rheumatoid arthritis (RA). Patients who did not have an adequate response to methotrexate (MTX) had etanercept (50 mg/week subcutaneously [SC]) added to existing MTX therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses of MTX) at baseline and were followed for 6 months. After 6 months of therapy, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: either discontinue MTX (tapered over 6 weeks) and continue etanercept alone or continue both etanercept plus MTX for an additional 18 months.
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Exclusion Criteria:
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
Biological: Etanercept · Drug: Methotrexate
After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
Biological: Etanercept · Drug: Methotrexate
Commercially available etanercept administered subcutaneously at 50 mg/week.
Also known as: Enbrel®
Commercially available methotrexate administed orally, subcutaneously or intramuscularly 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses)
Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.
Time frame: Month 6 (randomization) and Month 12
Disease Activity Score (DAS) 28 Response
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Change From Baseline in Disease Activity Score 28 (DAS28)
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.
Time frame: Baseline and Month 6, 12, 18 and 24
Drug Persistence
Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.
Time frame: Month 6, 12, 18 and 24
Change From Baseline in Modified Total Sharp Score (mTSS)
The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.
Time frame: Baseline, Month 12 and Month 24
Change From Baseline in Joint Erosion Score
X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.
Time frame: Baseline, Month 12 and Month 24
Change From Baseline in Joint Space Narrowing
X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows: 0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN. End of study is Month 24 or early termination.
Time frame: Baseline, Month 12 and Month 24
Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)
The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)
The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Change From Month 6 in Short Form 36 Health Survey (SF-36)
The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant. The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. End of study is month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Change From Month 6 in Work Productivity and Activity Impairment (WPAI)
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)
The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 - 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.
Time frame: Month 6, 12, 18 and 24
Number of Participants With Adverse Events (AEs)
A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
Time frame: 25 months
First patient was enrolled 28 June 2008 and last patient was enrolled 07 November 2010.
| Milestone | Non-randomized | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|---|
| Started | 53 | 98 | 107 |
| Completed | 0 | 50 | 75 |
| Not completed | 53 | 48 | 32 |
| Withdrew: Ineligibility determined | 6 | 0 | 0 |
| Withdrew: Protocol deviation | 3 | 2 | 1 |
| Withdrew: Non-compliance | 2 | 1 | 2 |
| Withdrew: Withdrawal by subject | 5 | 2 | 2 |
| Withdrew: Disease progression | 21 | 31 | 13 |
| Withdrew: Requirement for alternative therapy | 1 | 1 | 1 |
| Withdrew: Physician decision | 0 | 0 | 2 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 2 |
| Withdrew: Other | 0 | 2 | 3 |
| Withdrew: Adverse event | 14 | 9 | 6 |
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28) | -0.39 ± 0.11 | 0.02 ± 1.26 |
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.
| Percentage of participants | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Month 6: Remission | 30.5 (21.3 to 39.8) | 25.7 (17.4 to 34.1) |
| Month 6: Low | 16.8 (9.3 to 24.4) | 19.0 (11.5 to 26.6) |
| Month 6: Moderate | 41.1 (31.2 to 50.9) | 41.9 (32.5 to 51.3) |
| Month 6: High | 11.6 (5.1 to 18.0) | 13.3 (6.8 to 19.8) |
| Month 12: Remission | 19.4 (11.6 to 27.2) | 23.4 (15.3 to 31.4) |
| Month 12: Low | 10.2 (4.2 to 16.2) | 19.6 (12.1 to 27.2) |
| Month 12: Moderate | 49.0 (39.1 to 58.9) | 44.9 (35.4 to 54.3) |
| Month 12: High | 21.4 (13.3 to 29.6) | 12.1 (6.0 to 18.3) |
| Month 18: Remission | 21.4 (13.3 to 29.6) | 32.7 (23.8 to 41.6) |
| Month 18: Low | 12.2 (5.8 to 18.7) | 19.6 (12.1 to 27.2) |
| Month 18: Moderate | 41.8 (32.1 to 51.6) | 34.6 (25.6 to 43.6) |
| Month 18: High | 24.5 (16.0 to 33.0) | 13.1 (6.7 to 19.5) |
| End of Study: Remission | 21.4 (13.3 to 29.6) | 29.9 (21.2 to 38.6) |
| End of Study: Low | 8.2 (2.7 to 13.6) | 14.0 (7.4 to 20.6) |
| End of Study: Moderate | 45.9 (36.1 to 55.8) | 39.3 (30.0 to 48.5) |
| End of Study: High | 24.5 (16.0 to 33.0) | 16.8 (9.7 to 23.9) |
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from Baseline to Month 6 | 1.97 ± 1.23 | 1.97 ± 1.51 |
| Change from Baseline to Month 12 | 1.43 ± 1.27 | 1.91 ± 1.61 |
| Change from Baseline to Month 18 | 1.35 ± 1.30 | 2.01 ± 1.59 |
| Change from Baseline to End of Study | 1.37 ± 1.32 | 1.86 ± 1.71 |
Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.
| percentage of participants | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Month 6 | 100 | 100 |
| Month 12 | 93.2 | 87.6 |
| Month 18 | 81.9 | 78.8 |
| Month 24 | 51.4 | 69.5 |
The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from Baseline to Month 12 (n=89, 102) | 0.3 ± 1.9 | 0.1 ± 1.2 |
| Change from Baseline to End of Study (n=94, 104) | 0.4 ± 1.9 | 0.0 ± 1.4 |
X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from Baseline to Month 12 (n=89, 102) | 0.0 ± 0.6 | 0.0 ± 0.6 |
| Change from Baseline to End of Study (n=94, 104) | 0.1 ± 0.6 | 0.0 ± 0.7 |
X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows: 0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from Baseline to Month 12 (n=89, 102) | 0.2 ± 1.5 | 0.1 ± 0.9 |
| Change from Baseline to End of Study (n=94, 104) | 0.3 ± 1.5 | -0.0 ± 1.0 |
The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from Month 6 to Month 12 | 0.148 ± 0.354 | 0.026 ± 0.430 |
| Change from Month 6 to Month 18 | 0.179 ± 0.452 | -0.004 ± 0.485 |
| Change from Month 6 to End of Study | 0.198 ± 0.448 | 0.016 ± 0.539 |
The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Change from month 6 to month 12 | 7.3 ± 21.3 | 2.4 ± 23.8 |
| Change from month 6 to month 18 | 8.0 ± 25.6 | 1.8 ± 24.4 |
| Change from month 6 to end of study | 8.7 ± 26.1 | 5.1 ± 27.3 |
The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant. The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. End of study is month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Physical Component: Change at Month 12 | -1.74 ± 8.87 | -0.30 ± 7.40 |
| Physical Component: Change at Month 18 | -3.28 ± 9.40 | -0.10 ± 8.61 |
| Physical Component: Change at End of Study | -3.08 ± 8.95 | -0.75 ± 9.42 |
| Mental Health Component: Change at 12 Months | -1.16 ± 10.29 | -1.27 ± 9.40 |
| Mental Health Component: Change at 18 Months | -0.30 ± 9.40 | -0.92 ± 10.34 |
| Mental Health Component: Change at End of Study | -1.30 ± 10.47 | 0.08 ± 10.70 |
This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Work Time Missed: Month 12 (n=45, 44) | -4.2 ± 19.3 | -0.3 ± 15.0 |
| Work Time Missed: Month 18 (n=42, 43) | -5.5 ± 20.2 | 0.9 ± 17.5 |
| Work Time Missed: End of Study (n=42, 44) | -3.8 ± 23.3 | -0.1 ± 15.6 |
| Work Impairment: Month 12 (n=43, 46) | 5.8 ± 15.0 | -1.3 ± 19.6 |
| Work Impairment: Month 18 (n=40, 45) | 7.3 ± 24.2 | -1.3 ± 21.8 |
| Work Impairment: End of Study (n=40, 46) | 10.5 ± 22.2 | -1.7 ± 24.1 |
| Overall Work Impairment: Month 12 (n=43, 44) | 3.4 ± 16.8 | -0.7 ± 20.1 |
| Overall Work Impairment: Month 18 (n=40, 43) | 4.3 ± 26.0 | -2.7 ± 24.2 |
| Overall Work Impairment: End of Study (n=40, 44) | 8.2 ± 26.4 | -1.7 ± 25.0 |
| Activity Impairment: Month 12 (n=98, 107) | 6.7 ± 21.2 | 4.3 ± 22.7 |
| Activity Impairment: Month 18 (n=98, 107) | 7.4 ± 25.8 | 0.7 ± 25.3 |
| Activity Impairment: End of Study (n=98, 107) | 9.1 ± 27.0 | 1.8 ± 27.4 |
The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 - 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.
