Date: 2011-07-19
Type of information:
phase: 3
Announcement: results
Company: Chugai (Japan) Roche (Switzerland)
Product: Actemra® (tocilizumab)
Action mechanism: Actemra® is a humanized monoclonal antibody against the IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details: The phase III clinical study consists of a double-blind, randomized, parallel group study and subsequent open label long-term extension administration with the subcutaneous formulation. The first part is a 24 week study to compare the efficacy and safety between subcutaneous injection of Actemra® 162 mg once every two weeks and intravenous infusion of Actemra® 8 mg/kg once every four weeks. The second part is an open label roll-over extension study to evaluate the efficacy and safety of the long-term administration of the subcutaneous formulation.
Latest
news: Chugai Pharmaceutical has announced that subcutaneous injection of its humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody Actemra® (tocilizumab) has demonstrated non-inferiority in efficacy compared to intravenous infusion, in its phase III clinical study for rheumatoid arthritis.
The initial-24-week study has demonstrated non-inferiority of efficacy, defined by the ACR20 response which is the primary endpoint, by subcutaneous injection compared with that by intravenous infusion. The clinical safety profile of the subcutaneous injection was consistent in nature with that observed with the intravenous infusion. The details of the study results will be presented at major upcoming conferences or in future publications.
The application for approval of Actemra® for subcutaneous injection is planned to be filed in Japan in 2012 based on the results of this study.
