RecruitingPhase 4NCT06003283

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

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

134 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for managing rituximab dosing in people with rheumatoid arthritis: stretching out doses over longer intervals versus adjusting doses based on how active the disease is. **You may be eligible if:** - You are 18 or older - You have been diagnosed with rheumatoid arthritis - You are currently being treated with rituximab and have responded well to it - You read and write Dutch or French - You are on a stable dose of methotrexate or another standard arthritis drug **You may NOT be eligible if:** - You are taking another biologic medication (other than rituximab) for arthritis - You are taking a targeted synthetic disease-modifying drug - You are pregnant or wish to become pregnant - You have a reason that rituximab is medically unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

IV rituximab


Locations(7)

ZNA Jan Palfijn

Merksem, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc Bruxelles

Brussels, Brussels Capital, Belgium

Reumacentrum Genk

Genk, Limburg, Belgium

ReumaClinic Genk

Genk, Limburg, Belgium

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

RZ Heilig Hart

Leuven, Vlaams-Brabant, Belgium

University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, Belgium

View Full Details on ClinicalTrials.gov

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NCT06003283


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