NCT03804723Unknown不适用
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 321
- 主要终点
- disease flare
研究概览
简要总结
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations
- •Aged 18 to 75 years old, inclusive, at the time of informed consent
- •Documented diagnosis of SLE according to the current ACR criteria
- •Stable immunosuppressive treatment for SLE for a minimum of one year/six months
- •Stable treatment with antimalarials for a minimum of 3 months
- •stable (lasting for at least 6 months) low disease activity
排除标准
- •Disease activity (non LLDAS) within 6 months prior to screening
- •Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC).
- •Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule
- •Nursing mothers, pregnant women or women planning to become pregnant during the study.
研究组 & 干预措施
GC withdrawal
Experimental
干预措施: oral Prednisone 5mg (Drug)
non GC withdrawal
Placebo Comparator
干预措施: oral Prednisone 5mg (Drug)
结局指标
主要结局
disease flare
时间窗: 35 months
The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period.
次要结局
未报告次要终点
研究者
Marta Mosca
Assistant Professor of Rheumatology
University of Pisa
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