Avacostar - (PASS)

CSL Vifor

Status: Enrolling

Conditions: ANCA-associated Vasculitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05897684

CS-AVA-2022-0016

Details and patient eligibility

About

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.

Full description

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.

Germany and the United Kingdom (UK) have been selected for the study. Additional countries may be considered according to availability of avacopan and suitability for the study. Patients will be enrolled prospectively, but up to 6 months of data may be collected retrospectively if necessary. Baseline visit is defined as the day that induction treatment (avacopan or non-avacopan standard of care (SoC) cyclophosphamide or rituximab) is started for active severe AAV. Patients who started avacopan/SoC induction therapy for active severe AAV within 6 months of the enrolment visit and fulfil eligibility criteria may be enrolled in the PASS. Individual participant follow-up data will be collected periodically at routine clinic visits until the LPLV, which will be 4 years after the last participant is enrolled.

The primary objective of the study is:

To evaluate the incidence of defined Medical Events of Special Interest (MESIs) in patients with AAV commencing avacopan.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
• Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
• Age ≥18 years of either sex.
• Has provided written informed consent.
• Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.

Exclusion criteria

• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.

Trial design

500 participants in 2 patient groups

Treated with avacopan for active AAV

Description:

The study will enrol approximately 250 adult patients diagnosed with AAV (MPA or GPA) treated with avacopan for active severe AAV.

Treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active AAV

Description:

The study will enrol approximately 250 adult patients diagnosed with AAV (MPA or GPA) treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV.