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

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Other: therapeutic drug monitoring

• Registration Number: NCT03006991
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

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.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-28
• Last Update Submitted: 2016-12-28
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30
• Primary Completion: 2020-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
good efficacy	therapeutic drug monitoring	using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.

Primary Outcome Measures

Name	Time	Method
Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism	3 months	genotype are collected from hospital system.

Secondary Outcome Measures

Name	Time	Method
Concentration as measured by liquid chromatography mass spectrometry	3 months	concentration of methotrexate are collected from hospital system

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guandong, Guangdong, China