Early-access Avacopan in Real-world ANCA-associated Vasculitis
ConditionANCA Associated Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Established diagnosis of GPA or MPA
Treatment (initiation) with avacopan
Informed consent for use of medical data
Disqualifiers
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
Trial population
A multicenter, non-interventional, longitudinal cohort study which will collect incident as well as prevalent AAV patients treated with an avacopan-based regimen. The cohort will include retrospective and prospective data capture on real-life management and outcomes.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Assess 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 year2
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 year3
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 year4
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 yearsSecondary outcomes
1
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
University of Udine
Collaborator
University of Modena and Reggio Emilia
Collaborator
Hospital Universitari de Bellvitge
Collaborator
ZOL Hospital Genk Belgium
Collaborator
Source ClinicalTrials.gov