An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have ulcerative colitis or Crohn's disease. This study will determine the
safety profile of long-term vedolizumab treatment.

The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300
mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:

• Vedolizumab 300 mg

All participants received vedolizumab intravenous infusion every 4 weeks for approximately up
to 510 weeks.

This multicenter trial is being conducted worldwide. The overall time to participate in this
study was up to October 2017 until vedolizumab was available in the country in which the
participant resided, or until participant withdrawal, whichever came first. Participants made
multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab
and were being followed up for 2-years during which a safety questionnaire was administered
by telephone for follow-up assessments.

Inclusion Criteria:

1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study
C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the
investigator, was well tolerated OR b. Moderate to severe Crohn's disease or
ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)

2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or
ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease