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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
To evaluate the incidence of defined MESIs
To evaluate the incidence of defined MESIs in patients with AAV commencing avacopan. MESIs include liver injury, cardiac safety, serious infection, and malignancy.
Time frame: up to 7 years
Incidence rates of AE in the avacopan and non-avacopan groups
Time frame: up to 7 years
AEs leading to discontinuation of therapy in the avacopan group
Time frame: up to 7 years
Incidence of SAEs in the avacopan and non-avacopan groups
Time frame: up to 7 years
Incidence of ADRs in the avacopan group
Time frame: up to 7 years
Incidence of SADRs in the avacopan group
Time frame: up to 7 years
Change in eGFR over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in IgG over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in CPK over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in ALT over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in AST over time in the avacopan and non-avacopan groups
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Charité University Medicine
Berlin, Germany
RECRUITINGUniversity Hospital of Cologne
Cologne, Germany
RECRUITINGMunicipal Hospital Dresden
Dresden, Germany
NOT_YET_RECRUITINGUniversity Hospital Essen
Essen, Germany
RECRUITINGUniversity Hospital Freiburg
Freiburg im Breisgau, Germany
RECRUITINGUniversity Medical Center Göttingen
Göttingen, Germany
RECRUITINGUniversity Hospital Eppendorf
Hamburg, Germany
NOT_YET_RECRUITINGKRH Klinikum Siloah
Hanover, Germany
RECRUITINGRheumazentrum Ruhrgebiet
Herne, Germany
RECRUITINGLMU
Munich, Germany
NOT_YET_RECRUITING...and 25 more locations
Time frame: up to 7 years
Change in billirubin over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change in WBC over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Change Albumin over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Time to first flare over time in the avacopan and non-avacopan groups
A flare is defined in the BVAS as a score of more than 0. No flare is defined as a BVAS score equal to 0
Time frame: up to 7 years
Change in VDI scores over time in the avacopan and non-avacopan groups
Time frame: up to 7 years
Incidence of MESIs in the non-avacopan group
Time frame: up to 7 years
Incidence rates of SAEs and MESIs in the avacopan group compared to the non-avacopan group,
Time frame: up to 7 years
Incidence rates of MESIs in the avacopan group compared to the non-avacopan group,
Time frame: up to 7 years
Use of concomitant immunosuppression over time and cumulative by treatment group,
Time frame: up to 7 years
Duration of GC-free periods
Time frame: up to 7 years
Proportion of GC-free patients over time by treatment group.
Time frame: up to 7 years
Duration of treatment with avacopan by reason for treatment discontinuation.
Time frame: up to 7 years