Actively Recruiting
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-06-25
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether monitoring certain blood markers like circulating B-cell reconstitution and serum rituximab levels can help detect relapse in patients with autoimmune diseases treated with rituximab. The study focuses on autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, and autoimmune cytopenia, aiming to identify risk factors for clinical relapse based on these blood markers. Participants receive routine care monitoring after rituximab treatment, with clinical visits every three months during the first year and every six months thereafter. At each visit, blood tests measure total gammaglobulins, IgG, CD19+ cells, and additional markers such as CD27+ and CD38+ B cells, serum rituximab, and anti-rituximab antibodies. The study compares these markers between patients who relapse and those who remain stable over time. During the study, leftover blood samples from routine care are used to analyze these immune markers over the first year of follow-up. Patients will be monitored regularly for up to five years, with assessments at each consultation to track their disease status. The main outcome is to identify the relationship between these blood markers and clinical relapse in various autoimmune disorders.
CONDITIONS
Brief Title
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who undergo rituximab treatment according to routine care and having one of the following disorders:
- primary immune thrombocytopenia
- primary autoimmune hemolytic anemia
- systemic lupus erythematous
- systemic sclerosis
- rheumatoid arthritis
- inflammatory myopathy
- ANCA associated vasculitis
- Cryoglobulinemic vasculitis
You will not qualify if you...
- Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who undergo rituximab treatment as part of routine care are observed to monitor blood B-cell reconstitution, circulating rituximab levels, and the presence of anti-rituximab antibodies, comparing those experiencing clinical relapse with those who remain stable.
Consultations at each visit during 5 years
Trial Site Locations
Total: 1 location
1
Chu de Nice
Nice, Alpes Maritimes, France, 06000
Actively Recruiting
Research Team
M
MICHAEL Levraut
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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