Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
This study has been withdrawn prior to enrollment.
Information provided by:
First received: July 18, 2006
Last updated: May 25, 2012
Last verified: May 2012
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Secondary Outcome Measures:
- Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
|Study Start Date:||January 2007|
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