Roche Announces Phase III Results of Actemra Monotherapy Trial

Roche announced that AMBITION, the study analyzing the safety and efficacy of Actemra monotherapy, successfully met its primary endpoint in patients with moderate-to-severe rheumatoid arthritis (RA).

Roche said this fourth study in Actemra’s (tocilizumab) Phase III development program is a two-arm, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of Actemra (8 mg/kg) compared with methotrexate in RA patients.

Patients received either Actemra intravenously (8 mg/kg) every four weeks plus placebo capsules weekly, or placebo infusions every four weeks plus methotrexate weekly, the company said. The study included 673 patients at 252 trial sites in 18 countries, including the U.S., the company added.

The data show that a greater proportion of patients treated with Actemra (8 mg/kg), achieved a significant improvement in disease signs and symptoms following 24 weeks of treatment, compared with patients treated with methotrexate alone, the company added.