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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT06003283

S67309

Details and patient eligibility

About

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)

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Tapering of rituximab based on disease activity guided dose reduction

Experimental group

Description:

Treatment with rituximab every 6 months (24 weeks) with dosing based on disease activity, measured by the DAS28-CRP. DAS28-CRP ≤ 3.2: dose reduction according to the following sequence: 1 x 1000 mg IV (maximum), 1 x 500 mg IV, 1 x 200 mg IV (minimum). DAS28-CRP \> 3.2: administration of previously effective dose.

Treatment:

Drug: Rituximab

Tapering of rituximab based on interval prolongation

Active Comparator group

Description:

Treatment with fixed dose of rituximab (1 x 1000 mg IV) if DAS28-CRP ≥ 3.2 AND interval of at least 6 months (24 weeks) since previous administration of rituximab.

Treatment:

Drug: Rituximab