Trial · NCT02720107
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
NCT02720107, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01). Trials, record NCT02720107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
- NCT number
- NCT02720107
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 133 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- fingolimod
- First posted
- 2016-03-25
- Last updated
- 2019-02-08
- Results first posted
- 2019-02-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Baseline up to approximately 48 months | Aim of trial was to was to show reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of 2 types of effector memory T cells TEM (CCR7- CD45RA-) and TEMRA (CCR7- CD45RA+) in peripheral venous blood. Changes from baseline to month 48 in biomarkers were analyzed for all patients in the FAS. |
| Secondary | Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | Baseline up to approximately 48 months | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score \> 5.0. |
| Secondary | Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | Baseline, month 6 up to approximately 48 months | EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score \> 5.0. |
| Secondary | Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) | Baseline up to approximately 48 months | Changes in immune status of B cells (CD19+, CD20+, CD69+), monocytes (CD14+) and NK cells (CD56+) were analyzed as a percentage of parent cell population (CD4+, CD8+ or total lymphocytes) by flow cytometry |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Baseline up to approximately 48 months | required baseline and month 48 visit measurement of the respective cell count | percentage of parent population | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | Baseline up to approximately 48 months | percentage of participants | NUMBER | |
| SECONDARY | Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | Baseline, month 6 up to approximately 48 months | scores on a scale | MEAN | |
| SECONDARY | Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) | Baseline up to approximately 48 months | analysis required valid samples for baseline and month 48 | percentage of parent population | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD4+ Naïve T cells | -23.7 | Standard Error 0.62 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD4+Central memory T cells | -1.2 | Standard Error 0.59 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD4+ Effector memory T cells | 22.2 | Standard Error 2.37 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD8+ Naïve T cells | -37.2 | Standard Error 0.38 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD8+ Central memory T cells | -1.6 | Standard Error 0.07 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | CD8+ Effector memory T cells | -12.9 | Standard Error 1.59 | percentage of parent population |
| Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) | Fingolimod | TH17 central memory cells | -0.6 | Standard Error 0.03 | percentage of parent population |
| Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) | Fingolimod | 21.54 | percentage of participants | ||
| Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | Fingolimod | Baseline | 2.7 | Standard Deviation 1.17 | scores on a scale |
| Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) | Fingolimod | Month 6 | 2.6 | Standard Deviation 1.38 | scores on a scale |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod | 130 | |
| Overall Study | COMPLETED | Fingolimod | 130 | |
| Overall Study | NOT COMPLETED | Fingolimod | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Blood immunoglobulin M decreased | Investigations | Fingolimod 0.5 mg | 1 | 130 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod 0.5 mg | ||
| Total, other adverse events | Fingolimod 0.5 mg | 1 | 130 |
| Total, serious adverse events | Fingolimod 0.5 mg | 0 | 130 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02720107
GET https://conductscience.org/api/trials/v1/NCT02720107/registered