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
Sites (65)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.