Schröder 2006.

Methods	Randomized, open‐label, pilot study
Participants	Eligible patients had a history of chronic active CD, as defined by refractoriness to or dependency on corticosteroids and resistance or intolerance to azathioprine (N = 19)
Interventions	Infliximab infusion, 5 mg/kg (week 0 and 2) for all patients Methotrexate 20 mg/week (IV infusions for weeks 0 to 5, then switch to oral administration) for patients randomly assigned at study entry (n = 11) Patients in the control group did not receive a methotrexate placebo (n = 8)
Outcomes	The primary outcome: clinical remission at the end of the trial as defined by a CDAI score of less than 150 Secondary outcomes: the time to clinical remission and the corticosteroid‐tapering effect of treatment Safety parameters: incidence of adverse events, changes in vital signs, and routine laboratory measures monitored during each infusion and at each study visit
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The published report did not describe the method used for randomization
Allocation concealment (selection bias)	Unclear risk	The methods used for allocation concealment were not described
Blinding (performance bias and detection bias) All outcomes	High risk	The study design was open‐label
Incomplete outcome data (attrition bias) All outcomes	Low risk	All patients were accounted for in the study
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported in the published reports
Other bias	Low risk	The study appeared to be free of other sources of biases