Torii 2010.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind study Date of study: not stated Location: 28 centres in Japan |
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Participants |
Randomised: 54 participants Inclusion criteria
Exclusion criteria
Baseline characteristics N = 54 participants, mean age 46 years, 36 male Dropouts and withdrawals 7/54 (13%) at W14
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Interventions |
Intervention A. Infliximab (n = 35), IV, 5 mg/kg, weeks 0, 2, 6; 10 weeks Control intervention B. Placebo (n = 19), IV, weeks 0, 2, 6; 10 weeks |
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Outcomes | Assessments at 10 weeks Primary outcome
Secondary outcomes
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Notes |
Funding source: not stated Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (p 41): "Eligible patients were randomised in a 2:1 ratio to either... using the dynamic allocation method". Comment: no description of the methods used to guarantee the random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 41): "Eligible patients were randomised in a 2:1 ratio to either... using the dynamic allocation method". Comment: no description of the methods used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 41): "The induction phase of the treatment was .. double‐blind placebo controlled trial... Infliximab or placebo was administered by IV drip infusion over a period of at least 2h ..." Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 41): "The induction phase of the treatment was .. double‐blind placebo controlled trial... Infliximab or placebo was administered by intravenous drip infusion over a period of at least 2h ..." Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 54, analysed 54 Quote (p 42): "This primary endpoint analysis was performed on an "intent‐to‐treat" basis...Patients who discontinued the study treatment ... were handled as "not improved" in the assessment". Comment: probably done |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported. |