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

August 27, 2026 updated by: AstraZeneca

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • AOU Ospedali Riuniti di Ancona - Presidio Torrette
      • Bari, Italy, 70124
        • Withdrawn
        • Azienda Ospedaliero-Universitaria Policlinico di Bari
      • Brescia, Italy, 25123
        • Recruiting
        • ASST Spedali Civili di Brescia
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy
        • Not yet recruiting
        • IRCCS Ospedale San Raffaele
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Modena, Italy, 41124
        • Not yet recruiting
        • Policlinico di Modena - AOU di Modena
      • Naples, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
      • Padova, Italy, 35128
        • Not yet recruiting
        • Azienda Ospedaliera di Padova
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
      • Roma, Italy, 00133
        • Not yet recruiting
        • Policlinico Tor Vergata
      • Roma, Italy, 00161
        • Recruiting
        • Policlinico Umberto I - Sapienza Università di Roma
      • Torino, Italy, 10128
        • Not yet recruiting
        • Azienda Ospedaliera Ordine Mauriziano Umberto I
      • Trieste, Italy, 34128
        • Recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
      • Udine, Italy, 33100
        • Recruiting
        • ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
      • Verona, Italy, 37134
        • Recruiting
        • AOUI Verona - Ospedale Borgo Roma
    • CA
      • Monserrato, CA, Italy, 09032
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy
        • Recruiting
        • IRCCS Casa Sollievo della Sofferenza
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • IRCCS Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and percentage of patients achieving LLDAS5
Time Frame: 52 weeks

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and percentage of patients reaching LLDAS5 at each time point
Time Frame: week 24, 76 and 104

Proportion of patients with LLDAS5, according the following definition:

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.
week 24, 76 and 104
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
Time Frame: week 4, 12, 24, 52, 76, 104 vs baseline
Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0
week 4, 12, 24, 52, 76, 104 vs baseline
Median (range) cumulative dose of GCS
Time Frame: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
Median cumulative dose of GCS calculated at each 6 month period following T0
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
Time Frame: week 4, 12, 24, 52, 76 and 104 vs week 0
Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity)
week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Power Doppler (PD) Signal Total score
Time Frame: week 4, 12, 24, 52, 76 and 104 vs week 0
Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high)
week 4, 12, 24, 52, 76 and 104 vs week 0
mean (SD) change in Synovial Hypertrophy (SH) Total score
Time Frame: week 4, 12, 24, 52, 76 and 104 vs week 0
Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high).
week 4, 12, 24, 52, 76 and 104 vs week 0
Annualize flaire rate
Time Frame: week 52 and week 104
Annualized flare rate in the first and second years
week 52 and week 104
Number and percentage of patients meeting the DORIS clinical remission
Time Frame: week 12, 24, 52, 76 and 104

Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:

  • Clinical SLEDAI-2K = 0;
  • PGA < 0.5;
  • Prednisolone ≤ 5 mg/day
week 12, 24, 52, 76 and 104
Number and percentage of patients with sustained DORIS remission
Time Frame: week 104
Number and percentage of patients with sustained DORIS remission, defined as remaining in remission at or greater than 12 weeks after having met the DORIS definition
week 104
Mean (SD) HDRS (Hamilton Depression Rating Scale) total score
Time Frame: week 12, 24, 52 and 104 vs week 0
Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe)
week 12, 24, 52 and 104 vs week 0
Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score
Time Frame: week 12, 24, 52 and 104 vs week 0
Change in PROMIS Depression Short Form 8b total score at different timepoints compared to week 0 (baseline). PROMIS raw scores ranges from 8 (no depression) to 40 (severe)
week 12, 24, 52 and 104 vs week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3461R00093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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