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

PHASE3CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

November 16, 2012

Primary Completion Date

April 5, 2016

Study Completion Date

April 5, 2016

Conditions
Granulomatosis With PolyangiitisMicroscopic PolyangiitisRenal Limited Forms
Interventions
DRUG

Rituximab (Arm B)

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.

DRUG

Rituximab (Arm A)

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.

Trial Locations (1)

75014

Cochin Hospital, Paris

All Listed Sponsors
collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01731561 - Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis | Biotech Hunter | Biotech Hunter