Relapsing-remitting Multiple SclerosisPhase 4NCT02720107

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

A Phase 4 study testing fingolimod in people with Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsing-remitting Multiple Sclerosis
What is being tested?: fingolimod
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 26 sitesGermany
Study dates: 12 May 2016to 14 Nov 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Germany26 sites

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

Other trials in Germany

About this study

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)

Conditions: Relapsing-remitting Multiple Sclerosis
Being tested: fingolimod
Keywords: fingolimod, Biomarker, Multiple sclerosis, Relapsing-remitting multiple sclerosis
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fingolimodDrug

Study groups in NCT02720107
Study group	Role	What they receive
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). Receives: Drug: fingolimod

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline up to approximately 48 months

Secondary outcomes (3)

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.
Measured: 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)
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.
Measured: Baseline, month 6 up to approximately 48 months
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
Measured: Baseline up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201614 Nov 2016

First posted25 Mar 2016 (estimated)
Study start12 May 2016
Primary completion14 Nov 2016
Study completion14 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02720107
Sponsor's protocol ID: CFTY720DDE01E1
Status last verified: Sep 2018
First submitted: 21 Mar 2016
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02720107
Acronym / sponsor ID: CFTY720DDE01E1
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: fingolimod, Biomarker, Multiple sclerosis, Relapsing-remitting multiple sclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 12 May 2016 (actual)
Primary completion: 14 Nov 2016 (actual)
Study completion: 14 Nov 2016 (actual)
First posted: 25 Mar 2016 (estimated)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
fingolimod	Experimental	Drug: fingolimodPatients 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fingolimod	Drug	fingolimod

Primary outcome

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.

3 secondary outcomes

Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)
Time frame: 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)
Time frame: Baseline, month 6 up to approximately 48 months
Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)
Time frame: Baseline up to approximately 48 months

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fingolimod	130	130

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

Time frame: Baseline up to approximately 48 months. Least squares mean (Standard Error). Unit: percentage of parent population

Measure	Fingolimod n = 130
CD4+ Naïve T cells	-23.7 (0.62)
CD4+Central memory T cells	-1.2 (0.59)
CD4+ Effector memory T cells	22.2 (2.37)
CD8+ Naïve T cells	-37.2 (0.38)
CD8+ Central memory T cells	-1.6 (0.07)
CD8+ Effector memory T cells	-12.9 (1.59)
TH17 central memory cells	-0.6 (0.03)

Fingolimod: p < 0.0001, ANCOVA
Fingolimod: p = 0.0493, ANCOVA
Fingolimod: p < 0.0001, ANCOVA

Population analysed: required baseline and month 48 visit measurement of the respective cell count

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: (Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.(approximately 48 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fingolimod 0.5 mg	0 of 130 (0%)	1 of 130 (0.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fingolimod in people with Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in T Cells Status (Decrease or Increase) at Month 48 (FAS) (time frame: Baseline up to approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.