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)
EU CTIS ID: 2024-519991-18-00
What this study is testing
The primary objective is to show the non-inferiority of the 200mg dose of rituximab compared to the standard 1g dose on disease activity, as measured by mean DAS28-CRP between the first infusion and 12 months afterward, in patients treated with rituximab for rheumatoid arthritis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Rheumatic autoimmune disease other than RA (except associated Sjogren’s disease, which is allowed)
- Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision
- Subject in exclusion period (determined by a previous or ongoing study)
- 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
- Concurrent treatment with any other targeted therapy than Rituximab
See the full eligibility criteria
- 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
- Rheumatic autoimmune disease other than RA (except associated Sjogren’s disease, which is allowed)
- Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision
- Subject in exclusion period (determined by a previous or ongoing study)
- 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
- Concurrent treatment with any other targeted therapy than Rituximab
- Any contraindication to Rituximab or to NaCl 0.9%
- 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 or IgG <5 g/L
- Pregnancy (women of childbearing potential : positive urinary pregnancy test at the inclusion visit), breastfeeding, or planned pregnancy during the study (on subject declaration)
- Drug addiction, alcohol addiction
- Patients who cannot be followed for the 12 month-duration
The study team makes the final eligibility decision.
Where it's taking place
- France
- Monaco
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France; Monaco. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.