NCT07330245 Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
| NCT ID | NCT07330245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Lupus Erythematosus, Systemic |
| Study Type | OBSERVATIONAL |
| Enrollment | 218 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2028-09-30 |
Trial Parameters
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Brief Summary
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
Eligibility Criteria
Inclusion Criteria: * Provided informed consent to participate in the study; * Aged 18 years or older; * Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry; * Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria; Exclusion Criteria: * Patients who are at LLDAS5 at the time of study entry; * Previous exposure to anifrolumab; * 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, or active severe or unstable neuropsychiatric lupus * Currently participating in any interventional clinical trial with an investigational product; * Inability to understand and sign the informed consent and to fill in patient questionnaires
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