Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Crohn's Disease Clinical Trial

— PPOD  

Official title:

Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02316678
• Other study ID #: 818347
• Status: Active, not recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: July 18, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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:

1. Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.

2. Less than 6 months of follow-up time within the data source prior to initiation of the therapy.

3. Diagnosis of cancer in the 6 months prior to initiation of the study medication.

4. Initiation of anti-TNF therapies within the first 6 months following surgery.

5. Patients who are in managed care plans (Medicare Part C).

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention
There is no intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	Crohn's and Colitis Foundation, Duke University, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death		Up to 66 months	No