Trial Information

Summary: Multi-Center Double -Blind Randomized Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Response in Patients With Crohn's Disease

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderately to Severely Active Crohn's Disease

The primary objective of the study is to evaluate efficacy of Certolizumab Pegol in inducing a clinical response in patients with moderately to severe Crohn's disease as compared with placebo based on CDAI score at week 6.

Inclusion Criteria:

• male/female
• 18 - 75 years inclusive
• diagnosis of Crohn's disease confirmed
• active disease confirmed
• on a stable dose of concomitant medication

Exclusion Criteria:

• previous participation in a certolizumab pegol study
• general exclusion as common for studies in this indication

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Trial listings updated: June 1, 2008 at 6:45:27 AM