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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria

• DAS28 ≤ 5.1

• Current maintenance treatment with Rituximab regardless of dose and/or duration of Rituximab treatment and with at least first cycle of Rituximab ended (2 initial infusions)

• Last Rituximab infusion between 6 and 18 months prior to inclusion

• Corticosteroids ≤10 mg/day within 4 weeks prior to inclusion

• Affiliation to a social insurance system or beneficiary

• Written informed consent to participate in the study, dated and signed before starting the trial

• Effective method of birth control during the study

Locations
Other Locations
France
Hôpitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Time Frame
Start Date: 2025-07-11
Estimated Completion Date: 2026-07
Participants
Target number of participants: 260
Treatments
Experimental: Rituximab 200mg/6months
Active_comparator: Rituximab 1g/6 months
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov