An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
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;
- •rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
- •active disease;
- •DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
排除标准
- •autoimmune disease other than rheumatoid arthritis;
- •bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
- •concurrent treatment with any DMARD or antiTNF-alfa;
- •intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
研究组 & 干预措施
MabThera/Rituxan
干预措施: rituximab [MabThera/Rituxan] (Drug)
MabThera/Rituxan
干预措施: methotrexate (Drug)
MabThera/Rituxan
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
时间窗: Baseline, Week 24
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) 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
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 24)