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ISRCTN
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ISRCTN58708001
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ClinicalTrials.gov identifier
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Public title
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Dyslipidemia in Japanese Patients with Rheumatoid Arthritis
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Scientific title
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Dyslipidemia in Japanese Patients with Rheumatoid Arthritis: A Retrospective Multicentre 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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N/A
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Study hypothesis
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By investigating the prevalence of dyslipidemia and its relationships with disease activity, or medical interventions, it is possible to reduce subsequent mortality and morbidity of cardiovascular disease in patients with rheumatoid arthritis (RA).
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Lay summary
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Ethics approval
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The Institutional Review Board of the Kyushu University School of Medicine approved on the 10th of May 2010
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Study design
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Retrospective multicentre observational study
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Countries of recruitment
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Japan
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Disease/condition/study domain
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Rheumatoid arthritis
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Participants - inclusion criteria
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1. Age > 18 yrs
2. Fulfilled the 1987 revised criteria for RA of the American College of Rheumatology
3. Access to medical record information
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Participants - exclusion criteria
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History of medical conditions other than RA which may affect lipid profile
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Anticipated start date
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01/06/2009
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Anticipated end date
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31/03/2013
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Status of trial
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Ongoing |
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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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500
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Interventions
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Non-interventional, observational study.
The blood samples from a cohort of patients being treated with lipid-lowering drugs will be taken at baseline, 2, 4, 6, 8 months after administration.
Information will be collected on the patient's history of cardiovascular events.
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Primary outcome measure(s)
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1. To investigate the lipid profile and estimate the prevalence of dyslipidemia
2. To determine the relationships between the lipid profiles and the RA disease activity, or the treatments such as Disease Modifying Antirheumatic Drugs (DMARDs), biologics, glucocorticoids.
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Secondary outcome measure(s)
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To investigate the effect of administered statins in the treatment of dyslipidemia in Japanese patients with RA.
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Sources of funding
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Graduate School of Medical Sciences, Kyushu University (Japan) - Department of Orthopaedic Surgery
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Trial website
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Publications
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Contact name
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Dr
Taro
Mawatari
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Address
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Maidashi 3-1-1
Higashi-ku
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City/town
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Fukuoka
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Zip/Postcode
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812-8582
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Country
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Japan
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Sponsor
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Kyushu University (Japan)
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Address
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Department of Orthopaedic Surgery
Graduate School of Medical Sciences
Maidashi 3-1-1
Higashi-ku
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City/town
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Fukuoka
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Zip/Postcode
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812-8582
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Country
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Japan
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Date applied
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02/06/2010
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Last edited
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29/06/2010
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Date ISRCTN assigned
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29/06/2010
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