Phase 4
Completed N=130
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
Source: ClinicalTrials.gov NCT02720107 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) — -23.7; -1.2; 22.2; -37.2 percentage of parent population — p=< 0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) |
-23.7; -1.2; 22.2; -37.2; -1.6; -12.9 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) |
21.54 | — |
| SECONDARY Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) |
2.7; 2.6; 2.7; -0.1; 0.2; 0.0 | — |
| SECONDARY Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) |
-7.2; 42.3; 28.0 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent before any assessment was performed.
- Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.
- Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.
- Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.
Exclusion criteriat:
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
- Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.
- Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.
Data sourced from ClinicalTrials.gov (NCT02720107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.