| Primary | 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 | Percentage of participants with Grade 3 or 4 CTCAE v 4.0 toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. | Posted | | Number | | Percentage of participants | | Baseline up to Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
| | | Title | Denominators | Categories |
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| Grade 3 or 4 Lymphocyte toxicity | | | | Grade 3 or 4 Hemoglobin toxicity | | |
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| Primary | Double Blind Period: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) in Infections and Infestations System Organ Class (SOC) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration.TEAEs were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0 | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. | Posted | | Number | | Percentage of participants | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. |
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| Primary | Double Blind Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs. | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. | Posted | | Count of Participants | | Participants | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. |
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| Primary | Double Blind Period: Time to First Grade 3 or 4 Hematological Toxicity or Liver Toxicity | Time to first Grade 3 or 4 hematological toxicity or liver toxicity (lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin) were estimated using the Kaplan-Meier method. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th and 20th percentiles estimated from Kaplan-Meier survival curve. Due to the small number of events, estimates from Kaplan-Meier survival curves could only be derived for lower percentiles. The median (50th percentile) could not be estimated if less than 50% of the participants had an event during the time of the study. Accordingly, lower percentiles are presented according to the number of events observed. | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Number | | Months | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. |
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| Primary | Double Blind Period: Time to Recovery From Grade 3 or 4 Hematological Toxicity | Time to recovery from grade 3 or 4 hematological were reported: lymphocytes, platelets, neutrophils, white blood cells and hemoglobin. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Recovery" as "Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who had a Grade 3 or 4 abnormality and evaluable at specified category. | Posted | | Mean | Standard Deviation | Days | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Changes in Lymphocytes, White Blood Cells (WBC), Neutrophils and Platelets Values From Baseline to Week 96 | Mean changes in lymphocytes, WBC, neutrophils and platelets from baseline to week 96 were reported. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Maximum Corrected QT Interval (QTc) | Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec). | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure | Mean change from baseline in vital signs- systolic and diastolic blood pressure was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mm*hg) | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Vital Signs- Pulse Rate | Mean change from baseline in vital signs- Pulse Rate was reported. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | beats per minutes | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Vital Signs- Weight | Mean change from baseline in vital signs- weight was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Kilogram | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Vital Signs- Temperature | Mean change from baseline in vital signs- temperature was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- Heart Rate | Mean change from baseline in ECG parameters- Heart Rate was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | beats per minutes | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- PR, RR, QRS and OT Interval | Mean change from baseline in ECG parameters- PR, RR, QRS and OT interval was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Changes From Baseline in Hemoglobin Level to Week 96 | Mean changes in hemoglobin level from baseline to week 96 was reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | gram per liter (g/L) | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Changes From Baseline in CD4+ Count, CD8+ Count, and CD19+ to Week 96 | Mean changes CD4+ Count, CD8+ Count, and CD19+ from baseline to Week 96 were reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Cells per microliter | | Baseline, Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Primary | Double Blind Period: Mean Changes From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Week 96 | Mean changes in ALT and AST from baseline to week 96 were reported. | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Units per liter | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Number of Combined Unique Active (CUA) Lesions, Active Time Constant 2 (T2) Lesions, and Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan | Number of CUA lesions, active T2 lesions, and T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of Participants analyzed"= participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Lesions | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Mean Number of T1 Hypointense Lesions Per Participant Per Scan at Week 96 | Mean number of T1 hypointense lesions per participant per scan at 96 weeks were reported. T1 hypointense lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Lesions | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Percentage of Participants With no Active T2 Lesions at Week 96 | Percentage of participants with no active T2 lesions at week 96 were reported. Active T2 lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Percentage of Participants With no Active T1 Gd-Enhanced Lesions at Week 96 | Percentage of participants with no active T1 Gd-enhanced lesions at week 96 were reported. Active T1 Gd-Enhanced lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Mean Change in T2 Lesion Volume From Baseline to Week 96 | Mean change in T2 lesion volume From baseline to Week 96 were reported. T2 lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | | Mean | Standard Deviation | cubic millimeters (mm^3) | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Percent Change in Normalized Brain Volume From Baseline to Week 96 | Brain volume was measured using magnetic resonance imaging (MRI) scans of the brain. Percent change in normalized brain volume from baseline to week 96 was reported. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
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| Secondary | Double Blind Period: Mean Change in T1 Hypointense Lesion Volume From Baseline to Week 96 | Mean change in T1 hypointense lesion volume from baseline to week 96 was reported. T1 Hypointense lesions were measured by using magnetic resonance imaging (MRI) scans. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | | Mean | Standard Deviation | millimeter cubic | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
|
| Secondary | Double Blind Period: Annualized Qualifying Relapse Rate | A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. | Posted | | Number | 95% Confidence Interval | relapses per year | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | |
|
| Secondary | Double Blind Period: Percentage of Participants Qualifying Relapse-free | A qualifying relapse was defined as a 2-grade increase in 1 or more Kurtzke Functional Systems (KFS) or a 1-grade increase in 2 or more KFS, excluding changes in bowel/bladder or cognition, in the absence of fever, lasting for >= 24 hours, and preceded by at least 30 days of clinical stability or improvement. Percentage of participants qualifying relapse-free were reported. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. | Posted | | Number | | Percentage of Participants | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
|
| Secondary | Double Blind Period and OLE Period: Time to 3-Month Sustained Expanded Disability Status Scale (EDSS) Progression | EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in Multiple Sclerosis (MS). Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. Time to sustained disability progression was analyzed using a Cox proportional hazards model. 10th and 20th percentiles estimated from Kaplan-Meier survival curve. Due to the small number of events, estimates from Kaplan-Meier survival curves could only be derived for lower percentiles. The median (50th percentile) could not be estimated if less than 50% of the participants had an event during the time of the study. Accordingly, lower percentiles are presented according to the number of events observed. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Number | | Days | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. |
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| Secondary | Double Blind Period and OLE Period: Time to First Qualifying Relapse | A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. Time to first qualifying relapse were analyzed using a Cox proportional hazards model. 10th and 20th percentiles estimated from Kaplan-Meier survival curve. Due to the small number of events, estimates from Kaplan-Meier survival curves could only be derived for lower percentiles. The median (50th percentile) could not be estimated if less than 50% of the participants had an event during the time of the study. Accordingly, lower percentiles are presented according to the number of events observed. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Number | | Days | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. |
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| Primary | Open Label Extension Period: Maximum Corrected QT Interval (Qtc) | Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec). | Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Vital Signs- Systolic and Diastolic Blood Pressure | Mean change from baseline in vital signs- systolic and diastolic blood pressure was reported. | Safety population was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mm*hg) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Vital Signs- Pulse Rate | Mean change from baseline in vital signs- Pulse Rate was reported. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | beats per minutes | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Vital Signs- Weight | Mean change from baseline in vital signs- weight was reported. | Safety population was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | Kilogram | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Vital Signs- Temperature | Mean change from baseline in vital signs- temperature was reported. | Safety population was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | Degree celsius | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- Heart Rate | Mean change from baseline in ECG parameters- Heart Rate was reported. | Safety population was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | beats per minutes | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | Open Label Extension Period: Mean Change From Baseline in Electrocardiogram (ECG) Parameters- PR, RR, QRS and OT Interval | Mean change from baseline in ECG parameters- PR, RR, QRS and OT interval was reported. | Safety population was used. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Only those participants with data available at the specified time point were reported. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
|
| Secondary | Double Blind Period: Mean Change in New T1 Gd+ Lesions From Baseline to Week 96 | Mean change in new T1 Gd+ lesions from baseline to week 96 was reported. | ITT population included all randomized participants who had received at least one dose of study medication in the DB period. Here "Number of participants analyzed" signifies those participants who were evaluated for this outcome measure. | Posted | | Mean | Standard Deviation | Lesions | | Baseline, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta (DB Period) | Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 milligram per kilogram (mg/kg) along with interferon (IFN)-beta therapy (Rebif® new formulation [RNF] 44 mcg three times a week, subcutaneously; Avonex® 30 microgram (mcg) every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the Double blind period (DBP) of 96 weeks. | | OG001 | Placebo, IFN-beta (DB Period) | Participants received matching placebo tablets orally over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks. |
| |
| Primary | 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 | Percentage of participants with Grade 3 or 4 CTCAE v 4.0 toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. | Safety population: all randomized participants who received at least 1 dose of study drug in DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Number | | Percentage of participants | | Baseline (OLEP) up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. | | OG001 | Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) |
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| Primary | OLE and Safety Follow-up Period: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) in Infections and Infestations System Organ Class (SOC) | An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration.TEAEs were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0 | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. | Posted | | Number | | Percentage of participants | | Baseline (OLEP) up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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| Primary | OLE and Safety Follow-up Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs. | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. | Posted | | Count of Participants | | Participants | | Baseline (OLEP) up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
|
| Primary | Open Label Extension Period: Time to First Grade 3 or 4 Hematological Toxicity or Liver Toxicity | Time to first Grade 3 or 4 hematological toxicity or liver toxicity (lymphocytes, cluster of differentiation 4 (CD4+) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin) were estimated using the Kaplan-Meier method. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th and 20th percentiles estimated from Kaplan-Meier survival curve. Due to the small number of events, estimates from Kaplan-Meier survival curves could only be derived for lower percentiles. The median (50th percentile) could not be estimated if less than 50% of the participants had an event during the time of the study. Accordingly, lower percentiles are presented according to the number of events observed. | Safety population included all randomized participants who received at least one dose of study medication in the DBP and had follow-up safety data. Here "Number of Participants analyzed"= participants evaluable for this outcome measure and "number analyzed"= participants who were evaluable for specified category. | Posted | | Number | | Months | | Baseline up to Week 96 | | | | ID | Title | Description |
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| OG000 | Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext) | Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks. |
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