AzTrials
AzTrials

Multiple SclerosisPhase 3TRANSFORMSNCT00340834

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

A Phase 3 study testing Fingolimod 1.25 mg, Fingolimod 0.5 mg and Interferon β-1a 30 µg in people with Multiple Sclerosis, run by Novartis at 170 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Fingolimod 1.25 mg, Fingolimod 0.5 mg and Interferon β-1a 30 µg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,292 participants
Where
170 sitesin 18 countries
Study dates
May 2006to Jul 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

170 sites in 18 countries.

170 sites in 18 countries

United States35 sites

  • Neurology & Neuroscience Associates, Inc

    Akron, Ohio, 44302

  • Northern Ohio Neuroscience, LLC

    Bellevue, Ohio, 44811

  • Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201

    Bristol, Tennessee, 37620

  • Neuroscience and Spine Center

    Charlotte, North Carolina, 28207

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • North Central Neurology Associates, PC, 1809 Kress Street

    Cullman, Alabama, 35058

  • Associated Neurologists, PC, 69 Sand Pit Road, Suite 300

    Danbury, Connecticut, 06810

  • Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff

    Fairfield, Connecticut, 06824

  • Advanced Neurosciences Institute

    Franklin, Tennessee, 37064

  • Absher Neurology, 274-A Commonwealth Drive

    Greenville, South Carolina, 29615

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Florida Health Science Center

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100

    Lenexa, Kansas, 66214

  • Private Practice, 3815 23rd Street

    Lubbock, Texas, 79410

  • Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1

    Maitland, Florida, 32751

  • University of Miami, Department of Neurology

    Miami, Florida, 33136

  • Center for Neurological Disorders - Aurora St. Luke's Med Center

    Milwaukee, Wisconsin, 53215

  • West Virginia University Health Associates

    Morgantown, West Virginia, 26506

  • Yale University Multiple Sclerosis Center

    New Haven, Connecticut, 06510

  • The Neurology Center, 3907 Waring Road, Suite 3

    Oceanside, California, 92056

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh, Department of Neurology

    Pittsburgh, Pennsylvania, 15213

  • Neurological Associates

    Pompano Beach, Florida, 33060

  • Raleigh Neurology Associates, 1540 Sunday Drive

    Raleigh, North Carolina, 27607

  • Integra Clinical Research, 4242 Medical Drive, Suite 6100

    San Antonio, Texas, 78229

  • Roskamp Institute, 2040 Whitfield Ave.

    Sarasota, Florida, 34243

  • Swedish Neuroscience Institute

    Seattle, Washington, 98122

  • Rockwood Clinic, P.S.

