Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

Summary

The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.

Timeline

Start

2017-08-03

Primary completion

2020-08-14

Completion

2020-08-14

Outcome

Missed primary endpoint

registry analysis (superiority test); Induction Phase: Placebo vs Induction Phase: Vedolizumab 300 mg; p =0.347; Risk Difference (RD) -5.2 (95% CI -17.2 to 6.8); NCT03234907 ↗

Drugs

Indications