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NCT07037732
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
trial in Autoimmune Cytopenia in 50 participants. Currently enrolling.
1 January 2030
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nice |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 June 2025 |
| Primary completion | 1 January 2030 |
| Estimated completion | 1 June 2030 |
| Sites | 1 location across France |
Conditions studied
- Autoimmune Cytopenia — all drugs for Autoimmune Cytopenia →
- Connective Tissue Disorder — all drugs for Connective Tissue Disorder →
- Systemic Vasculitis — all drugs for Systemic Vasculitis →
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.
Verify or expand the search:
- PubMed search for NCT07037732
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Autoimmune Cytopenia
Currently open trials in the same condition.
- NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia · Phase 1, PHASE2 · recruiting
Other Centre Hospitalier Universitaire de Nice trials
Trials by the same sponsor.
- NCT05897996 — Percutaneous Anastomosis Creation for Hemodialysis Access · NA · withdrawn
- NCT07499869 — INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR · NA · not yet recruiting
- NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran · Phase 2 · not yet recruiting
- NCT07511608 — Development of a New Technique for Quantifying Mitochondrial DNA in Single Muscle Fibers · NA · not yet recruiting
- NCT07582406 — Codesign, Physical Activity, and Seniors · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07037732 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice
- Last refreshed: 25 June 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing