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NCT07330245Recruiting

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

DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
218 (estimated)
First submitted
19 Dec 2025
Start date
31 Dec 2025
Primary completion date
30 Sept 2028
Lead sponsor
AstraZeneca
Diseases
Lupus (SLE)
NCT number
NCT07330245

What you commit to

  • Study type: Observational
  • Planned participants: 218
  • From 31 Dec 2025 to the primary completion date, 30 Sept 2028
  • 22 sites in 1 country
  • 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

  • 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;

Other

  • Patients who are at LLDAS5 at the time of study entry;
  • Inability to understand and sign the informed consent and to fill in patient questionnaires

Who the study is looking for

  • 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;

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AOU Ospedali Riuniti di Ancona - Presidio Torrette
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico di Bari
Coordinator of this site? Confirm its status
BariItalyWithdrawn
ASST Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Coordinator of this site? Confirm its status
ConaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Policlinico di Modena - AOU di Modena
Coordinator of this site? Confirm its status
ModenaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
Coordinator of this site? Confirm its status
MonserratoItalyRecruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyNot yet recruiting
Azienda Ospedaliera di Padova
Coordinator of this site? Confirm its status
PadovaItalyNot yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
Coordinator of this site? Confirm its status
PaviaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
Coordinator of this site? Confirm its status
PisaItalyNot yet recruiting
Policlinico Tor Vergata
Coordinator of this site? Confirm its status
RomaItalyNot yet recruiting
Policlinico Umberto I - Sapienza Università di Roma
Coordinator of this site? Confirm its status
RomaItalyRecruiting
IRCCS Humanitas Research Hospital
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
IRCCS Casa Sollievo della Sofferenza
Coordinator of this site? Confirm its status
San Giovanni RotondoItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano Umberto I
Coordinator of this site? Confirm its status
TorinoItalyNot yet recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Coordinator of this site? Confirm its status
TriesteItalyRecruiting
ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
Coordinator of this site? Confirm its status
UdineItalyRecruiting
AOUI Verona - Ospedale Borgo Roma
Coordinator of this site? Confirm its status
VeronaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.