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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02720107
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: fingolimod Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: fingolimod



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS) [ Time Frame: 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.


  2. Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS) [ Time Frame: 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.


  3. Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720107


Locations
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Germany
Novartis Investigative Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
Novartis Investigative Site
Altenholz-Stift, Germany, 24161
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 10713
Novartis Investigative Site
Berlin, Germany, 12163
Novartis Investigative Site
Berlin, Germany, 13347
Novartis Investigative Site
Boblingen, Germany, 71032
Novartis Investigative Site
Celle, Germany, 29223
Novartis Investigative Site
Dortmund, Germany, 44137
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Erbach, Germany, 64711
Novartis Investigative Site
Frankfurt, Germany, 60313
Novartis Investigative Site
Göttingen, Germany, 37073
Novartis Investigative Site
Jena, Germany, 07740
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Klingenmünster, Germany, 76889
Novartis Investigative Site
Lappersdorf, Germany, 93138
Novartis Investigative Site
Leverkusen, Germany, 51375
Novartis Investigative Site
Mönchengladbach, Germany, 41239
Novartis Investigative Site
München, Germany, 81829
Novartis Investigative Site
Neuburg an der Donau, Germany, 86633
Novartis Investigative Site
Siegen, Germany, 57076
Novartis Investigative Site
Singen, Germany, 78224
Novartis Investigative Site
Troisdorf, Germany, 53844
Novartis Investigative Site
Ulm, Germany, 89073
Novartis Investigative Site
Unterhaching, Germany, 82008
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02720107    
Other Study ID Numbers: CFTY720DDE01E1
First Posted: March 25, 2016    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
Last Verified: September 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
fingolimod
Biomarker
Multiple sclerosis
Relapsing-remitting multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs