An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •rheumatoid arthritis for >=6 months;
- •previous inadequate response to a single anti-TNF alpha inhibitor;
- •methotrexate at a stable dose range 7.5-25 mg/week.
排除标准
- •other chronic inflammatory articular disease or systemic autoimmune disease;
- •previous treatment with MabThera or intolerance to MabThera;
- •corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;
研究组 & 干预措施
MabThera (Rituximab)
干预措施: rituximab [MabThera] (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
时间窗: Week 24
The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis \[RA\] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
次要结局
- DAS28 Score(Screening and Weeks 8, 16, and 24)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate(Weeks 8, 16, and 24)
- Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24(Week 24)
- Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24(Week 24)
- Percentage of Participants Achieving a Response By EULAR Category(Weeks 8, 16, and 24)
- Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(Screening and Weeks 8, 16, and 24)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score(Screening and Weeks 8, 16, and 24)
- Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)(Screening and Weeks 8, 16, and 24)
- SF-36 Domain Scores(Screening and Weeks 8, 16, and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)(Weeks 8, 16, and 24)
- Swollen Joint Count (SJC)(Screening and Weeks 8, 16, and 24)
- Tender Joint Count (TJC)(Screening and Weeks 8, 16, and 24)
- Physician's Global Assessment of Disease Activity(Screening and Weeks 8, 16, and 24)
- Patient's Assessment of Disease Activity(Screening and Weeks 8, 16, and 24)
- Patient's Assessment of Pain(Screening and Weeks 8, 16, and 24)
- C-Reactive Protein (CRP)(Screening, Days 1 and 15, and Weeks 8, 16, and 24)
- Erythrocyte Sedimentation Rate (ESR)(Screening, Days 1 and 15, and Weeks 8, 16, and 24)
- Rheumatoid Factor (RF)(Screening and Weeks 8, 16, and 24)