| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| | | Title | Denominators | Categories |
|---|
| Baseline (BL) n=147,188 | - ParticipantsOG000147
- ParticipantsOG001188
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | | | least squares mean | -413.4 | Standard Error of the Mean | 4.7 | 2-Sided | 95 | -422.7 | -404. | | | | | Other | | | | | ANCOVA | | |
|
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
| |
| 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. | | Posted | | Number | | relapses | | Baseline to Month 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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| 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. | | Posted | | Count of Participants | | Participants | | Baseline to Month 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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| 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. | | Posted | | Mean | Standard Deviation | scores | | Baseline to Month 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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| Secondary | Change From Baseline in T2 Lesion Burden | | | Posted | | Mean | Standard Deviation | number of lesions | | Baseline to Month 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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| Secondary | Change From Baseline for New Gd-Enhancing T1 Lesion Count | | | Posted | | Mean | Standard Deviation | number of lesions | | Baseline to Month 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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| Secondary | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | | | Posted | | Mean | Standard Deviation | cells/uL | | Baseline to Month 6 and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1 | RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | | OG001 | Cohort 2 | RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years |
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