Relapsing Multiple Sclerosis
Conditions
Keywords
Relapsing Multiple Sclerosis, RMS, Relapsing Multiple Sclerosis (RMS), Multiple Sclerosis, MS, Multiple Sclerosis (MS), Fingolimod, FLUENT, Immune Phenotype, adult, FTY720
Brief summary
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod
Detailed description
This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The first cohort was to be comprised of approximately 200 patients with RMS, who were newly prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to be comprised of approximately 200 RMS patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..
Interventions
DRUGFingolimod
Commercially available 0.5mg hard capsules, taken orally once per day
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Two-cohort, non-randomized, open-label multicenter
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of relapsing forms of Multiple Sclerosis * Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years
Exclusion criteria
(per USPI): * Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure * History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker * Baseline QTc interval ≥ 500 msec * Treatment with Class Ia or Class III anti-arrhythmic drugs * Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Monocytes (CD14+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Neutrophils (CD16+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in NK Cells (CD56+) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Baseline to Month 6 | 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. |
| Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Baseline to Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis (MS) Relapses During Treatment | Baseline to Month 12 | 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. |
| Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Baseline to Month 12 | 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. |
| Change From Baseline in Patient Determined Disease Steps (PDDS) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) | Baseline to Month 12 | 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. |
| Change From Baseline for New Gd-Enhancing T1 Lesion Count | Baseline to Month 12 | — |
| Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Baseline to Month 6 and 12 | — |
| Change From Baseline in T2 Lesion Burden | Baseline to Month 12 | — |
| Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Monocytes (CD14+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Neutrophils (CD16+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in NK Cells (CD56+) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Baseline to Month 12 | 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. |
| Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Baseline to Month 12 | 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. |
Countries
United States
Participant flow
Pre-assignment details
165 patients were enrolled but only 163 were treated and included in the Safety Set
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day | 163 |
| Cohort 2 RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years | 217 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 25 | 12 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 12 | 4 |
| Overall Study | New therapy for study indication | 1 | 0 |
| Overall Study | No longer requires treatment | 0 | 1 |
| Overall Study | Non-compliance with fingolimod treatment | 4 | 2 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Protocol Violation | 5 | 3 |
| Overall Study | Technical problems | 4 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
| Overall Study | Withdrawal of informed consent | 9 | 5 |
Baseline characteristics
| Characteristic | Cohort 2 | Total | Cohort 1 |
|---|---|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 9.94 | 45.9 years STANDARD_DEVIATION 10.86 | 41.8 years STANDARD_DEVIATION 10.72 |
| Number of Patients with Relaspses within the last year Number of patients with at least 1 relapse | 32 Number of patients with relapse | 133 Number of patients with relapse | 101 Number of patients with relapse |
| Number of Patients with Relaspses within the last year Number of patients with no relapse | 183 Number of patients with relapse | 244 Number of patients with relapse | 61 Number of patients with relapse |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 22 Participants | 44 Participants | 22 Participants |
| Race/Ethnicity, Customized Caucasian | 186 Participants | 322 Participants | 136 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 158 Participants | 285 Participants | 127 Participants |
| Sex: Female, Male Male | 59 Participants | 95 Participants | 36 Participants |
