Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
DAHLIA
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
1 other identifier
observational
218
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2025
CompletedStudy Start
First participant enrolled
December 31, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
April 29, 2026
April 1, 2026
2.8 years
December 19, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and percentage of patients achieving LLDAS5
proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows: * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; * No new lupus disease activity compared with previous assessment as defined per protocol; * Physician's Global Assessment (PGA) ≤1; * Current prednisone (-equivalent) dose ≤ 5mg/day; * Well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
52 weeks
Secondary Outcomes (11)
Number and percentage of patients reaching LLDAS5 at each time point
week 24, 76 and 104
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
week 4, 12, 24, 52, 76, 104 vs baseline
Median (range) cumulative dose of GCS
from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
Mean(SD) change in tender and swollen joint count
week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Power Doppler (PD) Signal Total score
week 4, 12, 24, 52, 76 and 104 vs week 0
- +6 more secondary outcomes
Interventions
anifrolumab - fully human monoclonal antibody target type I INF
Eligibility Criteria
Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
Monserrato, CA, 09032, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
Cona, Ferrara, 44124, Italy
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089, Italy
AOU Ospedali Riuniti di Ancona - Presidio Torrette
Ancona, 60126, Italy
Azienda Ospedaliero-Universitaria Policlinico di Bari
Bari, 70124, Italy
ASST Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Policlinico di Modena - AOU di Modena
Modena, 41124, Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, 90127, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
Pisa, 56126, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Policlinico Umberto I - Sapienza Università di Roma
Roma, 00161, Italy
Azienda Ospedaliera Ordine Mauriziano Umberto I
Torino, 10128, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, 34128, Italy
ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
Udine, 33100, Italy
AOUI Verona - Ospedale Borgo Roma
Verona, 37134, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2025
First Posted
January 9, 2026
Study Start
December 31, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04