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 (RADAR)

Prior treatment

• Subject in exclusion period (determined by a previous or ongoing study)
• Concurrent treatment with any other targeted therapy than Rituximab
• Drug addiction, alcohol addiction

Other illness

• 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

Lab values

• Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin <8 g/dL, neutropenia < 1.5G/L or IgG <5 g/L

Age

• Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision

Other

• 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
• Any contraindication to Rituximab or to NaCl 0.9%
• Pregnancy (women of childbearing potential : positive urinary pregnancy test at the inclusion visit), breastfeeding, or planned pregnancy during the study (on subject declaration)
• Patients who cannot be followed for the 12 month-duration

• 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 day 0
• Corticosteroids ≤10 mg/day within 4 weeks prior to day 0
• 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