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 sites103 target enrollmentMarch 9, 2016

ConditionsTopic: Children, Dermatology Subtopic: Children (all Diagnoses), Dermatology (Skin)Disease: All Diseases, Dermatology Skin and Connective Tissue Diseases Severe atopic eczema

Overview

Phase: 未知
Intervention: Not specified
Conditions: Topic: Children, Dermatology
Sponsor: King's College London (UK)
Enrollment: 103
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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)

Registry

who.int

Start Date

March 9, 2016

End Date

July 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

King's College London (UK)

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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