Trial · NCT03257358
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
NCT03257358, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2020-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod. Trials, record NCT03257358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03257358
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
- NCT number
- NCT03257358
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 382 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Fingolimod
- First posted
- 2017-08-22
- Last updated
- 2021-10-07
- Results first posted
- 2020-07-21
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
| PRIMARY | Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-) | Baseline to Month 6 | Safety analysis set | cells/uL | MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group260
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 1 | Baseline (BL) n=147,188 | 404.4 | Standard Deviation 273.56 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 2 | Baseline (BL) n=147,188 | 3.4 | Standard Deviation 20.69 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 1 | Month 6 n=97,156 | 7.6 | Standard Deviation 38.04 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 2 | Month 6 n=97,156 | 4.8 | Standard Deviation 23.52 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 1 | Change from BL to Month 6, n=97,156 | -411.4 | Standard Deviation 273.31 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+) | Cohort 2 | Change from BL to Month 6, n=97,156 | 0.8 | Standard Deviation 25.12 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Cohort 1 | Baseline (BL) n=147,188 | 374.6 | Standard Deviation 216.36 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Cohort 2 | Baseline (BL) n=147,188 | 16.3 | Standard Deviation 45.11 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Cohort 1 | Month 6 n=97,156 | 19.6 | Standard Deviation 58.77 | cells/uL |
| Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+) | Cohort 2 | Month 6 n=97,156 | 18.3 | Standard Deviation 42.89 | cells/uL |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 165 | |
| Overall Study | STARTED | Cohort 2 | 217 | |
| Overall Study | Never Received Treatment | Cohort 1 | 2 | |
| Overall Study | Never Received Treatment | Cohort 2 | 0 | |
| Overall Study | COMPLETED | Cohort 1 | 94 | |
| Overall Study | COMPLETED | Cohort 2 | 183 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 71 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 34 |
Source ClinicalTrials.gov
Adverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 1 | 3 | 163 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 2 | 2 | 217 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1 | 9 | 163 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2 | 1 | 217 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 | 3 | 163 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 | 3 | 217 | |
| other | Bradycardia | Cardiac disorders | Cohort 1 | 2 | 163 | |
| other | Bradycardia | Cardiac disorders | Cohort 2 | 0 | 217 | |
| other | Blepharospasm | Eye disorders | Cohort 1 | 2 | 163 | |
| other | Blepharospasm | Eye disorders | Cohort 2 | 0 | 217 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 0 | 163 |
| Total, all-cause mortality | Cohort 2 | 0 | 217 |
| Total, other adverse events | Cohort 1 | 70 | 163 |
| Total, other adverse events | Cohort 2 | 66 | 217 |
| Total, serious adverse events | Cohort 1 | 9 | 163 |
| Total, serious adverse events | Cohort 2 | 12 | 217 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03257358
GET https://conductscience.org/api/trials/v1/NCT03257358/registered?page=2