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
Chiba University
160 participants
Nov 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria13
- Prior treatment for ANCA-associated vasculitis before trial entry
- ANCA-associated vasculitis related glomerulonephritis (eGFR less than 15ml/min) or alveolar hemorrhage (oxygen inhalation more than 2L/min)
- Presence of another multisystem autoimmune disease
- Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection
- Desire to bear children, pregnancy or lactating
- History of malignancy within the past 5 years or any evidence of persistent malignancy
- Ongoing or recent (last 1 year) evidence of active tuberculosis
- History of severe allergy or anaphylaxis to monoclonal antibody therapy
- Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg
- Any biological B cell depleting agent (such as rituximab or belimumab)-use within the past 6 months
- Past history of medication of avacopan
- Patients can not take avacopan and prednisolone orally
- Other conditions, in the investigator\'s opinion, inappropriate for the trial entry
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Interventions
Patients in the avacoapn group will be treated with avacoapn, short-term reduced-dose prednisolone and rituximab.
Patients in the glucocorticoid arm will be treated with reduced-dose prednisolone and rituximab.
Locations(22)
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NCT06611696