Triple Combination Therapy in High Risk Crohn's Disease (CD)

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have CD. This study will look at the endoscopic remission and mucosal
healing of gastrointestinal tract of people who take vedolizumab as triple combination
therapy with adalimumab and methotrexate.

The study will enroll approximately 60 participants. Participants will receive triple
combination therapy which includes:

- Vedolizumab 300 mg (intravenous)

- Adalimumab 160/80/40 mg (subcutaneous)

- Methotrexate 15 mg (Oral)

All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22
along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg
once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets
orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will
receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and
102.

This multi-center trial will be conducted in the United States and Canada. The overall time
to participate in this study is 128 weeks. Participants will make multiple visits to the
clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up
assessment. Participants will also participate in a long-term safety questionnaire, by phone,
at 26 weeks (6 months) from the last dose of study drug.

Inclusion Criteria:

1. Has an initial diagnosis of CD established within 24 months prior to screening with
involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

2. Has moderate to severely active CD during Screening defined by a centrally assessed
SES-CD score >=7 (or >=4 if isolated ileal disease).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
abscess.

3. Has a known perianal fistula with abscess. (The participant may have a perianal
fistula without abscess.)

4. Has a known fistula (other than perianal fistula).