Efficacy Study of Two Treatments in the Remission of Vasculitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT00748644
Phase
PHASE3
Status
Completed

Conditions

  • Microscopic Polyangiitis
  • Wegener Granulomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    rituximab infusion will be performed at J1, J15, 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.
  • Azathioprine — DRUG
    azathioprine (2 mg/kg/d) for 12 months, then progressively tapered until its discontinuation at month 22. 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

Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine

Key Dates

Start date
Oct 31, 2008
Status verified
Oct 2025
Primary completion
Mar 31, 2013
Completion
Jun 30, 2013

Study Design

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

Arms

  • Experimental: 1
    Experimental drug = rituximab for maintenance
  • Active Comparator: 2
    Comparator drug = azathioprine for maintenance

Primary Outcome Measure

Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up) [ Time Frame: 28 months ]

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