Subject disposition | |
Enrolled | 105* |
Completed baseline visit | 105† |
Primary analysis population | 103 |
Safety analysis population | 100 |
Completed week 24 visit | 85 (81.0%) |
Completed week 48 visit | 69 (65.7%) |
Subject characteristics | Evaluable patients (N=103) |
Age, mean (SD), years | 49.5 (11.8) |
Female, n (%) | 82 (79.6) |
Race, n (%) | |
Caucasian/white | 98 (95.1) |
Not Caucasian | 3 (2.9) |
Unknown | 2 (1.9) |
Time since first symptoms of MS‡, mean (SD), years | 9.1 (8.8) (n=100) |
Time since most recent relapse‡, mean (SD), months | 36.9 (64.6) (n=99) |
Number of relapses in the last year, mean (SD) | 0.6 (0.6) |
Baseline EDSS score, median (range) | 1.0 (0.0–8.0) (n=81) |
Gadolinium-enhancing lesions present on current MRI§, n (%) | 17 (16.5) |
Previous/recent DMT, n (%) | |
Yes | 49 (47.6) |
No | 54 (52.4) |
Previous/other DMTs, n (%) | 20 (19.4) |
*One subject did not have RRMS; one subject was unable to complete questionnaires.
†In addition to the two patients excluded from the primary analysis population, three patients did not receive teriflunomide.
‡Calculated from the date of the first dose of teriflunomide.
§Most recent MRI could be performed up to 2 months prior to first dose of teriflunomide.
DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; RRMS, relapsing-remitting multiple sclerosis.