Strober 2011.
| Study characteristics | ||
| Methods | RCT, placebo‐controlled, double‐blind Date of study: July 2008 ‐ April 2009 Location: 41 centres in the USA |
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| Participants |
Randomised: 211 participants (mean age 45 years, 131 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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| Interventions |
Intervention A. Etanercept (n = 139), SC auto‐administered, 50 mg twice a week, 11 weeks Control intervention B. Placebo (n = 72), SC auto‐administered, twice a week |
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| Outcomes | Assessments at 12 weeks Primary outcomes of the trial
Secondary outcomes of the trial At 4, 8, 12 weeks
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| Notes | Funding source, quote (Appendix 1): "Abbott Laboratories funded this study and participated in the study design, data collection, data management, data analysis and preparation of the manuscript. All of the authors had full access to the data and were involved in the analysis of data, development and revision of the manuscript, and decision to submit the manuscript for publication. The corresponding author takes responsibility for the integrity of the data and the accuracy of the data analysis." Declarations of interest (appendix 1): "B.E.S. has been an investigator, consultant, speaker, and served on an advisory board for Amgen, Abbott and Centocor; and has also been a speaker for Astellas. J.J.C. has received research support from Abbott, Amgen, Centocor, Celgene and Eli Lilly; has been a consultant for Abbott, Amgen and Centocor; and has been a speaker for Abbott. P.S.Y. has served as a consultant, principle investigator, speaker or advisory board member for Abbott, Amgen, Astellas and Centocor. M.O. and D.A.W. are employees of Abbott." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote (p 662): "Patients were randomised..." Comment: no description of the method used to guarantee random sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Quote (p 662): "Patients were 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 662): “Patients enrolled in the placebo arm received SC injections matching active treatment to maintain the blind. To maintain the blind, all patients received two SC injections at weeks 0 and 4 and one SC injection at week 8, consisting of either briakinumab or matching placebo, depending on the treatment arm. In addition, each patient also received two SC injections biweekly, 3 days apart, week 0 through week 11, consisting of either etanercept or matching placebo, depending on the treatment arm.” Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 662): “Patients enrolled in the placebo arm received SC injections matching active treatment to maintain the blind. To maintain the blind, all patients received two SC injections at weeks 0 and 4 and one SC injection at week 8, consisting of either briakinumab or matching placebo, depending on the treatment arm. In addition, each patient also received two SC injections biweekly, 3 days apart, week 0 through week 11, consisting of either etanercept or matching placebo, depending on the treatment arm.” Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 211, analysed 211 Management of missing data: Quote (p 663): “The primary efficacy analysis consisted of four comparisons performed in the intent‐to‐treat population (i.e. all randomised patients), …, Nonresponder imputation was used to handle missing data.” Comment: done |
| Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00710580) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported |