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NCT06794827 | RECRUITING | ANCA Associated Vasculitis

Early-access Avacopan in Real-world ANCA-associated Vasculitis
Sponsor:

Leiden University Medical Center

Information provided by (Responsible Party):

Y.K.Onno Teng

Brief Summary:

The current study proposal aims to investigate the clinical practice variation of the initial use of avacopan for AAV patients in Europe. The study will describe patient characteristics and organ-specific clinical benefit of avacopan treatment in a unique, first-experience cohort of AAV patients. By studying the clinical practice variation of first-experience avacopan treatment, this study will be uniquely positioned to identify pivotal issues on the real-life implementation of avacopan treatment. These observational data can ultimately serve to address current knowledge gaps on avacopan treatment in AAV patients, improve the care and drug-access for AAV patients with avacopan treatment and generate new areas of research.

Condition or disease

ANCA Associated Vasculitis

Detailed Description:

Objective: Analyse the clinical practice variation of the early access use of avacopan in real-world treated patients with ANCA-associated vasculitis. Study design: Observational cohort study Study population: AAV patients treated with avacopan. Main study parameters/endpoints: * Describe physician's treatment indications for starting avacopan * Describe AAV patients clinical characteristics * Describe the concomitant treatment strategies employed with avacopan * Describe clinical outcomes of avacopan treatment * Investigate determinants of clinical benefit as well as non-response and/or relapse within the study cohort

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Established diagnosis of GPA or MPA
  • * Treatment (initiation) with avacopan
  • * Informed consent for use of medical data
Exclusion Criteria
  • * If there is no AAV disease activity present that can be supported by an objectifiable clinical measure or assessment
  • * If a subject is below 16 years old
Early-access Avacopan in Real-world ANCA-associated Vasculitis

Location Details

NCT06794827

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Netherlands,

Leiden University Medical Center

Leiden, Netherlands,