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

Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03006991
Enrollment
100
Registered
2016-12-30
Start date
2016-11-30
Completion date
2023-12-31
Last updated
2016-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Keywords

methotrexate, Juvenile Idiopathic Arthritis

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.

Interventions

OTHERtherapeutic drug monitoring

dose of methotrexate can be adjusted by therapeutic drug monitoring.

Sponsors

Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism3 monthsgenotype are collected from hospital system.

Secondary

MeasureTime frameDescription
Concentration as measured by liquid chromatography mass spectrometry3 monthsconcentration of methotrexate are collected from hospital system

Countries

China

Contacts

Primary ContactXiaolan Mo, master
allenmor@163.com18820095289
Backup ContactPing Zeng, master
734242355@qq.com18198915521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026