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

Evaluating Clinical Practice of Early Access Avacopan Treatment for ANCA-associated Vasculitis in European Countries

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06794827

Acronym

AVAC-EUR

Enrollment

100

Registered

2025-01-27

Start date

2023-11-01

Completion date

2026-12-31

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA Associated Vasculitis

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Assess physician's treatment indications for starting avacopan as reported in the database questionnaire	1 year	Assess physician's treatment indications for starting avacopan as reported in the database questionnaire. Options to choose are: Refractory disease, Relapsing disease, Steroid dependent, Steroid toxicity or Other
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire	1 year	Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire including: Gender (Male/Female) Age Date of AAV diagnosis Type AAV (GPA or MPA) Autoantibodies (PR3 or MPO) Organs affected
Assess concomitant immunosuppressive treatment strategies employed with avacopan as registered in the database questionnaire	1 year	Assess concomitant treatment strategies employed with avacopan at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts. Possible options include steroids, cyclophosphamide, rituximab, azathioprine or other
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63]	2 years	Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score \[0-63\] as reported at baseline, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months and 24 monhts.

Secondary

Measure	Time frame	Description
Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire	2 years	Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire including: Gender (Male/Female) Age Date of AAV diagnosis Type AAV (GPA or MPA) Autoantibodies (PR3 or MPO) Organs affected

Countries

Netherlands

Contacts

Primary ContactY.K.O. Teng, MD, PhD

y.k.o.teng@Lumc.nl+31715262148

Outcome results