Clinical Trial: Efficacy Study of Two Treatments in the Remission of Vasculitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis

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

Detailed Summary: Randomized, controlled, national, multicenter, prospective study to compare between azathioprine (conventional therapy) and rituximab in patients with systemic ANCA-associated vasculitis, in remission (achieved with an induction treatment combining corticosteroids and an immunosuppressant, mainly intravenous pulses of cyclophosphamide, and plasma exchanges and/or polyvalent immunoglobulins when indicated) after the first flare of the disease (new diagnosis) or after a relapse. It is planned to stratify patients by first flare (66% of the patients) or relapse (33% of the patients). Patients complying with the inclusion criteria may be included when they are in remission from their vasculitis. Patients who have already received biologics (antiCD20, antiTNFα) will not be included. Patients will be included at the time of remission and then randomized. They will receive maintenance treatment by azathioprine for 18 months or a rituximab infusion every 6 months until month 18 (i.e. a total of 4 infusions), at the dose of 375 mg/m2 (maximum dosage, 500 mg). ANCA status and CD19+ lymphocyte count will be monitored but will not be used to adjust therapy. After the 18 month length of maintenance phase, i.e. after stopping immunosuppressive maintenance therapy, patients will be followed for an additional 10 month period. Patients with Wegener's granulomatosis will be prescribed cotrimoxazole 160/800 tid (for 2 additional years).
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess the number of adverse events and their severity in each group [ Time Frame: 28 months ]
  • Number of patients with ANCA in each group [ Time Frame: 28 months ]
  • mortality rate in each group [ Time Frame: 28 months ]
  • number of minor relapse in each group [ Time Frame: 28 months ]
  • Cumulated dose and the length of corticosteroid treatment in each group at 28 months [ Time Frame: 28 months ]
  • same criteria with an analysis at 6 months after the end of maintenance treatment [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 5, 2008
Date Started: October 2008
Date Completion:
Last Updated: August 2, 2013
Last Verified: January 2012