Date: 2012-03-02
Type of information:
phase: 4
Announcement: results
Company: Roche (Switzerland)
Product: RoActemra® (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: ADACTA is a Phase IV multi-centre, randomized, double blinded, parallel group study designed to compare the reduction in signs and symptoms during monotherapy treatment with RoACTEMRA versus adalimumab in adult patients with severe active RA who either have an intolerance to methotrexate (MTX) or in whom continued MTX treatment is inappropriate. Also, patients participating in the trial had not previously received a biologic medicine for RA.
326 patients were randomised (1:1) to receive RoACTEMRA 8 mg/kg IV every 4 weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every 2 weeks (plus placebo RoACTEMRA) for 24 weeks. The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score at 24 weeks in patients receiving RoACTEMRA as a monotherapy compared to those receiving adalimumab as a monotherapy. The safety profile of RoACTEMRA in the ADACTA study is consistent with previous findings in the RoACTEMRA clinical trials.
Latest news: Roche has announced that preliminary results from the ADACTA study (ADalimumab ACTemrA) showed that patients who received RoACTEMRA (tocilizumab) as monotherapy achieved a significantly greater reduction in disease activity (assessed by the mean change of DAS281) after 24 weeks than those given adalimumab monotherapy. Statistical significance was also achieved on key secondary endpoints including DAS28 remission and low disease activity, ACR20, 50 and 702 (standard criteria to assess effectiveness of treatments for rheumatoid arthritis). Preliminary safety analysis showed adverse event rates were similar between the two groups. Data from the study will be submitted for presentation at an upcoming medical meeting.
