Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Completed

Conditions studied: Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02316678

Run by

University of Pennsylvania

People needed

9573

Starts

2014-09-01

Expected to finish

2016-12-01

Last updated by the study team

2017-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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