Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis

Phase 1

• Conditions: Granulomatosis with polyangiitis Microscopic polyangiitis; MedDRA version: 18.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 18.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2015-001807-29-FR
• Lead Sponsor: CHU de Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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 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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate whether serum rituximab levels at M+1 are predictive of clinical outcome at M+6;Secondary Objective: -To evaluate whether serum rituximab levels at M+3 are predictive of clinical outcome at M+6<br>-To find out a serum rituximab level threshold predictive of non-response to rituximab<br>-To evaluate whether the presence of anti-rituximab antibodies in patients is correlated with clinical outcome at M+6<br>-To evaluate whether ANCA and/or B lymphocytes count (CD19+ cells) increase is correlated with clinical outcome at M+6<br>-To describe the frequency and nature of rituximab-attributed adverse events in those patients, taking into account their anti-rituximab antibodies status<br>;Primary end point(s): Number of non-responders (Birmingham Vasculitis Activity Score > 0) at M+6;Timepoint(s) of evaluation of this end point: 6 month after the stop of induction treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Serum ANCA levels (M+1, M+3 and M+6)<br>-Serum B lymphocytes (CD19+ cells) levels (M+1, M+3 and M+6)<br>-Frequency and nature of rituximab-attributed adverse events during the 6 month follow-up<br>;Timepoint(s) of evaluation of this end point: at 1, 3 and 6 month after the stop of induction treatment