Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis : a Predictive Factor of Clinical Outcome? (MONITUX)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Granulomatosis, Wegener's
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 28
- Locations
- 4
- Primary Endpoint
- serum rituximab levels
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
serum rituximab levels
Time Frame: 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 Outcomes
- serum rituximab levels(6 months after stop of rituximab induction regimen)
- serum anti-rituximab antibodies(6 months after stop of rituximab induction regimen)
- Serum B lymphocytes (CD19+ cells) levels(6 months after stop of rituximab induction regimen)
- patient number with adverse event(from start of induction rituximab regimen until six monthes after stop of induction regimen)