A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mabion SA
- 入组人数
- 709
- 试验地点
- 51
- 主要终点
- Percentage of patients in each treatment group achieving the primary efficacy endpoint of a ≥ 20% improvement on the American College of Rheumatology score (ACR20) at Week 24.
研究概览
简要总结
The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and the reference product - MabThera® (rituximab) and to demonstrate comparative safety and tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with moderate to severe active rheumatoid arthritis.
详细描述
Subjects who meet the criteria for participation in this study receive 2 intravenous infusions of MabionCD20® or MabThera® with two weeks interval in combination with methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks, in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a possibility to repeat treatment after 6 months of the first infusions if subject meets the retreatment criteria.
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
- Double (Participant, Investigator)
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
- •Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit
- •Patients who are naive to tumor necrosis factor (TNF) antagonists or any other monoclonal antibody therapies
- •Patients who have had an inadequate response to an adequate regimen of methotrexate
排除标准
- •History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA
- •Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation
- •Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
- •Prior treatment with rituximab, other anti-CD20 mAb, anti-TNF-alpha drug or any other monoclonal antibodies
- •Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion
- •Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components
- •Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies
研究组 & 干预措施
MabionCD20®
A course of MabionCD20® in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
干预措施: Rituximab (Drug)
MabThera®
A course of MabThera® (Rituximab, Roche) in rheumatoid arthritis patients consists of two 1000 mg intravenous infusions with two weeks interval.
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of patients in each treatment group achieving the primary efficacy endpoint of a ≥ 20% improvement on the American College of Rheumatology score (ACR20) at Week 24.
时间窗: 24 weeks
次要结局
未报告次要终点