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Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase (TRANSFORMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fingolimod 1.25 mg
Fingolimod 0.5 mg
Interferon β-1a 30 µg
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring FTY720, Interferon, RRMS, Multiple Sclerosis, Efficacy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • North Central Neurology Associates, PC, 1809 Kress Street
  • Barrow Neurological Institute
  • The Neurology Center, 3907 Waring Road, Suite 3
  • Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
  • Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff
  • Yale University Multiple Sclerosis Center
  • University of Florida Health Science Center
  • Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1
  • University of Miami, Department of Neurology
  • Neurological Associates
  • Roskamp Institute, 2040 Whitfield Ave.
  • AMO Corporation
  • Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401
  • University of South Florida, Department of Neurology
  • The MS Center of Vero Beach
  • University of Kansas Medical Center
  • Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100
  • University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304
  • Neuroscience and Spine Center
  • Raleigh Neurology Associates, 1540 Sunday Drive
  • Neurology & Neuroscience Associates, Inc
  • Northern Ohio Neuroscience, LLC
  • Cleveland Clinic
  • Oregon Neurology
  • University of Pittsburgh, Department of Neurology
  • Absher Neurology, 274-A Commonwealth Drive
  • Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201
  • Advanced Neurosciences Institute
  • Baylor College of Medicine
  • Private Practice, 3815 23rd Street
  • Integra Clinical Research, 4242 Medical Drive, Suite 6100
  • Swedish Neuroscience Institute
  • Rockwood Clinic, P.S.
  • West Virginia University Health Associates
  • Center for Neurological Disorders - Aurora St. Luke's Med Center
  • Ineba
  • Fundacion Rosarina de Neurorehabilitacion
  • Instituto de Neurociencias de Rosario
  • Hospital Italiano de Buenos Aires
  • Fundacion Lenox Cordoba
  • Hospital J. M. Ramos Mejia
  • FLENI
  • Strategic Health Evaluators
  • Royal Prince Alfred Hospital
  • Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street
  • Gosford Private Hospital
  • St George Private Hospital
  • Box Hill Hopsital, Level 3, 16 Arnold Street
  • Royal Melbourne Hospital
  • Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4
  • Landes-Narvenklinik Wagner-Jauregg
  • Universitätsklinik f. Neurologie Innsbruck
  • Landes-Nervenklinik Christian Doppler Klinik
  • Evangel.Krankenh./Wien-Waehring Außenstelle
  • Univ.-Klinik fuer Neurologie AKH
  • Cliniques Universitaires Saint Luc
  • UZ Brussel
  • Nationaal Multiple Sclerose Centrum v.z.w
  • Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef
  • Hospital Sao Rafael
  • Hospital das Clincas - UNICAMP
  • Hospital das Clinicas da FMRPUSP
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Hospital dos Servidores do Estado
  • Hospital Universitario Gaffree e Guinle
  • Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street
  • UBC MS Research, 2211 Westbrook Mall
  • Nepean Medical Centre, 1 Centrepointe Drive, Suite 407
  • St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing
  • Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North
  • Charles Lemoyne Hospital
  • CHUM - Hopital Notre-Dame
  • Montreal Neurological Institute, 3801 University Street
  • The Ottawa General Hospital, 501 Smyth Rd.
  • Private Clinic, 48 Sidi Gaber St.
  • 35, Dokki St., Apt. 4
  • Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18
  • Private Clinic, 35 Dokki St., Apt. 4
  • Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen
  • Hopital La Timone Cpcet, Rue Jean Moulin
  • Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny
  • Hôpital Pellegrin
  • Hopital De Purpan
  • Centre Hospitalier de Poissy, 10 rue du Champ Gaillard
  • Hoppital Pasteur, Archet II, 30 avenue de la Voie
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  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Univ. Hospital of Heraklion
  • Errikos Dinan General Hospital, 107 Mesogion Ave.
  • General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.
  • Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1
  • General University Hospital of Patra-RIO
  • Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.
  • Debreceni Egyetem Orvos es Egszstd. Centr.
  • Petz Aladár Megyei Oktató Kórház
  • Veszprem Megyei Csolnoky Ferenc Korhaz
  • Pecsi Tudomanyegyetem Neurologiai Klinika
  • Peterfy Sandor u. Hospital, Neurology
  • Uzsoki korhaz
  • Azienda Sanitaria Osp. S. Luigi
  • Ospedale S. Antonio Abate
  • Presidio Ospedaliero Roberto Binaghi
  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  • Presidio Ospedaliero di Vaio Fidenza
  • Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS
  • Az. Osp. Niguarda Ca' Granda
  • Presidio Ospedaliero di Montichiari
  • IRCCS Neurologico C. Mondino
  • Az. Osp. Ospedale Consorziale e Policlinico
  • Az. Osp. Ospedale S. Martino - Università degli Studi
  • Ist. Neurol. Mediterraneo Neuromed
  • Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi
  • Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio
  • Azienda Ospedaliera Sant'Andrea - Università La Sapienza
  • Azienda Ospedaliera di Padova - Università degli Studi
  • Az. Osp. Universitaria Policlinico Tor Vergata
  • Ospedale San Raffaele - IRCCS
  • Policlinico - Università degli Studi Federico II
  • Istituto di Scienze Neurologiche Università di Catania
  • Ospedale Bellaria Maggiore
  • Azienda Ospedaliera Careggi - Università degli Studi
  • National Cancer Center, 809 Madu 1-dong, Ilsan-gu
  • Samsung Medical Center
  • Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku
  • Kyung Pook National University Hospital
  • Hospital Fernando Fonseca
  • Hospitais da Universidade de Coimbra
  • Hospital Sto. António dos
  • Hospital de São João
  • Hospital de S. Bernardo
  • Complejo Hospitalario Carlos Haya
  • Hospital Universitario Virgen Macarena
  • Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat
  • Hospital de Basurto
  • Hospital Clinico San Carlos
  • Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron
  • Puerta de Huerro Univeristy Hospital
  • Hospital Universitario La Fe.
  • Universitätsspital Zuerich
  • Universitätsspital Basel, Neurochirugishen Poliklinik
  • Novartis
  • Charing Cross Hospital
  • The Walton Centre for Neurology and Neurosurgery
  • Norfolk & Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fingolimod 1.25 mg

Fingolimod 0.5 mg

Interferon β-1a 30 µg

Arm Description

Outcomes

Primary Outcome Measures

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.

Secondary Outcome Measures

Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
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
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
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
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.

Full Information

First Posted
June 19, 2006
Last Updated
August 18, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00340834
Brief Title
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Acronym
TRANSFORMS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
FTY720, Interferon, RRMS, Multiple Sclerosis, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod 1.25 mg
Arm Type
Experimental
Arm Title
Fingolimod 0.5 mg
Arm Type
Experimental
Arm Title
Interferon β-1a 30 µg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fingolimod 1.25 mg
Other Intervention Name(s)
FTY720
Intervention Description
Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-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.
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5 mg
Other Intervention Name(s)
FTY720
Intervention Description
Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Intervention Type
Drug
Intervention Name(s)
Interferon β-1a 30 µg
Intervention Description
Core: Patients self-administered interferon β-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.
Primary Outcome Measure Information:
Title
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
Description
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
Description
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Time Frame
Baseline to Month 12
Title
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
Description
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Time Frame
Baseline to Month 12
Title
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Description
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Time Frame
Month 0 to end of study (up to approximately 4.5 years)
Title
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Description
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Time Frame
Month 12 to end of study (up to approximately 3.5 years)
Title
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
Description
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Time Frame
Baseline to end of study (up to approximately 4.5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmacuticals
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates, PC, 1809 Kress Street
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
The Neurology Center, 3907 Waring Road, Suite 3
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Yale University Multiple Sclerosis Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida Health Science Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami, Department of Neurology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Roskamp Institute, 2040 Whitfield Ave.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
AMO Corporation
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
University of South Florida, Department of Neurology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The MS Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Neuroscience and Spine Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Raleigh Neurology Associates, 1540 Sunday Drive
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology & Neuroscience Associates, Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Northern Ohio Neuroscience, LLC
City
Bellevue
State/Province
Ohio
ZIP/Postal Code
44811
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Neurology
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
University of Pittsburgh, Department of Neurology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Absher Neurology, 274-A Commonwealth Drive
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Private Practice, 3815 23rd Street
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Integra Clinical Research, 4242 Medical Drive, Suite 6100
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Rockwood Clinic, P.S.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
West Virginia University Health Associates
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Center for Neurological Disorders - Aurora St. Luke's Med Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Ineba
City
Guarda Vieja 4435, Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto de Neurociencias de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C118ACK
Country
Argentina
Facility Name
Fundacion Lenox Cordoba
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital J. M. Ramos Mejia
City
General Urquiza 609, Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
FLENI
City
Montaneses 2325, Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Strategic Health Evaluators
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Department of Medicine, Level, Missenden R, Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Gosford Private Hospital
City
North Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
St George Private Hospital
City
Suite 7E, Level 5, South Street, Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Box Hill Hopsital, Level 3, 16 Arnold Street
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Suite 30, Grattan St., Parkbville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4
City
St. Poelten
State/Province
Sankt Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Landes-Narvenklinik Wagner-Jauregg
City
Abteilung fuer Neurologie, Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Universitätsklinik f. Neurologie Innsbruck
City
Anichstrasse 35, Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landes-Nervenklinik Christian Doppler Klinik
City
