NCT07037732 Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
| NCT ID | NCT07037732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Autoimmune Cytopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07037732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autoimmune Cytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07037732 currently recruiting?
Yes, NCT07037732 is actively recruiting participants. Contact the research team at levraut.m@chu-nice.fr for enrollment information.
Where is the NCT07037732 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT07037732 clinical trial?
NCT07037732 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 50 participants.