    Spokane, Washington, 99202

  • University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304

    St Louis, Missouri, 63110

  • AMO Corporation

    Tallahassee, Florida, 32308

  • Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401

    Tampa, Florida, 33609

  • University of South Florida, Department of Neurology

    Tampa, Florida, 33612

  • Oregon Neurology

    Tualatin, Oregon, 97062

  • The MS Center of Vero Beach

    Vero Beach, Florida, 32960

Other trials in United States

Germany28 sites

  • Investigational Site

    Bamberg, 96049

  • Investigational Site

    Berlin, 10713

  • Investigational Site

    Berlin, 13439

  • Investigational Site

    Bremen, 28177

  • Investigational Site

    Buchholz, 21244

  • Investigational Site

    Cologne, 51109

  • Investigational Site

    Dresden, 01307

  • Investigational Site

    Düsseldorf, 40225

  • Investigational Site

    Erbach/Odenwald, 64711

  • Investigational Site

    Essen, 45122

  • Investigational Site

    Freiburg im Breisgau, 79106

  • Investigational Site

    Greifswald, 17475

  • Investigational Site

    Hamburg, 66421

  • Investigational Site

    Hanover, 30623

  • Investigational Site

    Heidelberg, 69120

  • Investigational Site

    Hennigsdorf, 16761

  • Investigational Site

    Lengerich, 49525

  • Investigational Site

    Mainz, 55131

  • Investigational Site

    München, 80331

  • Investigational Site

    München, 81675

  • Investigational Site

    Potsdam, 14471

  • Investigational Site

    Teupitz, 15755

  • Investigational Site

    Trier, 54292

  • Investigational Site

    Tübingen, 72076

  • Investigational Site

    Ulm, 89073

  • Investigational Site

    Ulm, 89075

  • Investigational Site

    Wermsdorf, 04779

  • Investigational Site

    Würzburg, 97070

Other trials in Germany

Italy22 sites

  • Presidio Ospedaliero Roberto Binaghi

    Cagliari, CA 09126

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Ferrara, FE 44100

  • Presidio Ospedaliero di Vaio Fidenza

    Fidenza, PR 43036

  • Azienda Sanitaria Osp. S. Luigi

    Gonzaga, Orbassano, TO 10043

  • Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS

    Milan, MI 20122

  • Az. Osp. Niguarda Ca' Granda

    Milan, MI 20162

  • Presidio Ospedaliero di Montichiari

    Montichiari, BS 25018

  • IRCCS Neurologico C. Mondino

    Pavia, PV 27100

  • Az. Osp. Ospedale Consorziale e Policlinico

    Piazza Giulio Cesare, 11 Bari, 70124

  • Az. Osp. Ospedale S. Martino - Università degli Studi

    Via Antonio de Toni, 5, Genova, 16132

  • Ist. Neurol. Mediterraneo Neuromed

    Via Atinense, 18, Pozzilli, 86077

  • Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi

    Via Conca, 71, Torrette Di Ancona, 60020

  • Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio

    Via Dei Vestini, 5 Chieti, 66100

  • Azienda Ospedaliera Sant'Andrea - Università La Sapienza

    Via Di Grottarossa, 1035/1039, Roma, 00189

  • Azienda Ospedaliera di Padova - Università degli Studi

    Via Giustiniani, 2, Padova, 35128

  • Az. Osp. Universitaria Policlinico Tor Vergata

    Via Montpellier, 1, Roma, 00133

  • Ospedale San Raffaele - IRCCS

    Via Olgettina, 48/60, Milano, 20132

  • Policlinico - Università degli Studi Federico II

    Via Pansini, 5, Napoli, 80131

  • Ospedale S. Antonio Abate

    Via Pastori, 4, Gallarate, VA, 21013

  • Istituto di Scienze Neurologiche Università di Catania

    Via Santa Sofia, 78, Catania, 95123

  • Ospedale Bellaria Maggiore

    Via Toscana Nazionale, 17/19, Bologna, 40139

  • Azienda Ospedaliera Careggi - Università degli Studi

    Viale Giovan Battista Morgagni, 85, Firenze, 50134

Other trials in Italy

Canada9 sites

  • Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North

    Fleurimont, Quebec, J1H 5N4

  • Charles Lemoyne Hospital

    Greenfield Park, Quebec, J4V 2H1

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Montreal Neurological Institute, 3801 University Street

    Montreal, Quebec, H3A 2B4

  • Nepean Medical Centre, 1 Centrepointe Drive, Suite 407

    Ottawa, Ontario, K2G 6E2

  • The Ottawa General Hospital, 501 Smyth Rd.

    Ottawa, K1H 8L6

  • St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing

    Toronto, Ontario, M5B 1W8

  • Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street

    Vancouver, British Columbia, V56 2X6

  • UBC MS Research, 2211 Westbrook Mall

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Spain8 sites

  • Complejo Hospitalario Carlos Haya

    Avda. Carlos Haya, S/n, Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Avenida Dr. Fedriani, 3, Sevilla, 41009

  • Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat

    Barcelona, 08907

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Clinico San Carlos

    C/ Dr. Martin Lagos, S/n, Madrid, 28040

  • Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron

    EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona, 08035

  • Puerta de Huerro Univeristy Hospital

    San Martin de Porres, 4, Madrid, 28035

  • Hospital Universitario La Fe.

