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Date: 2009-12-21
Phase: 32
Anouncement: Launch
Biotech:
Pharma: UCB (Belgium)
Product: certolizumab pegol - pegylated fab’ fragment of a humanized anti-TNF alpha monoclonal antibody
Disease: Crohn’s disease
Country: International and multicenter trial
Other: UCB announced the preliminary results of a recently completed Phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol in patients with moderately to severely
active Crohn’s disease.
The study randomized more than 400 adult patients from March 2008 through August 2009 at 104 medical facilities around the world.
The primary objective of the study was to evaluate the efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn’s disease as compared with standard of care based on a CDAI score at week 6.

The results showed that 32% of patients in the study taking certolizumab pegol achieved remission as early as week 6.
The study also showed that 25% of patients in the study taking a placebo achieved remission at week 6.
Certolizumab pegol results were numerically superior at all time points, but were not statistically significant in the overall population meaning the primary end point was not achieved.
Certolizumab pegol showed statistical significance in induction of remission in the more severe patient population as defined by inflammation levels and CDAI scores at baseline, as demonstrated by additional exploratory analyses.