Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Dyslipidemia in Japanese Patients with Rheumatoid Arthritis: A Retrospective Multicentre Observational Study
Acronym
Study hypothesis
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).
Ethics approval
The Institutional Review Board of the Kyushu University School of Medicine approved on the 10th of May 2010
Study design
Retrospective multicentre observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Rheumatoid arthritis
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
To investigate the effect of administered statins in the treatment of dyslipidemia in Japanese patients with RA.
Overall trial start date
01/06/2009
Overall trial end date
31/03/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age > 18 yrs
2. Fulfilled the 1987 revised criteria for RA of the American College of Rheumatology
3. Access to medical record information
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
History of medical conditions other than RA which may affect lipid profile
Recruitment start date
01/06/2009
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Japan
Trial participating centre
Maidashi 3-1-1
Fukuoka
812-8582
Japan
Funders
Funder type
University/education
Funder name
Graduate School of Medical Sciences, Kyushu University (Japan) - Department of Orthopaedic Surgery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary