A randomised, placebo controlled, double blind, multicentre, dose finding study to evaluate the safety and efficacy of PEG sTNF-RI in patients with RA | 395 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 RA | 194 enrolled (about 60 subjects per treatment arm) | Placebo, 400, or 800 μg/kg of PEG sTNF-RI weekly for 12 weeks. |