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ISRCTN
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ISRCTN93945409
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ClinicalTrials.gov identifier
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Public title
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Use of dried blood spots to measure methotrexate levels and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM)
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Scientific title
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Use of dried blood spots to measure methotrexate levels and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM): an observational study
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Acronym
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N/A
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Serial number at source
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11019
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Study hypothesis
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Use of dried blood spots to measure methotrexate and its polyglutamates as biomarkers of methotrexate use in paediatric patients with Juvenile Idiopathic Arthritis (JIA) and Juvenile Dermatomyositis (JDM).
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Lay summary
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Lay summary under review
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Ethics approval
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Office of Research Ethics Committees of Northern Ireland, First MREC approval date 01/10/2011, ref: 10/NIR03/33
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Study design
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Non-randomised observational cross-sectional study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM)
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Participants - inclusion criteria
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1. Children aged 4-16 years diagnosed with either juvenile idiopathic arthritis or juvenile dermatomyositis (confirmed by a consultant) attending the rheumatology clinic at the paediatric rheumatology outpatient clinics at three sites: the Royal Liverpool Children's Hospital (Liverpool), Musgrave Park Hospital (Belfast) and the University College London (UCL) Institute of Child Health / Great Ormond Street Hospital for Children (GOSH) (London)
2. The child is prescribed methotrexate for at least 2 months (oral or subcutaneous)
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Participants - exclusion criteria
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Do not meet the above inclusion criteria or if patients (or their parents/ guardians) do not wish to particpate in the research
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Anticipated start date
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01/04/2011
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Anticipated end date
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01/04/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 60; UK Sample Size: 60
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Interventions
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We will test the possibility of developing an analytical method for the determination of methotrexate and its polyglutamate metabolites in dried blood spot samples. We will also be examining the practicality of home sampling in children.
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Primary outcome measure(s)
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To determine the possibility of developing an analytical method for the determination of methotrexate and its polyglutamate metabolites in dried blood spot samples
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Secondary outcome measure(s)
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To determine whether home sampling is practical
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Sources of funding
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Arthritis Research UK (UK)
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Trial website
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Publications
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Contact name
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Mr
Abdel
Qader Al Bawab
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Address
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Main Campus
University Road
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City/town
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Belfast
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Zip/Postcode
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BT7 1NN
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Country
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United Kingdom
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Email
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aalbawab02@qub.ac.uk
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Sponsor
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Arthritis Research UK (UK)
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Address
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ARC Epidemiology Unit
The Queen’s University of Belfast
University Road
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City/town
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Belfast
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Zip/Postcode
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BT97 1NN
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Country
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United Kingdom
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Sponsor website:
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http://www.arthritisresearchuk.org/
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Date applied
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20/10/2011
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Last edited
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02/12/2011
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Date ISRCTN assigned
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02/12/2011
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