Condition category
Musculoskeletal Diseases
Date applied
02/06/2010
Date assigned
29/06/2010
Last edited
29/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Taro Mawatari

ORCID ID

Contact details

Maidashi 3-1-1
Higashi-ku
Fukuoka
812-8582
Japan

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

Sponsor information

Organisation

Kyushu University (Japan)

Sponsor details

Department of Orthopaedic Surgery
Graduate School of Medical Sciences
Maidashi 3-1-1
Higashi-ku
Fukuoka
812-8582
Japan

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes