EUCTR2022-003127-18-NL招募中1 期
REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica - REDUCE_PMR1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Newly diagnosed PMR (<12 weeks) according to the 2012 EULAR/ACR classification criteria.
- •Glucocorticoid treatment = 8 weeks
- •Glucocorticoid dose equivalent of prednisolone =30 mg/day.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
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 disease
- •Concomitant conditions that might significantly interfere with evaluation of PMR pain or movement as judged by the investigator
- •Previous hypersensitivity for RTX of contra-indications to RTX
- •Not being able to speak, read or write Dutch
研究者
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