NL-OMON47117
Completed
Phase 4
RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- chronic inflammation of the joints
- Sponsor
- Sint Maartenskliniek
- Enrollment
- 140
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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 (DAS28\-BSE\*3\.8\).
- •\- 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
Exclusion Criteria
- •\- Patients with known (non\-)response to ultra\-low dose RTX (below 1 × 1000 mg)
- •\- Current corticosteroid dosing above 10 mg per day prednisolone equivalent
Outcomes
Primary Outcomes
Not specified
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