Feagan 2005.

Methods	Randomised, double‐blind, placebo‐controlled, 8 week induction trial involving 20 centers. Computer‐generated block randomization schedule.
Participants	181 adult subjects (98M/83F) with moderately active UC (ulcerative colitis clinical score 5 to 9, with either stool frequency or rectal bleeding score at least 1, and modified Baron score of at least 2, with disease minimum 25cm from anal verge). Exclusion criteria: oral corticosteroids within 4 weeks, topical mesalamine or corticosteroids within 1 week, immunosuppressive therapy within 3 months, severe disease, abnormal WBC, platelet, AST, ALT, or creatinine, positive stool test for infectious pathogens, proteinuria.
Interventions	MLN02 0.5mg/kg (n=58), MLN02 2mg/kg (n=60), or placebo (n=63) intravenous infusion on day 1 and day 29.
Outcomes	Primary outcome measure: Clinical remission at week 6, defined as an ulcerative colitis clinical score of 0 or 1 and a modified Baron score of 0 or 1 with no evidence of rectal bleeding. Secondary outcome measures: Changes in ulcerative colitis clinical scores, Riley scores, and IBDQ scores. Proportion of subjects with clinical response (defined as a decrease of 3 or more on the Mayo score) at week 4 and 6, endoscopic remission (defined as a modified Baron score of 0) at week 4 and 6, endoscopic response (defined as a 2 or more grade improvement in the modified Baron score) at week 4 and 6. Patients were evaluated at baseline and one, two, four, and six weeks after randomization. Sigmoidoscopy was performed at weeks 0, 4 and 6.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "according to a computer generated schedule" Comment: The sequence was randomised
Allocation concealment (selection bias)	Low risk	Centralized randomization
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "Neither the investigators nor the patients were aware of the treatment assignment. The placebo was identical in appearance to MLN02." Comment: Blinding of assessors and participants was adequate.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates in the groups were 2%, 8% and 5% for the MLN02 0.5mg/kg, MLN02 2.0mg/kg and placebo groups. Quote: "No important differences were observed among the three groups in the reasons for withdrawal."
Selective reporting (reporting bias)	Low risk	All primary and secondary outcomes were reported.
Other bias	Low risk	No other apparent sources of bias.