Gordon 2006.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind trial Date of study: March 2003 ‐ June 2004 Location: Multicentre (n = 18) in USA, Canada |
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Participants |
Randomised: 148 participants (mean age 44 years, 99 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Adalimumab (n = 46), SC, 40 mg, 12 weeks, week 0: 2 injections, 1 injection eow B. Adalimumab, (n = 50), SC, 40 mg, 12 weeks, week 0, week 1: 2 injections, 1 injection weekly Control intervention C. Placebo (n = 52), SC, 12 weeks |
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Outcomes | Assessments at 12 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding, Quote (p 598): "Supported by Abbott Laboratories" Declarations of interest (p 598): "Dr Gordon has received research support and honoraria and is a consultant for Abbott. Dr Langley is an investigator and has received research funding to conduct research studies with Abbott. Dr Leonardi is a consultant and speaker for Abbott. Dr Menter has received honoraria and is a consultant for Abbott. Dr Kang is an ad‐hoc consultant for Abbott. Dr Heffernan is a consultant for and has received research funding from Abbott. Drs Zhong, Hoffman, and Okun and Ms Lim are full‐time employees of Abbott." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 599): "Patients were centrally randomised..." Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Quote (p 599): "Patients were centrally randomised..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 599): "To maintain blinding, prefilled syringes were identically labelled and all patients received the same number of injections at the same time points" Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 599): "To maintain blinding, prefilled syringes were identically labelled and all patients received the same number of injections at the same time points" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 148, analysed 147 Dropouts and withdrawals
Management of missing data, quote (p 601): "modified intent‐to‐treat analysis... a patient with missing data was counted as a nonresponder at that visit" Comment: few lost to follow‐up, well‐balanced number and reasons between groups |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |