Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.

Recruiting now

Conditions studied: Lupus Erythematosus, Systemic

In brief

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

Key facts

Study ID

NCT07330245

Run by

AstraZeneca

People needed

218

Starts

2025-12-31

Expected to finish

2028-09-30

Last updated by the study team

2026-07-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato — Monserrato, CA, Italy (enrolling)
• Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna — Cona, Ferrara, Italy (enrolling)
• IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, Foggia, Italy (enrolling)
• IRCCS Humanitas Research Hospital — Rozzano, Milano, Italy (enrolling)
• AOU Ospedali Riuniti di Ancona - Presidio Torrette — Ancona, Italy (enrolling)
• Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (enrolling)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" — Palermo, Italy (enrolling)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (enrolling)
• Policlinico Umberto I - Sapienza Università di Roma — Roma, Italy (enrolling)
• Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara — Trieste, Italy (enrolling)
• ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine — Udine, Italy (enrolling)
• AOUI Verona - Ospedale Borgo Roma — Verona, Italy (enrolling)
• ASST Spedali Civili di Brescia — Brescia, Italy (enrolling)
• Azienda Ospedaliero-Universitaria Policlinico di Bari — Bari, Italy
• Policlinico Tor Vergata — Roma, Italy
• Azienda Ospedaliera Ordine Mauriziano Umberto I — Torino, Italy
• Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara — Pisa, Italy
• IRCCS Ospedale San Raffaele — Milan, Italy
• Policlinico di Modena - AOU di Modena — Modena, Italy
• Azienda Ospedaliera Universitaria "Luigi Vanvitelli" — Naples, Italy
• Azienda Ospedaliera di Padova — Padova, Italy

Full record on ClinicalTrials.gov

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