Rituximab in Eosinophilic Granulomatosis With Polyangiitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT02807103
Phase
PHASE3
Status
Completed

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    1 g intravenous pulse at day1 and day15
  • Placebo-rituximab — DRUG
    intravenous pulses at day1 and day15
  • Cyclophosphamide — DRUG
    intravenous 9 pulses : 600 mg/m2 at days 1, 15 and 29, and then 500 mg-fixed dose at days 50, 71, 92, 113, 134 and 155.
  • Placebo-cyclophosphamide — DRUG
    intravenous 7 pulses : at days 29, 50, 71, 92, 113, 134 and 155.

Study Details

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)

Key Dates

Start date
Dec 5, 2016
Status verified
Jan 2026
Primary completion
Oct 21, 2020
Completion
Oct 21, 2020

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab with FFS=0
    All patients in the rituximab group will receive corticosteroids with a predefined tapering schedule similar to the conventional therapy group. Patients with FFS=0 will receive 1 gram of rituximab at day 1 and day 15 as induction treatment
  • Placebo Comparator: Conventional therapy with FFS=0
    All patients will receive corticosteroids with a predefined tapering schedule similar to the experimental group. Patients with FFS=0 will receive placebo-rituximab at day 1 and day 15.
  • Experimental: Rituximab with FFS≥1
    All patients in the rituximab group will receive corticosteroids with a predefined tapering schedule similar to the conventional therapy group. Patients with FFS≥1 will receive a total of 9 pulses : * 1 gram of rituximab at day 1 and day 15 as induction treatment * placebo-cyclophosphamide at days 1, 15, 29, 50, 71, 92, 113, 134 and 155. Maintenance therapy by azathioprine will be started at day 180 according to the standard of care of these patients, as recommended by the French Vasculitis Study Group.
  • Active Comparator: Conventional therapy with FFS≥1
    All patients will receive corticosteroids with a predefined tapering schedule similar to the experimental group. Patients with FFS≥1 will receive intravenous pulses of cyclophosphamide for a total of 9 pulses: 600 mg/m2 at days 1, 15 and 29, and then 500 mg-fixed dose at days 50, 71, 92, 113, 134 and 155. Maintenance therapy by azathioprine will be started at day 180 according to the standard of care of these patients, as recommended by the French Vasculitis Study Group.

Primary Outcome Measure

The percentage of patients who obtained a BVAS=0 and prednisone dose ≤7.5 mg/day at day 180. [ Time Frame: 180 days ]

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