Rich 2013.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind trial Date of study: July 2009 ‐ December 2010 Location: 60 centres in Portland, USA |
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Participants |
Randomised: 404 participants Secukinimab A (66) (mean age 43 years, 53 male) Secukinimab B (138) (mean age 44 years, 104 male) Secukinimab C (133) (mean age 45 years, 105 male) Placebo (67) (mean age 44 years, 44 male) Inclusion criteria
Exclusion criteria
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Interventions |
Intervention A. Secukinumab (n = 66), SC, 150 mg, week 0, 12 weeks Control intervention B. Secukinumab (n = 138), SC, 150 mg, weeks 0, 4, 8, 12 weeks C. Secukinumab (n = 133), SC, 150 mg, weeks 0, 1, 2, 4, 12 weeks D. Placebo (n = 67), SC, weeks 0, 1, 2, 4, 8, 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 support quote (p 402): "Novartis Pharma AG, Basel, Switzerland" Declarations of interest (appendix): "P.R. has received honoraria for lecturing in industry‐sponsored meetings and has received research grants from pharmaceutical companies as an investigator. B.S. has consulted for Novartis and several other pharmaceutical companies; he has served on an advisory board for Novartis and several other pharmaceutical companies. D.T. has served as a speaker and served on advisory boards for Abbott, Biogen‐Idec, Janssen‐Cilag, Leo, MSD, Novartis and Pfizer. C. Paul has received honoraria from and has been a paid consultant to Abbott, Amgen, Celgene, Janssen‐Cilag, Novartis and Pierre Fabre. K.R., E.H., A.G., M.M. and C. Papavassilis are full‐time employees of, and own stock in Novartis. J.‐P.O., A.M. and R.E.S. declare no conflicts of interest." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 404): “Randomization numbers were generated by the interactive response technology provider using a validated system that automated the random assignment of patients numbers to randomisation numbers” Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote (p 404): “Randomization numbers were generated by the interactive response technology provider using a validated system that automated the random assignment of patients numbers to randomisation numbers” Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 404): “Patients, investigator staff, persons performing the assessments and data analysts were blinded to the identity of treatment from the time of randomisation until primary outcome analysis” Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 404): “Patients, investigator staff, persons performing the assessment and data analysts were blinded to the identity of treatment from the time of randomisation until primary outcome analysis” Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 404 included/404 analysed Quote (p 405): "Following th intent‐to‐treat principle, data were analysed... Missing values were replaced using the last‐observation‐carried‐forward approach" Comment: ITT analyses |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00941031) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported |