This international multi-center, randomized, controlled, double blind study will investigate the efficacy, immunogenicity and safety of BCD-020 (NN: rituximab, CJSC Biocad) versus MabThera (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered in combination with methotrexate in patients with rheumatoid arthritis who had an inadequate response or intolerance to other DMARDs including one or more TNF inhibitor therapies.
Patients will be centrally randomized into one of the two study groups:
Patients from the first group will receive BCD-020 as 1000 mg single dose, intravenously, once in 2 weeks, with 2 infusions per course (on day 1 and day 15).
Patients from the second group will receive MabThera at the same regimen.
Read more: http://www.clinicaltrials.gov/ct2/show/NCT01759030?cond=%22Arthritis%22&lup_s=01/29/2014&lup_d=30