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Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics

NCT03006991 — Unknown, 100 participants, Guangzhou Women and Children's Medical Center
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Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics

RegistryNCT03006991
StatusUnknown
Study typeObservational
Enrollment100 (Estimated)
SponsorGuangzhou Women and Children's Medical Center (Other)
ConditionsJuvenile Idiopathic Arthritis
Interventionstherapeutic drug monitoring (Other)
Datesstart 2016-11-01, primary completion 2020-12-01 (estimated), completion 2023-12-01 (estimated), first posted 2016-12-30, last updated 2016-12-30
Locations1 site in China

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-Summary

This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

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+Detailed description

In order to find out "The critical reasons for individual variances in MTX of JIA pediatric patients and quantize the influence of these factors", based on early research, this study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

+Arms and interventions

ArmTypeInterventionsDescription
good efficacyOther: therapeutic drug monitoringusing therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.
poor efficacypatients can not reach effective outcome.
  • therapeutic drug monitoring (Other): dose of methotrexate can be adjusted by therapeutic drug monitoring.

+Outcome measures

Primary outcomes

  • Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism [3 months]: genotype are collected from hospital system.

Secondary outcomes

  • Concentration as measured by liquid chromatography mass spectrometry [3 months]: concentration of methotrexate are collected from hospital system

+Eligibility

Sex: All, ages: 1 Month to 18 Years

Inclusion Criteria:

* Pediatric patients with Juvenile Idiopathic Arthritis
* 7.5-10mg/m2 per week per dose of methotrexate
* all patients have been treated with methotrexate at least for 3 months

Exclusion Criteria:

* co-treated other drugs which can interact with methotrexate

+Locations (1)

FacilityCityCountryStatus
Guangzhou Women and Children's Medical CenterGuandong, GuangdongChinaRecruiting

+Publications

  • Yanagimachi M, Naruto T, Hara T, Kikuchi M, Hara R, Miyamae T, Imagawa T, Mori M, Kaneko T, Morita S, Goto H, Yokota S. Influence of polymorphisms within the methotrexate pathway genes on the toxicity and efficacy of methotrexate in patients with juvenile idiopathic arthritis. Br J Clin Pharmacol. 2011 Feb;71(2):237-43. doi: 10.1111/j.1365-2125.2010.03814.x. PMID 21219404

+Investigators

My Notes