Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT05637112
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT05637112
Study Brief:
Protocol Section:
NCT05637112