Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS

Phase 1

• Conditions: Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening; MedDRA version: 19.0Level: PTClassification code 10048594Term: Allergic granulomatous angiitisSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2016-000275-25-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-13
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

-Patients with a diagnosis of EGPA independently of ANCA status,
-Patient aged of 18 years or older,
-Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) > ou=3,
-Patients within the first 21 days following initiation/increase of corticosteroids at a dose -Patient able to give written informed consent prior to participation in the study.

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 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with GPA, MPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
-Patients with vasculitis in remission of the disease defined as a BVAS <3,
-Patients with severe cardiac failure defined as class IV in New York Heart Assocation
-Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study,
-Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
Patients with EGPA who have already been treated with rituximab within the previous 12 months,
-Patients with hypersensitivity to a monoclonal antibody or biologic agent,
-Patients with contraindication to use rituximab or cyclophosphamide,(only patients DFS< ou=1)
-Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
-Patients included in other investigational therapeutic study within the previous 3 months,
-Patients suspected not to be observant to the proposed treatments,
-Patients who have white blood cell count < ou=4,000/mm3,
-Patients who have platelet count < ou =100,000/mm3,
-Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease,
-Patients unable to give written informed consent prior to participation in the study.

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Study & Design

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