- Male or female subjects between the ages of 18 and 75 years at screening (upper age
limit will be 64 years in India and 65 years in the Netherlands).
- Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to
- Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a
baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.
- Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings
suggestive of UC.
- Subjects diagnosed with Crohn's disease but without previous exposure to treatment
- Subjects receiving the following treatment for Crohn's disease:
- Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
- Anti-TNF? therapy within 8 weeks prior to baseline.
- Interferon therapy within 8 weeks prior to baseline.
- Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
- Intravenous corticosteroids within 2 weeks prior to baseline.