Autoimmune Cytopenia, Connective Tissue Disorder, Systemic Vasculitis
Conditions
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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients with (Immune Thrombocytopenia) ITP | 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. |
| Patients with AIHA Autoimmune Hemolytic Anemia. | 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 |
| Patients with inflammatory myopathy | 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 |
| Patients with systemic lupus erythematous : | 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 |
| Patients with systemic vasculitis | At each consultation during 5 years | Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score |
Countries
France
Contacts
Primary ContactMICHAEL Levraut
Outcome results
None listed