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Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
fingolimod
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Relapsing-remitting Multiple Sclerosis focused on measuring fingolimod, Biomarker, Multiple sclerosis, Relapsing-remitting multiple sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fingolimod

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)
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.
Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS)
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.
Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)
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

Full Information

First Posted
March 21, 2016
Last Updated
September 6, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02720107
Brief Title
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
fingolimod, Biomarker, Multiple sclerosis, Relapsing-remitting multiple sclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fingolimod
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
fingolimod
Primary Outcome Measure Information:
Title
Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)
Description
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.
Time Frame
Baseline up to approximately 48 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)
Description
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.
Time Frame
Baseline up to approximately 48 months
Title
Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS)
Description
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.
Time Frame
Baseline, month 6 up to approximately 48 months
Title
Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)
Description
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
Time Frame
Baseline up to approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Ostfildern
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
Novartis Investigative Site
City
Altenholz-Stift
ZIP/Postal Code
24161
Country
Germany
Facility Name
Novartis Investigative Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Novartis Investigative Site
City
Boblingen
ZIP/Postal Code
71032
Country
Germany
Facility Name
Novartis Investigative Site
City
Celle
ZIP/Postal Code
29223
Country
Germany
Facility Name
Novartis Investigative Site
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Novartis Investigative Site
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Klingenmünster
ZIP/Postal Code
76889
Country
Germany
Facility Name
Novartis Investigative Site
City
Lappersdorf
ZIP/Postal Code
93138
Country
Germany
Facility Name
Novartis Investigative Site
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Novartis Investigative Site
City
Mönchengladbach
ZIP/Postal Code
41239
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
81829
Country
Germany
Facility Name
Novartis Investigative Site
City
Neuburg an der Donau
ZIP/Postal Code
86633
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegen
ZIP/Postal Code
57076
Country
Germany
Facility Name
Novartis Investigative Site
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Novartis Investigative Site
City
Troisdorf
ZIP/Postal Code
53844
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Novartis Investigative Site
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

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