Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Completed

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn's Disease
• Interventions: Other: No intervention

• Registration Number: NCT02316678
• Lead Sponsor: University of Pennsylvania

Brief 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-01-20
• Results First Submitted QC: 2017-01-20
• Results First Posted: 2017-03-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9573

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corticosteroids - no intervention	No intervention	Patients initiating corticosteroids
anti-TNF - no intervention	No intervention	Patients who are new users of anti-TNF therapy

Primary Outcome Measures

Name	Time	Method
Mortality Rate	See Outcome Measure Description above	Incidence of death per 1000 person-years; Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States