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

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ClinicalTrials.gov Identifier: NCT03006991
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Mo Xiaolan, Guangzhou Women and Children's Medical Center

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.

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis Other: therapeutic drug monitoring

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics
Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism [ Time Frame: 3 months ]
    genotype are collected from hospital system.


Secondary Outcome Measures :
  1. Concentration as measured by liquid chromatography mass spectrometry [ Time Frame: 3 months ]
    concentration of methotrexate are collected from hospital system


Biospecimen Retention:   Samples With DNA
DNA is extracted and stored in freezer with -80°C.


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients with Juvenile Idiopathic Arthritis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006991


Contacts
Contact: Xiaolan Mo, master 18820095289 ext +86 allenmor@163.com
Contact: Ping Zeng, master 18198915521 ext +86 734242355@qq.com

Locations
China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guandong, Guangdong, China, 510000
Contact: Huasong Zeng, Doctor    18902268736 ext +86    734242355@qq.com   
Contact: Hongwei Li, Master    18038767213 ext +86    734242355@qq.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
Principal Investigator: Xiaolan Mo, master Guangzhou Women and Children's Medical Center

Additional Information:
Publications:
Responsible Party: Mo Xiaolan, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT03006991     History of Changes
Other Study ID Numbers: 81603203
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mo Xiaolan, Guangzhou Women and Children's Medical Center:
methotrexate, Juvenile Idiopathic Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors