BENEFIT 11 is a Long-term Follow-up Study of the BENEFIT
(Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with a first demyelinating event suggestive of Multiple Sclerosis.
The objective of this study is to obtain clinical long-term data, magnetic resonance imaging (MRI), and optical coherence tomography (OCT) information after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS) enrolled in the Betaferon®/Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747) for an average of 11 years after their first clinical event. An integrated statistical analysis will include data from the BENEFIT (304747), the BENEFIT follow-up (305207), and the BENEFIT extension (311129) studies, and this BENEFIT 11 study (16401).
The primary objectives are to describe the disease course (conversion to clinically-definite multiple sclerosis) change in disability, cognitive function, resource use, and employment status, in relation to treatment with Interferon beta-1b.
The secondary objectives are to assess MRI, OCT and ophthalmologic parameters, treatment history, quality of life parameters, fatigue and depression, the choice of MS-specific medication, and to investigate tolerability of Interferon beta-1b in the full former clinically-isolated syndrome cohort as well as in subgroups of patients.