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.
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
Enrollment
100
Leiden University Medical Center
Leiden, Netherlands
RECRUITINGAssess physician's treatment indications for starting avacopan as reported in the database questionnaire
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
Time frame: 1 year
Assess AAV patients' clinical characteristics at baseline as reported in the database questionnaire
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
Time frame: 1 year
Assess concomitant immunosuppressive treatment strategies employed with avacopan as registered in the database questionnaire
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
Time frame: 1 year
Assess the relevant clinical benefit of avacopan treatment at the individual patient level based on the BVAS score [0-63]
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.
Time frame: 2 years
Investigate determinants of non-response and/or relapse upon avacopan treatment based on baseline characteristics registered in the database questionnaire
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
Time frame: 2 years
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