TY - JOUR
T1 - A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis
AU - Giovannoni, Gavin
AU - Comi, Giancarlo
AU - Cook, Stuart A
AU - Rammohan, Kottil
AU - Rieckmann, Peter
AU - Sorensen, Per Soelberg
AU - Vermersch, Patrick
AU - Chang, Peter Wushou
AU - Hamlett, Anthony
AU - Musch, Bruno
AU - CLARITY study group
AU - Hupperts, Raymond
AU - Greenberg, Steven J.
PY - 2010/2/4
Y1 - 2010/2/4
N2 - Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis.We randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks.Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33; P
AB - Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis.We randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks.Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33; P
U2 - 10.1056/NEJMoa0902533
DO - 10.1056/NEJMoa0902533
M3 - Article
C2 - 20089960
SN - 0028-4793
VL - 362
SP - 416
EP - 426
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 5
ER -