Ignaz Harrerstr. 79 , Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Evangel.Krankenh./Wien-Waehring Außenstelle
City
Vienna
ZIP/Postal Code
1010
Country
Austria
Facility Name
Univ.-Klinik fuer Neurologie AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires Saint Luc
City
Avenue Hippocrate 10, Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Brussel
City
Laarbeeklaan 101, Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Nationaal Multiple Sclerose Centrum v.z.w
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
Hospital Sao Rafael
City
Salvador
State/Province
BA
ZIP/Postal Code
41256 900
Country
Brazil
Facility Name
Hospital das Clincas - UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Hospital das Clinicas da FMRPUSP
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
48000-900
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
RS 90020-090
Country
Brazil
Facility Name
Hospital dos Servidores do Estado
City
Rio de Janeiro
ZIP/Postal Code
RJ 20221-903
Country
Brazil
Facility Name
Hospital Universitario Gaffree e Guinle
City
Rio de Janeiro
ZIP/Postal Code
RJ 20270-004
Country
Brazil
Facility Name
Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V56 2X6
Country
Canada
Facility Name
UBC MS Research, 2211 Westbrook Mall
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Nepean Medical Centre, 1 Centrepointe Drive, Suite 407
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Charles Lemoyne Hospital
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Montreal Neurological Institute, 3801 University Street
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
The Ottawa General Hospital, 501 Smyth Rd.
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Private Clinic, 48 Sidi Gaber St.
City
Alexandria
Country
Egypt
Facility Name
35, Dokki St., Apt. 4
City
Cairo
Country
Egypt
Facility Name
Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18
City
Cairo
Country
Egypt
Facility Name
Private Clinic, 35 Dokki St., Apt. 4
City
Cairo
Country
Egypt
Facility Name
Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen
City
Cairo
Country
Egypt
Facility Name
Hopital La Timone Cpcet, Rue Jean Moulin
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hôpital Pellegrin
City
Place Amélie Raba Léon, Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital De Purpan
City
Place du Dr. Baylac, Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier de Poissy, 10 rue du Champ Gaillard
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
Hoppital Pasteur, Archet II, 30 avenue de la Voie
City
Romaine
ZIP/Postal Code
06602
Country
France
Facility Name
Investigational Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
13439
Country
Germany
Facility Name
Investigational Site
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Investigational Site
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Investigational Site
City
Erbach/Odenwald
ZIP/Postal Code
64711
Country
Germany
Facility Name
Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Investigational Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Investigational Site
City
Hamburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Investigational Site
City
Hannover
ZIP/Postal Code
30623
Country
Germany
Facility Name
Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Investigational Site
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Investigational Site
City
Koeln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Investigational Site
City
Lengerich
ZIP/Postal Code
49525
Country
Germany
Facility Name
Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Investigational Site
City
Muenchen
ZIP/Postal Code
80331
Country
Germany
Facility Name
Investigational Site
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Investigational Site
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Investigational Site
City
Teupitz
ZIP/Postal Code
15755
Country
Germany
Facility Name
Investigational Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Investigational Site
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Investigational Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Investigational Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Investigational Site
City
Wermsdorf
ZIP/Postal Code
04779
Country
Germany
Facility Name
Investigational Site
City
Wurzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Univ. Hospital of Heraklion
City
Voutes, Heraklion
State/Province
Crete
ZIP/Postal Code
GR 71001
Country
Greece
Facility Name
Errikos Dinan General Hospital, 107 Mesogion Ave.
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.
City
Athens
ZIP/Postal Code
G-156 69
Country
Greece
Facility Name
Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1
City
Athens
ZIP/Postal Code
GR 18547
Country
Greece
Facility Name
General University Hospital of Patra-RIO
City
Patra - RIO
ZIP/Postal Code
GR- 26500
Country
Greece
Facility Name
Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.
City
Thessaloniki
ZIP/Postal Code
GR 54636
Country
Greece
Facility Name
Debreceni Egyetem Orvos es Egszstd. Centr.
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky Ferenc Korhaz
City
Korhaz u. 1, Veszprem
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Neurologiai Klinika
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Peterfy Sandor u. Hospital, Neurology
City
u. 8-20m, Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Uzsoki korhaz
City
Uzsoki u. 29., Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Azienda Sanitaria Osp. S. Luigi
City
Gonzaga
State/Province
Orbassano
ZIP/Postal Code
TO 10043
Country
Italy
Facility Name
Ospedale S. Antonio Abate
City
via Pastori, 4, Gallarate
State/Province
VA
ZIP/Postal Code
21013
Country
Italy
Facility Name
Presidio Ospedaliero Roberto Binaghi
City
Cagliari
ZIP/Postal Code
CA 09126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
City
Ferrara
ZIP/Postal Code
FE 44100
Country
Italy
Facility Name
