Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:November 2006
End Date:July 2009

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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 subjects with moderate to severe
Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at
a dose no higher than 30 mg/day prednisone or equivalent during the week prior to
randomization.


Inclusion Criteria:

- Men and women

- Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease
Activity Index (CDAI) score of ≥ 220 ≤450)

Exclusion Criteria:

- Active or draining fistula present at screening

- Lactating and/or pregnant female subjects

- 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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