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NCT07037732

Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders

Recruiting now Last updated 25 June 2025
What this trial tests

trial in Autoimmune Cytopenia in 50 participants. Currently enrolling.

Timeline
1 June 2025
Primary endpoint
1 January 2030
1 June 2030

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nice
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment50
Start date1 June 2025
Primary completion1 January 2030
Estimated completion1 June 2030
Sites1 location across France

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Autoimmune Cytopenia or Connective Tissue Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Autoimmune Cytopenia

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Nice trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07037732.

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