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MLN-0002_401 Entyvio (vedolizumab) long-term study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn's Disease. [Entyvio PASS Study]

NCT02674308

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

Associated Conditions

Inflammatory Bowel Disease (IBD)

Principal Investigator

Sponsor

Takeda Development Center Americas

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. Crohn’s Disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sore) 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 (a way to provide food through the nose or stomach), 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 (abnormal passage that can open up between the bowels and other parts of the body such as the skin) and GI abscesses (tender mass) and have serial bowel resections (removal of part of the bowels). Crohn’s Disease and Ulcerative Colitis can be treated with medications that suppress the immune system (the body system involved in inflammations and infections), or in some cases with surgery.