Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Between group difference in percentage of patients in glucocorticoid-free remission
研究概览
简要总结
Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
- •Experiencing a PMR relapse, defined as recurring of symptoms and increase in erythrocyte sedimentation rate (ESR)/ C reactive protein (CRP)
- •Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent
- •Informed consent
排除标准
- •Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 3 months prior to inclusion;
- •(clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases;
- •concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator;
- •previous hypersensitivity for RTX or contra-indications to RTX.
研究组 & 干预措施
Rituximab
1000mg rituximab intravenously once
干预措施: Rituximab (Drug)
Placebo
0mg rituximab (placebo) intravenously once
干预措施: Placebo (Drug)
结局指标
主要结局
Between group difference in percentage of patients in glucocorticoid-free remission
时间窗: At week 52
Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score \< 10) at week 52
次要结局
- Time to glucocorticoid-free remission(52 weeks)
- Percentage of patients in glucocorticoid-free remission(21 weeks)
- Time to relapse(52 weeks)
- Adverse events(52 weeks)
- Percentage of patients needing RTX/Placebo retreatment(52 weeks)
- Percentage of patients with glucocorticoid dose of ≤5mg/day(52 weeks)
- Number of relapses(52 weeks)
- Cumulative glucocorticoid dose(52 weeks)