EUCTR2016-000275-25-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 108
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\)
Outcomes
Primary Outcomes
Not specified
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