Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

Centre Hospitalier Universitaire de Saint Etienne28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Granulomatosis, Wegener's Microscopic Polyangiitis

Interventions

blood specimenOTHER

blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: 1 month after stop of rituximab induction regimen

Secondary Outcomes

serum rituximab levels

Time frame: 3 months after stop of rituximab induction regimen

serum rituximab levels

Time frame: 6 months after stop of rituximab induction regimen

serum anti-rituximab antibodies

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

Time frame: 1 month after stop of rituximab induction regimen

serum anti-rituximab antibodies

Time frame: 3 months after stop of rituximab induction regimen

serum anti-rituximab antibodies

Time frame: 6 months after stop of rituximab induction regimen

Serum B lymphocytes (CD19+ cells) levels

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

Time frame: 1 month after stop of rituximab induction regimen

Serum B lymphocytes (CD19+ cells) levels

Time frame: 3 months after stop of rituximab induction regimen

Serum B lymphocytes (CD19+ cells) levels

Time frame: 6 months after stop of rituximab induction regimen

patient number with adverse event

frequency and nature of rituximab-attributed adverse events

Time frame: from start of induction rituximab regimen until six monthes after stop of induction regimen

Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes