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Business decision due to slow enrollment
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To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Biological | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tuscaloosa | Alabama | 35406 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28900875 | Background | Bessette L, Khraishi M, Kivitz AJ, Kaliyaperumal A, Grantab R, Poulin-Costello M, Isaila M, Collier D. Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment. Rheumatol Ther. 2017 Dec;4(2):391-404. doi: 10.1007/s40744-017-0079-x. Epub 2017 Sep 12. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
A total of 90 participants were enrolled in the study, however, 4 participants from 1 site were excluded from all efficacy analyses due to good clinical practice (GCP) violations. Three of these participants who received etanercept are included in safety results.
This study was conducted at 30 centers in the United States and Canada. Participants were enrolled from 06 May 2013 to 02 December 2014.
Patients with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost satisfactory response to adalimumab when used as the first biologic agent in combination with methotrexate were eligible.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Methotrexate | Drug | Background methotrexate at least 15 mg weekly |
|
| Baseline and Week 12 |
| Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Baseline and Week 12 |
| Percentage of Participants With an ACR 20 Response at Week 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Baseline and Week 24 |
| Percentage of Participants With an ACR 50 Response at Weeks 12 and 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Baseline and Weeks 12 and 24 |
| Percentage of Participants With an ACR 70 Response at Weeks 12 and 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Baseline and Weeks 12 and 24 |
| Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) | The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement. | Baseline and weeks 12 and 24 |
| Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline | The DAS28-CRP 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; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. | Baseline and weeks 12 and 24 |
| Percentage of Participants With DAS 28-CRP < 3.2 | The DAS28-CRP 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; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity. | Weeks 12 and 24 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability). | Baseline and weeks 12 and 24 |
| Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. | Baseline and Week 12 |
| Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. | Baseline and Week 24 |
| 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. | Baseline, week 12 and week 24 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Research Site | Covina | California | 91723 | United States |
| Research Site | Hemet | California | 92543 | United States |
| Research Site | Murrieta | California | 92563 | United States |
| Research Site | San Diego | California | 92108 | United States |
| Research Site | Victorville | California | 92395 | United States |
| Research Site | Denver | Colorado | 80230 | United States |
| Research Site | Brandon | Florida | 33511 | United States |
| Research Site | Dunedin | Florida | 34698 | United States |
| Research Site | Largo | Florida | 33774 | United States |
| Research Site | Palm Harbor | Florida | 34684 | United States |
| Research Site | Tampa | Florida | 33609 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Bowling Green | Kentucky | 42101 | United States |
| Research Site | Paducah | Kentucky | 42003 | United States |
| Research Site | Fall River | Massachusetts | 02720 | United States |
| Research Site | Battle Creek | Michigan | 49017 | United States |
| Research Site | Lincoln | Nebraska | 68516 | United States |
| Research Site | Smithtown | New York | 11787 | United States |
| Research Site | Charlotte | North Carolina | 28210 | United States |
| Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Hixson | Tennessee | 37343 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Corpus Christi | Texas | 78404 | United States |
| Research Site | Houston | Texas | 77034 | United States |
| Research Site | Victoria | Texas | 77901 | United States |
| Research Site | Chesapeake | Virginia | 23320 | United States |
| Research Site | Roanoke | Virginia | 24016 | United States |
| Research Site | Seattle | Washington | 98133 | United States |
| Research Site | Clarksburg | West Virginia | 26301 | United States |
| Research Site | Victoria | British Columbia | V8V 3P9 | Canada |
| Research Site | Quispamsis | New Brunswick | E2E 4J8 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Research Site | Burlington | Ontario | L7R 1E2 | Canada |
| Research Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Research Site | Mississauga | Ontario | L5M 2V8 | Canada |
| Research Site | Toronto | Ontario | M5G 1X5 | Canada |
| Research Site | Montreal | Quebec | H2L 1S6 | Canada |
| Research Site | Montreal | Quebec | H3T 1Y3 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Québec | Quebec | G1W 4R4 | Canada |
| Research Site | Caguas | 00725 | Puerto Rico |
| Received Etanercept |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set, which included all participants enrolled who received at least 1 dose of etanercept. Three additional participants were excluded from the FAS due to GCP violations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Anti-adalimumab Antibody Status | Number | participants |
| |||||||||||||||||||||||
| Adalimumab Response Failure Type | Primary failure: Failure to achieve an American College of Rheumatology 20% improvement (ACR20) or equivalent as judged by the investigator; Secondary failure: Loss of an ACR20 response or equivalent as judged by the investigator. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR 20 Response at Week 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR 50 Response at Weeks 12 and 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR 70 Response at Weeks 12 and 24 | A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level. | Full analysis set with non-missing data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) | The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement. | Full analysis set, last observation carried forward imputation (LOCF) was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline | The DAS28-CRP 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; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. | Full analysis set, last observation carried forward imputation (LOCF) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With DAS 28-CRP < 3.2 | The DAS28-CRP 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; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity. | Full analysis set, last observation carried forward imputation (LOCF) was used. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) | The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability). | Full analysis set, last observation carried forward imputation (LOCF) was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and weeks 12 and 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. | Full analysis set; LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. | Full analysis set; LOCF imputation was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. "n" indicates the number of participants included in each analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 12 and week 24 |
|
|
34 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks. | 4 | 88 | 38 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Black (or African American) |
|
| Multiple |
|
| White |
|
| Other |
|
| Unknown |
|
| Participants |
|
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