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

Sint Maartenskliniek0 sites140 target enrollmentAugust 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 23, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- 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

•\- Patients with known (non\-)response to ultra\-low dose RTX (below 1 × 1000 mg)
•\- Current corticosteroid dosing above 10 mg per day prednisolone equivalent