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Optimizing Cimzia in Crohn's Patients - NCT01024647-30342(Clinical Trial 424802)



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City:  Atlanta
State:  
GA
Zip Code: 30342
Conditions: Crohn's Disease
Purpose: 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.
Study summary: This open label 26 week clinical trial will evaluate treatment options in patients with moderate to severe Crohn's disease who have had insufficient initial response or who have lost response to certolizumab pegol (Cimzia). 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.
Criteria: 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
Study is available at: Atlanta Gastroenterology Associates
Atlanta, GA 30342
United States

Primary Contact:
Katie Neri, BSN
Email: kneri@atlantagastro.com
Phone: 404-257-9000
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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