<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03006991</url>
  </required_header>
  <id_info>
    <org_study_id>81603203</org_study_id>
    <nct_id>NCT03006991</nct_id>
  </id_info>
  <brief_title>Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics</brief_title>
  <official_title>Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Women and Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Women and Children's Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective&#xD;
      concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics&#xD;
      model to provide reference for individual administration on JIA pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to find out &quot;The critical reasons for individual variances in MTX of JIA pediatric&#xD;
      patients and quantize the influence of these factors&quot;, based on early research, this study&#xD;
      will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of&#xD;
      MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide&#xD;
      reference for individual administration on JIA pediatric patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism</measure>
    <time_frame>3 months</time_frame>
    <description>genotype are collected from hospital system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration as measured by liquid chromatography mass spectrometry</measure>
    <time_frame>3 months</time_frame>
    <description>concentration of methotrexate are collected from hospital system</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>good efficacy</arm_group_label>
    <description>using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>poor efficacy</arm_group_label>
    <description>patients can not reach effective outcome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>therapeutic drug monitoring</intervention_name>
    <description>dose of methotrexate can be adjusted by therapeutic drug monitoring.</description>
    <arm_group_label>good efficacy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA is extracted and stored in freezer with -80°C.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients with Juvenile Idiopathic Arthritis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients with Juvenile Idiopathic Arthritis&#xD;
&#xD;
          -  7.5-10mg/m2 per week per dose of methotrexate&#xD;
&#xD;
          -  all patients have been treated with methotrexate at least for 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-treated other drugs which can interact with methotrexate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaolan Mo, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Women and Children's Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaolan Mo, master</last_name>
    <phone>18820095289</phone>
    <phone_ext>+86</phone_ext>
    <email>allenmor@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ping Zeng, master</last_name>
    <phone>18198915521</phone>
    <phone_ext>+86</phone_ext>
    <email>734242355@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guandong</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huasong Zeng, Doctor</last_name>
      <phone>18902268736</phone>
      <phone_ext>+86</phone_ext>
      <email>734242355@qq.com</email>
    </contact>
    <contact_backup>
      <last_name>Hongwei Li, Master</last_name>
      <phone>18038767213</phone>
      <phone_ext>+86</phone_ext>
      <email>734242355@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>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</url>
    <description>Influence of polymorphisms within the methotrexate pathway genes on the toxicity and efficacy of methotrexate in patients with juvenile idiopathic arthritis</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>21219404</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Women and Children's Medical Center</investigator_affiliation>
    <investigator_full_name>Mo Xiaolan</investigator_full_name>
    <investigator_title>Mo Xiaolan</investigator_title>
  </responsible_party>
  <keyword>methotrexate, Juvenile Idiopathic Arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03006991
org study id: 81603203
nct id: NCT03006991
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism
time frame: 3 months
description: genotype are collected from hospital system.
measure: Concentration as measured by liquid chromatography mass spectrometry
time frame: 3 months
description: concentration of methotrexate are collected from hospital system
arm group label: good efficacy
description: using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome.
arm group label: poor efficacy
description: patients can not reach effective outcome.
intervention type: Other
intervention name: therapeutic drug monitoring
description: dose of methotrexate can be adjusted by therapeutic drug monitoring.
arm group label: good efficacy
DNA is extracted and stored in freezer with -80°C.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Xiaolan Mo, master
role: Principal Investigator
affiliation: Guangzhou Women and Children's Medical Center
last name: Xiaolan Mo, master
phone: 18820095289
phone ext: +86
email: allenmor@163.com
last name: Ping Zeng, master
phone: 18198915521
phone ext: +86
email: 734242355@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
url: 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
description: Influence of polymorphisms within the methotrexate pathway genes on the toxicity and efficacy of methotrexate in patients with juvenile idiopathic arthritis
citation: 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.
PMID: 21219404
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Women and Children's Medical Center
investigator full name: Mo Xiaolan
investigator title: Mo Xiaolan
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: No