Understanding Methotrexate Induced Gastrointestinal Intolerance in Juvenile Idiopathic Arthritis and Childhood Leukemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02528435
• Date of registration: 28/05/2015
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Understanding Methotrexate Induced Gastrointestinal Intolerance in Juvenile Idiopathic Arthritis and Childhood Leukemia
• Scientific title: Role of Pharmacogenetic and Psychological Factors in Methotrexate Tolerance: Studies in Children With Chronic Arthritis and Children With Leukemia
• Date of first enrolment: December 2013
• Target sample size: 145
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02528435
• Study type: Observational

Key inclusion & exclusion criteria

Inclusion Criteria:

- children diagnosed with JIA according to ILAR criteria, whom are followed at the
departments of pediatrics at Aarhus University Hospital Skejby and Odense University
Hospital.

- and children diagnosed with ALL, whom are followed at the departments of pediatrics at
Aarhus University Hospital Skejby, Aalborg University Hospital, Odense University
Hospital and Rigshospitalet.

- aged 9 years and above

- currently treated with low-dose MTX for at least six weeks

Exclusion Criteria:

- Children with cognitive difficulties will be excluded

- Children without ability to speak Danish will be excluded.



Age minimum: 9 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

ALL

Juvenile Idiopathic Arthritis

Primary Outcome(s)

Methotrexate-induced Nausea [Time Frame: after project year 2 there will be final data analysis]

Secondary Outcome(s)

Methotrexate Intolerance [Time Frame: after project year 2 there will be final data analysis]

Secondary ID(s)

MTX Project

Source(s) of Monetary Support

Please refer to primary and secondary sponsors