Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT03920722
Phase
PHASE3
Status
Completed

Conditions

  • Microscopic Polyangiitis (MPA)

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
  • placebo — DRUG
    Placebo-Rituximab 1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine

Study Details

The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.

Key Dates

Start date
Oct 24, 2020
Status verified
Apr 2026
Primary completion
Sep 6, 2023
Completion
Sep 6, 2023

Study Design

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

Arms

  • Experimental: Rituximab
    Experimental regimen: One year Glucocorticoid treatment and Rituximab IV 1 gram on Day 1 and 15
  • Placebo Comparator: Rituximab-Placebo
    Standard regimen: One-year Glucocorticoid treatment and Placebo-Rituximab IV on Day 1 and 15

Primary Outcome Measure

Disease free survival rate [ Time Frame: 18 months ]

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