NCT00809172已完成3 期
Multicenter Randomised Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
研究概览
简要总结
The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.
Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.
We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 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
- None
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
- •Patients aged > 18 years old.
- •Both genders eligible for study.
- •Moderate to severe AD.
- •Scorad >
- •Participants must use a contraceptive method during the trial and for 3 months after the end of the trial for female and 5 months for male participants.
- •Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
- •Patients must be registered in a social security system or with a health insurance coverage.
排除标准
- •Pregnant or lactating women.
- •Evolutive skin disease.
- •Patients with a clinically significant disease (chronic, recurrent or active).
- •Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid the week before the inclusion.
- •Contra-indication to methotrexate and cyclosporine.
- •Exposure to phototherapy: cumulative dose > 2000 J/cm
- •Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
- •Patients under a protection measure.
- •Patients in a critical medical situation.
- •Patients with a personal situation evaluated by the investigator as unable to give optimal participation to the study, or where the study could constitute a risk for the patient.
研究组 & 干预措施
1
Active Comparator
Ciclosporin
干预措施: Ciclosporin (Drug)
2
Experimental
Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
proportion of patients with a 50% decrease of scorad ( scorad 50) after 8 weeks of treatment
时间窗: 36 months
次要结局
- Decrease of scorad by 50% at week4,12,16,20 and 24(at week4,12,16,20 and 24)
- Decrease of scorad by 75% and 90 % at week 8 and 24(at week 8 and 24)
- quality of life at week 8 and 24(at week 8 and 24)
- Concentration of cytokines CCL17 and CCL18(at week 8 and 24)
- number of adverse events(36 months)
研究者
研究点 (1)
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