接受Anifrolumab治疗的系统性红斑狼疮患者实现LLDAS5。 (DAHLIA)
DAHLIA：以≤5毫克皮质类固醇剂量实现低疾病活动度（LLDAS5）：意大利系统性红斑狼疮患者使用阿尼鲁单抗的真实世界研究
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：AstraZeneca Clinical Study Information Center
- 电话号码：1-877-240-9479
- 邮箱：information.center@astrazeneca.com
学习地点
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Ancona、意大利、60126
- 招聘中
- AOU Ospedali Riuniti di Ancona - Presidio Torrette
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Bari、意大利、70124
- 撤销
- Azienda Ospedaliero-Universitaria Policlinico di Bari
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Brescia、意大利、25123
- 招聘中
- ASST Spedali Civili di Brescia
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Florence、意大利、50134
- 招聘中
- Azienda Ospedaliero-Universitaria Careggi
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Milan、意大利
- 尚未招聘
- IRCCS Ospedale San Raffaele
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Milan、意大利、20122
- 招聘中
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Modena、意大利、41124
- 尚未招聘
- Policlinico di Modena - AOU di Modena
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Naples、意大利
- 尚未招聘
- Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
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Padova、意大利、35128
- 尚未招聘
- Azienda Ospedaliera di Padova
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Palermo、意大利、90127
- 招聘中
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
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Pavia、意大利、27100
- 招聘中
- Fondazione IRCCS Policlinico San Matteo
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Pisa、意大利、56126
- 尚未招聘
- Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
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Roma、意大利、00133
- 尚未招聘
- Policlinico Tor Vergata
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Roma、意大利、00161
- 招聘中
- Policlinico Umberto I - Sapienza Università di Roma
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Torino、意大利、10128
- 尚未招聘
- Azienda Ospedaliera Ordine Mauriziano Umberto I
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Trieste、意大利、34128
- 招聘中
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
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Udine、意大利、33100
- 招聘中
- ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
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Verona、意大利、37134
- 招聘中
- AOUI Verona - Ospedale Borgo Roma
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CA
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Monserrato、CA、意大利、09032
- 招聘中
- Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
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Ferrara
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Cona、Ferrara、意大利、44124
- 招聘中
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
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Foggia
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San Giovanni Rotondo、Foggia、意大利
- 招聘中
- IRCCS Casa Sollievo della Sofferenza
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Milano
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Rozzano、Milano、意大利、20089
- 招聘中
- IRCCS Humanitas Research Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number and percentage of patients achieving LLDAS5
大体时间：52 weeks
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proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows:
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52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number and percentage of patients reaching LLDAS5 at each time point
大体时间：week 24, 76 and 104
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Proportion of patients with LLDAS5, according the following definition: LLDAS5 is defined as follows:
|
week 24, 76 and 104
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Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
大体时间：week 4, 12, 24, 52, 76, 104 vs baseline
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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
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Median (range) cumulative dose of GCS
大体时间：from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
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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
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Mean(SD) change in tender and swollen joint count
大体时间：week 4, 12, 24, 52, 76 and 104 vs week 0
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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
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mean (SD) change in Power Doppler (PD) Signal Total score
大体时间：week 4, 12, 24, 52, 76 and 104 vs week 0
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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
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mean (SD) change in Synovial Hypertrophy (SH) Total score
大体时间：week 4, 12, 24, 52, 76 and 104 vs week 0
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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
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Annualize flaire rate
大体时间：week 52 and week 104
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Annualized flare rate in the first and second years |
week 52 and week 104
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Number and percentage of patients meeting the DORIS clinical remission
大体时间：week 12, 24, 52, 76 and 104
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Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:
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week 12, 24, 52, 76 and 104
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Number and percentage of patients with sustained DORIS remission
大体时间：week 104
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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
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Mean (SD) HDRS (Hamilton Depression Rating Scale) total score
大体时间：week 12, 24, 52 and 104 vs week 0
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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
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Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score
大体时间：week 12, 24, 52 and 104 vs week 0
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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
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.