| Time from Multiple Sclerosis Diagnosis until study treamtent | 12.94 years STANDARD_DEVIATION 7.007 | 10.30 years STANDARD_DEVIATION 8.033 | 6.78 years STANDARD_DEVIATION 7.984 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 163 | 0 / 217 |
| other Total, other adverse events | 70 / 163 | 66 / 217 |
| serious Total, serious adverse events | 9 / 163 | 12 / 217 |
Outcome results
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 374.6 cells/uL | Standard Deviation 216.36 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Month 6 n=97,156 | 19.6 cells/uL | Standard Deviation 58.77 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 6, n=97,156 | -368.9 cells/uL | Standard Deviation 218.4 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 16.3 cells/uL | Standard Deviation 45.11 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Month 6 n=97,156 | 18.3 cells/uL | Standard Deviation 42.89 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 6, n=97,156 | 1.1 cells/uL | Standard Deviation 51.29 |
95% CI: [-382.8, 354.7]ANCOVA
95% CI: [-7.1, 6.9]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 74.3 cells/uL | Standard Deviation 43.56 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Month 6, n=97,156 | 18.2 cells/uL | Standard Deviation 23 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | -51.5 cells/uL | Standard Deviation 36.24 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 22.8 cells/uL | Standard Deviation 41.21 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Month 6, n=97,156 | 21.7 cells/uL | Standard Deviation 33.28 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | -2.0 cells/uL | Standard Deviation 31.86 |
95% CI: [-57.2, -46.9]ANCOVA
95% CI: [-7.6, 1.4]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Baseline (BL) n=147,188 | 404.4 cells/uL | Standard Deviation 273.56 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Month 6 n=97,156 | 7.6 cells/uL | Standard Deviation 38.04 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Change from BL to Month 6, n=97,156 | -411.4 cells/uL | Standard Deviation 273.31 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Baseline (BL) n=147,188 | 3.4 cells/uL | Standard Deviation 20.69 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Month 6 n=97,156 | 4.8 cells/uL | Standard Deviation 23.52 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Change from BL to Month 6, n=97,156 | 0.8 cells/uL | Standard Deviation 25.12 |
ANCOVA
95% CI: [-3.9, 3.6]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Baseline (BL) n=148,212 | 55.5 cells/uL | Standard Deviation 36.6 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Month 6 n=104,181 | 3.1 cells/uL | Standard Deviation 8.38 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Change from BL to Month 6 n=104,181 | -53.2 cells/uL | Standard Deviation 39.01 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Baseline (BL) n=148,212 | 2.4 cells/uL | Standard Deviation 5.96 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Month 6 n=104,181 | 2.8 cells/uL | Standard Deviation 6.91 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Change from BL to Month 6 n=104,181 | 0.5 cells/uL | Standard Deviation 6.77 |
95% CI: [-55.1, -51.3]ANCOVA
95% CI: [-0.7, 1.4]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Baseline (BL) n=148,211 | 53.8 cells/uL | Standard Deviation 38.29 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Month 6 n=104,180 | 7.6 cells/uL | Standard Deviation 15.12 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Change from BL to Month 6 n=104,180 | -43.6 cells/uL | Standard Deviation 32.51 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Baseline (BL) n=148,211 | 11.1 cells/uL | Standard Deviation 31.9 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Month 6 n=104,180 | 11.7 cells/uL | Standard Deviation 33.33 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Change from BL to Month 6 n=104,180 | -0.7 cells/uL | Standard Deviation 14.38 |
95% CI: [-46.9, -40.3]ANCOVA
95% CI: [-3, 1.7]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Baseline (BL) n=148,212 | 35.9 cells/uL | Standard Deviation 30.06 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Month 6 n=104,181 | 1.7 cells/uL | Standard Deviation 4.17 |
| Cohort 1 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Change from BL to Month 6 n=104,181 | -36.1 cells/uL | Standard Deviation 32.42 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Baseline (BL) n=148,212 | 1.1 cells/uL | Standard Deviation 4.01 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Month 6 n=104,181 | 1.6 cells/uL | Standard Deviation 5.55 |
| Cohort 2 | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Change from BL to Month 6 n=104,181 | 0.5 cells/uL | Standard Deviation 5.28 |
95% CI: [-37.2, -35.3]ANCOVA
95% CI: [-0.4, 1.2]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 93.1 cells/uL | Standard Deviation 75.22 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Month 6 n=97,156 | 5.9 cells/uL | Standard Deviation 16.42 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | -85.2 cells/uL | Standard Deviation 67.95 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 5.6 cells/uL | Standard Deviation 14.85 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Month 6 n=97,156 | 6.1 cells/uL | Standard Deviation 12.97 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | 0.0 cells/uL | Standard Deviation 15.92 |
95% CI: [-89, -81.4]ANCOVA
95% CI: [-2.3, 1.9]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 108.2 cells/uL | Standard Deviation 93.28 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Month 6 n=97,156 | 55.4 cells/uL | Standard Deviation 102.88 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | -40.6 cells/uL | Standard Deviation 103.03 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 63.8 cells/uL | Standard Deviation 115.28 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Month 6 n=97,156 | 52.6 cells/uL | Standard Deviation 40.76 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 6 n=97,156 | -12.5 cells/uL | Standard Deviation 116.16 |
95% CI: [-51.1, -4.8]ANCOVA
95% CI: [-16.3, -2.6]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 150.9 cells/uL | Standard Deviation 119.48 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Month 6 n=97,156 | 4.2 cells/uL | Standard Deviation 22 |
| Cohort 1 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 6 n=97,156 | -139.3 cells/uL | Standard Deviation 113.25 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 1.8 cells/uL | Standard Deviation 8.87 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Month 6 n=97,156 | 3.3 cells/uL | Standard Deviation 15.84 |
| Cohort 2 | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 6 n=97,156 | 1.2 cells/uL | Standard Deviation 14.89 |
95% CI: [-145.8, -135]ANCOVA
95% CI: [-1.9, 3.3]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Baseline (BL) n=144,212 | 61.8 cells/uL | Standard Deviation 74.29 |
| Cohort 1 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Month 6 n=101,176 | 3.8 cells/uL | Standard Deviation 6.24 |
| Cohort 1 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Change from BL to Month 6 n=101,176 | -55.1 cells/uL | Standard Deviation 74.36 |
| Cohort 2 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Baseline (BL) n=144,212 | 3.3 cells/uL | Standard Deviation 22.58 |
| Cohort 2 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Month 6 n=101,176 | 4.0 cells/uL | Standard Deviation 21.18 |
| Cohort 2 | Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+) | Change from BL to Month 6 n=101,176 | 0.3 cells/uL | Standard Deviation 6.4 |
95% CI: [-56.5, -53.9]ANCOVA
95% CI: [-0.5, 1.1]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Monocytes (CD14+) | Baseline (BL) n=150,197 | 329.6 cells/uL | Standard Deviation 167.52 |
| Cohort 1 | Change From Baseline to Month 6 in Monocytes (CD14+) | Month 6 n=105,166 | 384.7 cells/uL | Standard Deviation 148.76 |
| Cohort 1 | Change From Baseline to Month 6 in Monocytes (CD14+) | Change from BL to Month 6 n=105,166 | 66.1 cells/uL | Standard Deviation 139.24 |
| Cohort 2 | Change From Baseline to Month 6 in Monocytes (CD14+) | Baseline (BL) n=150,197 | 251.7 cells/uL | Standard Deviation 118.46 |
| Cohort 2 | Change From Baseline to Month 6 in Monocytes (CD14+) | Month 6 n=105,166 | 379.2 cells/uL | Standard Deviation 131.42 |
| Cohort 2 | Change From Baseline to Month 6 in Monocytes (CD14+) | Change from BL to Month 6 n=105,166 | 123.1 cells/uL | Standard Deviation 123.85 |
95% CI: [97.1, 136.9]ANCOVA
95% CI: [42.1, 96.7]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Baseline (BL) n=144,212 | 201.1 cells/uL | Standard Deviation 134.16 |
| Cohort 1 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Month 6 n=101,176 | 15.0 cells/uL | Standard Deviation 10.5 |
| Cohort 1 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Change from BL to Month 6 n=101,176 | -181.4 cells/uL | Standard Deviation 125.71 |
| Cohort 2 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Baseline (BL) n=144,212 | 18.1 cells/uL | Standard Deviation 33.79 |
| Cohort 2 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Month 6 n=101,176 | 17.8 cells/uL | Standard Deviation 19.99 |
| Cohort 2 | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Change from BL to Month 6 n=101,176 | -0.2 cells/uL | Standard Deviation 36.61 |
95% CI: [-183.3, -179]ANCOVA
95% CI: [-4.1, 2.5]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Baseline (BL) n=149,197 | 4041.4 cells/uL | Standard Deviation 1576.73 |
| Cohort 1 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Month 6 n=105,166 | 3505.4 cells/uL | Standard Deviation 1512.81 |
