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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01498887




Registration number
NCT01498887
Ethics application status
Date submitted
19/12/2011
Date registered
26/12/2011

Titles & IDs
Public title
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Scientific 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.
Secondary ID [1] 0 0
2011-003484-30
Secondary ID [2] 0 0
CFTY720DES03
Universal Trial Number (UTN)
Trial acronym
EARLiMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod (FTY720)

Experimental: Naive or de novo participants - Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Experimental: Previously treated with first-line DMTs participants - Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.


Treatment: Drugs: Fingolimod (FTY720)
Hard gelatin capsules containing 0.5 mg of fingolimod.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Relapse Rate (ARR)
Assessment method [1] 0 0
ARR = 365 days \* number of relapses / total days taking the study medication.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Time to First Relapse
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Secondary outcome [2] 0 0
Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
baseline, 12 months
Secondary outcome [3] 0 0
Change From Baseline in Cerebral Volume
Assessment method [3] 0 0
Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Timepoint [3] 0 0
baseline, 12 months
Secondary outcome [4] 0 0
Percentage of Participants With Mild, Moderate or Severe Relapse
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Percentage of Relapse-free Participants
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Mean Number of T2 Active Lesions
Assessment method [6] 0 0
The mean number of new or enlarged T2 active lesions was assessed by MRI.
Timepoint [6] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/12/2015
Sample size
Target
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kanwal
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [5] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [6] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [7] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [8] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [9] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [10] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [11] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [12] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [13] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [14] 0 0
Novartis Investigative Site - Brisbane Queensland
Recruitment hospital [15] 0 0
Novartis Investigative Site - Geelong VIC
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3011 - Fitzroy
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [14] 0 0
4029 - Brisbane Queensland
Recruitment postcode(s) [15] 0 0
3220 - Geelong VIC
Recruitment outside Australia
Country [1] 0 0
Spain
State/province [1] 0 0
A Coruna
Country [2] 0 0
Spain
State/province [2] 0 0
Andalucia
Country [3] 0 0
Spain
State/province [3] 0 0
Asturias
Country [4] 0 0
Spain
State/province [4] 0 0
Cantabria
Country [5] 0 0
Spain
State/province [5] 0 0
Castilla La Mancha
Country [6] 0 0
Spain
State/province [6] 0 0
Castilla Y Leon
Country [7] 0 0
Spain
State/province [7] 0 0
Castilla Y León
Country [8] 0 0
Spain
State/province [8] 0 0
Catalunya
Country [9] 0 0
Spain
State/province [9] 0 0
Cataluña
Country [10] 0 0
Spain
State/province [10] 0 0
Comunidad Valenciana
Country [11] 0 0
Spain
State/province [11] 0 0
Galicia
Country [12] 0 0
Spain
State/province [12] 0 0
Islas Baleares
Country [13] 0 0
Spain
State/province [13] 0 0
Las Palmas De G.C
Country [14] 0 0
Spain
State/province [14] 0 0
Navarra
Country [15] 0 0
Spain
State/province [15] 0 0
Pais Vasco
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Las Palmas de Gran Canaria
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Santa Cruz de Tenerife

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01498887