Probert 2003.

Methods	Randomized, double blind, placebo‐controlled study at 4 centers in the United Kingdom and Germany
Participants	43 male and female patients (at least 18 years of age) with moderately severe glucocorticoid resistant UC Patients had to have received at least 30 mg prednisolone (or equivalent) for at least 1 week, for relapse but still had clinical activity Patients had to have an ulcerative colitis symptom score (UCSS) ≥6 and a sigmoidoscopy score of at least 2 on the Baron scale Patients had biopsies taken to verify the presence of active disease
Interventions	Patients were randomized to receive either placebo or 5 mg of infliximab/kg of body weight at 0 and 2 weeks Consectuive patients were randomized in blocks of 4 within each center
Outcomes	The primary outcome was the proportion of patients in remission at week 6 (UCSS ≤ 2 and a Baron score of 0) Secondary outcomes included change in the UCSS, Baron score, HRQL, C‐reactive protein levels and change in daily glucocorticoid dose HRQL was assessed with the IBDQ and EQ‐5D indices
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Consecutive patients randomized in blocks of 4 at each center
Allocation concealment (selection bias)	Unclear risk	Method of randomisation and allocation was not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Pharmacists, investigators and participants were blinded to the treatment administered
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described in the methods
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients completed the 6 week study and all results reported
Selective reporting (reporting bias)	Low risk	Results of all outcomes and patients reported in the text
Other bias	Low risk	No other apparent sources of bias