CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 145 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02528435
NCT02528435N/ACompleted

Role of Pharmacogenetic and Psychological Factors in Methotrexate Tolerance: Studies in Children With Chronic Arthritis and Children With Leukemia

University of Aarhus·observational·Posted Aug 19, 2015·Updated Aug 20, 2018

In Brief

An observational study for Juvenile Idiopathic Arthritis and ALL. Completed, enrolled 145 participants.

Detailed Summary

Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in high-dose as part of the initial phase of treatment, gastrointestinal toxicity is a known problem. However when children reach maintenance treatment with low-dose methotrexate this is not described as a significant challenge. Children with juvenile idiopathic arthritis are another patient group receiving low-dose methotrexate. Among these patients gastrointestinal intolerance is such a significant problem that treatment may be ceased. The aim of this project is to create a greater understanding of gastrointestinal intolerance associated to low-dose methotrexate treatment by investigating the differences between these two patient groups, investigating genetic and psychological factors.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartDec 1, 2013
Primary CompletionAug 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.9 years ago