NCT04852666

Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)

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
• Phase: —
• Study type: Observational
• Enrollment: 465 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease
• Ulcerative Colitis

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-04-21
• Last updated: 2024-06-14
• Results posted: 2024-06-14

Locations

2 sites across 1 country: United States