UMIN ID: UMIN000001240
Registered date:10/07/2008
The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | rheumatoid arthritis |
| Date of first enrollment | 2008/07/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years |
Outcome(s)
| Primary Outcome | DAS28 to be evaluated every 6 months for 3 years |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. pregnant women or women trying to get pregnant 2. patients with dementia 3. patients considered inappropriate judged by attending physicians |
Related Information
| Primary Sponsor | Division of Rheumatology & Clinical Immunology, Jichi Medical University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| hiro-iwa@jichi.ac.jp | |
| Affiliation | Jichi medical University Division of Rheumatology & Clinical Immunology |
| scientific contact | |
| Name | Masahiro Iwamoto |
| Address | 3311-1 Yakushiji, Shimotsuke, Tochigi Japan |
| Telephone | |
| Affiliation | Jichi medical University Division of Rheumatology & Clinical Immunology |