Optimizing Cimzia in Crohn's Patients

Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy

The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Inclusion Criteria:

• ileal and/or colonic Crohn's disease
• moderate to severe Crohn's disease

Exclusion Criteria:

• short bowel syndrome
• ostomy
• anti-TNF therapy within 4 weeks
• prior certolizumab therapy