Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Monocytes (CD14+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Neutrophils (CD16+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in NK Cells (CD56+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Primary |
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 6 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Monocytes (CD14+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Neutrophils (CD16+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in NK Cells (CD56+) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) |
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected. |
Baseline to Month 12 |
|
| Secondary |
Multiple Sclerosis (MS) Relapses During Treatment |
A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection. |
Baseline to Month 12 |
|
| Secondary |
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment |
A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline in Patient Determined Disease Steps (PDDS) |
PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden. |
Baseline to Month 12 |
|
| Secondary |
Change From Baseline in T2 Lesion Burden |
|
Baseline to Month 12 |
|
| Secondary |
Change From Baseline for New Gd-Enhancing T1 Lesion Count |
|
Baseline to Month 12 |
|
| Secondary |
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) |
|
Baseline to Month 6 and 12 |
|
