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NCT Number: NCT06794827

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

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.

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Key information

Conditions

ANCA Associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, Netherlands

Location status: Recruiting

Location contact

YKO Teng, MD, PhD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assess physician's treatment indications for starting avacopan as reported in the database questionnaire

    Time frame: 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

  2. Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire

    Time frame: 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

  3. Assess concomitant immunosuppressive treatment strategies employed with avacopan as registered in the database questionnaire

    Time frame: 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

  4. Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63]

    Time frame: 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 outcomes

  1. Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Y.K.O. Teng, MD, PhD

CONTACT

[email protected]

+31715262148

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Hospital Universitari de Bellvitge
  • University of Modena and Reggio Emilia
  • University of Udine
  • ZOL Hospital Genk Belgium

Registry information

Official study title

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

Acronym: AVAC-EUR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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