Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
研究概览
简要总结
This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.
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 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
- •active rheumatoid arthritis (DAS28-CRP>3.2)
- •refractory to one or more anti-TNF
- •on stable treatment for RA for >/=4 weeks
- •evidence of erosive disease and/or synovitis in wrist and/or knuckles
排除标准
- •active systemic or local infection
- •previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
- •signs of immunodeficiency, HIV infection or tuberculosis
- •contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
研究组 & 干预措施
A
干预措施: rituximab [Mabthera/Rituxan] (Drug)
A
干预措施: methotrexate (Drug)
B
干预措施: placebo (Drug)
B
干预措施: methotrexate (Drug)
B
干预措施: rituximab [Mabthera/Rituxan] (Drug)
结局指标
主要结局
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
时间窗: 6 months
次要结局
- Synovitis score on MRI using RAMRIS(months 6, 12 and 24)
- Tender or swollen joint count (ACR criteria)(months 12 and 24)
- Bone edema score on MRI using RAMRIS(months 6, 12 and 24)
- Bone erosion score on MRI using RAMRIS(months 12 and 24)
- Disease activity according to DAS28-CRP(months 12 and 24)
- Health assessment questionnaire (HAQ)(months 12 and 24)