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Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

Study acronym: ARRIA
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 22 of 22 sites
    v4
  2. Notable Start date: Sep 30, 2024 to Nov 15, 2024
    • Secondary endpoints: 15 to 18
    • Site details revised at 5 of 22 sites
    • Publications: details revised at 8 of 8 entries
    v3
  3. Minor Site details revised at 3 of 22 sites
    • Publications expanded, about 434 words
    • Study description expanded, about 2 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are: Is avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan? Participants will: Be treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks). Be assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission/relapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events. The primary endpoint is remission rates at 26 weeks.
Trial Details
NCT Number NCT06611696
Lead Sponsor Chiba University
Collaborators: Kissei Pharmaceutical Co., Ltd., International University of Health and Welfare
Conditions
(from sponsor)
ANCA Associated Vasculitis (AAV)
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov