Research study for those with severe ulcerative colitis or Crohn's disease
A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease
A Phase 3, Open-Label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) In Patients with Ulcerative Colitis and Crohn’s Disease (Gemini LTS) Category: Crohn’s disease (moderate to severe) and ulcerative colitis (moderate to severe) Description: This is a multicenter, open-label study to collect data on the long term safety and efficacy of vedolizumab in adults with moderate to severe ulcerative colitis or Crohn’s disease. The duration of the study will vary by patient based on continued benefit, until vedolizumab is available for prescription in the US or until March 2016, whichever comes first. This research study continues to test the effect of an investigational drug, vedolizumab, in adults with moderate to severe ulcerative colitis or Crohn’s disease. Patients will be asked to come to the clinic monthly during active treatment. The dosing period will be followed by a post-treatment observation and safety assessment period of two years. Potential risks and discomforts may include headaches, nausea, stomach pain, tiredness and common cold. As with any investigational drug, additional risks and discomforts may be possible, like infections and hypersensitivity reactions (allergic response to the study drug). You should speak to a doctor who is participating in the study to receive a full description of the potential risks and discomforts. Millennium Pharmaceuticals, Inc. is the sponsor of this study.