Back to resultsEfficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy (EARLiMS)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fingolimod (FTY720)
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fingolimod, Early multiple sclerosis, Naive patients
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- 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 2
Arm Type
Experimental
Experimental
Arm Label
Naive or de novo participants
Previously treated with first-line DMTs participants
Arm Description
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Outcomes
Primary Outcome Measures
Annual Relapse Rate (ARR)
ARR = 365 days * number of relapses / total days taking the study medication.
Secondary Outcome Measures
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.
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.
Change From Baseline in Cerebral Volume
Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
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.
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.
Mean Number of T2 Active Lesions
The mean number of new or enlarged T2 active lesions was assessed by MRI.
Full Information
NCT ID
NCT01498887
First Posted
December 19, 2011
Last Updated
August 15, 2018
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01498887
Brief Title
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Acronym
EARLiMS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 24, 2011 (Actual)
Primary Completion Date
December 26, 2015 (Actual)
Study Completion Date
December 26, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fingolimod, Early multiple sclerosis, Naive patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naive or de novo participants
Arm Type
Experimental
Arm Description
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Arm Title
Previously treated with first-line DMTs participants
Arm Type
Experimental
Arm Description
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Intervention Type
Drug
Intervention Name(s)
Fingolimod (FTY720)
Intervention Description
Hard gelatin capsules containing 0.5 mg of fingolimod.
Primary Outcome Measure Information:
Title
Annual Relapse Rate (ARR)
Description
ARR = 365 days * number of relapses / total days taking the study medication.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to First Relapse
Description
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.
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
Title
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Description
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.
Time Frame
baseline, 12 months
Title
Change From Baseline in Cerebral Volume
Description
Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Time Frame
baseline, 12 months
Title
Percentage of Participants With Mild, Moderate or Severe Relapse
Description
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.
Time Frame
12 months
Title
Percentage of Relapse-free Participants
Description
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.
Time Frame
12 months
Title
Mean Number of T2 Active Lesions
Description
The mean number of new or enlarged T2 active lesions was assessed by MRI.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
East Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Novartis Investigative Site
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Novartis Investigative Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Novartis Investigative Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novartis Investigative Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novartis Investigative Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novartis Investigative Site
City
Bedford Park
ZIP/Postal Code
SA 5042
Country
Australia
Facility Name
Novartis Investigative Site
City
Brisbane Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Novartis Investigative Site
City
Geelong VIC
ZIP/Postal Code
3220
Country
Australia
Facility Name
Novartis Investigative Site
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Novartis Investigative Site
City
Córdoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Novartis Investigative Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novartis Investigative Site
City
Albacete
State/Province
Castilla La Mancha
ZIP/Postal Code
02006
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla Y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Leon
State/Province
Castilla Y León
ZIP/Postal Code
24080
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Tarragona
State/Province
Cataluña
ZIP/Postal Code
43007
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
State/Province
Las Palmas De G.C
ZIP/Postal Code
35010
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novartis Investigative Site
City
Barakaldo
State/Province
Pais Vasco
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
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