Study of Methotrexate Given to Juvenile Idiopathic Arthri... | NCT03006991

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

NCT03006991

Sponsor

Guangzhou Women and Children's Medical Center

Status

Unknown status

Last Update Posted

Dec 30, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Juvenile Idiopathic Arthritis

Interventions

therapeutic drug monitoring

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 28, 2016

First Submission Date that Met QC Criteria

Dec 28, 2016

First Posted Date

Dec 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2016

Last Update Posted Date

Dec 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mo Xiaolan, Mo Xiaolan, Guangzhou Women and Children's Medical CenterPrincipal Investigator

Lead Sponsor

Guangzhou Women and Children's Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
good efficacy		using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.	Other: therapeutic drug monitoring
poor efficacy		patients can not reach effective outcome.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
therapeutic drug monitoring	Other	dose of methotrexate can be adjusted by therapeutic drug monitoring.	good efficacy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients with Juvenile Idiopathic Arthritis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaolan Mo, master	Contact	18820095289	+86	allenmor@163.com
Ping Zeng, master	Contact	18198915521	+86	734242355@qq.com

Overall Officials

Name	Affiliation	Role
Xiaolan Mo, master	Guangzhou Women and Children's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Women and Children's Medical Center	Recruiting	Guandong	Guangdong	510000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21219404	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases