Early-access Avacopan in Real-world ANCA-associated Vasculitis (AVAC-EUR)

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: ANCA Associated Vasculitis

Study type: Observational

Funder types: Other

Identifiers

NCT06794827

IIS-AVA-2023-0005

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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