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Compares treatment options for ANCA Associated Vasculitis (AAV)
Official title Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis
ClinicalTrials.gov ID: NCT06611696
What this study is testing
What is Avacopan, prednisolone and rituximab?
Avacopan, prednisolone and rituximab is an investigational medicine, given as a monthly, being studied as a potential treatment for anca associated vasculitis (aav).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Positive test by ELISA, CLEIA or FEIA for proteinase 3-ANCA or myeloperoxidase-ANCA
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toyoake, Aichi-ken, Japan
- Asahi, Chiba, Japan
- Chiba, Chiba, Japan
- Ichihara, Chiba, Japan
- Kamogawa, Chiba, Japan
- Narita, Chiba, Japan
- Maebashi, Gunma, Japan
- Hiragi, Kagawa-ken, Japan
- Kawasaki, Kanagawa, Japan
- Sendai, Miyagi, Japan
- Nagasaki, Nagasaki, Japan
- Okayama, Okayama-ken, Japan
- Osaka, Osaka, Japan
- Kawagoe, Saitama, Japan
- Mibu, Tochigi, Japan
- Bunkyoku, Tokyo, Japan
- Mitaka, Tokyo, Japan
- Ōta-ku, Tokyo, Japan
- tabashi City, Tokyo, Japan
- Chuo-shi, Yamanashi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toyoake, Aichi-ken, Japan; Asahi, Chiba, Japan; Chiba, Chiba, Japan; Ichihara, Chiba, Japan; Kamogawa, Chiba, Japan; Narita, Chiba, Japan and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.