| scores on a scale | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Effectiveness: Month 12 (n=98, 107) | -5.0 ± 27.3 | -1.2 ± 30.0 |
| Effectiveness: Month 18 (n=98, 107) | -7.4 ± 25.2 | -1.1 ± 29.4 |
| Effectiveness: End of Study (n=98, 107) | -5.0 ± 25.6 | -1.5 ± 29.7 |
| Side Effects: Month 12 (n= 97, 106) | 2.5 ± 21.4 | 0.6 ± 19.0 |
| Side Effects: Month 18 (n=97, 106) | -0.5 ± 24.8 | 0.9 ± 17.9 |
| Side Effects: End of Study (n=97, 106) | 0.6 ± 24.7 | 1.2 ± 19.4 |
| Convenience: Month 12 (n=97, 107) | 0.6 ± 16.5 | 0.9 ± 14.3 |
| Convenience: Month 18 (n=97, 107) | 0.9 ± 15.6 | -0.8 ± 15.1 |
| Convenience: End of Study (n=97, 107) | 2.0 ± 15.0 | -0.6 ± 15.3 |
| Global Satisfaction: Month 12 (n=97, 107) | -1.3 ± 19.4 | 1.2 ± 17.3 |
| Global Satisfaction: Month 18 (n=97, 107) | -6.3 ± 24.0 | -1.5 ± 20.0 |
| Global Satisfaction: End of Study (n=97, 107) | -5.4 ± 23.7 | -1.3 ± 20.9 |
A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
| participants | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|
| Any adverse event | 86 | 92 |
| Serious adverse event | 11 | 17 |
| AEs leading to withdrawal from study drug | 9 | 6 |
Collected over 25 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-randomized | — | 7/53 (13.2%) | 18/53 (34%) |
| Etanercept Alone | — | 11/98 (11.2%) | 56/98 (57.1%) |
| Etanercept + Methotrexate | — | 17/107 (15.9%) | 73/107 (68.2%) |
| Event | Non-randomized | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|---|
| PneumoniaInfections and infestations | 2/53 | 3/98 | 2/107 |
| Atrial fibrillationCardiac disorders | 1/53 | 1/98 | 0/107 |
| Cardiac failure chronicCardiac disorders | 1/53 | 0/98 | 0/107 |
| Prinzmetal anginaCardiac disorders | 1/53 | 0/98 | 0/107 |
| SepsisInfections and infestations | 1/53 | 0/98 | 0/107 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/53 | 0/98 | 0/107 |
| Lung squamous cell carcinoma stage unspecifiedNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/53 | 0/98 | 0/107 |
| Cerebrovascular accidentNervous system disorders | 1/53 | 1/98 | 0/107 |
| Demyelinating polyneuropathyNervous system disorders | 1/53 | 0/98 | 0/107 |
| AlveolitisRespiratory, thoracic and mediastinal disorders | 1/53 | 0/98 | 0/107 |
| Event | Non-randomized | Etanercept Alone | Etanercept + Methotrexate |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/53 | 13/98 | 19/107 |
| NasopharyngitisInfections and infestations | 1/53 | 10/98 | 12/107 |
| SinusitisInfections and infestations | 1/53 | 8/98 | 11/107 |
| HeadacheNervous system disorders | 5/53 | 9/98 | 9/107 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/53 | 5/98 | 10/107 |
| PneumoniaInfections and infestations | 1/53 | 1/98 | 9/107 |
| RashSkin and subcutaneous tissue disorders | 1/53 | 4/98 | 9/107 |
| Urinary tract infectionInfections and infestations | 4/53 | 3/98 | 8/107 |
| InfluenzaInfections and infestations | 0/53 | 7/98 | 5/107 |
| Injection site reactionGeneral disorders | 2/53 | 6/98 | 7/107 |
| Age, Continuous(years) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| Mean | 56.2 ± 13.4 | 54.3 ± 11.9 | 54.4 ± 12.7 | 54.7 ± 12.5 |
| Sex: Female, Male(Participants) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| Female | 41 | 72 | 84 | 197 |
| Male | 12 | 26 | 23 | 61 |
| Race/Ethnicity, Customized(participants) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| White or Caucasian | 47 | 96 | 103 | 246 |
| Black or African American | 2 | 1 | 0 | 3 |
| Hispanic or Latino | 0 | 0 | 1 | 1 |
| Asian | 2 | 0 | 0 | 2 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 3 | 3 |
| Aborigine | 1 | 0 | 0 | 1 |
| Other | 1 | 1 | 0 | 2 |
| Duration of rheumatoid arthritis(participants) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| < 2 years | 11 | 23 | 23 | 57 |
| >= 2 years | 42 | 75 | 84 | 201 |
| Reimbursement type(participants) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| Private | 23 | 48 | 55 | 126 |
| Public | 16 | 33 | 37 | 86 |
| Combination/Other | 14 | 17 | 15 | 46 |
| Disease Activity Score (DAS28-ESR)(participants) | Non-randomized | Etanercept Alone | Etanercept + Methotrexate | Total |
|---|---|---|---|---|
| <= 5.1 | 20 | 43 | 41 | 104 |
| > 5.1 | 33 | 55 | 66 | 154 |
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