A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Launched by ASTRAZENECA · Nov 24, 2022
Trial Information
Current as of February 05, 2025
Recruiting
Keywords
ClinConnect Summary
The ASTER study is looking at how effective a new treatment called anifrolumab is for patients with Systemic Lupus Erythematosus (SLE) in everyday medical practice. This study aims to gather real-world information about how well anifrolumab works and how it affects patients' quality of life after they start this treatment. By doing so, it will help doctors, insurance companies, and patients understand the benefits of using anifrolumab alongside standard treatment for SLE.
To join the study, participants need to be diagnosed with SLE and be starting anifrolumab for the first time based on their doctor's recommendation. They should not have taken anifrolumab before and must meet specific health criteria. While the study is currently recruiting patients aged between 18 and 75, it's important to note that those with certain severe kidney or brain complications from lupus may not be eligible. Participants can expect to provide information about their health and treatment experiences, which will contribute to valuable insights about managing SLE effectively.
Gender
ALL
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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Berlin, , Germany
Liege, , Belgium
Leuven, , Belgium
Vienna, , Austria
Liège, , Belgium
Firenze, , Italy
Pisa, , Italy
Greifswald, Mecklenburg Vorpommern, Germany
Magdeburg, Sachsen Anhalt, Germany
Berlin, , Germany
Milano, , Italy
Leuven, , Belgium
Liege, , Belgium
Graz, , Austria
Bari, , Italy
Graz, Styria, Austria
Linz, Upper Austria, Austria
Firenze, , Italy
Linz, , Austria
Stockholm, , Sweden
Tel Aviv, , Israel
Dusseldorf, North Rhine Westphalia, Germany
Pisa, , Italy
Hamilton, Ontario, Canada
Abu Dhabi, , United Arab Emirates
Strasbourg, Bas Rhin, France
Roma, , Italy
Aalborg, , Denmark
Paris, , France
Ancona, , Italy
Nantes, Loire Atlantique, France
Calgary, Alberta, Canada
Copenhagen, , Denmark
Sherbrooke, Quebec, Canada
Erlangen, Bayern, Germany
Bordeaux Cedex, Gironde, France
Lille Cedex, Nord, France
Heidelberg, Baden Wuerttemberg, Germany
Haifa, , Israel
Strasbourg, Bas Rhin, France
Rimouski, Quebec, Canada
Orebro, , Sweden
Tiberias, , Israel
Innsbruck, Tirol, Austria
Vienna, , Austria
Ste Foy, Quebec, Canada
Innsbruck, Tirol, Austria
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Arhus N, , Denmark
Bad Bramstedt, Hamburg, Germany
Mainz A. Rhein, Rheinland Pfalz, Germany
Magdeburg, Sachsen Anhalt, Germany
Dusseldorf, , Germany
Greifwald, , Germany
Herne, , Germany
Koln, , Germany
Planegg, , Germany
Kfar Saba, Hamerkaz, Israel
Ramat Gan, Tel Aviv, Israel
Graz, Styria, Austria
Linz, Upper Austria, Austria
Copenhagen, Capital Region, Denmark
Aarhus N, Central Denmark Region, Denmark
Aalborg, North Denmark, Denmark
Munich, Monachium, Germany
Planegg, Monachium, Germany
Düsseldorf, North Rhine Westphalia, Germany
Herne, North Rhine Westphalia, Germany
Köln, North Rhine Westphalia, Germany
Erfurt, Thuringia, Germany
Greifwald, Vorpommern Greifswald, Germany
Tiberias, Galilee, Israel
Haifa, Haifa District, Israel
Ramat Gan, Tel Aviv District, Israel
Tel Aviv, Tel Aviv District, Israel
Orebro, Narke, Sweden
Stockholm, Uppland, Sweden
Nice Cedex, Alpes Maritimes, France
