REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO

Sint Maartenskliniek0 个研究点目标入组 140 人开始时间: 2016年8月23日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•- Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion.
•- RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included.
•- At least 6 months of stable, low disease activity after the last RTX infusion (operationalized by either DAS28-CRP<2.9 (DAS28-BSE <3.2) or judgement of low disease activity by a rheumatologist) AND a current DAS28-CRP =3.5.
•- Patient informed consent, =18 years old and mentally competent
•- Ability to measure the outcome of the study in this patient (e.g. life expectancy > 6 months, no planned relocation out of reach of study centre)
•- Ability to read and communicate well in Dutch
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

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