Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398626
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-30
Brief Title:
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis ENDEAVOUR-UC
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ENDEAVOUR-UC
Brief Summary:
The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod
All patients will be prescribed etrasimod according to standard of care Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms These questionnaires will be completed by patients at various timepoints during the study using their mobile phone tablet or computer
The study is 52 weeks with 28 days of safety follow up The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod
All patients will be prescribed etrasimod according to standard of care Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms These questionnaires will be completed by patients at various timepoints during the study using their mobile phone tablet or computer
The study is 52 weeks with 28 days of safety follow up The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ENDEAVOUR-UC | OTHER | Alias Study Number | None |