Clinical Trials Overview
Studied in an extensive clinical trial program across disease states involving more than 5000 patients1
CIMZIA has been the subject of a comprehensive clinical program that includes two phase 3 studies: PRECiSE 1 and PRECiSE 2. The PRECiSE clinical trials were both double-blind, randomized, placebo-controlled studies that enrolled a total of more than 1000 adults with active moderate to severe Crohn's disease.1
These trials yielded robust data showing that CIMZIA provides sustained response and remission in a wide range of patients1-3:
- Bio-naïve (patients who have failed on conventional therapies)
- Bio-experienced (patients who have failed on conventional therapy and lost response or failed on prior biologics)
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
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References:
- CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2009.
- Sandborn WJ, Feagan BG, Stoinov S, et al; for the PRECiSE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007;375:228-238.
- Abreu M, Sandborn W, D'Haens G, et al. Certolizumab pegol is efficacious in Crohn's disease patients who have failed infliximab regardless of concomitant therapy or reason for failure (WELCOME). Poster presented at: American College of Gastroenterology Annual Meeting; October 3-8, 2008; Orlando, FL.