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

December 28, 2016 updated by: Mo Xiaolan, Guangzhou Women and Children's Medical Center

Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaolan Mo, master
  • Phone Number: +86 18820095289
  • Email: allenmor@163.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guandong, Guangdong, China, 510000
        • Recruiting
        • Guangzhou Women And Children's Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric patients with Juvenile Idiopathic Arthritis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
good efficacy
using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.
Other: therapeutic drug monitoring
dose of methotrexate can be adjusted by therapeutic drug monitoring.
poor efficacy
patients can not reach effective outcome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism
Time Frame: 3 months
genotype are collected from hospital system.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration as measured by liquid chromatography mass spectrometry
Time Frame: 3 months
concentration of methotrexate are collected from hospital system
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Investigators

  • Principal Investigator: Xiaolan Mo, master, Guangzhou Women And Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81603203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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