RecruitingRecruiting
Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
NCT07330245 · AstraZeneca
In plain English
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Official title
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
About this study
DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.
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
Study design
Enrollment target: 218 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2025-12-31
Estimated completion: 2028-09-30
Last updated: 2026-06-25
Interventions
Biological: Anifrolumab
Primary outcomes
- • Number and percentage of patients achieving LLDAS5 (52 weeks)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (22)
Azienda Ospedaliero-Universitaria di Cagliari Presidio di MonserratoRecruiting
Monserrato, CA, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'AnnaRecruiting
Cona, Ferrara, Italy
IRCCS Casa Sollievo della SofferenzaRecruiting
San Giovanni Rotondo, Foggia, Italy
IRCCS Humanitas Research HospitalRecruiting
Rozzano, Milano, Italy
AOU Ospedali Riuniti di Ancona - Presidio TorretteRecruiting
Ancona, Italy
Azienda Ospedaliero-Universitaria Policlinico di BariWithdrawn
Bari, Italy
ASST Spedali Civili di BresciaRecruiting
Brescia, Italy
Azienda Ospedaliero-Universitaria CareggiRecruiting
Florence, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
IRCCS Ospedale San RaffaeleNot Yet Recruiting
Milan, Italy
Policlinico di Modena - AOU di ModenaNot Yet Recruiting
Modena, Italy
Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Not Yet Recruiting
Naples, Italy
Azienda Ospedaliera di PadovaNot Yet Recruiting
Padova, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"Recruiting
Palermo, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa ChiaraNot Yet Recruiting
Pisa, Italy
Policlinico Tor VergataNot Yet Recruiting
Roma, Italy
Policlinico Umberto I - Sapienza Università di RomaRecruiting
Roma, Italy
Azienda Ospedaliera Ordine Mauriziano Umberto INot Yet Recruiting
Torino, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di CattinaraRecruiting
Trieste, Italy
ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di UdineRecruiting
Udine, Italy
AOUI Verona - Ospedale Borgo RomaRecruiting
Verona, Italy