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

August 18, 2017 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1292

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fingolimod 1.25 mg
Drug: Fingolimod 1.25 mg

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.

Other Names:
  • FTY720
Experimental: Fingolimod 0.5 mg
Drug: Fingolimod 0.5 mg

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.

Other Names:
  • FTY720
Active Comparator: Interferon β-1a 30 µg
Drug: Interferon β-1a 30 µg

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
Time Frame: Baseline to Month 12
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.
Baseline to Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
Time Frame: Baseline to Month 12
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.
Baseline to Month 12
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
Time Frame: Baseline to Month 12
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.
Baseline to Month 12
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Time Frame: Month 0 to end of study (up to approximately 4.5 years)
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.
Month 0 to end of study (up to approximately 4.5 years)
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Time Frame: Month 12 to end of study (up to approximately 3.5 years)
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.
Month 12 to end of study (up to approximately 3.5 years)
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
Time Frame: Baseline to end of study (up to approximately 4.5 years)
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.
Baseline to end of study (up to approximately 4.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmacuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 20, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2302
  • CFTY720D2302E1 (Other Identifier: Novartis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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