Methods | RCT, active placebo‐controlled, double blind Date of study: 14 May 1998‐22 February 1999 Location: 22 centres in USA |
|
Participants |
Randomised: 229 participants (mean age 45 years, 163 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
|
|
Interventions |
Intervention A. Alefacept (n = 57), IV, 0.025 mg/kg, once a week, 12 weeks Control intervention B. Alefacept (n = 55), IV, 0.075 mg/kg, once a week, 12 weeks C. Alefacept (n = 58), IV, 0.150 mg/kg, once a week, 12 weeks D. Placebo (n = 59), IV, once a week, 12 weeks |
|
Outcomes | Assessments at 14 weeks Primary or secondary outcomes of the trial
Outcomes of the trial
|
|
Notes | Funding (p 254) : "supported by Biogen and a grant from the National Institutes of Health ... at the university of Utah" Declarations of interest (p 254): "A patent on the use of alefacept (LFA3TIP) for the treatment of psoriasis has been assigned to Biogen and the University of Michigan; neither Dr. Ellis nor Dr. Krueger has a financial interest in the patent. Dr. Ellis and Dr. Krueger are consultants to Biogen, as well as to other companies that manufacture treatments for psoriasis." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 249): “Randomization scheme was generated before the study, with a block size of four at each center” Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Quote (p 249): “Randomization scheme was generated before the study, with a block size of four at each center” Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 249): "Double blind... all preparations were identical in appearance" Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: no specific description of the method used to guarantee blinding of outcome assessment however considering that this is a placebo‐controlled trial with no known systematic AEs we considered the risk as low |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote (p 250): "were conducted according to the intention‐to‐treat principle" Dropouts and withdrawals
Comment: no description of the method used to guarantee missing data management, number of participants analysed not stated |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The pre‐specified outcomes mentioned in the methods section appeared to have been reported |