Avacostar - A Post Authorization Safety Study (PASS) to Evaluate the Incidence of Safety Events of Interest in Patients Treated With Avacopan for ANCA-associated Vasculitis (AAV)
Status: Recruiting
Location: See all (35) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Charité University Medicine
RECRUITING
Berlin
University Hospital of Cologne
RECRUITING
Cologne
Municipal Hospital Dresden
NOT_YET_RECRUITING
Dresden
University Hospital Essen
RECRUITING
Essen
University Hospital Freiburg
RECRUITING
Freiburg Im Breisgau
University Medical Center Göttingen
RECRUITING
Göttingen
University Hospital Eppendorf
NOT_YET_RECRUITING
Hamburg
KRH Klinikum Siloah
RECRUITING
Hanover
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
LMU
NOT_YET_RECRUITING
Munich
Medius Kliniken
RECRUITING
Plochingen
St. Josef-Stift Sendenhorst
NOT_YET_RECRUITING
Sendenhorst
United Kingdom
UHB NHS Foundation Trust
RECRUITING
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust
RECRUITING
Bradford
North Bristol NHS Trust
RECRUITING
Bristol
Addenbrookes Hospital
RECRUITING
Cambridge
East Kent Hospitals University NHS FT
RECRUITING
Canterbury
Cardiff and Vale UHB
RECRUITING
Cardiff
Epsom & St. Helier NHS Trust
RECRUITING
Carshalton
University Hospitals Coventry and Warwickshire
RECRUITING
Coventry
Royal Devon University Healthcare NHS Foundation Trust
RECRUITING
Exeter
NHS Greater Glasgow & Clyde
RECRUITING
Glasgow
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Barts Health
RECRUITING
London
Hammersmith Hospital, Imperial College Healthcare NHS Trust
RECRUITING
London
Kings College Hospital
RECRUITING
London
Royal Free
RECRUITING
London
St Thomas' Hospital
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Nottingham university hospitals NHS trust
RECRUITING
Nottingham
Rheumatology Department, Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Royal Berkshire NHS foundation trust
RECRUITING
Reading
Northern Care Alliance
RECRUITING
Salford
Swansea Bay University LHB
RECRUITING
Swansea
York & Scarborough Teaching Hospitals NHS FT
RECRUITING
York
Contact Information
Primary
Avacostar Study Team
clinicaltrials@cslbehring.com
+41 58 851 80 00
Time Frame
Start Date:2023-09-11
Estimated Completion Date:2030-12-01
Participants
Target number of participants:500
Treatments
Treated with avacopan for active AAV
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
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.