Status:
COMPLETED
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Crohn's and Colitis Foundation
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
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 no...
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 sur...
Eligibility Criteria
Inclusion
- age greater than or equal to 18;
- diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
- initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Exclusion
- less than 18 years of age
Key Trial Info
Start Date :
July 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT04852666
Start Date
July 25 2019
End Date
December 15 2022
Last Update
June 14 2024
Active Locations (2)
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1
Crohn's & Colitis Foundation
New York, New York, United States, 10017
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7555