NCT01551069已完成3 期
A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 103
- 试验地点
- 22
- 主要终点
- A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score
研究概览
简要总结
Primary Objective:
- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI [Cutaneous Lupus Erythematosus Disease Area and Severity Index] activity score is ≥4) concomitant treatment with or without corticosteroid.
Secondary Objectives:
- To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid.
- To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.
- To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid
- To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.
详细描述
Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HCQ
Active Comparator
HCQ 200~400mg, once daily, oral administration
干预措施: hydroxychloroquine (Z0188) (Drug)
Placebo
Other
HCQ-placebo, once daily, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score
时间窗: from baseline (at visit 2) to 16 weeks treatment (at visit 6)
次要结局
- A change in CLASI activity score(from baseline (at visit 2) to 52 weeks treatment (at visit 15))
- BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE(7 timepoints during 52 weeks)
- RAPID 3 (Routine assessment of patient index data 3) to be conducted in patients complicated with SLE : daily life activity, pain associated with the original disease, patient's severity related to the original disease(7 timepoints during 52 weeks)
- QOL related to skin manifestations (skindex-29)(4 timepoints during 52 weeks)
- Dose reduction of concomitant corticosteroid(From 16 weeks to 55 weeks after the initiation of the treatment)
- Global assessment by investigator (skin and other)(3 timepoints during 52 weeks)
- Global assessment by patient (skin)(3 timepoints during 52 weeks)
- Immunological parameters(up to maximum of 13 timepoints during 52 weeks)
- Number of patients with serious adverse events / adverse events(up to a maximum of 59 weeks)
- Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination)(14 timepoints during 52 weeks)
研究者
研究点 (22)
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