Predicting response to low-dose rituximab for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational validation of a PK-PD based prediction model applied to patients receiving low-dose rituximab (1000 mg once per cycle). The model uses clinical and laboratory inputs including body surface area, serum IgG, residual rituximab concentration, and CD4+ T-cell count to predict clinical response. The primary outcome is the correlation and coefficient of determination between observed DAS28-CRP six months after a second low-dose cycle and the DAS28 predicted by the model. Participants are adults with rheumatoid arthritis who are switching from standard-dose rituximab to the low-dose regimen as part of routine care.

Why it matters

Who can join: the full rules

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.).

Where it's running

• University hospital
  Tours, France Recruiting

Study contacts

• Study coordinator: Simon BRUNET
• Email: simon.brunet@chu-tours.fr
• Phone: 247475917

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.