Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

- Males or females 18 years of age and older - Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion - Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX) - Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")

- History of cancer other than some skin and cervical cancers - History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis - Subjects with other, poorly controlled medical conditions - Subjects with any prior exposure to Tysabri® (natalizumab) - Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer) - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study