Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:8/11/2018
Start Date:March 2008
End Date:November 2009

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Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered 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
clinical remission in patients with moderate to severe Crohn's disease as compared with
placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.


Inclusion Criteria:

- male/female

- 18 - 75 years inclusive

- diagnosis of Crohn's disease confirmed

- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)

- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

- previous participation in a certolizumab pegol study

- general exclusion criteria as common for studies in this indication
We found this trial at
25
sites
1813
mi
from 91732
Pell City, AL
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2309
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from 91732
Annapolis, MD
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1979
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from 91732
Chesterfield, MI
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1729
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Chicago, IL
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1880
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Cincinnati, OH
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2032
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from 91732
Cleveland, OH
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Colorado Springs, Colorado 80910
804
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from 91732
Colorado Springs, CO
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15 Concord Road
Concord, New South Wales 2137
7519
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Concord,
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1600
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from 91732
Germantown, TN
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2315
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Hollywood, FL
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2127
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Jacksonville, FL
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812
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from 91732
Lakewood, CO
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2313
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from 91732
Lancaster, PA
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813
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from 91732
Littleton, CO
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1813
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Louisville, KY
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1648
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Metairie, LA
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1495
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Monroe, LA
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2114
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New Port Richey, FL
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2336
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Norfolk, VA
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2214
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Raleigh, NC
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1524
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Rochester, MN
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964
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from 91732
Seattle, WA
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2300
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from 91732
Towson, MD
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West Bloomfield, Michigan 48322
1951
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from 91732
West Bloomfield, MI
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2184
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from 91732
Winter Park, FL
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