Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT04852666
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Biologics or Small Molecule Therapies After Failure of Anti-TNF Treatment in Patients With Crohn's Disease and Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2024-01
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:
COMPARE
Brief Summary:
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
Detailed Description:
This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.
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 |
|---|---|---|---|---|
| PaCR-2017C2-8172-IC | OTHER_GRANT | Patient-Centered Outcomes Research Institute (PCORI) | View |