Multiple Sclerosis Head-to-Head Study Comparing TYRABRI To Copaxone And Rebif

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Mar 2010 - 2:00 PDT

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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.

"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."

About SURPASS

SURPASS is a global, Phase IIIb, multicenter, randomized, rater-blinded, parallel-group, active-controlled trial designed to provide direct comparative data to inform patients and physicians of the relative benefits of different treatment options when faced with breakthrough disease activity. The large, well-controlled comparative study assessing TYSABRI, Copaxone and Rebif is expected to enroll 1,800 patients with RRMS, ages 18 to 60 years old, with a baseline Expanded Disability Status Scale (EDSS) score from 0.0 to 5.5. Patients must have been treated with a stable regimen of either Copaxone or Rebif as their principal first therapy for MS for six to 18 months prior to randomization. Patients must also have had disease activity within 12 months prior to screening defined as one or more clinical relapses or two or more new MRI lesions (Gd+ and/or T2 hyperintense lesions).

The primary endpoint of the study is the annualized relapse rate. Secondary endpoints include the change from baseline to 48 weeks in T2 lesion volume and the proportion of subjects who remain free of disease activity - defined as no clinical relapses, no new Gd+ lesions, no new or newly-enlarging T2 lesions, and no sustained progression on EDSS. Additional study objectives will evaluate the safety and tolerability of switching to TYSABRI.
Participants will be randomized in a 2:1:1 ratio to one of the following groups:

- Group 1: 900 patients will receive TYSABRI 300 mg intravenous (IV) every four weeks;

- Group 2: 450 patients will receive interferon beta-1a 44 mcg subcutaneous (SC) three times per week; and

- Group 3: 450 patients will receive glatiramer acetate 20 mg SC once daily.

Patients interested in learning more about the SURPASS trial may speak with their physician or e-mail SURPASS.study@biogenidec.com.

Dr. Richard Rudick is a paid consultant and speaker for Biogen Idec.

Source
Biogen Idec
Elan Pharmaceuticals Inc

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