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A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

NCT05637112

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: None (Observational study)

Countries: Austria, Belgium, Canada, France, Germany, Israel, Italy, Sweden

Anifrolumab 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (79)
  • Innsbruck, Tyrol, Austria
  • Linz, Upper Austria, Austria
  • Vienna, Austria
  • Liège, Li Ge, Belgium
  • Aalst, Oost-Vlaanderen, Belgium
  • Bruges, West Flanders, Belgium
  • Leuven, Belgium
  • Calgary, Alberta, Canada
  • Winnipeg, Manitoba, Canada
  • Hamilton, Ontario, Canada
  • Orillia, Ontario, Canada
  • Toronto, Ontario, Canada
  • Rimouski, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • Ste-Foy, Quebec, Canada
  • Nice, Alpes-Maritimes, France
  • Clermont-Ferrand, Auvergne-Rh ne-Alpes, France
  • Strasbourg, Bas-Rhin, France
  • Finist Re, Brest Cedex, France
  • Dijon, C te-d'Or, France
  • Bordeaux, Gironde, France
  • Grenoble, Is Re, France
  • Saint-Denis, La R Union, France
  • Nantes, Loire-Atlantique, France
  • Bouches-du-Rh Ne, Lyon, France
  • FORT de France Cedex, Martinique, France
  • Lille, Nord, France
  • Seine-Maritime, Rouen, France
  • Paris, France
  • Paris, France
  • + 49 more on CT.gov