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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02528435
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease
Juvenile Idiopathic Arthritis ALL

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

JIA patients
observationational study including children diagnosed with JIA. Patients aged 9 years and above, whom are treated with low-dose MTX may be included.
ALL patients
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 :
  1. Methotrexate-induced Nausea [ Time Frame: after project year 2 there will be final data analysis ]
    "faces nausea scale" in the nausea diary

Secondary Outcome Measures :
  1. Methotrexate Intolerance [ Time Frame: after project year 2 there will be final data analysis ]
    Methotrexate Intolerance Severity Score by Bulatovic et al (see citation list)

Biospecimen Retention:   Samples With DNA
Blood sample to SNP analysis - see project description

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
see under project - and group description

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.


Responsible Party: University of Aarhus Identifier: NCT02528435     History of Changes
Other Study ID Numbers: MTX Project
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: April 2017

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors