Granulomatosis, Wegener's, Microscopic Polyangiitis
Conditions
Brief summary
The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients. All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included. Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.
Interventions
OTHERblood specimen
blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
Sponsors
Theradiag
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA * Decision taken to start an induction regimen with rituximab * Informed and having signed the study consent form * If of child-bearing potential, female patients will have use an effective method of contraception during RTX (rituximab) treatment and in the 12 months following RTX treatment stop * no-breast-feeding during RTX treatment and in the 12 months following RTX treatment stop
Exclusion criteria
* Other primary or secondary systemic vasculitis * Incapacity or refusal to sign the informed consent form * Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study * Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab) * severe active infection * Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease Pregnancy, except for cases where the expected benefit oj treatment seems to surpass the potential risks * Patients with active hepatitis B * Any live vaccine within four weeks prior to the first infusion of RTX
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum rituximab levels | 1 month after stop of rituximab induction regimen | rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0, 6 months after stop of induction regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum rituximab levels | 3 months after stop of rituximab induction regimen | rituximab level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen |
| serum anti-rituximab antibodies | 1 month after stop of rituximab induction regimen | serum anti-rituximab antibodies level comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen |
| Serum B lymphocytes (CD19+ cells) levels | 1 month after stop of rituximab induction regimen | Serum B lymphocytes (CD19+ cells) levels comparison between number of non-responders and number of responders after rituximab induction regimen. The number of non-responders is defined by a Birmingham Vascularitis Activity score \> 0 six months after stop of induction regimen |
| patient number with adverse event | from start of induction rituximab regimen until six monthes after stop of induction regimen | frequency and nature of rituximab-attributed adverse events |
Countries
France
Outcome results
None listed