A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Inclusion Criteria:

• Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
• If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

Exclusion Criteria:

• Ulcerative colitis or indeterminate colitis
• History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
• Body weight is below 30 kg
• Surgical bowel resections within the past 6 months
• Females who are pregnant or breast-feeding or considering becoming pregnant during the study