Krueger 2016a.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: March 2013 ‐ November 2013 Location: 6 centres in the USA |
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Participants |
Randomised: 12 participants (mean age 45.5 years, 8 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Tofacitinib (n = 9), orally, 10 mg twice daily Control intervention B. Placebo (n = 3) |
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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 source: Quote (p 1079): “This study was sponsored by Pfizer Inc. Both Pfizer Inc and non‐Pfizer Inc authors have participated in the study design, data collection, data analysis, and open scientific discussion of the data; its interpretation; and the development of the associated manuscript. The views and opinions expressed within the manuscript are those of all authors and do not necessarily represent those of the funding organization. Medical writing support was funded by Pfizer Inc.”. Declarations of interest (p 1079) : "J. Krueger received research funding from Novartis, Pfizer Inc, Janssen, Lilly, Merck, Kadmon, Dermira, Boehringer, BMS, and Paraxel during the conduct of the study; grants paid to institutions from Amgen, Innovaderm and Kyowa; and personal fees from Serono, BiogenIdec, Delenex, AbbVie, Sanofi, Baxter, Xenoport, and Kineta. M. Suárez‐Fariñas receives research funding and speakers' fees from Pfizer. J. D. Clark, H. Tan, R. Wolk, S. T. Rottinghaus, M. Z. Whitley, H. Valdez, D. von Schack, S. P. O'Neil, P. S. Reddy, and S. Tatulych are employees of Pfizer Inc. The rest of the authors declare that they have no relevant 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 1079): “Patients were randomised 3:1 to receive 10 mg of oral tofacitinib or placebo twice daily for 12 weeks by using an automated Web or telephone randomization system” Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote (p 1079): “Patients were randomised 3:1 to receive 10 mg of oral tofacitinib or placebo twice daily for 12 weeks by using an automated Web or telephone randomisation system” Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 1079): “This was a phase 2, randomised, placebo‐controlled, double‐blind study carried out in 6 centers” Comment: placebo‐controlled, probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 1079): “This was a phase 2, randomised, placebo‐controlled, double‐blind study carried out in 6 centers” Comment: placebo‐controlled, probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomly assigned 12, analysed 11 Management of missing data: not mentioned |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01710046) The prespecified outcomes in the protocol or those mentioned in the Methods section have been reported in the Results section |