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Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
Sponsor: Chiba University
Summary
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.
Official title: Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-11-15
Completion Date
2028-09-30
Last Updated
2025-05-04
Healthy Volunteers
No
Conditions
Interventions
Avacopan, prednisolone and rituximab
Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.
Prednisolone and rituximab
Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.
Locations (22)
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
Chiba Aoba Municipal Hospital
Chiba, Chiba, Japan
Chiba University
Chiba, Chiba, Japan
Chiba Rosai Hospital
Ichihara, Chiba, Japan
Kameda Medical Centre
Kamogawa, Chiba, Japan
International University of Health and Welfare
Narita, Chiba, Japan
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan
Gunma University
Maebashi, Gunma, Japan
Kagawa University
Hiragi, Kagawa-ken, Japan
St.Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
Tohoku Univerisity
Sendai, Miyagi, Japan
Nagasaki University
Nagasaki, Nagasaki, Japan
Okayama University
Okayama, Okayama-ken, Japan
Kitano Hospital
Osaka, Osaka, Japan
Saitama Medical University
Kawagoe, Saitama, Japan
Dokkyo Medical University
Mibu, Tochigi, Japan
Juntendo Univeristy
Bunkyoku, Tokyo, Japan
Kyorin University
Mitaka, Tokyo, Japan
Toho University
Ōta-ku, Tokyo, Japan
Teikyo University
tabashi City, Tokyo, Japan
Yamanashi University
Chuo-shi, Yamanashi, Japan