NCT01162421已完成4 期
Radiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis Patients
AbbVie (prior sponsor, Abbott)0 个研究点目标入组 77 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 主要终点
- Percentage of Participants With No Radiographic Progression at Month 12
研究概览
简要总结
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised American College of Rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis.
- •Subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a Disease Activity Score DAS28 > 3.2 (at Screening visit).
- •Subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate >/= 20 mm/1h or C-reactive protein > upper limit of normal.
- •Subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on X-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.
排除标准
- •Subject has previous exposure to any biologic therapy including adalimumab.
- •Prior disease-modifying antirheumatic drugs triple therapy with methotrexate.
- •Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
- •Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of Baseline.
- •Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study.
研究组 & 干预措施
Early Adalimumab
Experimental
Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.
干预措施: adalimumab (Biological)
Early Adalimumab
Experimental
Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.
干预措施: Methotrexate (Drug)
Standard of Care
Active Comparator
Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.
干预措施: adalimumab (Biological)
Standard of Care
Active Comparator
Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With No Radiographic Progression at Month 12
时间窗: Baseline, Month 12
Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. 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 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
次要结局
- Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in mTSS at Months 6, 12 and 24(Baseline, Month 6, Month 12, Month 24)
- Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With No Radiographic Progression at Month 6 and Month 24(Baseline, Month 6, Month 24)
- Percentage of Participants With Rapid Radiographic Progression at Month 12(Month 12)
- Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With Flare-Up After Remission by Month 24(Month 24)
- Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24(Baseline, Months 3, 6, 9, 12, 18, 24)
- Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24(Months 3, 6, 9, 12, 18, 24)
- Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline(Baseline)
- HCR: Medical Insurance at Final Visit(Final Visit (up to Month 24))
- HCR: Health Care for RA in the Past 4 Weeks at Baseline(Baseline)
- HCR: Health Care for RA in the Past 4 Weeks at Final Visit(Final Visit (up to Month 24))
- HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline(Baseline)
- HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit(Final Visit (up to Month 24))
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