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

Study acronym: RADAR
StatusRecruiting
PhasePhase 4
Started2025-07-11
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 23, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-07-18
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07→confirmed 2025-07-11
Study titlerevised
Evaluation of 200 Mgmg of Rituximab Every 6 Months Asas Maintenance Treatment of Rituximab-treated Patients withWith Rheumatoid Arthritis
2025-03-25
minor
Original filing
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.
Trial Details
NCT Number NCT06906549
Lead Sponsor University Hospital, Strasbourg, France
Conditions Rheumatoid Arthritis (RA), Rituximab (RTx)
Enrollment 260 participants
Start Date 2025-07-11
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-23