NCT01407679终止2 期
Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study
University Hospital Muenster3 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
研究概览
简要总结
To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
- •Total RCLASI activity score of skin lesions >6 (at least 3 points in at least 2 locations);
- •At least one primary but preferably 2 methods of contraception;
排除标准
- •Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
- •Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •Active severe infection diseases, including chronic or localized;
- •Patients with hepatic insufficiency (AST, ALT > 2.5 x ULN), severe renal failure (creatinine clearance < 60ml/min), or hypercholesterolemia characterized by:
- •Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
- •Fasting total cholesterol > 1.5 x ULN
- •Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
- •Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
- •Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
- •Topical corticosteroids within 14 days prior to dosing;
- •Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
- •Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John"s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment;
- •Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life);
- •Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
- •Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
- •Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Alitretinoin
Experimental
干预措施: Alitretinoin (Drug)
结局指标
主要结局
Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.
时间窗: Week 24 or at the latest assessment for patients who withdrew prematurely.
Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")
次要结局
- Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions).(End of therapy (up to 24 weeks))
- Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment.(12 weeks after the beginning of treatment)
- Number of Participants with Adverse Events (AEs) and their severity.(24 weeks of treatment + 5 weeks of follow up)
- Proportion of patients with RCLASI 50 at week 12 of treatment.(Week 12 of treatment)
- Patient's global assessment and VAS for itch and pain at the end of therapy.(End of therapy (up to 24 weeks))
研究者
研究点 (3)
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