UMIN ID: UMIN000001203
Registered date:01/09/2008
Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE)
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 15000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 1. accumulated incidence of malignant lymphoma in patients with RA who have received biological DMARDs 2. pathological classification and percentages of malignant lymphoma in patients with RA who have received biological DMARDs |
|---|---|
| Secondary Outcome | 1. Five-year survival rate of patients with RA who have received biological DMARDs 2. accumulated incidence of hematological malignancy including malignant lymphoma in patients with RA who have received biological DMARDs 3. accumulated incidence of non-hematological malignancy in patients with RA who have received biological DMARDs 4. classification and percentages of malignancies in patients with RA who have received biological DMARDs 5. percentages of malignancy as causes of death in patients with RA who have received biological DMARDs |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| 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 refuses to join the study or withdraw his or her consent. 2. When a doctor judged a patient not appropriate to join the study based on medical or social reasons. |
Related Information
| Primary Sponsor | Japan College of Rheumatology |
|---|---|
| Secondary Sponsor | None |
| Source(s) of Monetary Support | Japan College of Rheumatology Depertment of Pharmacovigilance, Tokyo Medical and Dental university,None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masayoshi Harigai |
| Address | 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo Japan |
| Telephone | 03-5803-4677 |
| secure.phv@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental university Depertment of Pharmacovigilance, Depertment of medicine and Rheumatology |
| scientific contact | |
| Name | Takao Koike |
| Address | N15 W7, Kita-ku, Sapporo Japan |
| Telephone | 011-716-1161(5913) |
| Affiliation | Hokkaido University Graduate School of Medicine Department of Medicine II |