NCT02558517Unknown3 期
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus
Groupe Hospitalier Pitie-Salpetriere1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
研究概览
简要总结
Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with SLE according to the ACR revised criteria.
- •Quiescent disease without flare since at least one year (SELENA SLEDAI < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year
排除标准
- •failure to sign the informed consent or unable to consent
- •Patient participating to another clinical trial
- •Pregnancy or plan to become pregnant
研究组 & 干预措施
Prednisone discontinuation
Experimental
Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..)
干预措施: prednisone discontinuation (Drug)
结局指标
主要结局
Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
时间窗: 12 months
次要结局
未报告次要终点
研究者
Dr Cohen Aubart
MD, PhD
Groupe Hospitalier Pitie-Salpetriere
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease StateSystemic Lupus Erythematosus (SLE)NCT04451772AbbVie185
已完成
不适用
Disease Progression and Activity in Patients With Systemic Lupus ErythematosusLupusNCT00339261National Institute of Environmental Health Sciences (NIEHS)716
终止
不适用
Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in FranceLupusNCT03953690Centre Hospitalier Universitaire Dijon221
尚未招募
不适用
Myeloid Derived Suppressor Cells in Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05424627Central Hospital, Nancy, France80
进行中（未招募）
2 期
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteineSystemic Lupus ErythematosusNCT00775476State University of New York - Upstate Medical University290