Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Cytopenia, Connective Tissue Disorder, Systemic Vasculitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study
Overview
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.
Primary outcome measures
- Patients with (Immune Thrombocytopenia) ITP [Time frame: At each consultation during 5 years]
- Patients with AIHA Autoimmune Hemolytic Anemia. [Time frame: At each consultation during 5 years]
- Patients with inflammatory myopathy [Time frame: At each consultation during 5 years]
- Patients with systemic lupus erythematous : [Time frame: At each consultation during 5 years]
- Patients with systemic vasculitis [Time frame: At each consultation during 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu de Nice — Nice
Identifiers
NCT: NCT07037732 · 25Immuno01