Relapsing Remitting Multiple SclerosisPhase 4EARLiMSNCT01498887

Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

A Phase 4 study testing Fingolimod (FTY720) in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 47 sites in 2 countries.

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

This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Relapsing Remitting Multiple Sclerosis
What is being tested?: Fingolimod (FTY720)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 347 participants
Where: 47 sitesin 2 countries
Study dates: 24 Dec 2011to 26 Dec 2015
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 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.
Patients
Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Who cannot join

Patients who have received treatment with:
Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.
Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

47 sites in 2 countries.

Country

City, postcode or hospital

47 sites in 2 countries

Spain32 sites

Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Albacete, Castille-La Mancha, 02006
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barakaldo, Basque Country, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Bilbao, Basque Country, 48013
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
Ferrol, A Coruna, 15405
Novartis Investigative Site
Granada, Andalusia, 18012
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de G.C, 35010
Novartis Investigative Site
Las Palmas de Gran Canaria, 35016
Novartis Investigative Site
León, Castille and León, 24080
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28007
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Tarragona, Catalonia, 43007
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigative Site
Valencia, Valencia, 46017
Novartis Investigative Site
Valencia, Valencia, 46026
Novartis Investigative Site
Valladolid, Castille and León, 47011

Other trials in Spain

Australia15 sites

Novartis Investigative Site
Adelaide, South Australia
Novartis Investigative Site
Auchenflower, Queensland, 4066
Novartis Investigative Site
Bedford Park, SA 5042
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Brisbane Queensland, 4029
Novartis Investigative Site
East Gosford, New South Wales, 2250
Novartis Investigative Site
Fitzroy, Victoria, 3011
Novartis Investigative Site
Geelong VIC, 3220
Novartis Investigative Site
Kanwal, New South Wales, 2259
Novartis Investigative Site
Liverpool, New South Wales, 2170
Novartis Investigative Site
Melbourne, Victoria, 3000
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
New Lambton Heights, New South Wales, 2305
Novartis Investigative Site
Parkville, Victoria, 3050
Novartis Investigative Site
Sydney, New South Wales, 2050

Other trials in Australia

About this study

Official title: A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.

Conditions: Relapsing Remitting Multiple Sclerosis
Being tested: Fingolimod (FTY720)
Keywords: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fingolimod, Early multiple sclerosis, Naive patients
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.

Fingolimod (FTY720)Drug
Hard gelatin capsules containing 0.5 mg of fingolimod.

Study groups in NCT01498887
Study group	Role	What they receive
Naive or de novo participants	Experimental	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Receives: Drug: Fingolimod (FTY720)
Previously treated with first-line DMTs participants	Experimental	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Receives: Drug: Fingolimod (FTY720)

What is being measured

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

Annual Relapse Rate (ARR)
ARR = 365 days * number of relapses / total days taking the study medication.
Measured: 12 months

Secondary outcomes (6)

Time to First Relapse
Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.
Measured: first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.
Measured: baseline, 12 months
Change From Baseline in Cerebral Volume
Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Measured: baseline, 12 months
Percentage of Participants With Mild, Moderate or Severe Relapse
The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.
Measured: 12 months
Percentage of Relapse-free Participants
Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.
Measured: 12 months
Mean Number of T2 Active Lesions
The mean number of new or enlarged T2 active lesions was assessed by MRI.
Measured: 12 months

Timeline

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

24 Dec 201126 Dec 2015

First posted26 Dec 2011 (estimated)
Study start24 Dec 2011
Primary completion26 Dec 2015
Study completion26 Dec 2015

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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01498887
Sponsor's protocol ID: CFTY720DES03
Other IDs: 2011-003484-30
Acronym: EARLiMS
Status last verified: Aug 2018
First submitted: 19 Dec 2011
Last updated: 25 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.
ClinicalTrials.gov ID: NCT01498887
Acronym / sponsor ID: EARLiMS / CFTY720DES03
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fingolimod, Early multiple sclerosis, Naive patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 347 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 24 Dec 2011 (actual)
Primary completion: 26 Dec 2015 (actual)
Study completion: 26 Dec 2015 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 25 Jan 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Naive or de novo participants	Experimental	Drug: Fingolimod (FTY720)Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Previously treated with first-line DMTs participants	Experimental	Drug: Fingolimod (FTY720)Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.
Patients
Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Key exclusion criteria (3 listed)

Patients who have received treatment with:
Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.
Other protocol defined inclusion/exclusion criteria may apply

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 (FTY720)Hard gelatin capsules containing 0.5 mg of fingolimod.	Drug	Naive or de novo participants, Previously treated with first-line DMTs participants

Primary outcome

Annual Relapse Rate (ARR)
Time frame: 12 months
ARR = 365 days * number of relapses / total days taking the study medication.

6 secondary outcomes

Time to First Relapse
Time frame: first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: baseline, 12 months
Change From Baseline in Cerebral Volume
Time frame: baseline, 12 months
Percentage of Participants With Mild, Moderate or Severe Relapse
Time frame: 12 months
Percentage of Relapse-free Participants
Time frame: 12 months
Mean Number of T2 Active Lesions
Time frame: 12 months

Results and safety

Results posted to the registry on 25 Jan 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
Naive or de Novo Participants	200	184
Previously Treated With First-line DMTs Participants	147	136

Primary outcome: Annual Relapse Rate (ARR)

Time frame: 12 months. Mean (Standard Deviation). Unit: Relapses per year

Measure	Naive or de Novo Participants n = 185	Previously Treated With First-line DMTs Participants n = 135
Value	0.290 (0.7399)	0.354 (0.8547)

Naive or de Novo Participants vs Previously Treated With First-line DMTs Participants: p = 0.3118, Wilcoxon (Mann-Whitney)

Population analysed: The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, approximately 4 years.. Other adverse events reported at 0.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naive or de Novo Participants	11 of 200 (5.5%)	143 of 200 (71.5%)	Not reported
Previously Treated With First-line DMTs Participants	4 of 147 (2.7%)	114 of 147 (77.6%)	Not reported
All Participants	15 of 347 (4.3%)	257 of 347 (74.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

47 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fingolimod (FTY720) in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 47 sites in 2 countries.

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 5 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Spain, Australia. 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 25 Jan 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?

Annual Relapse Rate (ARR) (time frame: 12 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 NCT01498887.

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 25 Jan 2019.