Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
NCT ID: NCT00340834
Last Updated: 2017-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1292 participants
INTERVENTIONAL
2006-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fingolimod 1.25 mg
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.
Fingolimod 0.5 mg
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.
Interferon β-1a 30 µg
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a relapsing-remitting disease course
* Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5
Exclusion Criteria
* Pregnant or nursing women
* Patients who cannot tolerate treatment with an interferon
18 Years
55 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmacuticals
Locations
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North Central Neurology Associates, PC, 1809 Kress Street
Cullman, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
The Neurology Center, 3907 Waring Road, Suite 3
Oceanside, California, United States
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
Danbury, Connecticut, United States
Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff
Fairfield, Connecticut, United States
Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States
University of Florida Health Science Center
Jacksonville, Florida, United States
Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1
Maitland, Florida, United States
University of Miami, Department of Neurology
Miami, Florida, United States
Neurological Associates
Pompano Beach, Florida, United States
Roskamp Institute, 2040 Whitfield Ave.
Sarasota, Florida, United States
AMO Corporation
Tallahassee, Florida, United States
Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401
Tampa, Florida, United States
University of South Florida, Department of Neurology
Tampa, Florida, United States
The MS Center of Vero Beach
Vero Beach, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100
Lenexa, Kansas, United States
University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304
St Louis, Missouri, United States
Neuroscience and Spine Center
Charlotte, North Carolina, United States
Raleigh Neurology Associates, 1540 Sunday Drive
Raleigh, North Carolina, United States
Neurology & Neuroscience Associates, Inc
Akron, Ohio, United States
Northern Ohio Neuroscience, LLC
Bellevue, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Neurology
Tualatin, Oregon, United States
University of Pittsburgh, Department of Neurology
Pittsburgh, Pennsylvania, United States
Absher Neurology, 274-A Commonwealth Drive
Greenville, South Carolina, United States
Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201
Bristol, Tennessee, United States
Advanced Neurosciences Institute
Franklin, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Private Practice, 3815 23rd Street
Lubbock, Texas, United States
Integra Clinical Research, 4242 Medical Drive, Suite 6100
San Antonio, Texas, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Rockwood Clinic, P.S.
Spokane, Washington, United States
West Virginia University Health Associates
Morgantown, West Virginia, United States
Center for Neurological Disorders - Aurora St. Luke's Med Center
Milwaukee, Wisconsin, United States
Ineba
Guarda Vieja 4435, Capital Federal, Buenos Aires, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario, Santa Fe Province, Argentina
Instituto de Neurociencias de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Fundacion Lenox Cordoba
Córdoba, , Argentina
Hospital J. M. Ramos Mejia
General Urquiza 609, Buenos Aires, , Argentina
FLENI
Montaneses 2325, Buenos Aires, , Argentina
Strategic Health Evaluators
Chatswood, New South Wales, Australia
Royal Prince Alfred Hospital
Department of Medicine, Level, Missenden R, Camperdown, New South Wales, Australia
Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street
Liverpool, New South Wales, Australia
Gosford Private Hospital
North Gosford, New South Wales, Australia
St George Private Hospital
Suite 7E, Level 5, South Street, Kogarah, New South Wales, Australia
Box Hill Hopsital, Level 3, 16 Arnold Street
Box Hill, Victoria, Australia
Royal Melbourne Hospital
Suite 30, Grattan St., Parkbville, Victoria, Australia
Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4
Sankt Pölten, Sankt Poelten, Austria
Landes-Narvenklinik Wagner-Jauregg
Abteilung Fuer Neurologie, Linz, , Austria
Universitätsklinik f. Neurologie Innsbruck
Anichstrasse 35, Innsbruck, , Austria
Landes-Nervenklinik Christian Doppler Klinik
Ignaz Harrerstr. 79 , Salzburg, , Austria
Evangel.Krankenh./Wien-Waehring Außenstelle
Vienna, , Austria
Univ.-Klinik fuer Neurologie AKH
Vienna, , Austria
Cliniques Universitaires Saint Luc
Avenue Hippocrate 10, Bruxelles, , Belgium
UZ Brussel
Laarbeeklaan 101, Brussels, , Belgium
Nationaal Multiple Sclerose Centrum v.z.w
Melsbroek, , Belgium
Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef
Sint-Truiden, , Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil
Hospital das Clincas - UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clinicas da FMRPUSP
Ribeirão Preto, São Paulo, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, , Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, , Brazil
Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street
Vancouver, British Columbia, Canada
UBC MS Research, 2211 Westbrook Mall
Vancouver, British Columbia, Canada
Nepean Medical Centre, 1 Centrepointe Drive, Suite 407
Ottawa, Ontario, Canada
St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North
Fleurimont, Quebec, Canada
Charles Lemoyne Hospital
Greenfield Park, Quebec, Canada
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
Montreal Neurological Institute, 3801 University Street
Montreal, Quebec, Canada
The Ottawa General Hospital, 501 Smyth Rd.
Ottawa, , Canada
Private Clinic, 48 Sidi Gaber St.
