A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Systemic Lupus ErythematosusAnifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.
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Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Fulfilled the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology) criteria for SLE at the time of study entry.
* Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
* The Physician's decision to prescribe anifrolumab must occur prior to any study-related discussion.
* In countries where prescription reimbursements are authorised on a case-by-case basis, authorisation (ie, patient access to treatment) will be required for study entry.
Exclusion Criteria:
* Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
* Any previous exposure to anifrolumab (including as part of a clinical trial or early access programme).
* 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 (in absence of other SLE manifestations, ie. skin/joint involvement), or active severe or unstable neuropsychiatric lupus.
* Any other condition which the investigator deems to limit a patient's ability to understand the informed consent.
Lieu de l'étude
Research Site
Research SiteCalgary, Alberta
Canada
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Research Site
Research SiteToronto, Ontario
Canada
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Research Site
Research SiteOrillia, Ontario
Canada
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Research Site
Research SiteSte-Foy, Quebec
Canada
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Research Site
Research SiteWinnipeg, Manitoba
Canada
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Research Site
Research SiteRimouski, Quebec
Canada
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Research Site
Research SiteHamilton, Ontario
Canada
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Research Site
Research SiteSherbrooke, Quebec
Canada
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Research Site
Research SiteOrillia, Ontario
Canada
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Research Site
Research SiteSte-Foy, Quebec
Canada
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Research Site
Research SiteHamilton, Ontario
Canada
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Research Site
Research SiteSherbrooke, Quebec
Canada
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Research Site
Research SiteRimouski, Quebec
Canada
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Research Site
Research SiteWinnipeg, Manitoba
Canada
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Research Site
Research SiteCalgary, Alberta
Canada
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Research Site
Research SiteToronto, Ontario
Canada
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- Étude parrainée par
- AstraZeneca
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05637112