Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)
The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other than for the evaluation of MS (multiple sclerosis).
• Males and females meeting 2009 RIS criteria
• Identified RIS cases with the initial MRI demonstrating anomalies suggestive of demyelinating disease dated \> 2009
• Incidental anomalies identified on MRI of the brain or spinal cord with the primary reason for the acquired MRI resulting from an evaluation of a process other than MS
• CNS white matter anomalies meeting the following MRI criteria:
‣ Ovoid, well-circumscribed, and homogeneous foci with or without involvement of the corpus callosum
⁃ T2-hyperintensities measuring \> 3mm2 and fulfilling 3 of 4 Barkhof-Tintoré criteria for dissemination in space
⁃ CNS anomalies not consistent with a vascular pattern
⁃ Qualitative determination that CNS anomalies have a characteristic appearance of demyelinating lesions
• MRI anomalies do not account for clinically apparent neurological impairments in patients