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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 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.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
certolizumab pegol, certolizumab pegol, certolizumab pegol, certolizumab pegol
Atlanta Gastroenterology Associates
Not yet recruiting
Atlanta Gastroenterology Associates
Published on BioPortfolio: 2014-08-27T03:17:33-0400
This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blin...
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...