A Phase 4 interventional study of Fingolimod in Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Completed at 66 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Basic science
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Among 34 studies testing fingolimod in Multiple Sclerosis — 2 open to participants now, 4 under way, 3 of them phase 3. fingolimod · Multiple Sclerosis.
Among the 34 studies testing fingolimod in Multiple Sclerosis, this one is the 10th largest by enrollment, is one of 2 that started in 2017, is one of 17 in phase 4, and was the 30th registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →2 of the 34 studies testing fingolimod in Multiple Sclerosis are open now, in 3 countries. Recruiting first, the newest first:
TG Therapeutics, Inc. · Sites in United States, Poland, Slovakia
Ages 10–17
Biogen
Ages 10–17
By country, each count listing its studies:
fingolimod: first FDA approval 2010 (GILENYA), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 13 · Phase 4 17
First in 2003; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 382 is above the median of 50 across 2,205 interventional studies indexed under Multiple Sclerosis.
Median enrollment 167 across the 34 interventional studies. Of the 28 that completed or were terminated, 23 (82%) have results posted.
This tab as a report to print or save as PDF → With an account.
32 of 34 have an industry lead sponsor. The 6 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
107 studies in Multiple Sclerosis by Novartis: 9 open now, 25 under way, 7 of them phase 3. Of 78 finished, 45 (58%) have results posted.
Among the 107 studies in Multiple Sclerosis by Novartis, this one is the 16th largest by enrollment of the 65 interventional ones that give a count, is the only one that started in 2017, is one of 26 in phase 4, and was the 48th registered.
Novartis’s Multiple Sclerosis studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 34 studies testing fingolimod in Multiple Sclerosis, from their registry updates:
Among Novartis’s 107 in Multiple Sclerosis:
This tab as a report to print or save as PDF → With an account.
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod
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..
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria (per USPI):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
Drug: Fingolimod
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
Drug: Fingolimod
Commercially available 0.5mg hard capsules, taken orally once per day
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change From Baseline in T2 Lesion Burden
Time frame: Baseline to Month 12
Change From Baseline for New Gd-Enhancing T1 Lesion Count
Time frame: Baseline to Month 12
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
Time frame: Baseline to Month 6 and 12
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 165 | 217 |
| Never received treatment | 2 | 0 |
| Completed | 94 | 183 |
| Not completed | 71 | 34 |
| Withdrew: Adverse event | 25 | 12 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Lost to follow-up | 12 | 4 |
| Withdrew: Non-compliance with fingolimod treatment | 4 | 2 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Protocol violation | 5 | 3 |
| Withdrew: Technical problems | 4 | 1 |
| Withdrew: Withdrawal by subject | 8 | 3 |
| Withdrew: Withdrawal of informed consent | 9 | 5 |
| Withdrew: New therapy for study indication | 1 | 0 |
| Withdrew: No longer requires treatment | 0 | 1 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 404.4 ± 273.56 | 3.4 ± 20.69 |
| Month 6 n=97,156 | 7.6 ± 38.04 | 4.8 ± 23.52 |
| Change from BL to Month 6, n=97,156 | -411.4 ± 273.31 | 0.8 ± 25.12 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 374.6 ± 216.36 | 16.3 ± 45.11 |
| Month 6 n=97,156 | 19.6 ± 58.77 | 18.3 ± 42.89 |
| Change from BL to Month 6, n=97,156 | -368.9 ± 218.40 | 1.1 ± 51.29 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 74.3 ± 43.56 | 22.8 ± 41.21 |
| Month 6, n=97,156 | 18.2 ± 23.00 | 21.7 ± 33.28 |
| Change from BL to Month 6 n=97,156 | -51.5 ± 36.24 | -2.0 ± 31.86 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,211 | 53.8 ± 38.29 | 11.1 ± 31.90 |
| Month 6 n=104,180 | 7.6 ± 15.12 | 11.7 ± 33.33 |
| Change from BL to Month 6 n=104,180 | -43.6 ± 32.51 | -0.7 ± 14.38 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,212 | 35.9 ± 30.06 | 1.1 ± 4.01 |
| Month 6 n=104,181 | 1.7 ± 4.17 | 1.6 ± 5.55 |
| Change from BL to Month 6 n=104,181 | -36.1 ± 32.42 | 0.5 ± 5.28 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,212 | 55.5 ± 36.60 | 2.4 ± 5.96 |
| Month 6 n=104,181 | 3.1 ± 8.38 | 2.8 ± 6.91 |
| Change from BL to Month 6 n=104,181 | -53.2 ± 39.01 | 0.5 ± 6.77 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 150.9 ± 119.48 | 1.8 ± 8.87 |
| Month 6 n=97,156 | 4.2 ± 22.00 | 3.3 ± 15.84 |
| Change from BL to Month 6 n=97,156 | -139.3 ± 113.25 | 1.2 ± 14.89 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 93.1 ± 75.22 | 5.6 ± 14.85 |
| Month 6 n=97,156 | 5.9 ± 16.42 | 6.1 ± 12.97 |
| Change from BL to Month 6 n=97,156 | -85.2 ± 67.95 | 0.0 ± 15.92 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 108.2 ± 93.28 | 63.8 ± 115.28 |
| Month 6 n=97,156 | 55.4 ± 102.88 | 52.6 ± 40.76 |
| Change from BL to Month 6 n=97,156 | -40.6 ± 103.03 | -12.5 ± 116.16 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 201.1 ± 134.16 | 18.1 ± 33.79 |
| Month 6 n=101,176 | 15.0 ± 10.50 | 17.8 ± 19.99 |
| Change from BL to Month 6 n=101,176 | -181.4 ± 125.71 | -0.2 ± 36.61 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 61.8 ± 74.29 | 3.3 ± 22.58 |
| Month 6 n=101,176 | 3.8 ± 6.24 | 4.0 ± 21.18 |
| Change from BL to Month 6 n=101,176 | -55.1 ± 74.36 | 0.3 ± 6.40 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 12.3 ± 12.88 | 5.3 ± 7.66 |
| Month 6 n=101,176 | 4.8 ± 3.92 | 6.1 ± 5.16 |
| Change from BL to Month 6 n=101,176 | -7.4 ± 10.64 | 0.9 ± 8.15 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=150,197 | 329.6 ± 167.52 | 251.7 ± 118.46 |
| Month 6 n=105,166 | 384.7 ± 148.76 | 379.2 ± 131.42 |
| Change from BL to Month 6 n=105,166 | 66.1 ± 139.24 | 123.1 ± 123.85 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=149,197 | 4041.4 ± 1576.73 | 3717.9 ± 1552.87 |
| Month 6 n=105,166 | 3505.4 ± 1512.81 | 3312.6 ± 1311.04 |
| Change from BL to Month 6 n=105,166 | -586.0 ± 1463.26 | -439.6 ± 1274.80 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=149,197 | 166.4 ± 98.23 | 181.0 ± 113.95 |
| Month 6 n=105,166 | 133.6 ± 83.41 | 154.5 ± 88.99 |
| Change from BL to Month 6 n=105,166 | -29.4 ± 76.42 | -28.0 ± 81.73 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=156,213 | 936.3 ± 443.31 | 64.4 ± 122.56 |
| Month 6 n=110,182 | 53.4 ± 114.61 | 71.3 ± 112.50 |
| Change from BL to Month 6 n=110,182 | -884.1 ± 440.65 | 1.4 ± 105.17 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=157,213 | 49.40 ± 10.115 | 11.95 ± 12.637 |
| Month 6 n=111,183 | 11.08 ± 9.875 | 12.82 ± 13.687 |
| Change from BL to Month 6 n=111,183 | -39.09 ± 12.052 | 0.32 ± 6.119 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=156,213 | 419.9 ± 257.71 | 124.6 ± 213.41 |
| Month 6 n=110,182 | 120.1 ± 148.82 | 116.8 ± 101.44 |
| Change from BL to Month 6 n=110,182 | -266.2 ± 209.45 | -13.5 ± 205.59 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=157,213 | 21.86 ± 7.852 | 25.25 ± 14.406 |
| Month 6 n=111,183 | 25.33 ± 14.998 | 24.99 ± 13.863 |
| Change from BL to Month 6 | 4.63 ± 11.327 | -0.39 ± 4.528 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=151,213 | 259.7 ± 167.94 | 21.4 ± 45.19 |
| Month 6 n=106,179 | 19.5 ± 15.91 | 21.8 ± 34.75 |
| Change from BL to Month 6 n=106,179 | -231.3 ± 153.49 | 0.1 ± 40.66 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=152,213 | 13.97 ± 7.245 | 4.81 ± 5.294 |
| Month 6 n=107,180 | 5.38 ± 4.368 | 4.83 ± 5.236 |
| Change from BL to Month 6 n=107,180 | -8.53 ± 6.723 | 0.23 ± 3.027 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 404.4 ± 273.56 | 3.4 ± 20.69 |
| Change from BL to Month 12 n=82,150 | -376.3 ± 277.23 | -0.8 ± 20.10 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 374.6 ± 216.36 | 16.3 ± 45.11 |
| Change from BL to Month 12 n=83,150 | -356.8 ± 237.76 | 3.9 ± 55.06 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 74.3 ± 43.56 | 22.8 ± 41.21 |
| Change from BL to Month 12 n=83,150 | -50.4 ± 40.40 | -3.3 ± 30.24 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,211 | 53.8 ± 38.29 | 11.1 ± 31.90 |
| Change from BL to Month 12 n=88,175 | -42.3 ± 38.9 | -2.1 ± 15.04 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,212 | 35.9 ± 30.06 | 1.1 ± 4.01 |
| Change from BL to Month 12 | -36.3 ± 34.63 | 0.4 ± 4.93 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=148,212 | 55.5 ± 36.60 | 2.4 ± 5.96 |
| Change from BL to Month 12 n=88,175 | -52.1 ± 41.20 | 0.5 ± 7.70 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 150.9 ± 119.48 | 1.8 ± 8.87 |
| Change from BL to Month 12 n=83,150 | -126.3 ± 103.38 | 0.6 ± 10.24 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 93.1 ± 75.22 | 5.6 ± 14.85 |
| Change from BL to Month 12 n=83,150 | -86.5 ± 75.75 | 0.0 ± 16.88 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=147,188 | 108.2 ± 93.28 | 63.8 ± 115.28 |
| Change from BL to Month 12 n=83,150 | -55.9 ± 57.48 | -15.9 ± 122.31 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 201.11 ± 134.16 | 18.1 ± 33.79 |
| Change from BL to Month 12 n=82,174 | -177.0 ± 114.43 | -0.5 ± 40.72 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 61.8 ± 74.29 | 3.3 ± 22.58 |
| Change from BL to Month 12 n=82,174 | -46.4 ± 39.15 | 1.4 ± 19.59 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=144,212 | 12.3 ± 12.88 | 5.3 ± 7.66 |
| Change from BL to Month 12 n=82,174 | -7.7 ± 11.60 | 0.8 ± 8.88 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=150,197 | 329.6 ± 167.52 | 251.7 ± 118.46 |
| Change from BL to Month 12 n=86,164 | 57.1 ± 139.91 | 112.4 ± 130.82 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=149,197 | 4041.4 ± 1576.73 | 3717.9 ± 1552.87 |
| Change from BL to Month 12 n=87, 164 | -815.9 ± 1368.23 | -345.0 ± 1253.29 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=149,197 | 166.4 ± 98.23 | 181.0 ± 113.95 |
| Change from BL to Month 12 n=87,164 | -32.6 ± 97.86 | -28.9 ± 86.71 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=156,213 | 936.3 ± 443.31 | 64.4 ± 122.56 |
| Change from BL to Month 12 n=94,176 | -844.9 ± 439.92 | 0.7 ± 101.82 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=157,213 | 49.40 ± 10.115 | 11.95 ± 12.637 |
| Change from BL to Month 12 n=95,176 | -37.90 ± 12.756 | 0.70 ± 6.127 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=156,213 | 419.9 ± 257.71 | 124.6 ± 213.41 |
| Change from BL to Month 12 n=94,176 | -265.1 ± 168.81 | -11.6 ± 216.00 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=157,213 | 21.86 ± 7.852 | 25.25 ± 14.406 |
| Change from BL to Month 12 n=95,176 | 4.33 ± 11.185 | 0.34 ± 5.150 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=151,213 | 259.7 ± 167.94 | 21.4 ± 45.19 |
| Change from BL to Month 12 n=88,176 | -218.9 ± 127.69 | 1.0 ± 52.35 |
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.
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=152,213 | 13.97 ± 7.245 | 4.81 ± 5.294 |
| Change from BL to Month 12 n=89,176 | -8.86 ± 7.222 | 0.20 ± 3.210 |
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.
| relapses | Cohort 1 | Cohort 2 |
|---|---|---|
| Number of patients with relapses | 11 | 13 |
| Total number of relapses | 12 | 13 |
| Relapses not requiring steroid use | 5 | 5 |
| Relapses requiring steroid use | 7 | 8 |
| Mild relapse | 5 | 8 |
| Moderate relapse | 6 | 5 |
| Severe relapse | 1 | 0 |
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.
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Patients with ≥ 1 relapses | 11 | 13 |
| Patients with relapse who received ≥ 1 steroid | 7 | 8 |
| Corticosteroids for systemic use | 7 | 8 |
| Methylprednisolone sodium succinate | 4 | 4 |
| Methylprednisolone | 3 | 2 |
| Prednisone | 0 | 3 |
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.
| scores | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=163,217 | 1.7 ± 1.85 | 1.8 ± 1.90 |
| Month 12 n=103,188 | 1.8 ± 1.95 | 1.8 ± 2.02 |
| Change from BL to Month 12 n=103,188 | -0.1 ± 0.87 | -0.0 ± 0.78 |
| number of lesions | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=91,84 | 8.1 ± 12.74 | 9.7 ± 15.47 |
| Month 12 n=21,17 | 6.5 ± 8.20 | 13.1 ± 13.22 |
| Change from BL to Month 12 n=21,17 | -0.8 ± 2.36 | 3.2 ± 12.46 |
| number of lesions | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=125,147 | 0.4 ± 1.09 | 0.2 ± 1.21 |
| Month 12 n=33,28 | 0.1 ± 0.24 | 0.2 ± 0.83 |
| Change from BL to Month 12 n=33,28 | -0.2 ± 0.61 | 0.2 ± 0.77 |
| cells/uL | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline (BL) n=159,215 | 1.273 ± 1.2930 | 1.391 ± 1.2600 |
| Change from BL to Month 6 n=116,195 | 0.038 ± 0.2874 | 0.045 ± 0.4724 |
| Change from BL to Month 12 n=100,180 | 0.040 ± 0.3397 | 0.145 ± 0.6062 |
Collected over Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/163 (0%) | 9/163 (5.5%) | 70/163 (42.9%) |
| Cohort 2 | 0/217 (0%) | 12/217 (5.5%) | 66/217 (30.4%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Abdominal painGastrointestinal disorders | 1/163 | 0/217 |
| NauseaGastrointestinal disorders | 1/163 | 0/217 |
| VomitingGastrointestinal disorders | 1/163 | 0/217 |
| HyperplasiaGeneral disorders | 1/163 | 0/217 |
| Non-cardiac chest painGeneral disorders | 1/163 | 0/217 |
| AppendicitisInfections and infestations | 1/163 | 0/217 |
| InfluenzaInfections and infestations | 1/163 | 0/217 |
| Pneumonia bacterialInfections and infestations | 1/163 | 0/217 |
| Urinary tract infectionInfections and infestations | 1/163 | 0/217 |
| Post procedural complicationInjury, poisoning and procedural complications | 1/163 | 0/217 |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| HeadacheNervous system disorders | 13/163 | 4/217 |
| FallInjury, poisoning and procedural complications | 5/163 | 12/217 |
| LymphopeniaBlood and lymphatic system disorders | 9/163 | 1/217 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 9/163 | 3/217 |
| FatigueGeneral disorders | 8/163 | 3/217 |
| Upper respiratory tract infectionInfections and infestations | 8/163 | 6/217 |
| DizzinessNervous system disorders | 6/163 | 1/217 |
| Urinary tract infectionInfections and infestations | 0/163 | 7/217 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/163 | 6/217 |
| HypoaesthesiaNervous system disorders | 5/163 | 1/217 |
There were 165 participants enrolled in the trial but 2 participants in Cohort 1 never received treatment
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 41.8 ± 10.72 | 48.9 ± 9.94 | 45.9 ± 10.86 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 127 | 158 | 285 |
| Male | 36 | 59 | 95 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Caucasian | 136 | 186 | 322 |
| Black | 22 | 22 | 44 |
| Asian | 0 | 3 | 3 |
| Native American | 1 | 2 | 3 |
| Unknown | 3 | 1 | 4 |
| Other | 1 | 3 | 4 |
| Time from Multiple Sclerosis Diagnosis until study treamtent(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 6.78 ± 7.984 | 12.94 ± 7.007 | 10.30 ± 8.033 |
| Number of Patients with Relaspses within the last year(Number of patients with relapse) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Number of patients with at least 1 relapse | 101 | 32 | 133 |
| Number of patients with no relapse | 61 | 183 | 244 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Sep 2017 to primary completion in Mar 2019, 17 months.
Results were first posted in Jul 2020, 1 year 4 months after primary completion. A results delay was requested in Jun 2019.
Of 36 industry-sponsored phase 4 interventional studies under Multiple Sclerosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 37. This study's 17 months is below that.
Counting every sponsor, half of 69 studies reached it within 34 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fingolimod