Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 7:41 PM
Study NCT ID:
NCT03824561
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Special Drug-Use Surveillance Study on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
Detailed Description:
The drug being tested in this study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.
This study is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.
This multi-center observational trial will be conducted in Japan.
This study is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.
This multi-center observational trial will be conducted in Japan.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| jRCT1080224534 | REGISTRY | jRCT | View |