The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis.
The main questions it aims to answer are:
* What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact?
* What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy?
Participants will be randomized to one of two study arms:
* Tapering based on disease-activity guided dose reduction (experimental arm)
* Tapering based on interval prolongation (active comparator arm)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Able and willing to give written informed consent and participate in the study before any study procedure.
* Age ≥ 18 years.
* Understanding and able to write in Dutch or French.
* Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for rheumatoid arthritis.
* Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab).
* Current treatment with rituximab.
* Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score ≥3.2).
* Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.
Exclusion Criteria:
* Current treatment with another biological DMARD than rituximab.
* Current treatment with a targeted synthetic DMARD.
* Pregnancy or pregnancy wish.
* Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.
Primary outcome measure(s)
Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire — Over 2 years (104 weeks) RAID questionnaire score range: 0 - 10, with higher scores indicating worse status.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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