| Cohort 1 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Change from BL to Month 6 n=105,166 | -586.0 cells/uL | Standard Deviation 1463.26 |
| Cohort 2 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Baseline (BL) n=149,197 | 3717.9 cells/uL | Standard Deviation 1552.87 |
| Cohort 2 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Month 6 n=105,166 | 3312.6 cells/uL | Standard Deviation 1311.04 |
| Cohort 2 | Change From Baseline to Month 6 in Neutrophils (CD16+) | Change from BL to Month 6 n=105,166 | -439.6 cells/uL | Standard Deviation 1274.8 |
95% CI: [-1058.2, -507.1]ANCOVA
95% CI: [-667.3, -304.4]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in NK Cells (CD56+) | Baseline (BL) n=149,197 | 166.4 cells/uL | Standard Deviation 98.23 |
| Cohort 1 | Change From Baseline to Month 6 in NK Cells (CD56+) | Month 6 n=105,166 | 133.6 cells/uL | Standard Deviation 83.41 |
| Cohort 1 | Change From Baseline to Month 6 in NK Cells (CD56+) | Change from BL to Month 6 n=105,166 | -29.4 cells/uL | Standard Deviation 76.42 |
| Cohort 2 | Change From Baseline to Month 6 in NK Cells (CD56+) | Baseline (BL) n=149,197 | 181.0 cells/uL | Standard Deviation 113.95 |
| Cohort 2 | Change From Baseline to Month 6 in NK Cells (CD56+) | Month 6 n=105,166 | 154.5 cells/uL | Standard Deviation 88.99 |
| Cohort 2 | Change From Baseline to Month 6 in NK Cells (CD56+) | Change from BL to Month 6 n=105,166 | -28.0 cells/uL | Standard Deviation 81.73 |
95% CI: [-48.2, -18.5]ANCOVA
95% CI: [-36.7, -14.9]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline (BL) n=144,212 | 12.3 cells/uL | Standard Deviation 12.88 |
| Cohort 1 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Month 6 n=101,176 | 4.8 cells/uL | Standard Deviation 3.92 |
| Cohort 1 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Change from BL to Month 6 n=101,176 | -7.4 cells/uL | Standard Deviation 10.64 |
| Cohort 2 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline (BL) n=144,212 | 5.3 cells/uL | Standard Deviation 7.66 |
| Cohort 2 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Month 6 n=101,176 | 6.1 cells/uL | Standard Deviation 5.16 |
| Cohort 2 | Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Change from BL to Month 6 n=101,176 | 0.9 cells/uL | Standard Deviation 8.15 |
95% CI: [-8, -6.4]ANCOVA
95% CI: [0.3, 2]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Baseline (BL) n=151,213 | 259.7 cells/uL | Standard Deviation 167.94 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Month 6 n=106,179 | 19.5 cells/uL | Standard Deviation 15.91 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Change from BL to Month 6 n=106,179 | -231.3 cells/uL | Standard Deviation 153.49 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Baseline (BL) n=151,213 | 21.4 cells/uL | Standard Deviation 45.19 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Month 6 n=106,179 | 21.8 cells/uL | Standard Deviation 34.75 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count | Change from BL to Month 6 n=106,179 | 0.1 cells/uL | Standard Deviation 40.66 |
95% CI: [-234.5, -227.6]ANCOVA
95% CI: [-5.2, 4.5]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Baseline (BL) n=152,213 | 13.97 cells/uL | Standard Deviation 7.245 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Month 6 n=107,180 | 5.38 cells/uL | Standard Deviation 4.368 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Change from BL to Month 6 n=107,180 | -8.53 cells/uL | Standard Deviation 6.723 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Baseline (BL) n=152,213 | 4.81 cells/uL | Standard Deviation 5.294 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Month 6 n=107,180 | 4.83 cells/uL | Standard Deviation 5.236 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%) | Change from BL to Month 6 n=107,180 | 0.23 cells/uL | Standard Deviation 3.027 |
95% CI: [-9.21, -7.4]ANCOVA
95% CI: [-0.17, 0.82]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Baseline (BL) n=156,213 | 936.3 cells/uL | Standard Deviation 443.31 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Month 6 n=110,182 | 53.4 cells/uL | Standard Deviation 114.61 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Change from BL to Month 6 n=110,182 | -884.1 cells/uL | Standard Deviation 440.65 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Baseline (BL) n=156,213 | 64.4 cells/uL | Standard Deviation 122.56 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Month 6 n=110,182 | 71.3 cells/uL | Standard Deviation 112.5 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count | Change from BL to Month 6 n=110,182 | 1.4 cells/uL | Standard Deviation 105.17 |
95% CI: [-914.6, -862.7]ANCOVA
95% CI: [-17.6, 11]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Baseline (BL) n=157,213 | 49.40 cells/uL | Standard Deviation 10.115 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Month 6 n=111,183 | 11.08 cells/uL | Standard Deviation 9.875 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Change from BL to Month 6 n=111,183 | -39.09 cells/uL | Standard Deviation 12.052 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Baseline (BL) n=157,213 | 11.95 cells/uL | Standard Deviation 12.637 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Month 6 n=111,183 | 12.82 cells/uL | Standard Deviation 13.687 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD4+ Differential Cell Count | Change from BL to Month 6 n=111,183 | 0.32 cells/uL | Standard Deviation 6.119 |
95% CI: [-41.59, -37.42]ANCOVA
95% CI: [-0.87, 1.14]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Baseline (BL) n=156,213 | 419.9 cells/uL | Standard Deviation 257.71 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Month 6 n=110,182 | 120.1 cells/uL | Standard Deviation 148.82 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Change from BL to Month 6 n=110,182 | -266.2 cells/uL | Standard Deviation 209.45 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Baseline (BL) n=156,213 | 124.6 cells/uL | Standard Deviation 213.41 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Month 6 n=110,182 | 116.8 cells/uL | Standard Deviation 101.44 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count | Change from BL to Month 6 n=110,182 | -13.5 cells/uL | Standard Deviation 205.59 |
95% CI: [-278.7, -219.2]ANCOVA
95% CI: [-25.1, 5.4]ANCOVA
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.
Time frame: Baseline to Month 6
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Baseline (BL) n=157,213 | 21.86 cells/uL | Standard Deviation 7.852 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Month 6 n=111,183 | 25.33 cells/uL | Standard Deviation 14.998 |
| Cohort 1 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Change from BL to Month 6 | 4.63 cells/uL | Standard Deviation 11.327 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Baseline (BL) n=157,213 | 25.25 cells/uL | Standard Deviation 14.406 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Month 6 n=111,183 | 24.99 cells/uL | Standard Deviation 13.863 |
| Cohort 2 | Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%) | Change from BL to Month 6 | -0.39 cells/uL | Standard Deviation 4.528 |
95% CI: [3.13, 8.08]ANCOVA
95% CI: [-0.68, 0.76]ANCOVA
Secondary
Change From Baseline for New Gd-Enhancing T1 Lesion Count
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Baseline (BL) n=125,147 | 0.4 number of lesions | Standard Deviation 1.09 |
| Cohort 1 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Month 12 n=33,28 | 0.1 number of lesions | Standard Deviation 0.24 |
| Cohort 1 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Change from BL to Month 12 n=33,28 | -0.2 number of lesions | Standard Deviation 0.61 |
| Cohort 2 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Baseline (BL) n=125,147 | 0.2 number of lesions | Standard Deviation 1.21 |
| Cohort 2 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Month 12 n=33,28 | 0.2 number of lesions | Standard Deviation 0.83 |
| Cohort 2 | Change From Baseline for New Gd-Enhancing T1 Lesion Count | Change from BL to Month 12 n=33,28 | 0.2 number of lesions | Standard Deviation 0.77 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Baseline (BL) n=163,217 | 1.7 scores | Standard Deviation 1.85 |
| Cohort 1 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Month 12 n=103,188 | 1.8 scores | Standard Deviation 1.95 |
| Cohort 1 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Change from BL to Month 12 n=103,188 | -0.1 scores | Standard Deviation 0.87 |
| Cohort 2 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Baseline (BL) n=163,217 | 1.8 scores | Standard Deviation 1.9 |
| Cohort 2 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Month 12 n=103,188 | 1.8 scores | Standard Deviation 2.02 |
| Cohort 2 | Change From Baseline in Patient Determined Disease Steps (PDDS) | Change from BL to Month 12 n=103,188 | -0.0 scores | Standard Deviation 0.78 |
Secondary
Change From Baseline in T2 Lesion Burden
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline in T2 Lesion Burden | Baseline (BL) n=91,84 | 8.1 number of lesions | Standard Deviation 12.74 |
| Cohort 1 | Change From Baseline in T2 Lesion Burden | Month 12 n=21,17 | 6.5 number of lesions | Standard Deviation 8.2 |
| Cohort 1 | Change From Baseline in T2 Lesion Burden | Change from BL to Month 12 n=21,17 | -0.8 number of lesions | Standard Deviation 2.36 |
| Cohort 2 | Change From Baseline in T2 Lesion Burden | Baseline (BL) n=91,84 | 9.7 number of lesions | Standard Deviation 15.47 |
| Cohort 2 | Change From Baseline in T2 Lesion Burden | Month 12 n=21,17 | 13.1 number of lesions | Standard Deviation 13.22 |
| Cohort 2 | Change From Baseline in T2 Lesion Burden | Change from BL to Month 12 n=21,17 | 3.2 number of lesions | Standard Deviation 12.46 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 374.6 cells/uL | Standard Deviation 216.36 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -356.8 cells/uL | Standard Deviation 237.76 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 16.3 cells/uL | Standard Deviation 45.11 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | 3.9 cells/uL | Standard Deviation 55.06 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 74.3 cells/uL | Standard Deviation 43.56 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -50.4 cells/uL | Standard Deviation 40.4 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 22.8 cells/uL | Standard Deviation 41.21 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -3.3 cells/uL | Standard Deviation 30.24 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 404.4 cells/uL | Standard Deviation 273.56 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 12 n=82,150 | -376.3 cells/uL | Standard Deviation 277.23 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 3.4 cells/uL | Standard Deviation 20.69 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 12 n=82,150 | -0.8 cells/uL | Standard Deviation 20.1 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) | Baseline (BL) n=148,212 | 55.5 cells/uL | Standard Deviation 36.6 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) | Change from BL to Month 12 n=88,175 | -52.1 cells/uL | Standard Deviation 41.2 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) | Baseline (BL) n=148,212 | 2.4 cells/uL | Standard Deviation 5.96 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+) | Change from BL to Month 12 n=88,175 | 0.5 cells/uL | Standard Deviation 7.7 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) | Baseline (BL) n=148,211 | 53.8 cells/uL | Standard Deviation 38.29 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) | Change from BL to Month 12 n=88,175 | -42.3 cells/uL | Standard Deviation 38.9 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) | Baseline (BL) n=148,211 | 11.1 cells/uL | Standard Deviation 31.9 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+) | Change from BL to Month 12 n=88,175 | -2.1 cells/uL | Standard Deviation 15.04 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) | Baseline (BL) n=148,212 | 35.9 cells/uL | Standard Deviation 30.06 |
| Cohort 1 | Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) | Change from BL to Month 12 | -36.3 cells/uL | Standard Deviation 34.63 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) | Baseline (BL) n=148,212 | 1.1 cells/uL | Standard Deviation 4.01 |
| Cohort 2 | Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+) | Change from BL to Month 12 | 0.4 cells/uL | Standard Deviation 4.93 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 93.1 cells/uL | Standard Deviation 75.22 |
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -86.5 cells/uL | Standard Deviation 75.75 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 5.6 cells/uL | Standard Deviation 14.85 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | 0.0 cells/uL | Standard Deviation 16.88 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 108.2 cells/uL | Standard Deviation 93.28 |
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -55.9 cells/uL | Standard Deviation 57.48 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline (BL) n=147,188 | 63.8 cells/uL | Standard Deviation 115.28 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Change from BL to Month 12 n=83,150 | -15.9 cells/uL | Standard Deviation 122.31 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 150.9 cells/uL | Standard Deviation 119.48 |
| Cohort 1 | Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 12 n=83,150 | -126.3 cells/uL | Standard Deviation 103.38 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline (BL) n=147,188 | 1.8 cells/uL | Standard Deviation 8.87 |
| Cohort 2 | Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+) | Change from BL to Month 12 n=83,150 | 0.6 cells/uL | Standard Deviation 10.24 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) | Baseline (BL) n=144,212 | 61.8 cells/uL | Standard Deviation 74.29 |
| Cohort 1 | Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) | Change from BL to Month 12 n=82,174 | -46.4 cells/uL | Standard Deviation 39.15 |
| Cohort 2 | Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) | Baseline (BL) n=144,212 | 3.3 cells/uL | Standard Deviation 22.58 |
