A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if cladribine tablets are a safe and effective
      treatment for relapsing-remitting multiple sclerosis (RRMS).
    

Detailed description: 
      This is a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The
      study includes a pre-study evaluation period (up to 28 days prior to the start of treatment);
      an initial treatment period from Week 1 to 48; and a re-treatment period during Week 49 to
      96.

      During the initial treatment period (Week 1 to 48), eligible subjects are equally randomized
      by a central randomization system to receive either a) cladribine at a low dose (0.875
      milligram per kilogram per course [mg/kg/course] for two courses plus placebo for two
      courses); b) cladribine at a high dose (0.875 mg/kg/course for four courses); or c) placebo
      (four courses). During the re-treatment period (Weeks 49 to 96), subjects received either a)
      cladribine at a low dose (0.875 mg/kg/course for two courses); or b) placebo (two courses).

      For all randomized subjects, there is a rescue option of treatment with Rebif® (interferon
      beta-1a 44 microgram (mcg) given subcutaneously three times a week), if the subject
      experienced more than one qualifying relapse, and/or experienced a sustained increase in
      their EDSS score of greater than or equal to (>=) 1 point, or >=1.5 points if baseline EDSS
      score is 0, (over a period of three months or greater), during a calendar year beginning at
      Week 24.

      To maintain the blind, there is a treating physician who view clinical laboratory results and
      assess adverse events and safety information, and an independent blinded evaluating physician
      who will perform neurological exams. A central neuroradiology center, also blinded to
      treatment, will assess magnetic resonance imaging (MRI) evaluations.
    

Intervention name(s): Cladribine 5.25 mg/kg; Cladribine 3.5 mg/kg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.; Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.; Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Intervention MeSH terms: Cladribine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment