Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT00340834
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1292
- 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
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
- Pregnant or nursing women
- Patients who cannot tolerate treatment with an interferon
Other protocol-defined inclusion/exclusion criteria applied to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fingolimod 1.25 mg Fingolimod 1.25 mg - Fingolimod 0.5 mg Fingolimod 0.5 mg - Interferon β-1a 30 µg Interferon β-1a 30 µg -
- Primary Outcome Measures
Name Time Method Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study 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.
- Secondary Outcome Measures
Name Time Method Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study 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.
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 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.
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study 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.
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study 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.
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 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.
Trial Locations
- Locations (143)
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
🇺🇸Danbury, Connecticut, United States
AMO Corporation
🇺🇸Tallahassee, Florida, United States
Neurological Associates
🇺🇸Pompano Beach, Florida, United States
Investigational Site
🇩🇪Wurzburg, Germany
Univ.-Klinik fuer Neurologie AKH
🇦🇹Vienna, Austria
Royal Prince Alfred Hospital
🇦🇺Department of Medicine, Level, Missenden R, Camperdown, New South Wales, Australia
Gosford Private Hospital
🇦🇺North Gosford, New South Wales, Australia
Royal Melbourne Hospital
🇦🇺Suite 30, Grattan St., Parkbville, Victoria, Australia
Roskamp Institute, 2040 Whitfield Ave.
🇺🇸Sarasota, Florida, United States
The Neurology Center, 3907 Waring Road, Suite 3
🇺🇸Oceanside, California, United States
Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1
🇺🇸Maitland, Florida, United States
Landes-Nervenklinik Christian Doppler Klinik
🇦🇹Ignaz Harrerstr. 79 , Salzburg, Austria
Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen
🇪🇬Cairo, Egypt
St George Private Hospital
🇦🇺Suite 7E, Level 5, South Street, Kogarah, New South Wales, Australia
Hoppital Pasteur, Archet II, 30 avenue de la Voie
🇫🇷Romaine, France
The MS Center of Vero Beach
🇺🇸Vero Beach, Florida, United States
Absher Neurology, 274-A Commonwealth Drive
🇺🇸Greenville, South Carolina, United States
Advanced Neurosciences Institute
🇺🇸Franklin, Tennessee, United States
Strategic Health Evaluators
🇦🇺Chatswood, New South Wales, Australia
Hospital J. M. Ramos Mejia
🇦🇷General Urquiza 609, Buenos Aires, Argentina
Hospital das Clinicas da FMRPUSP
🇧🇷Ribeirao Preto, SP, Brazil
Uzsoki korhaz
🇭🇺Uzsoki u. 29., Budapest, Hungary
Raleigh Neurology Associates, 1540 Sunday Drive
🇺🇸Raleigh, North Carolina, United States
Hospital dos Servidores do Estado
🇧🇷Rio de Janeiro, Brazil
UZ Brussel
🇧🇪Laarbeeklaan 101, Brussels, Belgium
Nationaal Multiple Sclerose Centrum v.z.w
🇧🇪Melsbroek, Belgium
Northern Ohio Neuroscience, LLC
🇺🇸Bellevue, Ohio, United States
Private Clinic, 35 Dokki St., Apt. 4
