Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

Recruiting now · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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)

Key facts

Study ID

NCT06003283

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

134

Starts

2024-01-09

Expected to finish

2027-12-01

Last updated by the study team

2025-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ReumaClinic Genk — Genk, Limburg, Belgium (enrolling)
• RZ Heilig Hart — Leuven, Vlaams-Brabant, Belgium (enrolling)
• University Hospitals Leuven (UZ Leuven) — Leuven, Vlaams-Brabant, Belgium (enrolling)
• Reumacentrum Genk — Genk, Limburg, Belgium (enrolling)
• OLV Aalst — Aalst, Oost-Vlaanderen, Belgium (enrolling)
• Cliniques Universitaires Saint-Luc Bruxelles — Brussels, Brussels Capital, Belgium
• ZNA Jan Palfijn — Merksem, Antwerpen, Belgium

Full record on ClinicalTrials.gov

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