BIOGEN IDEC
Protocol Number: 109MS302
Therapeutic Area: Neurology
Summary:
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Inclusion Criteria:
- Age 18-55
- Confirmed diagnosis of RRMS according to McDonald criteria #1-4
- Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of Gd-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
Exclusion Critera:
- Any previous treatment with:
- FUMADERM® or BG00012 (FAG-201)
- Glatiramer acetate (Copaxone®).
- Prior treatment with any of the following:
- Total lymphoid irradiation
- Cladribine
- T-cell or T-cell receptor vaccination
- Any therapeutic monoclonal antibody, with the exception of TYSABRI® (natalizumab)
- Prior treatment with any of the following within 1 year prior to randomization:
- Mitoxantrone
- Cyclophosphamide
* Additional Eligibility Criteria Exist *
Center Name: Mercy Research Institute at Mercy Hospital
Contact Information: Mercy Research Institute Clinical Trial Coordinators
Address: 3659 South Miami Avenue, Suite 3001, Miami, Florida 33133
Phone: (305) 854-4400, ext. 2312
Fax: (305) 285-2791
E-mail: mcontreras@mercymiami.org