Bissonnette 2008.
Methods | Placebo‐controlled, parallel‐arm trial Three centres in Canada (community centre clinics) Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria
Baseline data: participants were randomised 2:1 to subcutaneous injections of either etanercept 50 mg twice per week (n = 10) or placebo (n = 5)
Withdrawal: no dropouts |
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Interventions |
Intervention A: etanercept 50 mg subcutaneously twice per week (10 participants) Control intervention B: placebo (5 participants) Co‐interventions: none Duration of treatment: 3 months |
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Outcomes |
Primary outcome
Other outcome
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Notes | The study was funded by Amgen Canada Inc and Wyeth Pharmaceuticals Clinical trial: NCT00353119 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects were randomised 2:1 to receive subcutaneous injections of either etanercept 50 mg or a placebo" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Quote: "Subjects were randomised 2:1 to receive subcutaneous injections of either etanercept 50 mg or a placebo" Comment: the method use to guarantee concealment is not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind study" Comment: double‐blind placebo‐controlled. We consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind study" Comment: double‐blind placebo‐controlled. We consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All randomised subjects completed the study" Comment: no missing data (no dropouts neither in the intervention group nor in the control group) |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes of interest in the review have been reported in the pre‐specified way |