Clinical Trials in France / NCT06933134
Recruiting
Observational
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
NCT06933134 · tracked via the Priya Life Science France tracker
Condition(s) studied
Rheumatoid Arthritis (RA)
Study 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
Inclusion Criteria:
. 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 Criteria:
* 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.).
Primary outcome measure(s)
- Observed Disease Activity Score(DAS) 28-CRP — 6 months after a second low-dose cycle
DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab - Calculated DAS28-CRP — 6 months after a second low-dose cycle
DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University hospital | Tours | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06933134 on ClinicalTrials.gov ↗ ← All trials in France