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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Ospedali Riuniti di Ancona - Presidio Torrette Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Withdrawn |
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna Coordinator of this site? Confirm its status | Cona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Policlinico di Modena - AOU di Modena Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato Coordinator of this site? Confirm its status | Monserrato | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Policlinico Umberto I - Sapienza Università di Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| IRCCS Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano Umberto I Coordinator of this site? Confirm its status | Torino | Italy | Not yet recruiting |
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| AOUI Verona - Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.