This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This will be a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study will include a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period during Year 1; and a retreatment period during Year 2. During the initial treatment period in Year 1, eligible subjects will be equally randomized by a central randomization system to receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles + placebo for two cycles); b) cladribine at a high dose (0.875 mg/kg/cycle for four cycles); or c) placebo (four cycles). During the retreatment period in Year 2, subjects will receive either a) cladribine at a low dose (0.875 mg/kg/cycle for two cycles); or b) placebo (two cycles). The primary objective of the study is to evaluate the efficacy of cladribine versus placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS. For all randomized subjects, there will be a rescue option of treatment with Rebif(44 mcg three times a week (tiw)) if the subject experiences more than one qualifying relapse, and/or experiences a sustained increase in their EDSS of ?one point, or ?1.5 points if baseline EDSS was 0, (over a period of three months or greater), during a calendar year beginning at Week 24. To maintain the blind, there will be a Treating Physician who will view clinical laboratory results and assess AEs and safety information, and an independent blinded Evaluating Physician who will perform neurological exams. A central neuroradiology center, also blinded to treatment, will assess MRI evaluations. This study will randomize approximately 1290 subjects (430 per treatment arm) with RRMS over the course of approximately 12 months. Subjects will be recruited from approximately 135 sites, located in, but not limited to, North America, South America, Western Europe, Russia, Eastern Europe and Australia. Cladribine is administered orally in 10 mg tablets. The number of tablets given is standardized based on weight, using 10 kg weight ranges (i.e. 60-69.9 kg, 70-79.9 kg, etc). A cycle is defined as daily administration given consecutively over four to five days during a 28-day period. The cycles administered for all treatment arms will begin at Study Day 1, Week 5, Week 9 and Week 13 (for Year 1), and at Week 48 and Week 52 (for Year 2).
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