Oppnåelse av LLDAS5 hos pasienter med systemisk lupus erythematosus behandlet med anifrolumab. (DAHLIA)
DAHLIA: Oppnåelse av lavt nivå av sykdomsaktivitet med en dose kortikosteroider mindre enn eller lik 5 mg (LLDAS5): en real-life studie med anifrolumab på pasienter med systemisk lupus erythematosus i Italia
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studiesteder
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Ancona, Italia, 60126
- Rekruttering
- AOU Ospedali Riuniti di Ancona - Presidio Torrette
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Bari, Italia, 70124
- Tilbaketrukket
- Azienda Ospedaliero-Universitaria Policlinico di Bari
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Brescia, Italia, 25123
- Rekruttering
- ASST Spedali Civili di Brescia
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Florence, Italia, 50134
- Rekruttering
- Azienda Ospedaliero-Universitaria Careggi
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Milan, Italia
- Har ikke rekruttert ennå
- IRCCS Ospedale San Raffaele
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Milan, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Modena, Italia, 41124
- Har ikke rekruttert ennå
- Policlinico di Modena - AOU di Modena
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Naples, Italia
- Har ikke rekruttert ennå
- Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
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Padova, Italia, 35128
- Har ikke rekruttert ennå
- Azienda Ospedaliera di Padova
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Palermo, Italia, 90127
- Rekruttering
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
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Pavia, Italia, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
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Pisa, Italia, 56126
- Har ikke rekruttert ennå
- Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
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Roma, Italia, 00133
- Har ikke rekruttert ennå
- Policlinico Tor Vergata
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Roma, Italia, 00161
- Rekruttering
- Policlinico Umberto I - Sapienza Università di Roma
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Torino, Italia, 10128
- Har ikke rekruttert ennå
- Azienda Ospedaliera Ordine Mauriziano Umberto I
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Trieste, Italia, 34128
- Rekruttering
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
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Udine, Italia, 33100
- Rekruttering
- ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
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Verona, Italia, 37134
- Rekruttering
- AOUI Verona - Ospedale Borgo Roma
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CA
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Monserrato, CA, Italia, 09032
- Rekruttering
- Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
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Ferrara
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Cona, Ferrara, Italia, 44124
- Rekruttering
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
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Foggia
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San Giovanni Rotondo, Foggia, Italia
- Rekruttering
- IRCCS Casa Sollievo della Sofferenza
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Milano
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Rozzano, Milano, Italia, 20089
- Rekruttering
- IRCCS Humanitas Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number and percentage of patients achieving LLDAS5
Tidsramme: 52 weeks
|
proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows:
|
52 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number and percentage of patients reaching LLDAS5 at each time point
Tidsramme: week 24, 76 and 104
|
Proportion of patients with LLDAS5, according the following definition: LLDAS5 is defined as follows:
|
week 24, 76 and 104
|
|
Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: week 12, 24, 52, 76 and 104
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D3461R00093
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