RecruitingPhase 4NCT06906549

Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis

Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis: a Non-inferiority Prospective Randomised Controlled Trial


Sponsor

University Hospital, Strasbourg, France

Enrollment

260 participants

Start Date

Jul 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting joints and causing progressive disability. Current treatment strategies involve conventional disease-modifying anti-rheumatic drugs (csDMARDs) and, in more resistant cases, biologic DMARDs (bDMARDs) such as Rituximab. Rituximab, a monoclonal antibody targeting CD20-positive B cells, is administered as an induction dose followed by maintenance therapy every six months. Standard maintenance dosing consists of 1g infusions, but lower doses may provide equivalent efficacy with fewer side effects. The RADAR trial is a multicenter, prospective, randomized, double-blinded, non-inferiority controlled trial designed to evaluate whether a 200 mg maintenance dose of Rituximab every six months is non-inferior to the standard 1g dose in patients with RA who are in low disease activity. The study will assess disease activity using the DAS28-CRP score over 12 months, alongside various secondary endpoints, including treatment failure rates, immune responses, and adverse events. By determining the minimum effective Rituximab dose, the study aims to optimize patient safety, reduce the risk of infections, and lower healthcare costs. This trial is particularly relevant as Rituximab has lost patent protection, making cost-effective treatment crucial, especially in low-resource settings. Findings from this study could lead to updated treatment guidelines, benefiting RA patients worldwide.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a lower maintenance dose of rituximab (200 mg every 6 months) is as effective as standard dosing for keeping rheumatoid arthritis (RA) under control in patients who are already responding well to rituximab — aiming to reduce drug exposure and potential side effects. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of rheumatoid arthritis - Your disease is reasonably well controlled (DAS28 ≤ 5.1) - You are currently on rituximab maintenance therapy and have completed at least your first treatment cycle - Your last rituximab infusion was between 6 and 18 months ago - You are on a low dose of steroids (10 mg/day or less) if applicable **You may NOT be eligible if...** - You have another autoimmune rheumatic disease (other than Sjögren's syndrome) - You are currently taking other biologics or receiving treatment for another active cancer - You are pregnant or planning to become pregnant during the study 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 200mg/6months

perfusion of Rituximab 200mg

DRUGRituximab 1g/6months

perfusion of Rituximab 1g


Locations(1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT06906549


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