    Valencia, 46009

Other trials in Spain

Argentina7 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C118ACK

  • Fundacion Lenox Cordoba

    Córdoba, 5000

  • Hospital J. M. Ramos Mejia

    General Urquiza 609, Buenos Aires, C1221ADC

  • Ineba

    Guarda Vieja 4435, Capital Federal, Buenos Aires, 1428

  • FLENI

    Montaneses 2325, Buenos Aires, C1428AQK

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, Santa Fe Province, 2000

  • Instituto de Neurociencias de Rosario

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Australia7 sites

  • Box Hill Hopsital, Level 3, 16 Arnold Street

    Box Hill, Victoria, 3128

  • Strategic Health Evaluators

    Chatswood, New South Wales, 2067

  • Royal Prince Alfred Hospital

    Department of Medicine, Level, Missenden R, Camperdown, New South Wales, 2050

  • Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street

    Liverpool, New South Wales, 2170

  • Gosford Private Hospital

    North Gosford, New South Wales, 2250

  • Royal Melbourne Hospital

    Suite 30, Grattan St., Parkbville, Victoria, 3050

  • St George Private Hospital

    Suite 7E, Level 5, South Street, Kogarah, New South Wales, 2217

Other trials in Australia

Austria6 sites

  • Landes-Narvenklinik Wagner-Jauregg

    Abteilung Fuer Neurologie, Linz, A-4020

  • Universitätsklinik f. Neurologie Innsbruck

    Anichstrasse 35, Innsbruck, 6020

  • Landes-Nervenklinik Christian Doppler Klinik

    Ignaz Harrerstr. 79 , Salzburg, A-5020

  • Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4

    Sankt Pölten, Sankt Poelten, 3100

  • Evangel.Krankenh./Wien-Waehring Außenstelle

    Vienna, 1010

  • Univ.-Klinik fuer Neurologie AKH

    Vienna, 1090

Other trials in Austria

Brazil6 sites

  • Hospital das Clincas - UNICAMP

    Campinas, São Paulo, 13083-970

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, RS 90020-090

  • Hospital das Clinicas da FMRPUSP

    Ribeirão Preto, São Paulo, 48000-900

  • Hospital dos Servidores do Estado

    Rio de Janeiro, RJ 20221-903

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, RJ 20270-004

  • Hospital Sao Rafael

    Salvador, Estado de Bahia, 41256 900

Other trials in Brazil

France6 sites

  • Hopital La Timone Cpcet, Rue Jean Moulin

    Marseille, 13385

  • Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny

    Nancy, 54035

  • Hôpital Pellegrin

    Place Amélie Raba Léon, Bordeaux Cedex, 33076

  • Hopital De Purpan

    Place Du Dr. Baylac, Toulouse Cedex, 31059

  • Centre Hospitalier de Poissy, 10 rue du Champ Gaillard

    Poissy, 78303

  • Hoppital Pasteur, Archet II, 30 avenue de la Voie

    Romaine, 06602

Other trials in France

Greece6 sites

  • Errikos Dinan General Hospital, 107 Mesogion Ave.

    Athens, 11526

  • General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.

    Athens, G-156 69

  • Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1

    Athens, GR 18547

  • General University Hospital of Patra-RIO

    Patra - RIO, GR- 26500

  • Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.

    Thessaloniki, GR 54636

  • Univ. Hospital of Heraklion

    Voutes, Heraklion, Crete, GR 71001

Other trials in Greece

Hungary6 sites

  • Debreceni Egyetem Orvos es Egszstd. Centr.

    Debrecen, 4012

  • Petz Aladár Megyei Oktató Kórház

    Győr, 9024

  • Veszprem Megyei Csolnoky Ferenc Korhaz

    Korhaz U. 1, Veszprem, H-8200

  • Pecsi Tudomanyegyetem Neurologiai Klinika

    Pécs, 7623

  • Peterfy Sandor u. Hospital, Neurology

    U. 8-20m, Budapest, 1076

  • Uzsoki korhaz

    Uzsoki U. 29., Budapest, 1145

Other trials in Hungary

Egypt5 sites

  • Private Clinic, 48 Sidi Gaber St.

