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

NCT ID: NCT06003283

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2027-12-31

Brief 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)

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapering of rituximab based on disease activity guided dose reduction

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.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

IV rituximab

Tapering of rituximab based on interval prolongation

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.

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

IV rituximab

Interventions

Rituximab

IV rituximab

Intervention Type: DRUG

Other Intervention Names

MabThera; Truxima; Ruxience; Rixathon

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Verschueren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Leuven/KU Leuven

Locations

ZNA Jan Palfijn

Merksem, Antwerpen, Belgium

Site Status: NOT_YET_RECRUITING

Cliniques Universitaires Saint-Luc Bruxelles

Brussels, Brussels Capital, Belgium

Site Status: NOT_YET_RECRUITING

Reumacentrum Genk

Genk, Limburg, Belgium

Site Status: RECRUITING

ReumaClinic Genk

Genk, Limburg, Belgium

Site Status: RECRUITING

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

RZ Heilig Hart

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Patrick Verschueren, MD, PhD

Role: CONTACT

patrick.verschueren@uzleuven.be

016342541 ext. +32

Johan Joly, MSc

Role: CONTACT

johan.joly@uzleuven.be

016340258 ext. +32

Facility Contacts

Alla Ishchenko, MD

Role: primary

Patrick Durez, MD, PhD

Role: primary

Philip Remans, MD, PhD

Role: primary

Johan Vanhoof, MD

Role: primary

Tom Zwaenepoel, MD

Role: primary

Veerle Taelman, MD

Role: primary

Patrick Verschueren, MD, PhD

Role: primary

Johan Joly, MSc

Role: backup

References

De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, Neerinckx B, Westhovens R, Verschueren P. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA). Trials. 2024 Oct 15;25(1):681. doi: 10.1186/s13063-024-08542-7.

Reference Type: DERIVED

PMID: 39407334 (View on PubMed)

Other Identifiers

S67309

Identifier Type: -

Identifier Source: org_study_id