🇪🇬Cairo, Egypt
Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North
🇨🇦Fleurimont, Quebec, Canada
Montreal Neurological Institute, 3801 University Street
🇨🇦Montreal, Quebec, Canada
35, Dokki St., Apt. 4
🇪🇬Cairo, Egypt
Ospedale S. Antonio Abate
🇮🇹via Pastori, 4, Gallarate, VA, Italy
Az. Osp. Ospedale S. Martino - Università degli Studi
🇮🇹via Antonio De Toni, 5, Genova, Italy
Azienda Ospedaliera Careggi - Università degli Studi
🇮🇹Viale Giovan Battista Morgagni, 85, Firenze, Italy
Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18
🇪🇬Cairo, Egypt
Veszprem Megyei Csolnoky Ferenc Korhaz
🇭🇺Korhaz u. 1, Veszprem, Hungary
Hospital Universitario Gaffree e Guinle
🇧🇷Rio de Janeiro, Brazil
Charles Lemoyne Hospital
🇨🇦Greenfield Park, Quebec, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Hospital das Clincas - UNICAMP
🇧🇷Campinas, SP, Brazil
Fundacion Lenox Cordoba
🇦🇷Cordoba, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing
🇨🇦Toronto, Ontario, Canada
Azienda Sanitaria Osp. S. Luigi
🇮🇹Gonzaga, Orbassano, Italy
Presidio Ospedaliero di Montichiari
🇮🇹Montichiari, Italy
Azienda Ospedaliera Sant'Andrea - Università La Sapienza
🇮🇹Via di Grottarossa, 1035/1039, Roma, Italy
Centre Hospitalier de Poissy, 10 rue du Champ Gaillard
🇫🇷Poissy, France
Hopital La Timone Cpcet, Rue Jean Moulin
🇫🇷Marseille, France
Hôpital Pellegrin
🇫🇷Place Amélie Raba Léon, Bordeaux Cedex, France
National Cancer Center, 809 Madu 1-dong, Ilsan-gu
🇰🇷Kyunggi, Goyang, Korea, Republic of
Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku
🇰🇷Seoul, Korea, Republic of
FLENI
🇦🇷Montaneses 2325, Buenos Aires, Argentina
Hospital Sao Rafael
🇧🇷Salvador, BA, Brazil
Peterfy Sandor u. Hospital, Neurology
🇭🇺u. 8-20m, Budapest, Hungary
The Ottawa General Hospital, 501 Smyth Rd.
🇨🇦Ottawa, Canada
Univ. Hospital of Heraklion
🇬🇷Voutes, Heraklion, Crete, Greece
General University Hospital of Patra-RIO
🇬🇷Patra - RIO, Greece
Private Clinic, 48 Sidi Gaber St.
🇪🇬Alexandria, Egypt
Presidio Ospedaliero Roberto Binaghi
🇮🇹Cagliari, Italy
Hopital De Purpan
🇫🇷Place du Dr. Baylac, Toulouse Cedex, France
Hospital Clinico San Carlos
🇪🇸C/ Dr. Martin Lagos, s/n, Madrid, Spain
Petz Aladár Megyei Oktató Kórház
🇭🇺Györ, Hungary
Pecsi Tudomanyegyetem Neurologiai Klinika
🇭🇺Pecs, Hungary
Hospital de São João
🇵🇹Porto, Portugal
General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave.
🇬🇷Athens, Greece
Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS
🇮🇹Milano, Italy
Az. Osp. Niguarda Ca' Granda
🇮🇹Milano, Italy
The Walton Centre for Neurology and Neurosurgery
🇬🇧Lower Lane, Fazakerly, Liverpool, United Kingdom
Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi
🇮🇹via Conca, 71, Torrette di Ancona, Italy
Az. Osp. Universitaria Policlinico Tor Vergata
🇮🇹via Montpellier, 1, Roma, Italy
Istituto di Scienze Neurologiche Università di Catania
🇮🇹via Santa Sofia, 78, Catania, Italy
Kyung Pook National University Hospital
🇰🇷Taegu, Korea, Republic of
Complejo Hospitalario Carlos Haya
🇪🇸Avda. Carlos Haya, s/n, Málaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Avenida Dr. Fedriani, 3, Sevilla, Spain
Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef
🇧🇪Sint-Truiden, Belgium
Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1
🇬🇷Athens, Greece
Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str.
