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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 218 participants in total. It began in 2025-12-31 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07330245 clinical trial?
This trial is open to participants of all sexes, studying Lupus Erythematosus, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07330245 currently recruiting?
Yes, NCT07330245 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07330245 trial being conducted?
This trial is being conducted at Monserrato, Italy, Cona, Italy, San Giovanni Rotondo, Italy, Rozzano, Italy and 11 additional locations.
Who is sponsoring the NCT07330245 clinical trial?
NCT07330245 is sponsored by AstraZeneca. The trial plans to enroll 218 participants.
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