Fact CheckerSign in

NCT05637112Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
551 (actual)
First submitted
24 Nov 2022
Start date
27 Feb 2023
Primary completion date
30 Dec 2030
Lead sponsor
AstraZeneca
Diseases
Lupus (SLE)
NCT number
NCT05637112

What you commit to

  • Study type: Observational
  • Participants enrolled: 551
  • From 27 Feb 2023 to the primary completion date, 30 Dec 2030
  • 65 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Any other condition which the investigator deems to limit a patient's ability to understand the informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (65)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesUnknown status
-
Coordinator of this site? Confirm its status
DubaiUnited Arab EmiratesUnknown status
-
Coordinator of this site? Confirm its status
Sharjah cityUnited Arab EmiratesUnknown status
-
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
-
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
-
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
-
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
-
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
-
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
-
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
-
Coordinator of this site? Confirm its status
OrilliaCanadaUnknown status
-
Coordinator of this site? Confirm its status
RimouskiCanadaUnknown status
-
Coordinator of this site? Confirm its status
SherbrookeCanadaUnknown status
-
Coordinator of this site? Confirm its status
Ste-FoyCanadaUnknown status
-
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
-
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
-
Coordinator of this site? Confirm its status
Bad BramstedtGermanyUnknown status
-
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
-
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
-
Coordinator of this site? Confirm its status
D SseldorfGermanyUnknown status
-
Coordinator of this site? Confirm its status
ErlangenGermanyUnknown status
-
Coordinator of this site? Confirm its status
GreifswaldGermanyUnknown status
-
Coordinator of this site? Confirm its status
GreifwaldGermanyUnknown status
-
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
-
Coordinator of this site? Confirm its status
HerneGermanyUnknown status
-
Coordinator of this site? Confirm its status
MagdeburgGermanyUnknown status
-
Coordinator of this site? Confirm its status
Mainz A. RheinGermanyUnknown status
-
Coordinator of this site? Confirm its status
Schleswig-HolsteinGermanyUnknown status
-
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
-
Coordinator of this site? Confirm its status
Bouches-du-Rh NeFranceUnknown status
-
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
-
Coordinator of this site? Confirm its status
DijonFranceUnknown status
-
Coordinator of this site? Confirm its status
Finist ReFranceUnknown status
-
Coordinator of this site? Confirm its status
Fort de France CedexFranceUnknown status
-
Coordinator of this site? Confirm its status
GrenobleFranceUnknown status
-
Coordinator of this site? Confirm its status
LilleFranceUnknown status
-
Coordinator of this site? Confirm its status
NantesFranceUnknown status
-
Coordinator of this site? Confirm its status
NiceFranceUnknown status
-
Coordinator of this site? Confirm its status
ParisFranceUnknown status
-
Coordinator of this site? Confirm its status
Saint-DenisFranceUnknown status
-
Coordinator of this site? Confirm its status
Seine-MaritimeFranceUnknown status
-
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
-
Coordinator of this site? Confirm its status
AfulaIsraelUnknown status
-
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
-
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
-
Coordinator of this site? Confirm its status
Kfar SabaIsraelUnknown status
-
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
-
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
-
Coordinator of this site? Confirm its status
Tel HaShomerIsraelUnknown status
-
Coordinator of this site? Confirm its status
TiberiasIsraelUnknown status
-
Coordinator of this site? Confirm its status
AnconaItalyUnknown status
-
Coordinator of this site? Confirm its status
BariItalyUnknown status
-
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
-
Coordinator of this site? Confirm its status
CagliariItalyUnknown status
-
Coordinator of this site? Confirm its status
ConaItalyUnknown status
-
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
-
Coordinator of this site? Confirm its status
MilanItalyUnknown status
-
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
-
Coordinator of this site? Confirm its status
PisaItalyUnknown status
-
Coordinator of this site? Confirm its status
RomaItalyUnknown status
-
Coordinator of this site? Confirm its status
RomeItalyUnknown status
-
Coordinator of this site? Confirm its status
TurinItalyUnknown status
-
Coordinator of this site? Confirm its status
UdineItalyUnknown status
-
Coordinator of this site? Confirm its status
ÖrebroSwedenUnknown status
-
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.