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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
fingolimod
Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).
Intervention: fingolimod (Drug)
Outcomes
Primary Outcomes
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)
Time Frame: 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 Outcomes
- Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)(Baseline up to approximately 48 months)
- Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)(Baseline up to approximately 48 months)
- 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)