Condition: ANCA Associated Vasculitis (AAV) · Sponsor: Chiba University
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.
This description comes directly from the study's public registry record.
Shunsuke Furuta, MD, PhD · 81+43-222-7171 · shfuruta@chiba-u.jp
Always discuss trial participation with your own doctor first.
| Fujita Health University Hospital | Toyoake, Aichi-ken, Japan | Not Yet Recruiting |
| Asahi General Hospital | Asahi, Chiba, Japan | Recruiting |
| Chiba Aoba Municipal Hospital | Chiba, Chiba, Japan | Recruiting |
| Chiba University | Chiba, Chiba, Japan | Recruiting |
| Chiba Rosai Hospital | Ichihara, Chiba, Japan | Recruiting |
| Kameda Medical Centre | Kamogawa, Chiba, Japan | Recruiting |
| International University of Health and Welfare | Narita, Chiba, Japan | Recruiting |
| Japanese Red Cross Narita Hospital | Narita, Chiba, Japan | Recruiting |
| Gunma University | Maebashi, Gunma, Japan | Recruiting |
| Kagawa University | Hiragi, Kagawa-ken, Japan | Recruiting |
| St.Marianna University School of Medicine | Kawasaki, Kanagawa, Japan | Recruiting |
| Tohoku Univerisity | Sendai, Miyagi, Japan | Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06611696