Rutgeerts 2012.

Study characteristics
Methods	Multicenter, randomized, double‐blind, placebo‐controlled trial The study was conducted at 19 sites in Europe, the United States, and Canada from August 2006 to September 2008 Intention‐to‐treat analysis performed Study duration 52 weeks
Participants	Adults aged 18 ‐ 75 with a diagnosis of ileocolonic CD for at least 4 months; CDAI score 220 ‐ 450 (N = 129) All participants received open‐label induction therapy with adalimumab 160 mg sc at week 0 and 80 mg sc at week 2
Interventions	Participants who responded to induction (decrease in CDAI of at least 70 points from baseline) were randomized at week 4 to adalimumab 40 mg eow (n = 64) or placebo (n = 65). Participants were followed for 52 weeks
Outcomes	Primary end points included mucosal healing at week 12 Secondary end points included: mucosal healing at week 52 (defined as CDEIS ≤ 9); CDEIS remission (defined as CDEIS score ≤ 4) at weeks 12 and 52; CDAI remission and response at weeks 12 and 52; the percentages of participants achieving > 75% decrease in CDEIS score from baseline at weeks 12 and 52
Notes	This study was funded by Abbott Laboratories. Author conflicts of interest are reported in the manuscript
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind trial
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators were blinded to participant assignment. Study primary end points included mucosal healing as per CDEIS, and other end points based on standardized rating scales (CDAI and CDEIS)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study used a modified ITT analysis. The number of dropouts was low
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported
Other bias	Low risk	No other apparent sources of bias