Overview

Rituximab in Eosinophilic Granulomatosis With Polyangiitis

Status:
Completed
Trial end date:
2020-10-21
Target enrollment:
0
Participant gender:
All
Summary
Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority research, comparing rituximab-based regimen with conventional therapeutic strategy for the induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive: - Experimental therapeutic strategy based on the use of rituximab (experimental group) - Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease severity (comparative group)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
French Vasculitis Study Group
French Vasculitis Study Group (FVSG)
Treatments:
Cyclophosphamide
Rituximab
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) ≥3,

- Patients within the first 21 days following initiation/increase of corticosteroids at
a dose ≤ 1 mg/kg/day (pulses of methylprednisolone before oral corticosteroid therapy
are authorized) ,

- Patient able to give written informed consent prior to participation in the study.

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 12 months duration of the study,

- 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, cyclophosphamide, mesna or
azathioprine,

- 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 ≤4,000/mm3,

- Patients who have platelet count ≤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.