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RECRUITINGPhase 4INTERVENTIONAL

Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provision of written willing to sign a consent form by a patient or a surrogate decision maker 2. Age=\>18 years 3. 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 4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA Who Should NOT Join This Trial: 1. Prior treatment for ANCA-associated vasculitis before trial entry 2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min) 3. Presence of another multisystem autoimmune conditions (where your immune system attacks your own body) 4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection 5. Desire to bear children, pregnancy or lactating 6. History of malignancy within the past 5 years or any evidence of persistent malignancy 7. Ongoing or recent (last 1 year) evidence of active tuberculosis 8. History of severe allergy or anaphylaxis to monoclonal antibody therapy 9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg 10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months 11. Past history of medication of avacopan 12. Patients can not take avacopan and prednisolone orally 13. Other conditions, in the investigator\'s opinion, inappropriate for the trial entry Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Provision of written informed consent by a patient or a surrogate decision maker 2. Age=\>18 years 3. 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 4. Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA Exclusion Criteria: 1. Prior treatment for ANCA-associated vasculitis before trial entry 2. ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min) 3. Presence of another multisystem autoimmune disease 4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection 5. Desire to bear children, pregnancy or lactating 6. History of malignancy within the past 5 years or any evidence of persistent malignancy 7. Ongoing or recent (last 1 year) evidence of active tuberculosis 8. History of severe allergy or anaphylaxis to monoclonal antibody therapy 9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg 10. Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months 11. Past history of medication of avacopan 12. Patients can not take avacopan and prednisolone orally 13. Other conditions, in the investigator\'s opinion, inappropriate for the trial entry

Treatments Being Tested

DRUG

Avacopan, prednisolone and rituximab

Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.

DRUG

Prednisolone and rituximab

Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.

Locations (20)

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