Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics
Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedDecember 30, 2016
December 1, 2016
4.1 years
December 28, 2016
December 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism
genotype are collected from hospital system.
3 months
Secondary Outcomes (1)
Concentration as measured by liquid chromatography mass spectrometry
3 months
Study Arms (2)
good efficacy
using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.
poor efficacy
patients can not reach effective outcome.
Interventions
dose of methotrexate can be adjusted by therapeutic drug monitoring.
Eligibility Criteria
Pediatric patients with Juvenile Idiopathic Arthritis
You may qualify if:
- Pediatric patients with Juvenile Idiopathic Arthritis
- mg/m2 per week per dose of methotrexate
- all patients have been treated with methotrexate at least for 3 months
You may not qualify if:
- co-treated other drugs which can interact with methotrexate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Women and Children's Medical Center
Guandong, Guangdong, 510000, China
Related Publications (1)
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: 21219404BACKGROUND
Related Links
Biospecimen
DNA is extracted and stored in freezer with -80°C.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolan Mo, master
Guangzhou Women and Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mo Xiaolan
Study Record Dates
First Submitted
December 28, 2016
First Posted
December 30, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2023
Last Updated
December 30, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share