Avacopan With Short-term Reduced-dose Glucocorticoids vs Reduced-dose Glucocorticoids Added to Rituximab on Remission Induction in ANCA-associated Vasculitis

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of written informed consent by a patient or a surrogate decision maker

• Age=\>18 years

• New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis) consistent with the 2012 Chapel Hill consensus definitions and 2022 EULAR/ACR classification criteria

• Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA

Locations
Other Locations
Japan
Asahi General Hospital
RECRUITING
Asahi
Juntendo Univeristy
RECRUITING
Bunkyoku
Chiba Aoba Municipal Hospital
RECRUITING
Chiba
Chiba University
RECRUITING
Chiba
Yamanashi University
RECRUITING
Chuo-shi
Kagawa University
RECRUITING
Hiragi
Chiba Rosai Hospital
RECRUITING
Ichihara
Kameda Medical Centre
RECRUITING
Kamogawa
Saitama Medical University
RECRUITING
Kawagoe
St.Marianna University School of Medicine
RECRUITING
Kawasaki
Gunma University
RECRUITING
Maebashi
Dokkyo Medical University
RECRUITING
Mibu
Kyorin University
RECRUITING
Mitaka
Nagasaki University
RECRUITING
Nagasaki
International University of Health and Welfare
RECRUITING
Narita
Japanese Red Cross Narita Hospital
RECRUITING
Narita
Okayama University
RECRUITING
Okayama
Kitano Hospital
RECRUITING
Osaka
Toho University
RECRUITING
Ōta-ku
Tohoku Univerisity
RECRUITING
Sendai
Teikyo University
RECRUITING
Tabashi City
Fujita Health University Hospital
NOT_YET_RECRUITING
Toyoake
Contact Information
Primary
Shunsuke Furuta, MD, PhD
shfuruta@chiba-u.jp
81+43-222-7171
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 160
Treatments
Active_comparator: Glucocorticoid group
Prednisolone will be commenced with dose of 0.5mg/kg/day and will be tapered and off within 5 months. If a patient fails to achieve BVAS=0 or normalization of CRP levels or normalization of ANCA levels, an investigator can keep 5mg/day of prednisolone and postpone the procedure of stopping prednisolone. Patients will also receive rituximab (375mg/m2/w x4).~During remission maintenance phase (6-24 months),, patients will receive rituximab (500mg/body) every 6 months as remission maintenance therapy.~In the case of inadequate response to the combination therapy of prednisolone and rituximab, additional administration of prednisolone 20mg/day (less than 2 weeks) can be allowed as the rescue therapy.~During remission maintenance phase, in the case of minor relapse, additional administration of prednisolone 20mg/day (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.
Experimental: Avacopan group
Prednisolone will be commenced with dose of 0.5mg/kg/day and will be tapered and off within 1 months. Patients will also receive avacopan (60mg/day) and rituximab (375mg/m2/w x4).~During remission maintenance phase (6-24 months), patients will receive avacopan (60mg/day) as remission maintenance therapy until the trial end.~In the case of inadequate response to the combination therapy of avacopan, prednisolone and rituximab, additional administration of prednisolone 20mg/day (less than 2 weeks) can be allowed as the rescue therapy.~During remission maintenance phase, in the case of minor relapse, additional administration of prednisolone 20mg/day (less than 2 weeks) can be allowed as the rescue therapy. Minor relapse is defined as relapse with no major BVAS item.
Related Therapeutic Areas
Sponsors
Collaborators: Kissei Pharmaceutical Co., Ltd., International University of Health and Welfare
Leads: Chiba University

This content was sourced from clinicaltrials.gov

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