Table 1

Summary of phase 2 studies of PEG sTNF-RI

Study titleSubjects (n)Treatment regimens
A randomised, placebo controlled, double blind, multicentre, dose finding study to evaluate the safety and efficacy of PEG sTNF-RI in patients with RA395 enrolled (about 70 subjects per treatment arm)Placebo, 50, 300, or 600 μg/kg PEG sTNF-RI every other week for 24 weeks
or 1000 μg/kg for 12 weeks followed by 300 μg/kg for the next 12 weeks.
A randomised, placebo controlled, double blind, multicentre, dose finding study to evaluate the safety and efficacy of weekly administration of PEG sTNF-RI in patients with RA194 enrolled (about 60 subjects per treatment arm)Placebo, 400, or 800 μg/kg of PEG sTNF-RI weekly for 12 weeks.