The goal of this study was to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the treatment of multiple sclerosis (MS). This study randomized around 200 participants from approximately 50 sites located world-wide, who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) participants, who were still experiencing relapses, and participants who have received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS treatment history, but were currently on IFN-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, were enrolled. Participants were randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with IFN-beta therapy. Participants who completed the double-blind portion of the study were invited to participate in an open-label extension phase of matching study design.
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Double Blind Period: Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE] v 4.0) Hematological or Liver Toxicity
Timeframe: Baseline up to Week 96
Double Blind Period: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) in Infections and Infestations System Organ Class (SOC)
Timeframe: Baseline up to Week 96
Double Blind Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Timeframe: Baseline up to Week 96
Double Blind Period: Time to First Grade 3 or 4 Hematological Toxicity or Liver Toxicity
Timeframe: Baseline up to Week 96
Double Blind Period: Time to Recovery From Grade 3 or 4 Hematological Toxicity
Timeframe: Baseline up to Week 96
Double Blind Period: Mean Changes in Lymphocytes, White Blood Cells (WBC), Neutrophils and Platelets Values From Baseline to Week 96
Timeframe: Baseline, Week 96
Double Blind Period: Maximum Corrected QT Interval (QTc)
Timeframe: Baseline up to Week 96
Double Blind Period: Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
Timeframe: Baseline, Week 96
Double Blind Period: Mean Change From Baseline in Vital Signs- Pulse Rate
Timeframe: Baseline, Week 96
Double Blind Period: Mean Change From Baseline in Vital Signs- Weight
Timeframe: Baseline, Week 96
Double Blind Period: Mean Change From Baseline in Vital Signs- Temperature
Timeframe: Baseline, Week 96
Double Blind Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- Heart Rate
Timeframe: Baseline, Week 96
Double Blind Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- PR, RR, QRS and OT Interval
Timeframe: Baseline, Week 96
Double Blind Period: Mean Changes From Baseline in Hemoglobin Level to Week 96
Timeframe: Baseline, Week 96
Double Blind Period: Mean Changes From Baseline in CD4+ Count, CD8+ Count, and CD19+ to Week 96
Timeframe: Baseline, Week 96
Double Blind Period: Mean Changes From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Week 96
Timeframe: Baseline, Week 96
Open Label Extension Period: Maximum Corrected QT Interval (Qtc)
Timeframe: Baseline up to Week 96
Open Label Extension Period: Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure
Timeframe: Baseline, Week 72
Open Label Extension Period: Mean Change From Baseline in Vital Signs- Pulse Rate
Timeframe: Baseline, Week 72
Open Label Extension Period: Mean Change From Baseline in Vital Signs- Weight
Timeframe: Baseline, Week 72
Open Label Extension Period: Mean Change From Baseline in Vital Signs- Temperature
Timeframe: Baseline, Week 72
Open Label Extension Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- Heart Rate
Timeframe: Baseline, Week 72
Open Label Extension Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- PR, RR, QRS and OT Interval
Timeframe: Baseline, Week 72
OLE and Safety Follow-up Period: Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE] v 4.0) Hematological or Liver Toxicity
Timeframe: Baseline (OLEP) up to Week 96
OLE and Safety Follow-up Period: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) in Infections and Infestations System Organ Class (SOC)
Timeframe: Baseline (OLEP) up to Week 96
OLE and Safety Follow-up Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Timeframe: Baseline (OLEP) up to Week 96
Open Label Extension Period: Time to First Grade 3 or 4 Hematological Toxicity or Liver Toxicity
Timeframe: Baseline up to Week 96