Publication date: Sep 10, 2019
Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial [published online September 3, 2019].
Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial [published online September 3, 2019].
This randomized, double-blind, double-dummy, active-controlled phase 3 trial was held at 152 academic medical centers and clinical practices in 20 countries. Patients included in the study had relapsing MS, a baseline expanded disability status scale score of 0. 0 to 5. 0, and either 1 or more relapse in the 12 months prior to screening or 1 or more relapse in the previous 24 months plus at least 1 gadolinium-enhancing lesion in the 12 months before screening. Patients were randomly assigned 1:1:1 to be treated for at least 12 months with either once-daily oral ozanimod 1. 0 mg (n = 447) or 0. 5 mg (n = 451) or weekly interferon β -1a 30 μg (n = 448).
Only 13 (2. 9%) patients taking ozanimod 1. 0 mg and 7 (1. 5%) patients taking ozanimod 0. 5 mg discontinued due to AEs compared with 16 (3. 6%) patients who received interferon β-1a. The second studywas a 24-month, multicenter, double-blind, double-dummy phase 3 trial with 1320 patients with relapsing MS at 147 medical centers and clinical practices in 21 countries.
A total of 1313 patients received a study drug, and they were randomly assigned 1:1:1 to be treated with either once-daily oral ozanimod 1. 0 mg (n = 433) or 0. 5 mg (n = 439) or weekly interferon β -1a 30 μg (n = 441).
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