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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT03164473
Phase
PHASE3
Status
Completed

Conditions

  • Eosinophilic Granulomatosis With Polyangiitis

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)
  • Azathioprine — DRUG
    oral tablets : 2 mg/kg/day for 24 months
  • Placebo-rituximab — DRUG
    4 infusions for 18 months
  • Placebo-azathioprine — DRUG
    oral tablets for 24 months

Study Details

The purpose of this study is to investigate, after achievement of remission, the efficacy of rituximab compared with azathioprine maintenance therapy on duration of remission, in patients with relapsing or newly-diagnosed Eosinophilic granulomatosis with polyangiitis EPGA receiving standard of care therapy including glucocorticoid therapy reduction/withdrawal.

Key Dates

Start date
Mar 7, 2018
Status verified
Oct 2025
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

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

Arms

  • Experimental: Rituximab
    * pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions) * plus orally placebo-azathioprine for 24 months
  • Active Comparator: Azathioprine
    * standard maintenance oral azathioprine therapy (2 mg/kg/day) for 24 months * plus 4 placebo-rituximab infusions given every 6 months for 18 months

Primary Outcome Measure

Duration of remission in weeks [ Time Frame: 28 months ]

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