Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS).
The study, called SURPASS, is expected to enroll 1,800 patients in 27 countries and provide direct comparative data of different treatment options for RRMS patients who experience breakthrough disease activity.
“Currently, there is limited data to inform decisions about how to switch in patients who have disease activity while on therapy. The goal of the SURPASS study is to provide that data so physicians can improve treatment decisions and outcomes for their MS patients.”
“Despite being on therapy, many MS patients still experience disease progression, resulting in loss of physical abilities and permanent damage to the central nervous system,” said Richard Rudick, M.D., chair of the SURPASS trial advisory committee and director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic. “Currently, there is limited data to inform decisions about how to switch in patients who have disease activity while on therapy. The goal of the SURPASS study is to provide that data so physicians can improve treatment decisions and outcomes for their MS patients.”
A significant number of MS patients continue to experience clinical relapses and disease progression despite treatment with disease-modifying therapies such as Copaxone and Rebif. The SURPASS study, a large, well-controlled comparative trial of MS treatments, will evaluate switching to TYSABRI versus staying on or switching between Copaxone and Rebif and determine whether early use of TYSABRI in the treatment algorithm ultimately leads to better outcomes.
“TYSABRI is a compelling treatment option that is bringing hope to many MS patients,” said Alfred Sandrock, M.D., M.P.H., senior vice president of neurology research and development at Biogen Idec. “By evaluating TYSABRI against other MS treatments, our goal is to provide the data needed to make better treatment decisions and improve patients’ lives.”
“We believe the SURPASS study has the potential to improve the way MS is treated,” said Carlos Paya, M.D., Ph.D., president at Elan. “Despite significant advances in treatment, the unmet medical need for many MS patients remains great and this study supports our commitment to continuing to advance the standard of care in MS.”
Research suggests no need for yellow fever vaccine booster after initial dose