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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00340834




Registration number
NCT00340834
Ethics application status
Date submitted
19/06/2006
Date registered
21/06/2006
Date last updated
21/09/2017

Titles & IDs
Public title
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Scientific title
A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Secondary ID [1] 0 0
CFTY720D2302E1
Secondary ID [2] 0 0
CFTY720D2302
Universal Trial Number (UTN)
Trial acronym
TRANSFORMS
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod 1.25 mg
Treatment: Drugs - Fingolimod 0.5 mg
Treatment: Drugs - Interferon ß-1a 30 µg

Experimental: Fingolimod 1.25 mg -

Experimental: Fingolimod 0.5 mg -

Active comparator: Interferon ß-1a 30 µg -


Treatment: Drugs: Fingolimod 1.25 mg
Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon ß-1a placebo intramuscular (im) injection once weekly.

Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.

Treatment: Drugs: Fingolimod 0.5 mg
Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon ß-1a placebo intramuscular (im) injection once weekly.

Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.

Treatment: Drugs: Interferon ß-1a 30 µg
Core: Patients self-administered interferon ß-1a 30 µg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.

Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
Timepoint [1] 0 0
Baseline to Month 12
Secondary outcome [1] 0 0
Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
Timepoint [1] 0 0
Baseline to Month 12
Secondary outcome [2] 0 0
Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study
Timepoint [2] 0 0
Baseline to Month 12
Secondary outcome [3] 0 0
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Timepoint [3] 0 0
Month 0 to end of study (up to approximately 4.5 years)
Secondary outcome [4] 0 0
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Timepoint [4] 0 0
Month 12 to end of study (up to approximately 3.5 years)
Secondary outcome [5] 0 0
Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study
Timepoint [5] 0 0
Baseline to end of study (up to approximately 4.5 years)

Eligibility
Key inclusion criteria
* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
* Patients with a relapsing-remitting disease course
* Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
* Pregnant or nursing women
* Patients who cannot tolerate treatment with an interferon

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
1292
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Strategic Health Evaluators - Chatswood
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Department of Medicine, Level, Missenden R, Camperdown
Recruitment hospital [3] 0 0
Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street - Liverpool
Recruitment hospital [4] 0 0
Gosford Private Hospital - North Gosford
Recruitment hospital [5] 0 0
St George Private Hospital - Suite 7E, Level 5, South Street, Kogarah
Recruitment hospital [6] 0 0
Box Hill Hopsital, Level 3, 16 Arnold Street - Box Hill
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Suite 30, Grattan St., Parkbville
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2050 - Department of Medicine, Level, Missenden R, Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2250 - North Gosford
Recruitment postcode(s) [5] 0 0
2217 - Suite 7E, Level 5, South Street, Kogarah
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3050 - Suite 30, Grattan St., Parkbville
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Oregon
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Pennsylvania
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Santa Fe
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Argentina
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Cordoba
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Argentina
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General Urquiza 609, Buenos Aires
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Argentina
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Montaneses 2325, Buenos Aires
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Austria
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Sankt Poelten
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Austria
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Abteilung fuer Neurologie, Linz
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Austria
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Anichstrasse 35, Innsbruck
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Austria
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Ignaz Harrerstr. 79 , Salzburg
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Austria
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Vienna
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Belgium
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Avenue Hippocrate 10, Bruxelles
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Belgium
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Laarbeeklaan 101, Brussels
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Belgium
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Melsbroek
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Belgium
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Sint-Truiden
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BA
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SP
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Ulm
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u. 8-20m, Budapest
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Uzsoki u. 29., Budapest
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Avda. Carlos Haya, s/n, Málaga
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Avenida Dr. Fedriani, 3, Sevilla
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Barcelona
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Bilbao
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C/ Dr. Martin Lagos, s/n, Madrid
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EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona
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San Martin de Porres, 4, Madrid
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Valencia
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Switzerland
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Neurologische Klinik, Frauenklinikstrasse 26, Zuerich
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Switzerland
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Petersgraben 4, Basel
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Investigational Site
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London
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Lower Lane, Fazakerly, Liverpool
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United Kingdom
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Norwick

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


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/NCT00340834