Bissonnette 2013.
Study characteristics | ||
Methods | RCT, placebo‐controlled, single‐blind Date of study: May 2009 ‐ June 2011 Location: Montréal, Quebec, Canada (5 centres) |
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Participants |
Randomised: 30 participants (median age 56 years (adalimumab) and 57 years (placebo), 23 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Adalimumab (n = 20), SC, 80/40 mg, eow Control intervention B. Topical treatment, phototherapy or no treatment (n = 10) |
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Outcomes | Assessment at 16 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding: Abbott Laboratories Declarations of interest: (quote p 89) "Dr Bissonnette and Dr Bolduc have been investigators, advisors and/ or consultants and received grants and/or honoraria from Abbott, Amgen, Astellas, Novartis, Janssen Ortho, Pfizer, Celgene, and Tribute. Drs Tardif, Harel, Pressacco, and Guertin have no conflicts of interest to declare." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 84): "were randomised a concealed computer generated code created by the sponsor" Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote (p 84): "were randomised a concealed computer generated code created by the sponsor" Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (pp 83‐4): "single‐blind (cardiologist and all staff involved in vascular imaging and analysis were blinded to treatment assignment)" Comment: no blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (pp 83‐4): "single‐blind (cardiologist and all staff involved in vascular imaging and analysis were blinded to treatment assignment)" Comment: probably done, but no statement about secondary outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 30, analysed 30 Quote (p 84): "For all end points, the analysis was conducted on the ITT population, ... for the PASI 75 end point,... a nonresponder imputation method was used" Comment: probably done |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00940862) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported |