A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis

Update Il y a 4 ans
Reference: EUCTR2007-004867-22

Woman and Man

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Extract

The primary objective of this study is to evaluate the clinical activity of AVONEX in subjects with moderate to severe UC. The primary endpoint is clinical response at Week 8, defined as a decrease from baseline in the Total Mayo Score/Disease Activity Index (DAI) of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 0 or 1.


Inclusion criteria

  • Moderate to severe Ulcerative Colitis