A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease

Update Il y a 5 ans
Reference: EUCTR2014-003824-36

Woman and Man

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Extract

Efficacy Objectives Induction Phase • To evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing CDAI remission, defined as a CDAI score < 150 at the end of the Induction Phase (Week 14) Maintenance Phase • To evaluate the efficacy of etrolizumab compared with placebo in maintaining corticosteroid (CS)-free CDAI remission for 1 year (52 weeks) among patients who achieved sustained CDAI remission at the end of the Induction Phase (Weeks 10 and 14) Safety Objectives • To evaluate the overall safety and tolerability of etrolizumab compared with placebo during Induction and Maintenance Phases of therapy


Inclusion criteria

  • Crohn’s Disease