A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy
概览
- 阶段
- 4 期
- 干预措施
- etanercept
- 疾病 / 适应症
- Rheumatoid Arthritis
- 发起方
- Amgen
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).
研究者
入排标准
入选标准
- •Male or female ≥18 and ≤80 years of age at time of screening
- •Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
- •Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) \> 3.2 and ≤ 5.1
- •Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
- •Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
排除标准
- •Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
- •Class IV rheumatoid arthritis according to ACR revised response criteria
- •Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
- •Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
- •Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
- •No more than 4 injections of adalimumab
- •No more than 8 (50 mg) injections of etanercept
- •No more than 2 infusions of infliximab
- •No more than 2 infusions of abatacept
- •Additional inclusion (exclusion) criteria may apply
研究组 & 干预措施
Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
干预措施: etanercept
Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
干预措施: Placebo
Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
干预措施: DMARD Therapy
Etanercept
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
干预措施: etanercept
Etanercept
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
干预措施: DMARD Therapy
结局指标
主要结局
Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
时间窗: Week 12
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. 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; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.
次要结局
- Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Tender 28-Joint Count (TJC28) at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Swollen 28-Joint Count (SJC28) at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Patient Global Assessment of Joint Pain at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point(Baseline and Weeks 4, 12, and 24)
- Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Percentage of Participants Achieving DAS28 Remission at Week 12(Week 12)
- Percentage of Participants Achieving DAS28 Remission at All Other Timepoints(Baseline and Weeks 2, 4, 8, 16, 20 and 24)
- Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving Count Remission at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints(Baseline and Weeks 2, 4, 8, 16, 20 and 24)
- Patient's Global Assessment of Disease Activity at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Percentage of Participants Achieving CDAI Remission at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Clinical Disease Activity Index (CDAI) Score at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving SDAI Remission at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Physician Global Assessment of Disease Activity at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- C-reactive Protein Levels at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Participant Assessment of Fatigue at Each Time Point(Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24)
- Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point(Baseline and Weeks 4, 12 and 24)
- Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point(Baseline and Weeks 4, 12 and 24)