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NCT03006991 Clinical Trial

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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:
Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03006991
Other study ID # 81603203
Secondary ID
Status Recruiting
Phase N/A
First received December 28, 2016
Last updated December 28, 2016
Start date November 2016
Est. completion date December 2023

Study information
Verified date December 2016
Source Guangzhou Women and Children's Medical Center
Contact Xiaolan Mo, master
Phone 18820095289
Email allenmor@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 18 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• therapeutic drug monitoring
dose of methotrexate can be adjusted by therapeutic drug monitoring.

Locations
Country Name City State
China Guangzhou Women and Children's Medical Center Guandong Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism genotype are collected from hospital system. 3 months No
Secondary Concentration as measured by liquid chromatography mass spectrometry concentration of methotrexate are collected from hospital system 3 months No
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