 - Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates ie, 5-aminosalicylic acid 5-ASA compounds or sulfasalazine SSZ, budesonide, systemic corticosteroids, or immunosuppressants eg, 6-mercaptopurine 6-MP, azathioprine AZA, or methotrexate MTX. 