Alexandria, , 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
Cairo, , Egypt
Hopital La Timone Cpcet, Rue Jean Moulin
Marseille, , France
Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny
Nancy, , France
Hôpital Pellegrin
Place Amélie Raba Léon, Bordeaux Cedex, , France
Hopital De Purpan
Place Du Dr. Baylac, Toulouse Cedex, , France
Centre Hospitalier de Poissy, 10 rue du Champ Gaillard
Poissy, , France
Hoppital Pasteur, Archet II, 30 avenue de la Voie
Romaine, , France
Investigational Site
Bamberg, , Germany
Investigational Site
Berlin, , Germany
Investigational Site
Berlin, , Germany
Investigational Site
Bremen, , Germany
Investigational Site
Buchholz, , Germany
Investigational Site
Cologne, , Germany
Investigational Site
Dresden, , Germany
Investigational Site
Düsseldorf, , Germany
Investigational Site
Erbach/Odenwald, , Germany
Investigational Site
Essen, , Germany
Investigational Site
Freiburg im Breisgau, , Germany
Investigational Site
Greifswald, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Hanover, , Germany
Investigational Site
Heidelberg, , Germany
Investigational Site
Hennigsdorf, , Germany
Investigational Site
Lengerich, , Germany
Investigational Site
Mainz, , Germany
Investigational Site
München, , Germany
Investigational Site
München, , Germany
Investigational Site
Potsdam, , Germany
Investigational Site
Teupitz, , Germany
Investigational Site
Trier, , Germany
Investigational Site
Tübingen, , Germany
Investigational Site
Ulm, , Germany
Investigational Site
Ulm, , Germany
Investigational Site
Wermsdorf, , Germany
Investigational Site
Würzburg, , Germany
Univ. Hospital of Heraklion
Voutes, Heraklion, Crete, Greece
Errikos Dinan General Hospital, 107 Mesogion Ave.
Athens, , Greece
General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.
Athens, , Greece
Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1
Athens, , Greece
General University Hospital of Patra-RIO
Patra - RIO, , Greece
Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.
Thessaloniki, , Greece
Debreceni Egyetem Orvos es Egszstd. Centr.
Debrecen, , Hungary
Petz Aladár Megyei Oktató Kórház
Győr, , Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz
Korhaz U. 1, Veszprem, , Hungary
Pecsi Tudomanyegyetem Neurologiai Klinika
Pécs, , Hungary
Peterfy Sandor u. Hospital, Neurology
U. 8-20m, Budapest, , Hungary
Uzsoki korhaz
Uzsoki U. 29., Budapest, , Hungary
Azienda Sanitaria Osp. S. Luigi
Gonzaga, Orbassano, Italy
Ospedale S. Antonio Abate
Via Pastori, 4, Gallarate, VA, Italy
Presidio Ospedaliero Roberto Binaghi
Cagliari, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, , Italy
Presidio Ospedaliero di Vaio Fidenza
Fidenza, , Italy
Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS
Milan, , Italy
Az. Osp. Niguarda Ca' Granda
Milan, , Italy
Presidio Ospedaliero di Montichiari
Montichiari, , Italy
IRCCS Neurologico C. Mondino
Pavia, , Italy
Az. Osp. Ospedale Consorziale e Policlinico
Piazza Giulio Cesare, 11 Bari, , Italy
Az. Osp. Ospedale S. Martino - Università degli Studi
Via Antonio de Toni, 5, Genova, , Italy
Ist. Neurol. Mediterraneo Neuromed
Via Atinense, 18, Pozzilli, , Italy
Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi
Via Conca, 71, Torrette Di Ancona, , Italy
Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio
Via Dei Vestini, 5 Chieti, , Italy
Azienda Ospedaliera Sant'Andrea - Università La Sapienza
Via Di Grottarossa, 1035/1039, Roma, , Italy
Azienda Ospedaliera di Padova - Università degli Studi
Via Giustiniani, 2, Padova, , Italy
Az. Osp. Universitaria Policlinico Tor Vergata
Via Montpellier, 1, Roma, , Italy
Ospedale San Raffaele - IRCCS
Via Olgettina, 48/60, Milano, , Italy
Policlinico - Università degli Studi Federico II
Via Pansini, 5, Napoli, , Italy
Istituto di Scienze Neurologiche Università di Catania
Via Santa Sofia, 78, Catania, , Italy
Ospedale Bellaria Maggiore
Via Toscana Nazionale, 17/19, Bologna, , Italy
Azienda Ospedaliera Careggi - Università degli Studi
Viale Giovan Battista Morgagni, 85, Firenze, , Italy
Hospital Fernando Fonseca
Amadora, , Portugal
Hospitais da Universidade de Coimbra
Av. Dr. Bissaya Barreto, Coimbra, , Portugal
Hospital Sto. António dos
Capuchos, , Portugal
Hospital de São João
Porto, , Portugal
Hospital de S. Bernardo
Rua Camilo Castelo Branco, Setubal, , Portugal
National Cancer Center, 809 Madu 1-dong, Ilsan-gu
Kyunggi, Goyang, South Korea
Samsung Medical Center
Seoul, Korea, South Korea
Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku
Seoul, , South Korea
Kyung Pook National University Hospital
Taegu, , South Korea
Complejo Hospitalario Carlos Haya
Avda. Carlos Haya, S/n, Málaga, , Spain
Hospital Universitario Virgen Macarena
Avenida Dr. Fedriani, 3, Sevilla, , Spain
Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital Clinico San Carlos
C/ Dr. Martin Lagos, S/n, Madrid, , Spain
Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron
EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona, , Spain
Puerta de Huerro Univeristy Hospital
San Martin de Porres, 4, Madrid, , Spain
Hospital Universitario La Fe.
Valencia, , Spain
Universitätsspital Zuerich
Neurologische Klinik, Frauenklinikstrasse 26, Zuerich, , Switzerland
Universitätsspital Basel, Neurochirugishen Poliklinik
Petersgraben 4, Basel, , Switzerland
Novartis
Investigational Site, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
The Walton Centre for Neurology and Neurosurgery
Lower Lane, Fazakerly, Liverpool, , United Kingdom
Norfolk & Norwich University Hospital
Norwick, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Fingolimod clinical trials information website
Other Identifiers
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CFTY720D2302E1
Identifier Type: OTHER
Identifier Source: secondary_id
CFTY720D2302
Identifier Type: -
Identifier Source: org_study_id