Phase 3 Actemra trial underway for patients with giant cell arteritis

Genentech announced completed enrollment of a phase 3 trial on Actemra for the treatment of giant cell arteritis, according to a company press release.

The multicenter, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of Actemra (tocilizumab, Genentech) for patients with giant cell arteritis (GCA). Patients will be randomized to receive either subcutaneous Actemra at 162 mg given weekly or every 2 weeks, or to receive a placebo for 52 weeks. Daily, oral prednisone will be tapered on either a 6-month or 12-month schedule.

John Stone

Patients in remission at 52 weeks will discontinue treatment and enter a long-term, follow-up study. Patients with active disease will be eligible to enter an open-label phase and receive 162 mg of tocilizumab for up to 104 weeks at the discretion of the investigating physician.

“GCA treatment usually involves high doses of corticosteroids, which are nearly invariably associated with significant side effects,” John Stone, MD, MPH, the Edward Fox Chair of Medicine at Massachusetts General Hospital and professor of medicine at Harvard Medical School, stated in the release. “This trial will certainly add valuable data to the clinical body of evidence surrounding GCA.”

According to the release, there is no current FDA-approved treatment for GCA.

Reference: www.gene.com.