UMIN ID: UMIN000056622
Registered date:04/01/2025
Switching from originator adalimumab to biosimilar (CT-P17) in patients with inflammatory bowel disease (SORATOBI study)
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Inflammatory bowel disease (Ulcerative colitis, Crohn's disease) |
| Date of first enrollment | 2025/01/04 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The continuation rate of adalimumab biosimilar (CT-P17) at 56 weeks. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | No regulations |
Related Information
| Primary Sponsor | Sapporo IBD Clinic |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sapporo IBD Clinic |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroki Tanaka |
| Address | Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN 064-0919 |
| Telephone | +81-11-213-0397 |
| hirokit@mtc.biglobe.ne.jp | |
| Affiliation | Sapporo IBD Clinic Director |
| scientific contact | |
| Name | Hiroki Tanaka |
| Address | Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN |
| Telephone | +81-11-213-0397 |
| hirokit@mtc.biglobe.ne.jp | |
| Affiliation | Sapporo IBD Clinic Director |