Status:
NOT_YET_RECRUITING
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Tours
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18+ years
Brief Summary
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.
Detailed Description
Rituximab is an anti-CD20 monoclonal antibody which is effective in RA. The dose indicated in the marketing authorisation is 1000 mg twice per cycle. However, rituximab is associated with adverse even...
Eligibility Criteria
Inclusion
- . Age ≥ 18 years
- Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
- Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
- In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
- If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.
Exclusion
- Other associated targeted disease-modifying therapy
- Sjögren's syndrome or other associated inflammatory rheumatism
- Fibromyalgia or other pathology having an impact on the assessment of disease activity
- Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
- Opposition to data processing
- No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06933134
Start Date
September 1 2025
End Date
April 1 2028
Last Update
August 7 2025
Active Locations (1)
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1
University hospital
Tours, France, 37044