Armuzzi 2013

Methods	Open‐label, single‐centre, randomised, controlled pilot study
Participants	Consecutive Crohn's disease patients who underwent a curative ileocolonic resection and were considered to be at 'high risk' of postoperative recurrence (N = 22) Exclusion criteria: active perianal disease, presence of stoma, adverse events during previous therapy with infliximab or azathioprine, age > 70 years, surgical complications, active infectious diseases, history of cancer, renal, cardiac or hepatic failure, history of acute or chronic pancreatitis, severe leucopenia and pregnancy
Interventions	Infliximab 5 mg/kg at weeks 0, 2 and 6 weeks and then every 8 weeks for 1 year (n = 11) Azathioprine 2.5 mg/kg/day for 1 year (n =11) All patients received oral metronidazole (500 mg twice daily) for 2 weeks after surgery Treatment was started within 2 to 4 weeks of surgery No other drugs were allowed
Outcomes	Co‐primary outcomes were endoscopic, histological and clinical recurrence at 12 months Secondary outcomes: Harvey‐Bradshaw Index, laboratory tests and adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label
Incomplete outcome data (attrition bias) All outcomes	Low risk	One patient in the azathioprine group withdrew due to adverse events (severe nausea and epigastric pain), no other patients withdrew
Selective reporting (reporting bias)	Low risk	Appropriate data reported
Other bias	Low risk	None apparent