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

Guangzhou Women and Children's Medical Center

Status: Unknown

Conditions: Juvenile Idiopathic Arthritis

Treatments: Other: therapeutic drug monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03006991

81603203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

good efficacy

Description:

using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.

Treatment:

Other: therapeutic drug monitoring

poor efficacy

Description:

patients can not reach effective outcome.