Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT01731561
Phase
PHASE3
Status
Completed

Conditions

  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis
  • Renal Limited Forms

Eligibility Criteria

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

Interventions

  • Rituximab (Arm B) — DRUG
    Rituximab infusion will be performed at D1 then ANCA status and CD19+ lymphocyte count will be monitored every 3 months, and patients will receive new 500 mg rituximab infusions either if CD19 are \> to 0/mm3, or if ANCA are positive again or if ANCA titer significantly raises. All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.
  • Rituximab (Arm A) — DRUG
    Rituximab infusion will be performed at D1, D15, M6, M12 and M18(i.e. a total of 5 infusions), at the dose of 500 mg at a fixed dosage.All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.

Study Details

The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.

Key Dates

Start date
Nov 16, 2012
Status verified
Aug 2025
Primary completion
Apr 5, 2016
Completion
Apr 5, 2016

Study Design

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

Arms

  • Experimental: Rituximab infusion according biological parameters
    Rituximab infusion based on ANCA and CD19 lymphocytes
  • Active Comparator: Systematic rituximab infusion
    Semestrial rituximab infusion until 18 months

Primary Outcome Measure

Number of relapses [ Time Frame: at 28 months ]

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