UMIN ID: UMIN000001407
Registered date:01/10/2008
The Efficacy and Safety of the new biologic agents (humanized anti-human Interlukin-6 receptor monoclonal antibody) on abnormal lipid metabolism and atherosclerosis for rheumatoid arthritis patients in Japan
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 120 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Adiponectin Remnant like particles-cholesterol Each type of serum cholesterol Carotid echo sonography |
|---|---|
| Secondary Outcome | DAS28 Remission rate ACR core set Total Sharp Score |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | RA patients who have serious infection patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies patients with Primary or secondary immunodeficiency |
Related Information
| Primary Sponsor | The First Department of Internal Medicine.University of Occupation & Environmental Health |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuyoshi Saito |
| Address | 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, JAPAN Japan |
| Telephone | 093-603-1611 |
| kazu-s@med.uoeh-u.ac.jp | |
| Affiliation | University of Occupation & Environmental Health The First Department of Internal Medicine |
| scientific contact | |
| Name | Yoshiya Tanaka |
| Address | 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, JAPAN Japan |
| Telephone | 093-603-1611 |
| tanaka@med.uoeh-u.ac.jp | |
| Affiliation | University of Occupation & Environmental Health The First Department of Internal Medicine |