Early Treatment in Multiple Sclerosis with Intravenous Immunoglobulin: Rationale and Study Design

Multiple sclerosis (MS) is a chronic debilitating disease that will cause significant disability to the majority of patients overtime [1]. Previous studies of the natural course of the disease showed that disability will accumulate in more that 90% of patients and additional relapses may result in significant handicap [2]. Assessment of patients with a diagnosis of probable MS with positive brain magnetic resonance imaging (MRI) demonstrated that the risk of relapsing within 1 year is 57.6% [3]. Treating patients early means treating patients with less disability. We describe the rationale for early treatment in patients with the first episode of neurological symptomatology suggestive of clinically probable MS, and the design of a randomized, double-blind, placebo-controlled trial of early treatment with intravenous immunoglobulin (IVIg, Omrix, Israel) in these patients. The primary objective of this study was to investigate the efficacy of IVIg treatment, administered at 0.4 g/kg per day for 5 consecutive days, as a loading dose, and 0.4 g/kg per day every 6 weeks thereafter as a booster dose, for a 1-year period, on the risk of patients with clinically probable MS and positive brain MRI to convert to clinically definite MS.