NCT06933134Recruiting
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 23 Apr 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- University Hospital, Tours
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06933134
What you commit to
- Study type: Observational
- Planned participants: 30
- From 23 Apr 2026 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
Other
- 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.).
Who the study is looking for
- . 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University hospital Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.