Oral Cladribine in Early Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of
      oral cladribine versus placebo in participants who had a first clinical demyelinating event
      (clinically isolated syndrome). Participants in either the cladribine or placebo group may
      also enter treatment periods with open-label interferon-beta or open-label cladribine
      depending upon the disease status. The primary objective of this study is to evaluate the
      effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to
      multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants
      with first clinical demyelinating event at high risk of converting to MS.
    

Detailed description: 
      This will be a randomized, double blind, three-arm, placebo-controlled, multi-center trial to
      evaluate the safety and efficacy of oral cladribine versus placebo in the treatment of
      participants who have sustained a first clinical demyelinating event within 75 days prior to
      the Screening. Participants must have a minimum of 2 clinically silent lesions on the
      Screening magnetic resonance imaging (MRI).

      The study will include a pre-study evaluation period (Screening period: between 10 and 28
      days prior to the start of treatment with blinded study medication (oral cladribine or
      placebo).

      Depending upon the clinical course of their MS, participants will then proceed from the ITP
      to either the Maintenance Treatment Period (with open-label interferon-beta treatment) or
      LTFU period (with either open-label low-dose cladribine or no additional treatment (if no
      progression to MS has been noted after the initial treatment period). The single primary
      endpoint for the overall study, which will be determined during the ITP, is time to
      conversion to MS (from randomization), according to the Poser criteria.

      For every participants, eligibility for study enrollment and entry into each of the study
      periods, and diagnosis of conversion to either McDonald MS or CDMS must be confirmed and
      approved by a Sponsor appointed study Adjudication Committee.
    

Intervention name(s): Cladribine; Placebo; Rebif® new formulation (RNF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cladribine tablets were administered until CDMS conversion, whichever occur first.; Placebo matched to cladribine tablets were administered.; Participants who converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received RNF subcutaneously at a dose of 44 microgram (mcg) three times a week. Participants who converted to CDMS during long-term follow-up (LTFU) period, received RNF subcutaneously at a dose of 44 mcg three times a week.
Intervention MeSH terms: Cladribine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clinically Isolated Syndrome (CIS); Early MS; Multiple Sclerosis