Trial record 114 of 180 for: "Arthritis, Juvenile Rheumatoid"
Understanding Methotrexate Induced Gastrointestinal Intolerance in Juvenile Idiopathic Arthritis and Childhood Leukemia
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|ClinicalTrials.gov Identifier: NCT02528435|
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : October 16, 2017
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
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.
|Condition or disease|
|Juvenile Idiopathic Arthritis ALL|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||Role of Pharmacogenetic and Psychological Factors in Methotrexate Tolerance: Studies in Children With Chronic Arthritis and Children With Leukemia|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||September 2017|
observationational study including children diagnosed with JIA. Patients aged 9 years and above, whom are treated with low-dose MTX may be included.
observationational study including children diagnosed with ALL. Patients aged 9 years and above, whom are in maintenance treatment with low-dose MTX may be included.
Primary Outcome Measures :
- Nausea ( "faces of nausea scale" in the nausea diary) [ Time Frame: after project year 2 there will be final data analysis ]
Biospecimen Retention: Samples With DNA
Blood sample to SNP analysis - see project description
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