Trial Information

Summary: Corticosteroid Sparing Effect of Certolizumab

A Phase IIIb Multicenter, Double-Blind, Placebo-Controlled,Randomized Trial to Examine the Corticosteroid-Sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in patients with moderate to severe Crohn's disease.

Inclusion Criteria:

• Men and women
• Age 18 years or older with moderate to severe Crohn's disease (CDAI score of ≥ 220 ≤450)

Exclusion Criteria:

• Active or draining fistula present at screening.
• Lactating and/or pregnant female patients.
• A history of any health condition that could potentially interfere with the disease and/or the treatment.
• A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.
• Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
• History of drug or alcohol abuse in the prior year.
• Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0.

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Trial listings updated: June 1, 2008 at 6:43:03 AM