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. 2023 Jul 17;2023(7):CD013611. doi: 10.1002/14651858.CD013611.pub2

1. Induction studies' characteristics.

Study ID Numbers randomised group Trial registration number Published protocol Do the outcomes reported match the protocol or trial register?
Feagan 2008 185 participants randomised into 3 arms.
  • IV placebo (n = 58) at days 1 and 29

  • IV vedolizumab (MLN0002) 0.5 mg/kg (n = 62) at days 1 and 29

  • IV vedolizumab (MLN0002) 2 mg/kg (n = 65) at days 1 and 29

Not found Not found N/A
Sandborn 2013 – Induction Phase 368 participants randomised into 2 arms in a 3:2 ratio (intervention:placebo)
  • IV placebo (n = 148) at weeks 0 and 2

  • IV vedolizumab 300 mg (n = 220) at weeks 0 and 2

ClinicalTrials.gov number: NCT00783692 Yes Yes
Sands 2014 315 participants randomised into 2 arms
  • IV placebo (n = 207) at weeks 0, 2 and 6

  • IV vedolizumab 300 mg (n = 209) at weeks 0, 2 and 6

ClinicalTrials.gov number: NCT01224171 Not found N/A
Watanabe 2020 – Induction Phase 157 participants randomised into 2 arms
  • IV placebo (n = 78) at weeks 0, 2 and 6

  • IV vedolizumab 300 mg (n = 79) at weeks 0, 2 and 6

ClinicalTrials.gov number: NCT02038920 Not found N/A

IV: intravenous; n: number of participants; N/A: not applicable.