Actively Recruiting
Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries
Led by Leiden University Medical Center · Updated on 2025-01-27
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
U
University of Udine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to analyze how avacopan is used early in the treatment of patients with ANCA-associated vasculitis (AAV) across Europe. It focuses on describing patient characteristics, the reasons doctors start avacopan, the treatment strategies combined with avacopan, and the clinical outcomes in a unique group of first-time avacopan users. By studying real-world use, the project hopes to identify important issues in applying avacopan in daily practice and to fill knowledge gaps to improve care and drug access for AAV patients. The study observes patients who have started avacopan treatment for AAV without assigning specific treatments or interventions. Data about the patients' clinical features, treatment choices, and responses are collected through questionnaires over one to two years. The study looks at how doctors decide to start avacopan, the combination of immunosuppressive treatments used, and the clinical benefits measured by the Birmingham Vasculitis Activity Score (BVAS). Researchers also investigate factors that may predict non-response or relapse during avacopan treatment. Participants provide informed consent to share their medical data, which is gathered and analyzed to understand treatment patterns and outcomes. The study monitors patient disease activity and treatment responses using clinical assessments recorded in the database over two years. This observational approach allows researchers to track real-life experiences with avacopan and identify areas for future research and care improvements.
CONDITIONS
Brief Title
Early-access Avacopan in Real-world ANCA-associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
- Initiation of treatment with avacopan
- Provided informed consent for use of medical data
You will not qualify if you...
- No active ANCA-associated vasculitis disease activity verified by clinical measures
- Under 16 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 2 years
Participants who undergo routine care with avacopan are observed to assess treatment indications, clinical characteristics, treatment strategies, and clinical outcomes.
Visits as part of routine clinical care over 2 years
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
Research Team
Y
Y.K.O. Teng, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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