Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

Inclusion Criteria:

• Subjects of Chinese descent with full Chinese parentage.
• Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.
• Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.
• Subject has a negative Tuberculosis (TB) Screening Assessment.
• Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Exclusion Criteria:

• Subject with ulcerative colitis or indeterminate colitis.
• Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.
• Subject with an ostomy or ileoanal pouch.
• Subject who has short bowel syndrome.
• Subject with symptomatic known obstructive strictures.
• Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
• Active, or chronic or recurring infections, or active tuberculosis.