Monitoring B cells and rituximab/anti‑rituximab antibodies during rituximab treatment for autoimmune disorders
Official title: Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
Run by Centre Hospitalier Universitaire de Nice · NCT07037732 · Data updated 2026-11-12
This project will test whether checking B-cell counts and rituximab or anti-rituximab levels in the blood can help spot relapses in people with autoimmune cytopenia, connective tissue diseases, or vasculitis who are treated with rituximab.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Nice, Alpes Maritimes) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | January 1, 2030 |
| Study ends | June 1, 2030 |
| Registry record updated | June 25, 2025 |
| Trial ID | NCT07037732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults receiving rituximab for autoimmune cytopenia, connective tissue disorders, or systemic vasculitis who are followed at CHU de Nice and have routine blood draws are ideal candidates.
✕Probably not a fit
Patients treated with multiple concurrent immunosuppressive drugs, those with hematologic malignancy, or those not followed at the enrolling center are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project follows patients treated with rituximab as part of routine care and uses leftover blood from regular clinic visits to measure B-cell subsets, serum rituximab, and anti-rituximab antibodies. Patients are monitored every three months during the first year and every six months thereafter, matching the institution's standard follow-up schedule. Laboratory measures will include CD19+, CD27+, and CD38+ B-cell counts, total gammaglobulins and IgG, and drug and anti-drug antibody levels to correlate with clinical relapse. The aim is to see if these biomarkers predict disease relapse across conditions such as autoimmune cytopenias, systemic lupus, rheumatoid arthritis, and ANCA-associated vasculitis.
Why it matters
Potential benefit: If successful, monitoring could allow earlier detection of relapse and more timely retreatment to prevent flares and complications.
How similar studies have gone: Previous retrospective studies and some small prospective series have reported links between B-cell reconstitution or anti-drug antibodies and rituximab failure, but consistent prospective validation and routine clinical use are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who undergo rituximab treatment according to routine care and having one of the following disorder: * primary immune thrombocytopenia * primary autoimmune hemolytic anemia * systmic lupus erythematous * systemic sclerosis * rheumatoid arthritis * inflammatory myopathy * ANCA associated vasculitis * Cryoglobulinemic vasculitis Exclusion Criteria: * Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy
Where it's running
-
Chu de Nice
Nice, Alpes Maritimes, France Recruiting
Study contacts
- Study coordinator: MICHAEL Levraut
- Email: levraut.m@chu-nice.fr
- Phone: 04.92.03.54.44
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.