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.
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)
Rheumatic autoimmune disease other than RA (except associated Sjogren's disease, which is allowed)
Concurrent treatment with any other targeted therapy than Rituximab
Any contraindication to Rituximab or to NaCl 0.9%
Significant uncontrolled associated disease or comorbidity
Parallel
Rituximab 200mg/6months
Drugperfusion of Rituximab 200mg
Rituximab 1g/6months
Drugperfusion of Rituximab 1g
Mean reduction of rheumatoid arthritis activity score (DAS28-CRP)
Mean reduction of rheumatoid arthritis activity score (DAS28-CRP) between inclusion and 12 months to show non-inferiority of the lower dose.
Compare the disease activity measured by DAS28-CRP between the two arms
DAS28 categories
Remission: DAS28 \< 2.6 ; Low Disease Activity: 2.6 ≤ DAS28 ≤ 3.2 ; Moderate Activity: 3.2 \< DAS28 ≤ 5.1; High Disease Activity: DAS28 \> 5.1 ; Boolean Remission Criteria defined as tender joint count (TJC) ≤ 1, swollen joint count (SJC) ≤ 1, CRP (mg/dL) ≤ 1, Patient global assessment (on a 0-10 scale) ≤ 1
Number of Rituximab infusions
Number of patients switching or initiating a cDMARD or switching from Rituximab to another bDMARD
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