Genentech completes phase III enrollment for Actemra study
Genentech has announced the completion of enrollment for a phase III clinical trial investigating the use of Actemra (tocilizumab) in patients with giant cell arteritis (GCA). The data from the trial (NCT01791153) is expected in 2016.
The aim of the study is to determine the efficacy and safety of Actemra for the treatment of GCA, a condition that affects about one in 5000 individuals over the age of 50 and is the most common form of primary vasculitis (arteritis). There currently is no FDA approved treatment for GCA and the only treatments known to be effective for this disease are steroids.
“GCA treatment usually involves high doses of corticosteroids, which are nearly invariably associated with significant side effects,” said John Stone, M.D., MPH, The Edward Fox Chair of Medicine at Massachusetts General Hospital and professor of medicine at Harvard Medical School. “This trial will certainly add valuable data to the clinical body of evidence surrounding GCA.”
The multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of Actemra (tocilizumab) in patients with giant cell arteritis. Patients will be randomized to receive Actemra 162mg subcutaneously weekly or every two weeks or placebo for 52 weeks, with tapering oral daily doses of prednisone according to either a six month or 12 month regime. After week 52, patients in remission will stop study treatment and enter long-term follow-up, whereas patients with disease activity or flares will receive open-label Actemra 162mg subcutaneously weekly for a maximum period of 104 weeks at the discretion of the investigator. Anticipated time on study is 39 months.