Papp AMAGINE‐1 2016.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: 29 August 2012 ‐ 12 March 2014 Location: 73 centres worldwide (Europe, USA and Canada) |
|
Participants |
Randomised: 661 participants (mean age 46 years, 484 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
|
|
Interventions |
Intervention A. Brodalumab (n = 222), SC, 210 mg every 2 weeks Control intervention B. Brodalumab (n = 219), SC, 140 mg every 2 weeks C. Placebo (n = 220) |
|
Outcomes | Assessments at 12 weeks Primary outcomes of the trial
Secondary outcomes of the trial
|
|
Notes | Funding source: Quote (p 1): "This study was funded by Amgen Inc. & AstraZeneca/MedImmune." Declarations of interest (pp 13‐14): "K.A.P. has served as a consultant, investigator and/or speaker for AbbVie, Amgen Inc., Astellas Pharma, Bayer AG, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Forward Pharma, Galderma, Janssen Biotech Inc., LEO Pharma, Merck, Novartis, Pfizer, Roche and UCB Pharma. K.R. has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Amgen Inc., Biogen‐Idec, Celgene, Centocor, Covagen, Forward Pharma, GSK, Janssen‐Cilag, LEO Pharma, Lilly, Medac, MSD, Novartis, Pfizer, Takeda and Vertex. C.P. has served as a consultant and investigator for Amgen Inc., AbbVie, Boehringer, Janssen‐Cilag, LEO Pharma, Lilly, Novartis and Pfizer. A.B. has served as a consultant and investigator for AbbVie, Amgen Inc., Anacor, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Genentech, Janssen, Merck, Novartis, Pfizer, Regeneron and Sandoz." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (pp 2 and 3): "Patients were randomized... IP supply was controlled by interactive voice response system and box numbers were assigned at each visit" Comment: no description of the method used to guarantee the random sequence generation |
Allocation concealment (selection bias) | Low risk | Quote (pp 2 and 3): "Patients were randomized...IP supply was controlled by interactive voice response system and box numbers were assigned at each visit". Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 3): "Randomizations remained blinded to all patients and investigators... Throughout the study, patients received placebo as needed to maintain the blind until it was broken." Comment: probably done, placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 3): "Randomizations remained blinded to all patients and investigators... Throughout the study, patients received placebo as needed to maintain the blind until it was broken." Comment: probably done, placebo‐controlled |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 661, 661 analysed Management of missing data: quote (pp 4‐5): "The full analysis set included all randomised patients... Mutiple imputations for missing data" Comment: probably done |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01708590; AMAGINE‐1). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported. |