Clinical trial · Observational
Understanding Methotrexate Induced Gastrointestinal Intolerance in Juvenile Idiopathic Arthritis and Childhood Leukemia
Role of Pharmacogenetic and Psychological Factors in Methotrexate Tolerance: Studies in Children With Chronic Arthritis and Children With Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Juvenile Idiopathic Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- JIA patients
- description
- observationational study including children diagnosed with JIA. Patients aged 9 years and above, whom are treated with low-dose MTX may be included.
- label
- ALL patients
- description
- 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 outcomes (1)
- measure
- Methotrexate-induced Nausea
- timeFrame
- after project year 2 there will be final data analysis
- description
- "faces nausea scale" in the nausea diary
Secondary outcomes (1)
- measure
- Methotrexate Intolerance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (40)
- BACKGROUNDLaverdiere C, Chiasson S, Costea I, Moghrabi A, Krajinovic M. Polymorphism G80A in the reduced folate carrier gene and its relationship to methotrexate plasma levels and outcome of childhood acute lymphoblastic leukemia. Blood. 2002 Nov 15;100(10):3832-4. doi: 10.1182/blood.V100.10.3832. PMID 12411325
- BACKGROUNDLevinsen M, Rosthoj S, Nygaard U, Heldrup J, Harila-Saari A, Jonsson OG, Bechensteen AG, Abrahamsson J, Lausen B, Frandsen TL, Weinshilboum RM, Schmiegelow K. Myelotoxicity after high-dose methotrexate in childhood acute leukemia is influenced by 6-mercaptopurine dosing but not by intermediate thiopurine methyltransferase activity. Cancer Chemother Pharmacol. 2015 Jan;75(1):59-66. doi: 10.1007/s00280-014-2613-7. Epub 2014 Oct 28. PMID 25347948
- BACKGROUNDLopez-Lopez E, Gutierrez-Camino A, Bilbao-Aldaiturriaga N, Pombar-Gomez M, Martin-Guerrero I, Garcia-Orad A. Pharmacogenetics of childhood acute lymphoblastic leukemia. Pharmacogenomics. 2014 Jul;15(10):1383-98. doi: 10.2217/pgs.14.106. PMID 25155938
- BACKGROUNDPui CH, Schrappe M, Ribeiro RC, Niemeyer CM. Childhood and adolescent lymphoid and myeloid leukemia. Hematology Am Soc Hematol Educ Program. 2004:118-45. doi: 10.1182/asheducation-2004.1.118. PMID 15561680
- BACKGROUNDRau T, Erney B, Gores R, Eschenhagen T, Beck J, Langer T. High-dose methotrexate in pediatric acute lymphoblastic leukemia: impact of ABCC2 polymorphisms on plasma concentrations. Clin Pharmacol Ther. 2006 Nov;80(5):468-76. doi: 10.1016/j.clpt.2006.08.012. PMID 17112803
- BACKGROUNDGutierrez-Suarez R, Burgos-Vargas R. The use of methotrexate in children with rheumatic diseases. Clin Exp Rheumatol. 2010 Sep-Oct;28(5 Suppl 61):S122-7. Epub 2010 Oct 28. PMID 21044445
- BACKGROUNDWallace CA. The use of methotrexate in childhood rheumatic diseases. Arthritis Rheum. 1998 Mar;41(3):381-91. doi: 10.1002/1529-0131(199803)41:33.0.CO;2-3. No abstract available.