RecruitingNCT06933134
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
Sponsor
University Hospital, Tours
Enrollment
30 participants
Start Date
Apr 23, 2026
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria6
- 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.).
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Locations(1)
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NCT06933134
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