N/A
N=9,573
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
Colitis, Ulcerative · Inflammatory Bowel Diseases · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02316678 ↗Enrolled (actual)
9,573
Serious AEs
—
Results posted
Mar 2017
Primary outcome: Primary: Mortality Rate — 21.4; 30.1 events per 1000 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Rate |
21.4; 30.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or corticosteroids. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.
Exclusion Criteria
- Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.
- Less than 6 months of follow-up time within the data source prior to initiation of the therapy.
- Diagnosis of cancer in the 6 months prior to initiation of the study medication.
- Initiation of anti-TNF therapies within the first 6 months following surgery.
- Patients who are in managed care plans (Medicare Part C).
Data sourced from ClinicalTrials.gov (NCT02316678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.