Enrollment begins for new phase IIIb clinical trial for MS treatment Tysabri

Demyelinization by MS -- Wikipedia

Biogen, with their partner Elan, have now started enrollment for the next phase clinical trial for treatment of multiple sclerosis (MS) and Tysabri.

The companies have signed up the first of what is expected to be 1,800 patients for this international, radomized, active-controlled study that includes 27 countries called SURPASS.

The study will evaluate the switching of Tysabri from Copaxone or Rebrif with those who have the replapsing remitting type of MS and Dr. Alfred Sandrock, senior vice-president of neurology research and development at Biogen Idec, has shown his confidence that it's drug represents a "compelling treatment option".

“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.”

SURPASS will have the 1,800 patients, who are ages 18 to 60 years old, have a baseline Expanded Disability Status Scale (EDSS) score from 0.0 to 5.5 and they must have been using either Copaxone or Rebrif as treatment as their only therapy for six to 18 months prior to the trial.

Patients who will be accepted into the trial also must have had disease activity within 12 months prior to their screening such as one or more clinical relapses or two or more new MRI seen lesions.

The primary reason for the study is the yearly relapse rate with secondary being the changes from their baseline to 48 weeks in amount of lesions and the amount of patients who stay free of disease activity.  This is defined as no clinical relapses, no new lesions, no enlarging lesions of what is already seen and no progression on the EDSS.

Patients who participate will be randomized in 2:1:1 ratio into these groups:

• Group 1:  900 patients will receive TYSABRI 300 mg intravenous (IV) every four weeks.
• Group 2:  450 patients will receive Rebrif 44 mcg subcutaneous (SC) three times per week.
• Group 3:  450 patients will receive Copaxone 20 mg SC once daily.

Says Dr. Sandrock, "By evaluating Tysabri against other MS treatments, our goal is to provide the data needed to make better treatment decisions and improve patients' lives."