ASTER: Anifrolumab Study for Treatment Effectiveness in the Real World Multi-National, Observational, Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Summary
The Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) will generate
critical real-world evidence on the benefits of adding anifrolumab to standard of care
treatment for patients with Systemic lupus erythematosis (SLE). This research is being done to better inform physicians and patients and to improve care for patients with SLE.
Eligibility
Eligible ages: 18 to 99
Inclusion criteria:
Eligible participants include those:
- age 18 years or older
- able to read, write and speak English
- with diagnosis of SLE
- prescribed anifrolumab for the first time by their physician
- willing to provide consent to participate in the study and to
allow the study physician access to their past medical records if held by other physicians.
Exclusion criteria:
Patients meeting any of the following criteria will not be included in the study:
1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial.
2. Previous exposure to anifrolumab as part of a clinical trial or early access program.
3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide [CYC] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.
4. Any other condition which the investigator deems to limit a patient’s ability to understand the informed consent or complete the study questionnaires.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
For more information please reach out to the study team.
Principal investigator:
Megan Barber
Clinical trial:
No
REB-ID:
REB23-0989