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Therapeutic Areas: Gastroenterology
Disease Category: Inflammatory Bowel Disease

Trial Information

Investigational Drug Vedolizumab (MLN0002) for Adults with Moderate to Severe Ulcerative Colitis

Researchers at the Massachusetts General Hospital Crohn’s and Colitis Center are taking part in a research study that will collect information about the long-term safety and effectiveness of an investigational drug, Vedolizumab, for the treatment of moderate to severe ulcerative colitis.

This research study is for adults diagnosed with moderate to severe Ulcerative Colitis who have not responded well to other drug therapies. Subjects will receive infusions (injected into the vein) of the study drug or placebo (inactive salt water) every four weeks through week 50, with the option of enrolling in a long-term trial of Vedolizumab to receive further treatment. The research study includes a Screening Visit followed by 17 visits for infusions and clinical visits with doctor. The End of Study visit is week 52. If you do not roll in to the long-term trial, you will also be asked to participate in a Week 66 safety visit and long-term safety phone calls every 6 months for 2 years. Your doctor’s decision to prescribe Vedolizumab is separate from your taking part in the trial. It will take you about one year to complete the study.

For more information, please contact Elisabeth Cole at ecole4@partners.org, or (617) 724-7559.

Elisabeth B Cole
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
Phone: 6177247559
EMail: ecole4@gmail.com

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