Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872491
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2021-05-03
Brief Title:
A Study of Vedolizumab in Adults in Real-World Practice
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Prospective Multicenter Single-arm Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohns disease
In this study adults with ulcerative colitis or Crohns disease will be treated with vedolizumab according to their clinics standard practice The main aim of the study is to check if participants have side effects from vedolizumab
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study
In this study adults with ulcerative colitis or Crohns disease will be treated with vedolizumab according to their clinics standard practice The main aim of the study is to check if participants have side effects from vedolizumab
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study
Detailed Description:
This is a non-interventional prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time
This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions
The study will enroll approximately 500 participants The data will be prospectively collected at the centers from routinely scheduled follow-up visits and recorded into electronic data capture eDC All participants will be enrolled in a single observational group
Participants with UC or CD
This multi-center trial will be conducted in China The overall duration of the study will be approximately 72 weeks
This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions
The study will enroll approximately 500 participants The data will be prospectively collected at the centers from routinely scheduled follow-up visits and recorded into electronic data capture eDC All participants will be enrolled in a single observational group
Participants with UC or CD
This multi-center trial will be conducted in China The overall duration of the study will be approximately 72 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None