Japanese pharmaceutical companies, Bristol Myers K K and Ono Pharmaceutical Co Ltd have initiated the Assessing Very Early Rheumatoid Arthritis Treatment -2 (AVERT-2) clinical study, an international randomized double-blind phase IIIb clinical study of Orencia (abatacept [rDNA]) in previously untreated rheumatoid arthritis, in Japan.
The AVERT-2 study is a clinical study in which facilities from approximately 30 countries worldwide are participating.
The study enrolled rheumatoid arthritis patients with poor prognosis factors, which is expected to experience progressive joint destruction, who are treatment naïve with either disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, or with biologics. The efficacy and safety of Orencia SC in combination with methotrexate compared to methotrexate monotherapy are being evaluated. In the trial, clinical remission using the ACR/EULAR remission criteria (2011), suppression of the progression of joint destruction and the maintenance of status after remission are being evaluated as well as other factors.
Commenting on the study, Gyo Sagara, President of Ono Pharmaceutical said, "Orencia features a new mechanism of action suppressing the upstream of inflammation development for rheumatoid arthritis. I believe this clinical study will result in increasing treatment options for those who are suffering from progression of joint destruction."
Bristol-Myers Squibb and Ono Pharmaceutical concluded a co-commercializing agreement of Orencia on September 21, 2011 and initiated co-promotion from June 4, 2013. Orencia is co-developed by the two companies.
