Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
- Conditions
- Granulomatosis, Wegener'sMicroscopic Polyangiitis
- Interventions
- Other: blood specimen
- Registration Number
- NCT02474888
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rituximab blood specimen a classical induction regimen with rituximab (decision taken before inclusion), implying an infusion of 375mg/m² per week, for 4 consecutive weeks (from week -3 until week 0) with blood specimen.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method serum rituximab levels 6 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 6 months 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 6 months 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
Trial Locations
- Locations (4)
Hôpital Edouard Herriot
🇫🇷Lyon, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
CH Lyon Sud
🇫🇷Pierre-Bénite, France
CHU Saint-Etienne
🇫🇷Saint-Etienne, France