UMIN ID: UMIN000001222
Registered date:01/08/2008
Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | rheumatoid arthritis |
| Date of first enrollment | 2005/05/01 |
| Target sample size | 2000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence rate of serious adverse events. |
|---|---|
| Secondary Outcome | Type of serious adverse events, long term prognosis, death rates. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | A patient who has any of the following will be excluded from the study. 1. When a patient is participating in a clinical trial for approval of drugs (i.e., chiken) at the enrollment. 2. When a patient is regarded as inappropriate to join the study based on medical reasons or other rational reasons. 3. When a patient refuses to join the study or withdraw his or her consent. 4. When it is revealed that a patient did not satisfy the inclusion criteria at the enrollment or satisfies one of the exclusion criteria at the enrollment. |
Related Information
| Primary Sponsor | Department of Pharmacovigilance, Tokyo Medical and Dental University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Pharmacovigilance, Tokyo Medical and Dental University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masayoshi Harigai |
| Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan Japan |
| Telephone | 03-5803-4677 |
| mharigai.mpha@tmd.ac.jp | |
| Affiliation | REAL study headquarters Tokyo Medical and Dental University, Department of Pharmacovigilance |
| scientific contact | |
| Name | Masayoshi Harigai |
| Address | 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan Japan |
| Telephone | 03-5803-4677 |
| mharigai.mpha@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental University Department of Pharmacovigilance |