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. 2014 Aug 8;2014(8):CD007571. doi: 10.1002/14651858.CD007571.pub2

Feagan 2000.

Methods Randomized, double‐blind, placebo controlled trial involving one administration of placebo or vedolizumab at various doses. Evaluated 30 days after administration of study medication.
Participants 29 patients (17M/12F) with diagnosed ulcerative colitis (moderately severe as defined by a minimum Mayo Clinical score of ≥5, ≥3 bowel movements per day and evidence of active disease on endoscopy).
One patient was withdrawn for not meeting inclusion criteria.
Interventions Vedolizumab 0.15mg/kg SC (n=5), vedolizumab 0.15mg/kg IV (n=5), vedolizumab 0.5mg/kg IV (n=5), vedolizumab 2.0mg/kg IV (n=5) or placebo (n=8)
Outcomes Endoscopic response (measured by a modified Baron score), Mayo Clinical score and adverse events
Notes Available as an abstract only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Centralized randomization
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind
Identical placebo
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No attrition
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk No other issues