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. 2015 Sep 22;2015(9):CD008655. doi: 10.1002/14651858.CD008655.pub3

Leiper 2011.

Methods Randomized, double‐blind, placebo‐controlled trial
Participants Patients (n = 24) over 18 years of age with active steroid‐resistant UC (Mayo score: 6‐12 points, failure to respond to at least 2 weeks of 40 mg/day of prednisolone treatment)
Interventions Patients received either an infusion of 1 g of rituximab or placebo on day 1 and at 2 weeks
Outcomes Primary outcome was remission at week 4
 Secondary outcomes consisted of clinical response at weeks 4 and 8, remission at weeks 8 and 12, mucosal healing at weeks 4 and 12 and improvement in the IBDQ
Notes This drug was not shown to be an effective therapy for active steroid‐resistant UC
NCT00261118
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomized 2:1 (treatment:placebo) in blocks of 5 by the hospital pharmacy department. The pharmacists had no other involvement in the trial
Allocation concealment (selection bias) Low risk Allocation was concealed from patients and investigators
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Allocation was not revealed until the last patient completed the trial
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessment of response or remission was made before unblinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk There was a high drop‐out rate in both groups
Only 6 out of 16 patients in the rituximab group and 2 out of 8 patients in the placebo group completed the 12 week study
Last value was carried forward for analyses
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk No other apparent sources of bias