Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX

CHU de Saint-Etienne0 个研究点目标入组 50 人开始时间: 2015年7月23日最近更新: 2020年11月3日

试验速览

暂无简介。

•-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 to use an effective method of contraception during RTX treatment and in the 12 monthes following RTX treatment stop
•- no breast-feeding during RTX treatment and in the 12 monthes following RTX treatment stop
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-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 of the 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

发起方

CHU de Saint-Etienne