Presidio Ospedaliero di Vaio Fidenza
City
Fidenza
ZIP/Postal Code
PR 43036
Country
Italy
Facility Name
Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS
City
Milano
ZIP/Postal Code
MI 20122
Country
Italy
Facility Name
Az. Osp. Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
MI 20162
Country
Italy
Facility Name
Presidio Ospedaliero di Montichiari
City
Montichiari
ZIP/Postal Code
BS 25018
Country
Italy
Facility Name
IRCCS Neurologico C. Mondino
City
Pavia
ZIP/Postal Code
PV 27100
Country
Italy
Facility Name
Az. Osp. Ospedale Consorziale e Policlinico
City
piazza Giulio Cesare, 11 Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Az. Osp. Ospedale S. Martino - Università degli Studi
City
via Antonio De Toni, 5, Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ist. Neurol. Mediterraneo Neuromed
City
Via Atinense, 18, Pozzilli
ZIP/Postal Code
86077
Country
Italy
Facility Name
Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi
City
via Conca, 71, Torrette di Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio
City
via dei Vestini, 5 Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea - Università La Sapienza
City
Via di Grottarossa, 1035/1039, Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera di Padova - Università degli Studi
City
Via Giustiniani, 2, Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Az. Osp. Universitaria Policlinico Tor Vergata
City
via Montpellier, 1, Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale San Raffaele - IRCCS
City
via Olgettina, 48/60, Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Policlinico - Università degli Studi Federico II
City
via Pansini, 5, Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto di Scienze Neurologiche Università di Catania
City
via Santa Sofia, 78, Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale Bellaria Maggiore
City
via Toscana Nazionale, 17/19, Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliera Careggi - Università degli Studi
City
Viale Giovan Battista Morgagni, 85, Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
National Cancer Center, 809 Madu 1-dong, Ilsan-gu
City
Kyunggi
State/Province
Goyang
ZIP/Postal Code
411-764
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku
City
Seoul
ZIP/Postal Code
135-230
Country
Korea, Republic of
Facility Name
Kyung Pook National University Hospital
City
Taegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Hospital Fernando Fonseca
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Av. Dr. Bissaya Barreto, Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Sto. António dos
City
Capuchos
Country
Portugal
Facility Name
Hospital de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital de S. Bernardo
City
Rua Camilo Castelo Branco, Setubal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Complejo Hospitalario Carlos Haya
City
Avda. Carlos Haya, s/n, Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Avenida Dr. Fedriani, 3, Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
C/ Dr. Martin Lagos, s/n, Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron
City
EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Puerta de Huerro Univeristy Hospital
City
San Martin de Porres, 4, Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Universitario La Fe.
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Universitätsspital Zuerich
City
Neurologische Klinik, Frauenklinikstrasse 26, Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Universitätsspital Basel, Neurochirugishen Poliklinik
City
Petersgraben 4, Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Novartis
City
Investigational Site
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W8 6RF
Country
United Kingdom
Facility Name
The Walton Centre for Neurology and Neurosurgery
City
Lower Lane, Fazakerly, Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwick
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26111826
Citation
Cohen JA, Khatri B, Barkhof F, Comi G, Hartung HP, Montalban X, Pelletier J, Stites T, Ritter S, von Rosenstiel P, Tomic D, Kappos L; TRANSFORMS (TRial Assessing injectable interferoN vS. FTY720 Oral in RRMS) Study Group. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J Neurol Neurosurg Psychiatry. 2016 May;87(5):468-75. doi: 10.1136/jnnp-2015-310597. Epub 2015 Jun 25.
Results Reference
derived
PubMed Identifier
25876473
Citation
Khatri BO, Pelletier J, Kappos L, Hartung HP, Comi G, Barkhof F, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Cohen JA; TRANSFORMS Study Group. Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon beta-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Mult Scler Relat Disord. 2014 May;3(3):355-63. doi: 10.1016/j.msard.2013.11.006. Epub 2013 Dec 12.
Results Reference
derived
PubMed Identifier
25245812
Citation
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.
Results Reference
derived
PubMed Identifier
23531349
Citation
Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
Results Reference
derived
PubMed Identifier
21571593
Citation
Khatri B, Barkhof F, Comi G, Hartung HP, Kappos L, Montalban X, Pelletier J, Stites T, Wu S, Holdbrook F, Zhang-Auberson L, Francis G, Cohen JA; TRANSFORMS Study Group. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol. 2011 Jun;10(6):520-9. doi: 10.1016/S1474-4422(11)70099-0. Epub 2011 May 13.
Results Reference
derived
PubMed Identifier
20937112
Citation
Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010 Oct 11;8:117. doi: 10.1186/1477-7525-8-117.
Results Reference
derived
PubMed Identifier
20089954
Citation
Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):402-15. doi: 10.1056/NEJMoa0907839. Epub 2010 Jan 20.
Results Reference
derived
Links:
URL
http://www.msclinicaltrials.com
Description
Fingolimod clinical trials information website

Learn more about this trial

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

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