NCT02720107

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

February 8, 2019

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

March 21, 2016

Results QC Date

November 14, 2017

Last Update Submit

September 6, 2018

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

fingolimodBiomarkerMultiple sclerosisRelapsing-remitting multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline up to approximately 48 months

Secondary Outcomes (3)

  • 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

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

    Baseline up to approximately 48 months

Study Arms (1)

fingolimod

EXPERIMENTAL

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

Interventions

fingolimodDRUG
fingolimod

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, 73760, Germany

Location

Novartis Investigative Site

Altenholz-Stift, Germany, 24161, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Berlin, 10713, Germany

Location

Novartis Investigative Site

Berlin, 12163, Germany

Location

Novartis Investigative Site

Berlin, 13347, Germany

Location

Novartis Investigative Site

Böblingen, 71032, Germany

Location

Novartis Investigative Site

Celle, 29223, Germany

Location

Novartis Investigative Site

Dortmund, 44137, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

Location

Novartis Investigative Site

Frankfurt, 60313, Germany

Location

Novartis Investigative Site

Göttingen, 37073, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Klingenmünster, 76889, Germany

Location

Novartis Investigative Site

Lappersdorf, 93138, Germany

Location

Novartis Investigative Site

Leverkusen, 51375, Germany

Location

Novartis Investigative Site

Mönchengladbach, 41239, Germany

Location

Novartis Investigative Site

München, 81829, Germany

Location

Novartis Investigative Site

Neuburg an der Donau, 86633, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Singen, 78224, Germany

Location

Novartis Investigative Site

Troisdorf, 53844, Germany

Location

Novartis Investigative Site

Ulm, 89073, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

May 12, 2016

Primary Completion

November 14, 2016

Study Completion

November 14, 2016

Last Updated

February 8, 2019

Results First Posted

February 8, 2019

Record last verified: 2018-09

Locations

DE(26)