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CFTY720DDE01

Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)
CompletedPhase 4Relapsing MSNCT02720107

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) < 0.0001
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) 0.0493

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)

Baseline up to approximately 48 months

GroupValueIntervalNumber analysed
Fingolimod-23.7 percentage of parent population0.62 (Standard Error)130
Fingolimod-1.2 percentage of parent population0.59 (Standard Error)130
Fingolimod22.2 percentage of parent population2.37 (Standard Error)130
Fingolimod-37.2 percentage of parent population0.38 (Standard Error)130
Fingolimod-1.6 percentage of parent population0.07 (Standard Error)130
Fingolimod-12.9 percentage of parent population1.59 (Standard Error)130
Fingolimod-0.6 percentage of parent population0.03 (Standard Error)130

p = < 0.0001

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Fingolimod 0.5 mg1300 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)

    Baseline up to approximately 48 months

    Blood or spinal fluid markersThinking and memoryImmune response

Other measures (3)

  • Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)

    Baseline up to approximately 48 months

    Disability progression

  • 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

    Disability progression

  • Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)

    Baseline up to approximately 48 months

    Immune response

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: 1. Written informed consent before any assessment was performed. 2. Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study. 3. Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study. 4. Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed. Exclusion criteriat: 1. 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. 2. 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. 3. 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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    History

      1. Started

        May 2016

      2. Main results due

        Nov 2016

      3. Finished

        Nov 2016

      4. Results posted

        Feb 2019

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