Randomized Evaluation oF Long-term Efficacy of rituXimab in RA (REFLEX) trial
This is a phase 3 study published in 2006. In this study, 520
patients who had active rheumatoid arthritis despite ongoing
treatment with both methotrexate and an anti-TNF-alpha agent
were included. They were randomized to receive either 1,000 mg
of rituximab (2 doses 2 weeks apart) plus methotrexate or
placebo plus Methotrexate. They also received 100 mg of
parenteral methylprednisolone immediately before each infusion,
as well as a brief course of oral glucocorticoids between the
The study was completed by 82% of patients in the treatment group and 54% of those in the placebo group.
Study results showed that at week 24, there were more patients receiving Rituximab who reached ACR20 than those on placebo. Of the study participants, 51% of patients in the rituximab group vs. vs. 18% in the placebo group achieved ACR20. In the rituximab group 27% achieved an ACR50, as did 5% of those receiving placebo. ACR 70% was achieved by 12 % of those in the rituximab group vs. 1% of the placebo group. DAS 28, another parameter used to assess the Rheumatoid arthritis activity decreased by an average of 1.83 points vs 0.34 points in the placebo group.
Less than 1% patients of the rituximab group & about 2 % of the patients belonging to the placebo group suffered from serious infections.
Rituximab for rheumatoid arthritis refractory to
anti-tumor necrosis factor therapy: Results of a multicenter,
randomized, double-blind, placebo-controlled, phase III trial
evaluating primary efficacy and safety at twenty-four weeks.
Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese
MC, Keystone EC, Loveless JE, Burmester GR, Cravets MW, Hessey
EW, Shaw T, Totoritis MC; REFLEX Trial Group.Arthritis Rheum.