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Recruiting Observational

Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis

NCT06933134 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-04-23
Last updated
2026-04-30

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
University hospital Tours France Recruiting
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