NCT00502840已完成3 期
An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 51
- 主要终点
- Change From Baseline in DAS28 Score at Week 24
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 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 with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
- •eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
排除标准
- •patients who have withdrawn from treatment in ML19070 pre-week 16;
- •patients with a previous response in DAS28 <0.6 to MabThera after week 16;
- •concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
研究组 & 干预措施
1
Experimental
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Change From Baseline in DAS28 Score at Week 24
时间窗: Week 24
DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.
次要结局
- DAS28 Score by Treatment Course and Follow-up (FU) Visit(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course(Week 24)
- Patient's Global Assessment of Disease Activity(Baseline and Week 24)
- Patient's Assessment of Pain(Baseline and Week 24)
- C-Reactive Protein(Baseline and Week 24)
- Erythrocyte Sedimentation Rate(Baseline and Week 24)
- Percentage of Participants Achieving a Response By EULAR Category and Treatment Course(Week 24)
- Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 MCS by Treatment Course(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Physical Functioning(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Bodily Pain(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Physical Role Functioning(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Emotional Role Functioning(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Emotional Well-Being(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Social Functioning(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - Vitality(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- SF-36 Domain Scores by Treatment Course - General Heath Perceptions(Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course(24 weeks after each course)
- Swollen Joint Count(Screening and Week 24)
- Tender Joint Count(Screening and Week 24)
- Physician's Global Assessment of Disease Activity(Baseline and Week 24)
- Rheumatoid Factor (RF)(Baseline and Week 24)
研究者
研究点 (51)
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