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ELN » Topics » The ENCORE Study

This excerpt taken from the ELN 6-K filed Jun 30, 2005.

The ENCORE Study

ENCORE was a Phase III, international, double-blind, placebo-controlled study of 510 patients at 114 sites to evaluate the safety and efficacy of intravenous TYSABRI in patients with moderately to severely active Crohn’s disease (based on a confirmed diagnosis of CD and a CDAI score of > 220 and < 450) and evidence of active inflammation (as evidenced by elevated C-reactive protein (CRP) levels of CRP > 2.87 mg/l, the upper limit of normal). Patients were randomized 1:1 to treatment with TYSABRI (300mg) or placebo infusions at weeks 0, 4, and 8. Efficacy and safety assessments were performed at weeks 4, 8 and 12, and the study remains ongoing for safety follow-up.

 

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