Testing a lower Rituximab dose for maintenance in rheumatoid arthritis
Tests whether a lower Rituximab maintenance dose works as well in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis
Key facts
- Where
- Bordeaux, Brest, Caen Cedex 9, Clermont Ferrand Cedex 1, Colmar Cedex, Créteil, La Roche Sur Yon Cedex 9, Le Coudray, Le Kremlin-Bicetre, Montivilliers, Montpellier Cedex 5, Nantes, Orleans Cedex 2, Paris, Paris Cedex 18, Poitiers, Reims Cedex, Rouen Cedex, Strasbourg Cedex 2, Toulouse, and Vandoeuvre Les Nancy Cedex, FranceSee the 22 sites
- Phase
- Phase 4
Where in France
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranceTaking people
- Centre Hospitalier De ColmarColmar Cedex, FranceTaking people
- Hopital Henri MondorCréteil, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Les Hopitaux De ChartresLe Coudray, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Groupe Hospitalier Du HavreMontivilliers, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire D OrleansOrleans Cedex 2, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire RouenRouen Cedex, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy Cedex, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Strasbourg, France
- Trial code
- NCT06906549EU 2024-519991-18-00
- Record updated
- 23 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Concurrent treatment with any other targeted therapy than Rituximab; Drug addiction, alcohol addiction; Subject in exclusion period (determined by a previous or ongoing study); Rheumatic autoimmune disease other than RA (except associated Sjogren's disease, which is allowed); Significant uncontrolled associated disease or comorbidity; Known active infection or history of serious recurrent or chronic infection; Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin <8 g/dL, neutropenia < 1.5G/L, IgM <0.4 g/L and/or IgG <5 g/L; Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision; Any contraindication to Rituximab or to NaCl 0.9%; Pregnancy, breastfeeding, or planned pregnancy during the study (on subject declaration); Patients who cannot be followed for the 12 month-duration; Patients unable to give informed consent (e.g., patients in a situation of medical emergency, patients who have difficulty comprehending the essential details of the trial...); Patients who have difficulty reading or understanding French, or who have an inability to understand the delivered information.