ISRCTN15837754已完成未知
A randomised controlled trial assessing the effectiveness, safety and cost-effectiveness of methotrexate versus ciclosporin in the treatment of severe atopic eczema in children: The TREatment of Severe Atopic Eczema Trial (TREAT)
King's College London (UK)0 个研究点目标入组 103 人开始时间: 2016年3月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29727479 protocol (added 11/07/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37722926/ (added 20/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent for study participation obtained from the patient or parents/legal guardian, with assent as appropriate by the patient, depending on the level of understanding
- •2. Aged 2-16 years at the time of the screening and randomisation visit
- •3. Diagnosis of severe recalcitrant atopic ezcema
- •4. History of inadequate clinical response (in the opinion of the treating clinician) to mild to potent topical corticosteroids
- •5. An objective (o)-SCORAD severity score of at least 30
- •6. Participants must live within travelling distance of the recruiting centre
- •7. Females of childbearing potential, who are sexually active, must commit to consistent and correct use of an acceptable method of contraception for the duration of the trial and for 3 months after the last dose of study drug
- •8. Willingness to comply with study requirements
- •9. Ability to swallow tablets/capsules
- •10. Baseline visit within 2 weeks of the screening visit
排除标准
- •1. Serious underlying medical condition which in the opinion of the Investigator would compromise the safety of the patient
- •2. Pregnant or nursing (lactating) females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •3. Any active and/or chronic infection at screening or baseline (randomisation) visit that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study
- •4. Presence of moderate to severe impaired renal function as indicated by clinically significantly abnormal creatinine (= 1.5 x upper normal limit (ULN) for age and sex) or eGFR <60ml/min/1.73m2 at screening visit*
- •5. Clinical evidence of liver disease or liver injury at screening visit as indicated by abnormal liver function tests such as AST, ALT, GGT, alkaline phosphatase, or serum bilirubin (must not exceed 1.5 x the upper limit value of the normal range for age and sex)
- •6. Total WBC count <3x109/L, or platelets <150x109/L or neutrophils <1.5x109/L or haemoglobin <8.5 g/dL at screening visit
- •7. Blood pressure values > 95th percentile for age and sex at screening and baseline visit
- •8. Received systemic cortico-steroids within 14 days prior to screening visit and 28 days of baseline visit
- •9. Received phototherapy within 4 weeks prior to screening visit and 6 weeks of the baseline visit
- •10. Previous exposure to any biologic agents or systemic immuno-suppressive therapy, except for oral corticosteroids (CS) for acute flare management
- •11. Concomitant use of disease-modifying and/or immunosuppressive drugs
- •12. Received live vaccines within 4 weeks prior to baseline visit
- •13. Currently participating in a conflicting study or participation in a clinical study involving a medicinal product in the last 28 days or less than 5 half-lives of the medicinal product prior to the screening visit
- •14. Known hypersensitivity to methotrexate or ciclosporin products
- •15. Insufficient understanding of the trial
- •*Formula for measuring eGFR = height (cm) x 40 / Plasma creatinine (micromol/l)
研究者
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