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 |
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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 |