EUCTR2005-000871-16-GB进行中（未招募）不适用
Methotrexate in adults with severe atopic dermatitis: a double-blind, randomised, parallel-group, placebo-controlled trial - Methotrexate vs. placebo in adults with severe atopic dermatitis
Dr John Berth-Jones0 个研究点目标入组 48 人开始时间: 2006年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of AD according to the revised criteria of Hanifin and Rajka (1980)
- •2. AD of severity assessed as severe, as defined by the criteria of Rajka and Langland (1989)
- •3. Aged between 16 and 70 years at the screening visit
- •4. Consistent use of the same topical corticosteroid for at least 1 month prior to the screening visit
- •5. Whether male or female, acceptance of need to use effective contraception during heterosexual activity, both during the study period and for 3 months after study medication has been discontinued
- •6. Finding on screening of:
- •- liver enzymes within 10% of the upper limit of normal
- •- normal renal function as assessed by serum creatinine
- •- normal full blood count or minor abnormality not of medical concern
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known to have liver impairment
- •2. History of, or currently admit to, high alcohol consumption
- •3. Known to have renal impairment
- •4. Suffering from an unexplained haematological abnormality
- •5. Significant pre-existing immunosuppression from any cause
- •6. History of malignancy, with the exception of cutaneous basal cell carcinoma
- •7. Scheduled elective surgical procedure during the trial period
- •8. Planning to start a family within the trial period or subsequent 3 months, whether male or female
- •9. In the case of female subjects, are < 8 weeks post partum or breast feeding
- •10. Suffering from pre-existing pulmonary fibrosis
- •11. Previous history of intolerance of MTX
- •12. Use of folate antagonists such as trimethoprim and co-trimoxazole, due to the risk of toxicity
- •13. Concomitant use of any systemic medication considered by the investigator to be likely to interact with MTX in a clinically significant manner, for example cytotoxic drugs, drugs with clear nephrotoxic or hepatotoxic potential, sulphonamides, pyrimethamine (in some antimalarials), dapsone and phenytoin.
- •14. Use of the following treatments within the following time limits before study treatment initiation:
- •- systemic corticosteroids during preceding 2 wks
- •- ciclosporin during preceding 2 wks
- •- topical immunosuppressantsduring preceding 4 wks
- •- PUVA / UVB during preceding 4 wks
- •- azathioprine during preceding 8 wks
- •- cytotoxic agents during preceding 8 wks
- •15. Suffering from active severe systemic infection, including viral hepatitis B or C
- •16. Likely requirement for vaccination during the course of the study
- •17. History of past or current substance abuse, psychiatric disease or condition which in the opinion of investigator may invalidate communication with the investigator
- •18. Any other chronic illness likely to alter the outcome of the study
- •19. Current participation in another clinical study, or previous participation in one within the preceding 3 months.
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