    Alexandria

  • 35, Dokki St., Apt. 4

    Cairo

  • Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18

    Cairo

  • Private Clinic, 35 Dokki St., Apt. 4

    Cairo

  • Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen

    Cairo

Other trials in Egypt

Portugal5 sites

  • Hospital Fernando Fonseca

    Amadora, 2720-276

  • Hospitais da Universidade de Coimbra

    Av. Dr. Bissaya Barreto, Coimbra, 3000-075

  • Hospital Sto. António dos

    Capuchos

  • Hospital de São João

    Porto, 4200-319

  • Hospital de S. Bernardo

    Rua Camilo Castelo Branco, Setubal, 2910-446

Other trials in Portugal

Belgium4 sites

  • Cliniques Universitaires Saint Luc

    Avenue Hippocrate 10, Bruxelles, 1200

  • UZ Brussel

    Laarbeeklaan 101, Brussels, 1090

  • Nationaal Multiple Sclerose Centrum v.z.w

    Melsbroek, 1820

  • Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef

    Sint-Truiden, 3800

Other trials in Belgium

South Korea4 sites

  • National Cancer Center, 809 Madu 1-dong, Ilsan-gu

    Kyunggi, Goyang, 411-764

  • Samsung Medical Center

    Seoul, Korea, 135-710

  • Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku

    Seoul, 135-230

  • Kyung Pook National University Hospital

    Taegu, 700-721

Other trials in South Korea

United Kingdom4 sites

  • Novartis

    Investigational Site

  • Charing Cross Hospital

    London, W8 6RF

  • The Walton Centre for Neurology and Neurosurgery

    Lower Lane, Fazakerly, Liverpool, L9 7LJ

  • Norfolk & Norwich University Hospital

    Norwick, NR4 7UY

Other trials in United Kingdom

Switzerland2 sites

  • Universitätsspital Zuerich

    Neurologische Klinik, Frauenklinikstrasse 26, Zuerich, 8091

  • Universitätsspital Basel, Neurochirugishen Poliklinik

    Petersgraben 4, Basel, 4031

Other trials in Switzerland

About this study

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

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.

Being tested
Fingolimod 1.25 mg, Fingolimod 0.5 mg, Interferon β-1a 30 µg
Keywords
FTY720, Interferon, RRMS, Multiple Sclerosis, Efficacy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fingolimod 1.25 mgDrug

    Also called FTY720

    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.

  • Fingolimod 0.5 mgDrug

    Also called FTY720

    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.

  • Interferon β-1a 30 µgDrug

    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.

Study groups in NCT00340834
Study groupRoleWhat they receive
Fingolimod 1.25 mgExperimentalNot described
Receives: Drug: Fingolimod 1.25 mg
Fingolimod 0.5 mgExperimentalNot described
Receives: Drug: Fingolimod 0.5 mg
Interferon β-1a 30 µgActive comparatorNot described
Receives: Drug: Interferon β-1a 30 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Month 12

Secondary outcomes (5)

  1. 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.

    Measured: Baseline to Month 12

  2. 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.

    Measured: Baseline to Month 12

  3. 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.

    Measured: Month 0 to end of study (up to approximately 4.5 years)

  4. 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.

    Measured: Month 12 to end of study (up to approximately 3.5 years)

  5. 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.

    Measured: Baseline to end of study (up to approximately 4.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
1,292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00340834
Sponsor's protocol ID
CFTY720D2302
Other IDs
CFTY720D2302E1
Acronym
TRANSFORMS
Status last verified
Aug 2017
First submitted
19 Jun 2006
Last updated
21 Sep 2017

Publications

  • 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.

    PubMed 26111826

  • 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.

    PubMed 25876473

  • 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.

    PubMed 25245812

  • 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.

    PubMed 23531349

  • 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.

    PubMed 21571593

  • 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.

    PubMed 20937112

  • 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.

    PubMed 20089954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fingolimod 1.25 mg, Fingolimod 0.5 mg and Interferon β-1a 30 µg in people with Multiple Sclerosis, run by Novartis at 170 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Germany, Italy, Canada, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00340834, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.

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