Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient who undergo rituximab treatment according to routine care and having one of the following disorder:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MICHAEL Levraut | Contact | 04.92.03.54.44 | + 33 | levraut.m@chu-nice.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Nice | Recruiting | Nice | Alpes Maritimes | 06000 | France |
Not provided
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D056647 | Systemic Vasculitis |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided