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

NCT07037732 | Recruiting

• 1 other identifier: 25Immuno01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autoimmune Cytopenia; Connective Tissue Disorder; Systemic Vasculitis

Outcome Measures

Primary Outcomes (5)

• Patients with (Immune Thrombocytopenia) ITP

  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.

  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

  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 :

  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

  Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score

  At each consultation during 5 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Chu de Nice

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Connective Tissue Diseases; Systemic Vasculitis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

MICHAEL Levraut

CONTACT

04.92.03.54.44; levraut.m@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 25, 2025

Record last verified: 2025-05

Locations

FR (1)