Maintenance of Remission with Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis with Polyangiitis.

PHASE3CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 7, 2018

Primary Completion Date

September 23, 2024

Study Completion Date

September 23, 2024

Conditions
Eosinophilic Granulomatosis with Polyangiitis
Interventions
DRUG

Rituximab

pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)

DRUG

Azathioprine

oral tablets : 2 mg/kg/day for 24 months

DRUG

Placebo-rituximab

4 infusions for 18 months

DRUG

Placebo-azathioprine

oral tablets for 24 months

Trial Locations (1)

75014

Hôpital Cochin, Paris

All Listed Sponsors
collaborator

French Vasculitis Study Group

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03164473 - Maintenance of Remission with Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis with Polyangiitis. | Biotech Hunter | Biotech Hunter