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

June 23, 2025 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • Recruiting
        • CHU de Nice
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Autoimmune cytopenia (immune thrombocytopenia or hemolytic anemia)
Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.
Connective tissu disorder (SLE, myopathie, RA…)
Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.
Systemic vasculitis (ANCA, essential cryoglobulinemia)
Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with (Immune Thrombocytopenia) ITP
Time Frame: At each consultation during 5 years
Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.
At each consultation during 5 years
Patients with AIHA Autoimmune Hemolytic Anemia.
Time Frame: At each consultation during 5 years
Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months
At each consultation during 5 years
Patients with inflammatory myopathy
Time Frame: At each consultation during 5 years
Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis
At each consultation during 5 years
Patients with systemic lupus erythematous :
Time Frame: At each consultation during 5 years
Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score
At each consultation during 5 years
Patients with systemic vasculitis
Time Frame: At each consultation during 5 years
Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score
At each consultation during 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

May 23, 2025

First Submitted That Met QC Criteria

June 23, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25Immuno01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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