LEMTRADA was studied in 2 two-year clinical trials against Rebif® (interferon beta-1a) 44 mcg, an interferon that is commonly prescribed for relapsing MS.
People were treated with LEMTRADA for 2 years and were then invited, if eligible, to continue in an Extension Study for an additional 4 years, for a total of 6 years.
ABOUT STUDY 1
people in the 2-year study (Study 1) with 426 taking LEMTRADA, and 202 taking Rebif
of people treated with LEMTRADA (387) entered the Study 1 Extension
of people treated with LEMTRADA (332) that began Study 1 remained through Year 6
LEMTRADA was studied in people who had a relapse on an MS therapy. The study included patients who had experienced at least 2 relapses during the 2 years prior to the trial, and at least 1 relapse during the year prior to the trial.
In addition, participants in Study 1 had to have relapsed on interferon beta or glatiramer acetate and had Expanded Disability Status Scale (EDSS) scores of 5 or less.
WHO ENTERED THE STUDY 1 CLINICAL TRIAL?
|GENDER||66 F%/34% M|
|AVG. YEARS WITH MS||4.6|
|AVG. RELAPSES IN PRIOR YEAR||1.7|
EDSS measures disability progression in people with MS on a scale of 0 to 10, where 0 represents no disability.