🇬🇷Thessaloniki, Greece
University of Miami, Department of Neurology
🇺🇸Miami, Florida, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Integra Clinical Research, 4242 Medical Drive, Suite 6100
🇺🇸San Antonio, Texas, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
IRCCS Neurologico C. Mondino
🇮🇹Pavia, Italy
Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio
🇮🇹via dei Vestini, 5 Chieti, Italy
Azienda Ospedaliera di Padova - Università degli Studi
🇮🇹Via Giustiniani, 2, Padova, Italy
Policlinico - Università degli Studi Federico II
🇮🇹via Pansini, 5, Napoli, Italy
Ospedale Bellaria Maggiore
🇮🇹via Toscana Nazionale, 17/19, Bologna, Italy
Center for Neurological Disorders - Aurora St. Luke's Med Center
🇺🇸Milwaukee, Wisconsin, United States
Hospital Fernando Fonseca
🇵🇹Amadora, Portugal
Landes-Narvenklinik Wagner-Jauregg
🇦🇹Abteilung fuer Neurologie, Linz, Austria
Universitätsklinik f. Neurologie Innsbruck
🇦🇹Anichstrasse 35, Innsbruck, Austria
Hospitais da Universidade de Coimbra
🇵🇹Av. Dr. Bissaya Barreto, Coimbra, Portugal
Instituto de Neurociencias de Rosario
🇦🇷Rosario, Santa Fe, Argentina
Evangel.Krankenh./Wien-Waehring Außenstelle
🇦🇹Vienna, Austria
Hospital de S. Bernardo
🇵🇹Rua Camilo Castelo Branco, Setubal, Portugal
Fundacion Rosarina de Neurorehabilitacion
🇦🇷Rosario, Santa Fe, Argentina
Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4
🇦🇹St. Poelten, Sankt Poelten, Austria
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
UBC MS Research, 2211 Westbrook Mall
🇨🇦Vancouver, British Columbia, Canada
North Central Neurology Associates, PC, 1809 Kress Street
🇺🇸Cullman, Alabama, United States
Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff
🇺🇸Fairfield, Connecticut, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304
🇺🇸Saint Louis, Missouri, United States
Neurology & Neuroscience Associates, Inc
🇺🇸Akron, Ohio, United States
Neuroscience and Spine Center
🇺🇸Charlotte, North Carolina, United States
University of Pittsburgh, Department of Neurology
🇺🇸Pittsburgh, Pennsylvania, United States
Private Practice, 3815 23rd Street
🇺🇸Lubbock, Texas, United States
Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201
🇺🇸Bristol, Tennessee, United States
Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street
🇦🇺Liverpool, New South Wales, Australia
Box Hill Hopsital, Level 3, 16 Arnold Street
🇦🇺Box Hill, Victoria, Australia
West Virginia University Health Associates
🇺🇸Morgantown, West Virginia, United States
Ineba
🇦🇷Guarda Vieja 4435, Capital Federal, Buenos Aires, Argentina
Cliniques Universitaires Saint Luc
🇧🇪Avenue Hippocrate 10, Bruxelles, Belgium
Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street
🇨🇦Vancouver, British Columbia, Canada
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Nepean Medical Centre, 1 Centrepointe Drive, Suite 407
🇨🇦Ottawa, Ontario, Canada
Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny
🇫🇷Nancy, France
Errikos Dinan General Hospital, 107 Mesogion Ave.
🇬🇷Athens, Greece
Debreceni Egyetem Orvos es Egszstd. Centr.
🇭🇺Debrecen, Hungary
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
🇮🇹Ferrara, Italy
Presidio Ospedaliero di Vaio Fidenza
🇮🇹Fidenza, Italy
Az. Osp. Ospedale Consorziale e Policlinico
🇮🇹piazza Giulio Cesare, 11 Bari, Italy
Ist. Neurol. Mediterraneo Neuromed
🇮🇹Via Atinense, 18, Pozzilli, Italy
Ospedale San Raffaele - IRCCS
🇮🇹via Olgettina, 48/60, Milano, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Hospital Sto. António dos
🇵🇹Capuchos, Portugal
Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, 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
Norfolk & Norwich University Hospital
🇬🇧Norwick, United Kingdom
University of South Florida, Department of Neurology
🇺🇸Tampa, Florida, United States
Yale University Multiple Sclerosis Center
🇺🇸New Haven, Connecticut, United States
Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401
🇺🇸Tampa, Florida, United States
Oregon Neurology
🇺🇸Tualatin, Oregon, United States
Rockwood Clinic, P.S.
🇺🇸Spokane, Washington, United States
Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100
🇺🇸Lenexa, Kansas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Charing Cross Hospital
🇬🇧London, United Kingdom