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Effectiveness of Anifrolumab for Systemic Lupus Erythematosus in Real-World Settings

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

Observational AstraZeneca · NCT05637112

This study is testing how well the new treatment anifrolumab works for people with systemic lupus erythematosus who are starting it for the first time, focusing on their overall health and skin symptoms over three years.

Quick facts

Study typeObservational
Enrollment562 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsanifrolumab, cyclophosphamide
Locations88 sites (Graz, Styria and 87 other locations)
Trial IDNCT05637112 on ClinicalTrials.gov

What this trial studies

The ASTER study aims to collect real-world data on the effectiveness of anifrolumab in patients diagnosed with systemic lupus erythematosus (SLE) who are starting this treatment for the first time. This multi-country, single-arm, prospective observational study will gather clinical and patient-reported outcome data over a three-year follow-up period, starting from the first prescription of anifrolumab. The study will also assess the impact of anifrolumab on skin manifestations associated with SLE. Data will be collected electronically to ensure consistency across various healthcare providers involved in the study.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have been diagnosed with SLE and are being prescribed anifrolumab for the first time.

Not a fit: Patients currently participating in other clinical trials or those with prior exposure to anifrolumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of anifrolumab, potentially improving treatment strategies for SLE patients.

How similar studies have performed: Other studies have shown promise in evaluating the effectiveness of treatments for SLE, but this specific observational approach with anifrolumab is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Graz, Styria and 87 other locations

+38 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus Erythematosuschronic autoimmune diseaseimmunosuppressantscorticosteroidshuman monoclonal antibodyReal World
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.