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 One patient was withdrawn for not meeting inclusion criteria. |
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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 |