An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 341
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
研究概览
简要总结
This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18-80 years of age with active RA;
- •patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
- •eligible for re-treatment, based on clinical symptoms;
- •patients of reproductive potential must be using reliable contraceptive methods.
排除标准
- •patients who participated in MabThera study WA17042 but withdrew into the safety follow-up;
- •current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;
- •development of any new contraindications to receiving MabThera;
- •women who are pregnant or breast-feeding.
研究组 & 干预措施
MabThera/Rituxan
干预措施: methotrexate (Drug)
MabThera/Rituxan
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response
时间窗: Baseline to the end of the retreatment period (up to 7 years, 6 months)
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.
次要结局
- Change From Baseline in the Disease Activity Score 28 (DAS28)(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Change From Baseline in the American College of Rheumatology n (ACRn) Response(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score(Baseline to the end of the retreatment period (up to 7 years, 6 months))
- Percentage of Participants With no Radiographic Progression From Baseline to Year 5(Baseline to Year 5)
- Change From Baseline in the Total Genant-modified Sharp Score at Year 5(Baseline to Year 5)
- Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5(Baseline to Year 5)
- Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5(Baseline to Year 5)
- Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5(Baseline to Year 5)