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

• Status: Recruiting
• Trial end date: 2026-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborator: Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)
• Treatments: Rituximab

Criteria

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.