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Age: 18Years +
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ID07037732

Monitoring Circulating B-Cells and Rituximab Levels to Detect Relapse in Autoimmune Disorders Treated with Rituximab

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy

Research Team

M

MICHAEL Levraut

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