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NCT Number: NCT07037732

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

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.

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Key information

Conditions

Autoimmune Cytopenia Cardiovascular Diseases Connective Tissue Diseases Connective Tissue Disorder Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

MICHAEL Levraut

CONTACT

[email protected]

04.92.03.54.44 ext. + 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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