BACKGROUND: Interferon beta ( @entity2391 ) is available in parenteral formulations for treatment of @entity15 ( @entity15 ). The purpose of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral @entity2391 -1a compared with placebo over six months in relapsing-remitting (RR) @entity15 @entity1 . METHODS: In this multicenter; double-blind randomized trial, RR- @entity15 @entity1 received 0.06, 0.6 or 6 million international units (MIU) @entity2391 -1a or placebo every other day for up to six months. @entity7241 -enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. @entity6421 was measured in 21 @entity1 and neutralizing antibodies in 24 @entity1 . RESULTS: Of 194 screened @entity1 , 173 were randomized (42-44 @entity1 per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. Adverse events showed no notable group differences. Approximately two-thirds of @entity1 in each group remained relapse free. No @entity1 showed neutralizing antibodies. Neopterin levels were comparable between groups. CONCLUSION: Oral @entity2391 -1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.

Oral interferon beta-1a in relapsing-remitting XXXX : a double-blind randomized study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity6421 :: ('MESH:D019798', 'Chemical') :: ['Neopterin'] @entity7241 :: ('MESH:D019786', 'Chemical') :: ['Gadolinium DTPA'] @entity2391 :: ('3456', 'Gene') :: ['IFNB'] @entity15 :: ('MESH:D009103', 'Disease') :: ['MS', 'multiple sclerosis']
@entity15 :: (MESH:D009103,Disease) :: ['multiple sclerosis']
