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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab | Biological | anifrolumab - fully human monoclonal antibody target type I INF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of patients achieving LLDAS5 | proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows:
| 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of patients reaching LLDAS5 at each time point | Proportion of patients with LLDAS5, according the following definition: LLDAS5 is defined as follows:
|
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato | Recruiting | Monserrato | CA | 09032 | Italy | |
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| week 24, 76 and 104 |
| Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction | 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 | 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 | 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 | 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 | 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 | Annualized flare rate in the first and second years | week 52 and week 104 |
| Number and percentage of patients meeting the DORIS clinical remission | Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:
| week 12, 24, 52, 76 and 104 |
| Number and percentage of patients with sustained DORIS remission | 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 | 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 | 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 |
| Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna |
| Recruiting |
| Cona |
| Ferrara |
| 44124 |
| Italy |
| IRCCS Casa Sollievo della Sofferenza | Recruiting | San Giovanni Rotondo | Foggia | Italy |
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | Milano | 20089 | Italy |
| AOU Ospedali Riuniti di Ancona - Presidio Torrette | Recruiting | Ancona | 60126 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico di Bari | Withdrawn | Bari | 70124 | Italy |
| ASST Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| IRCCS Ospedale San Raffaele | Not yet recruiting | Milan | Italy |
| Policlinico di Modena - AOU di Modena | Not yet recruiting | Modena | 41124 | Italy |
| Azienda Ospedaliera Universitaria "Luigi Vanvitelli" | Not yet recruiting | Naples | Italy |
| Azienda Ospedaliera di Padova | Not yet recruiting | Padova | 35128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" | Recruiting | Palermo | 90127 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
| Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara | Not yet recruiting | Pisa | 56126 | Italy |
| Policlinico Tor Vergata | Not yet recruiting | Roma | 00133 | Italy |
| Policlinico Umberto I - Sapienza Università di Roma | Recruiting | Roma | 00161 | Italy |
| Azienda Ospedaliera Ordine Mauriziano Umberto I | Not yet recruiting | Torino | 10128 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara | Recruiting | Trieste | 34128 | Italy |
| ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine | Recruiting | Udine | 33100 | Italy |
| AOUI Verona - Ospedale Borgo Roma | Recruiting | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582345 | anifrolumab |
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