Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis

Launched by CHIBA UNIVERSITY · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a condition called ANCA-associated vasculitis (AAV), which is an autoimmune disease that can cause inflammation in blood vessels. The researchers want to find out if a medication called avacopan, when used alongside a short course of lower-dose glucocorticoids and rituximab, is as effective as a longer treatment that includes more glucocorticoids. They will also look at how safe avacopan is over a long period. Participants will be monitored over two years to see if they go into remission (where symptoms improve) and to check for any side effects.

To be eligible for the trial, participants must be at least 18 years old, have recently been diagnosed with AAV, and have positive test results for certain markers in their blood. They should not have had previous treatment for AAV or have certain other health conditions. If someone joins the trial, they can expect to receive either the new treatment with avacopan or a longer course of glucocorticoids, and they will have regular check-ups to assess their health and any changes in their condition. This trial is not yet recruiting participants, so more information will be available soon.

Gender

ALL

Eligibility criteria

• 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