| Cohort 2 | Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+) | Change from BL to Month 12 n=82,174 | 1.4 cells/uL | Standard Deviation 19.59 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Monocytes (CD14+) | Baseline (BL) n=150,197 | 329.6 cells/uL | Standard Deviation 167.52 |
| Cohort 1 | Change From Baseline to Month 12 in Monocytes (CD14+) | Change from BL to Month 12 n=86,164 | 57.1 cells/uL | Standard Deviation 139.91 |
| Cohort 2 | Change From Baseline to Month 12 in Monocytes (CD14+) | Baseline (BL) n=150,197 | 251.7 cells/uL | Standard Deviation 118.46 |
| Cohort 2 | Change From Baseline to Month 12 in Monocytes (CD14+) | Change from BL to Month 12 n=86,164 | 112.4 cells/uL | Standard Deviation 130.82 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) | Baseline (BL) n=144,212 | 201.11 cells/uL | Standard Deviation 134.16 |
| Cohort 1 | Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) | Change from BL to Month 12 n=82,174 | -177.0 cells/uL | Standard Deviation 114.43 |
| Cohort 2 | Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) | Baseline (BL) n=144,212 | 18.1 cells/uL | Standard Deviation 33.79 |
| Cohort 2 | Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-) | Change from BL to Month 12 n=82,174 | -0.5 cells/uL | Standard Deviation 40.72 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Neutrophils (CD16+) | Baseline (BL) n=149,197 | 4041.4 cells/uL | Standard Deviation 1576.73 |
| Cohort 1 | Change From Baseline to Month 12 in Neutrophils (CD16+) | Change from BL to Month 12 n=87, 164 | -815.9 cells/uL | Standard Deviation 1368.23 |
| Cohort 2 | Change From Baseline to Month 12 in Neutrophils (CD16+) | Baseline (BL) n=149,197 | 3717.9 cells/uL | Standard Deviation 1552.87 |
| Cohort 2 | Change From Baseline to Month 12 in Neutrophils (CD16+) | Change from BL to Month 12 n=87, 164 | -345.0 cells/uL | Standard Deviation 1253.29 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in NK Cells (CD56+) | Baseline (BL) n=149,197 | 166.4 cells/uL | Standard Deviation 98.23 |
| Cohort 1 | Change From Baseline to Month 12 in NK Cells (CD56+) | Change from BL to Month 12 n=87,164 | -32.6 cells/uL | Standard Deviation 97.86 |
| Cohort 2 | Change From Baseline to Month 12 in NK Cells (CD56+) | Baseline (BL) n=149,197 | 181.0 cells/uL | Standard Deviation 113.95 |
| Cohort 2 | Change From Baseline to Month 12 in NK Cells (CD56+) | Change from BL to Month 12 n=87,164 | -28.9 cells/uL | Standard Deviation 86.71 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline (BL) n=144,212 | 12.3 cells/uL | Standard Deviation 12.88 |
| Cohort 1 | Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Change from BL to Month 12 n=82,174 | -7.7 cells/uL | Standard Deviation 11.6 |
| Cohort 2 | Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Baseline (BL) n=144,212 | 5.3 cells/uL | Standard Deviation 7.66 |
| Cohort 2 | Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+) | Change from BL to Month 12 n=82,174 | 0.8 cells/uL | Standard Deviation 8.88 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Baseline (BL) n=151,213 | 259.7 cells/uL | Standard Deviation 167.94 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Change from BL to Month 12 n=88,176 | -218.9 cells/uL | Standard Deviation 127.69 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Baseline (BL) n=151,213 | 21.4 cells/uL | Standard Deviation 45.19 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count | Change from BL to Month 12 n=88,176 | 1.0 cells/uL | Standard Deviation 52.35 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Baseline (BL) n=152,213 | 13.97 cells/uL | Standard Deviation 7.245 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Change from BL to Month 12 n=89,176 | -8.86 cells/uL | Standard Deviation 7.222 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Baseline (BL) n=152,213 | 4.81 cells/uL | Standard Deviation 5.294 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%) | Change from BL to Month 12 n=89,176 | 0.20 cells/uL | Standard Deviation 3.21 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count | Baseline (BL) n=156,213 | 936.3 cells/uL | Standard Deviation 443.31 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count | Change from BL to Month 12 n=94,176 | -844.9 cells/uL | Standard Deviation 439.92 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count | Baseline (BL) n=156,213 | 64.4 cells/uL | Standard Deviation 122.56 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count | Change from BL to Month 12 n=94,176 | 0.7 cells/uL | Standard Deviation 101.82 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) | Baseline (BL) n=157,213 | 49.40 cells/uL | Standard Deviation 10.115 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) | Change from BL to Month 12 n=95,176 | -37.90 cells/uL | Standard