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Official Title

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

Achievement of LLDAS5 in patients with systemic lupus erythematosus treated with anifrolumab.

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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anifrolumab - fully human monoclonal antibody target type I INF

Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant’Anna

Policlinico Umberto I – Sapienza Università di Roma

Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

Azienda Ospedaliera di Padova

Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico

Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato

Fondazione IRCCS Policlinico San Matteo

Azienda Ospedaliera Universitaria Policlinico “Paolo Giaccone”

Policlinico Tor Vergata

Azienda Ospedaliero-Universitaria Policlinico di Bari

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) – Ospedale di Cattinara

AOU Ospedali Riuniti di Ancona – Presidio Torrette

ASST Spedali Civili di Brescia

ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine

Azienda Ospedaliera Ordine Mauriziano Umberto I

Policlinico di Modena – AOU di Modena

Azienda Ospedaliero-Universitaria Careggi

IRCCS Humanitas Research Hospital

AOUI Verona – Ospedale Borgo Roma

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

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.

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.

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

Median cumulative dose of GCS calculated at each 6 month period following T0

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)

Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high)

Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high).

Annualized flare rate in the first and second years

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

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

Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe)

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)

Achievement of LLDAS5 in patients with systemic lupus erythematosus treated with anifrolumab. - DAHLIA

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