A one-year prospective, randomized, placebo-controlled, quadruple-blinded, phase II safety pilot trial of combination therapy with interferon beta-1a and @entity618 in early relapsing-remitting XXXX (TIME @entity15 ).

@entity1 @entity854 @entity2098 @entity618 @entity15
BACKGROUND: @entity618 ( @entity2098 ) is an oral DNA base synthesis inhibitor with immunomodulatory effects on B cells, T cells, and macrophages. OBJECTIVE: To conduct a safety and tolerability pilot study of interferon beta-1a (IFN-b1a) in combination with either placebo or oral @entity2098 in @entity15 ( @entity15 ). METHODS: Twenty-four treatment-na  ve R-RMS @entity1 participated in a one-year prospective, placebo-controlled, blinded, safety pilot clinical trial. Every @entity1 injected weekly intramuscular interferon beta-1a. The cohort was then randomized (1   :   1) to either active oral @entity2098 or identical-appearing placebo tablets. Clinical evaluations were assessed every 3 months, along with brain MRI scans performed at baseline and repeated every 60 days for one year. Comprehensive laboratory assessments were monitored for safety, along with adverse events. RESULTS: In this small pilot investigation, no differences were identified between the two treatment groups with respect to @entity1 -reported adverse events, MRI metrics, or @entity854 . Notwithstanding these observations, and the limited number of @entity1 treated, trends appeared to favor the combination therapy regimen. CONCLUSIONS: The combination treatment regimen of interferon beta-1a and @entity2098 appeared to be well tolerated in this pilot study. Despite the small sample size, therapeutic trends were observed in favor of combination therapy. An adequately powered controlled trial of @entity2098 in @entity15 appears warranted.
