Sandborn 2014.

Methods	An integrated double‐blind phase 2 dose‐finding and phase 3 dose‐confirmation trial
Participants	1064 adults with UC (Mayo score: 6‐12; endoscopic subscore > 2; n=774 patients in phase 3) were included
Interventions	Patients were randomized (1:1:1:1) to receive subcutaneous injections of placebo or golimumab 100/50 mg, 200/100 mg or 400/200 mg in phase 2 Patients were randomized (1:1:1) to received subcutaneous injections of placebo or golimumab 200/100 mg or 400/200 mg at weeks 0 and 2 in phase 3
Outcomes	The phase 3 primary end point was week‐6 clinical response Secondary end points included week‐6 clinical remission, mucosal healing, and Inflammatory Bowel Disease Questionnaire (IBDQ) score change
Notes	NCT00487539
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central randomization using an interactive voice response system In phase 2 patients were allocated using an adaptive randomization procedure with stratification by investigative site Following phase 2 allocation was performed using a permuted block randomization schema
Allocation concealment (selection bias)	Low risk	Central allocation was performed
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind and matched placebo but further detail not provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Methods not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	13/774 (1.7%) patients were excluded from the efficacy analysis due to noncompliance with good clinical practice (e.g. source documentation, informed consent process) at the study site
Selective reporting (reporting bias)	Low risk	Results of all outcomes were reported
Other bias	Low risk	No other apparent sources of bias