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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 218
- 试验地点
- 22
- 主要终点
- Number and percentage of patients achieving LLDAS5
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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
结局指标
主要结局
Number and percentage of patients achieving LLDAS5
时间窗: 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.
次要结局
- Number and percentage of patients reaching LLDAS5 at each time point(week 24, 76 and 104)
- Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction(week 4, 12, 24, 52, 76, 104 vs baseline)
- Median (range) cumulative dose of GCS(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(week 4, 12, 24, 52, 76 and 104 vs week 0)
- mean (SD) change in Power Doppler (PD) Signal Total score(week 4, 12, 24, 52, 76 and 104 vs week 0)
- mean (SD) change in Synovial Hypertrophy (SH) Total score(week 4, 12, 24, 52, 76 and 104 vs week 0)
- Annualize flaire rate(week 52 and week 104)
- Number and percentage of patients meeting the DORIS clinical remission(week 12, 24, 52, 76 and 104)
- Number and percentage of patients with sustained DORIS remission(week 104)
- Mean (SD) HDRS (Hamilton Depression Rating Scale) total score(week 12, 24, 52 and 104 vs week 0)
- Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score(week 12, 24, 52 and 104 vs week 0)