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

NCT ID: NCT03006991

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Juvenile Idiopathic Arthritis

Keywords

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methotrexate, Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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good efficacy

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

therapeutic drug monitoring

Intervention Type OTHER

dose of methotrexate can be adjusted by therapeutic drug monitoring.

poor efficacy

patients can not reach effective outcome.

No interventions assigned to this group

Interventions

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therapeutic drug monitoring

dose of methotrexate can be adjusted by therapeutic drug monitoring.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mo Xiaolan

Mo Xiaolan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaolan Mo, master

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

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Guangzhou Women and Children's Medical Center

Guandong, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaolan Mo, master

Role: CONTACT

Phone: 18820095289

Email: [email protected]

Ping Zeng, master

Role: CONTACT

Phone: 18198915521

Email: [email protected]

Facility Contacts

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Huasong Zeng, Doctor

Role: primary

Hongwei Li, Master

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 21219404 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=Influence+of+polymorphisms+within+the+methotrexate+pathway+genes+on+the+toxicity+and+efficacy+of+methotrexate+in+patients+with+juvenile+idiopathic+arthritis

Influence of polymorphisms within the methotrexate pathway genes on the toxicity and efficacy of methotrexate in patients with juvenile idiopathic arthritis

Other Identifiers

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81603203

Identifier Type: -

Identifier Source: org_study_id