Strasbourg, Bas Rhin, France
Grenoble, Isère, France
Nantes, Loire Atlantique, France
Orebro, Närke, Sweden
Nice Cedex, Alpes Maritimes, France
Dijon Cedex, Côte D'or, France
Saint Denis, Haute Marne, France
Fort De France Cedex, Martinique, France
Köln, Nordrhein Westfalen, Germany
Roma, , Italy
Roma, *Roma, Italy
Danderyd, Stockholm*, Sweden
Saint Denis, La Réunion, France
Finistère, Brest Cedex, France
Bouches Du Rhône, Lyon, France
Seine Maritime, Rouen, France
Paris, , France
Schleswig Holstein, Lübeck, Germany
Jerusalem, Yerushalayim, Israel
Napoli, Campania, Italy
Cona, Emilia Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Milano, Lombardia, Italy
Torino, Piemonte, Italy
Danderyd, Stockholm, Sweden
Flemish Brabant, Leuven, Belgium
Aalst, Oost Vlaanderen, Belgium
Brugge, West Flanders, Belgium
Clermont Ferrand, Auvergne Rhône Alpes, France
Greifswald, Mecklenburg Vorpommern, Germany
Beersheba, Hadarom, Israel
Tel Hashomer, Hamerkaz, Israel
Afula, Northern District, Israel
Cagliari, Sardegna, Italy
Sharjah, Ash Shariqah, United Arab Emirates
Dubai, Dubayy, United Arab Emirates
Aalst, Oost Vlaanderen, Belgium
Ste Foy, Quebec, Canada
Nice Cedex, Alpes Maritimes, France
Clermont Ferrand, Auvergne Rhone Alpes, France
Finistere, Brest Cedex, France
Dijon Cedex, Cote Dor, France
Grenoble, Isere, France
Saint Denis, La Reunion, France
Bouches Du Rhone, Lyon, France
Seine Maritime, Rouen, France
Schleswig Holstein, Lubeck, Germany
Greifswald, Mecklenburg Vorpommern, Germany
Koln, Nordrhein Westfalen, Germany
Dusseldorf, North Rhine Westphalia, Germany
Herne, North Rhine Westphalia, Germany
Mainz A Rhein, Rheinland Pfalz, Germany
Magdeburg, Sachsen Anhalt, Germany
Greifwald, Vorpommern Greifswald, Germany
Kfar Saba, Hamerkaz, Israel
Ramat Gan, Tel Aviv District, Israel
Udine, Friuli Venezia Giulia, Italy
Cagliari, Sardegna, Italy
Dijon Cedex, Cote D Or, France
Orillia, Ontario, Canada
Lille Cedex, Nord, France
Aalst, Oost Vlaanderen, Belgium
Brugge, West Flanders, Belgium
Copenhagen, Capital Region, Denmark
Aarhus N, Central Denmark Region, Denmark
Aalborg, North Denmark, Denmark
Nice Cedex, Alpes Maritimes, France
Clermont Ferrand, Auvergne Rhone Alpes, France
Finistere, Brest Cedex, France
Dijon Cedex, Cote Dor, France
Bordeaux Cedex, Gironde, France
Grenoble, Isere, France
Saint Denis, La Reunion, France
Nantes, Loire Atlantique, France
Bouches Du Rhone, Lyon, France
Fort De France Cedex, Martinique, France
Seine Maritime, Rouen, France
Heidelberg, Baden Wuerttemberg, Germany
Erlangen, Bayern, Germany
Bad Bramstedt, Hamburg, Germany
Schleswig Holstein, Lubeck, Germany
Munich, Monachium, Germany
Planegg, Monachium, Germany
Koln, Nordrhein Westfalen, Germany
Herne, North Rhine Westphalia, Germany
Mainz A. Rhein, Rheinland Pfalz, Germany
Erfurt, Thuringia, Germany
Greifwald, Vorpommern Greifswald, Germany
Tiberias, Galilee, Israel
Beersheba, Hadarom, Israel
Haifa, Haifa District, Israel
Kfar Saba, Hamerkaz, Israel
Tel Hashomer, Hamerkaz, Israel
Afula, Northern District, Israel
Ramat Gan, Tel Aviv District, Israel
Tel Aviv, Tel Aviv District, Israel
Jerusalem, Yerushalayim, Israel
Napoli, Campania, Italy
Cona, Emilia Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Milano, Lombardia, Italy
Orebro, N Rke, Sweden
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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