Monitoring B cells and rituximab/anti‑rituximab antibodies during rituximab treatment for autoimmune disorders
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Nice, Alpes Maritimes) |
| Trial ID | NCT07037732 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nice, Alpes Maritimes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.