Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn s Disease.

Brief description of study

This is an observational research study designed to gain additional information on patients with Inflammatory Bowel Disease (IBD) including Crohn’s Disease (CD) and Ulcerative Colitis (UC). The purpose of this study is to obtain long-term safety information on the disease and medications that you received or are receiving for your Inflammatory Bowel Disease. Results from this observational research study will be used to assist physicians in improving patient care with regard to clinical outcomes, and patient quality of life. Crohn’s Disease is characterized by inflammation and ulceration of the small and/or large intestines. Ulcerative Colitis is characterized by inflammation of the large intestine (colon). Patients with Crohn’s Disease and Ulcerative Colitis suffer from symptoms such as diarrhea, abdominal pain, rectal bleeding, weight loss, difficulty growing and fever. Many patients with UC or CD will continue to experience diarrhea that does not respond to normal treatment, rectal bleeding and require frequent hospitalizations, enteral nutrition, and surgical procedures. Specifically, patients with UC often will have surgery to remove part of the bowel, while patients with CD will regularly experience fistulae and GI abscesses and have serial bowel resections. Crohn’s Disease and Ulcerative Colitis can be treated with medications that suppress the immune system, or in some cases with surgery.

Clinical Study Identifier: s15-00918
ClinicalTrials.gov Identifier: NCT02674308
Principal Investigator: Lev Ginzburg.

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