Dyslipidemia in Japanese Patients with Rheumatoid Arthritis
| ISRCTN | ISRCTN58708001 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58708001 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/06/2010
- Registration date
- 29/06/2010
- Last edited
- 29/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Taro Mawatari
Scientific
Scientific
Maidashi 3-1-1
Higashi-ku
Fukuoka
812-8582
Japan
Study information
| Study design | Retrospective multicentre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dyslipidemia in Japanese Patients with Rheumatoid Arthritis: A Retrospective Multicentre Observational Study |
| Study objectives | 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(s) | The Institutional Review Board of the Kyushu University School of Medicine approved on the 10th of May 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2009 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key 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 |
| Key exclusion criteria | History of medical conditions other than RA which may affect lipid profile |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/03/2013 |
Locations
Countries of recruitment
- Japan
Study participating centre
Maidashi 3-1-1
Fukuoka
812-8582
Japan
812-8582
Japan
Sponsor information
Kyushu University (Japan)
University/education
University/education
Department of Orthopaedic Surgery
Graduate School of Medical Sciences
Maidashi 3-1-1
Higashi-ku
Fukuoka
812-8582
Japan
"ROR" |
https://ror.org/00p4k0j84 |
|---|
Funders
Funder type
University/education
Graduate School of Medical Sciences, Kyushu University (Japan) - Department of Orthopaedic Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
