PR3-AAV Resilient Remission or PRRR

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Mayo Clinic
Study ID
NCT05376319
Phase
PHASE2
Status
Terminated

Conditions

  • ANCA Associated Vasculitis
  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15
  • Rituximab — DRUG
    1000 mg per infusion given approximately two weeks apart, on day 1 and on day 15

Study Details

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).

Key Dates

Start date
Jun 30, 2023
Status verified
Apr 2026
Primary completion
May 7, 2024
Completion
May 7, 2024

Study Design

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

Arms

  • Experimental: Intravenous dose of obinutuzumab
    Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of obinutuzumab
  • Active Comparator: Intravenous dose of rituximab
    Subjects who have clinical diagnoses of either granulomatosis with polyangiitis or microscopic polyangiitis will receive two intravenous doses of rituximab

Primary Outcome Measure

Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. [ Time Frame: 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic RochesterRochesterMinnesota55905-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MAMayo Clinic Rochester· Rochester, MNUniversity of Pennsylvania· Philadelphia, PA

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