NCT02316678

Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,573 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

Detailed description

The investigators will conduct a comparative effectiveness study among Medicare Parts A, B, and D beneficiaries with inflammatory bowel disease. The investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. The investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. Cox regression will be employed to assess the hazard ratio for each of the outcomes.

Conditions

• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Crohn's Disease

Interventions

Type	Name	Description
OTHER	No intervention	There is no intervention

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-12-15
• Last updated: 2017-05-19
• Results posted: 2017-03-10

Locations

1 site across 1 country: United States