Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Inclusion Criteria:

Inclusion Criteria:

• Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
• Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
• C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Exclusion Criteria:

• Stoma patient
• Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
• Patients who participated in a clinical study with CDP870
• Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
• Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

Exclusion Criteria: