Dose-Ranging Assessment International Clinical Evaluation of Rituximab in RA (DANCER) trial
This is a phase IIB study published in 2006. 465 patients with
active rheumatoid arthritis despite methotrexate treatment were
included in the study. They were randomized to 9 treatment
groups comparing 500 mg rituximab vs. 1000 mg rituximab vs.
placebo. All of them received methotreaxte.
Study results showed that at week 24, there were more patients receiving Rituximab who reached ACR20/ ACR50/ ACR 70 than those on placebo. Of the study participants, 55% of the rituximab 500 mg group vs. 54% of the rituximab 1000mg group vs. 28% of the placebo group achieved ACR 20 response. The percentage of patients reaching ACR 50 & ACR 70 was (ACR50/ ACR70) 33%/13% in rituximab 500mg group vs. 13%/20% in rituximab 1000mg vs. 13%/5% in placebo group.
The trial also showed that premedication with glucocorticoids reduced the incidence of infusion reactions.
Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum 2006; 54:1390-1400.