Deviation 12.756 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) | Baseline (BL) n=157,213 | 11.95 cells/uL | Standard Deviation 12.637 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%) | Change from BL to Month 12 n=95,176 | 0.70 cells/uL | Standard Deviation 6.127 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count | Baseline (BL) n=156,213 | 419.9 cells/uL | Standard Deviation 257.71 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count | Change from BL to Month 12 n=94,176 | -265.1 cells/uL | Standard Deviation 168.81 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count | Baseline (BL) n=156,213 | 124.6 cells/uL | Standard Deviation 213.41 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count | Change from BL to Month 12 n=94,176 | -11.6 cells/uL | Standard Deviation 216 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) | Baseline (BL) n=157,213 | 21.86 cells/uL | Standard Deviation 7.852 |
| Cohort 1 | Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) | Change from BL to Month 12 n=95,176 | 4.33 cells/uL | Standard Deviation 11.185 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) | Baseline (BL) n=157,213 | 25.25 cells/uL | Standard Deviation 14.406 |
| Cohort 2 | Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%) | Change from BL to Month 12 n=95,176 | 0.34 cells/uL | Standard Deviation 5.15 |
Secondary
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
Time frame: Baseline to Month 6 and 12
Population: Safety analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Baseline (BL) n=159,215 | 1.273 cells/uL | Standard Deviation 1.293 |
| Cohort 1 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Change from BL to Month 6 n=116,195 | 0.038 cells/uL | Standard Deviation 0.2874 |
| Cohort 1 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Change from BL to Month 12 n=100,180 | 0.040 cells/uL | Standard Deviation 0.3397 |
| Cohort 2 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Baseline (BL) n=159,215 | 1.391 cells/uL | Standard Deviation 1.26 |
| Cohort 2 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Change from BL to Month 6 n=116,195 | 0.045 cells/uL | Standard Deviation 0.4724 |
| Cohort 2 | Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value) | Change from BL to Month 12 n=100,180 | 0.145 cells/uL | Standard Deviation 0.6062 |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Relapses requiring steroid use | 7 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Number of patients with relapses | 11 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Mild relapse | 5 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Relapses not requiring steroid use | 5 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Moderate relapse | 6 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Severe relapse | 1 relapses |
| Cohort 1 | Multiple Sclerosis (MS) Relapses During Treatment | Total number of relapses | 12 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Severe relapse | 0 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Number of patients with relapses | 13 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Total number of relapses | 13 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Relapses not requiring steroid use | 5 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Relapses requiring steroid use | 8 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Mild relapse | 8 relapses |
| Cohort 2 | Multiple Sclerosis (MS) Relapses During Treatment | Moderate relapse | 5 relapses |
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.
Time frame: Baseline to Month 12
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Patients with ≥ 1 relapses | 11 Participants |
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Patients with relapse who received ≥ 1 steroid | 7 Participants |
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Corticosteroids for systemic use | 7 Participants |
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Methylprednisolone sodium succinate | 4 Participants |
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Methylprednisolone | 3 Participants |
| Cohort 1 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Prednisone | 0 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Methylprednisolone | 2 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Patients with ≥ 1 relapses | 13 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Methylprednisolone sodium succinate | 4 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Patients with relapse who received ≥ 1 steroid | 8 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Prednisone | 3 Participants |
| Cohort 2 | Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment | Corticosteroids for systemic use | 8 Participants |