Clinical trial NCT02294058: Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 1346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).


Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* EDSS score between 0 and 5.0 at baseline

Exclusion Criteria:

• Primary progressive multiple sclerosis

Primary outcomes:
measure: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
timeFrame: 12 months
Secondary outcomes:
measure: Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months
timeFrame: 12 month treatment period; MRI scans were assessed at Month 6 and Month 12
measure: Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
timeFrame: Month 12
measure: Time to Onset of Disability Progression Confirmed After 3 Months
timeFrame: From first dose to the end of the 12-month treatment period
measure: Time to Onset of Disability Progression Confirmed After 6 Months
timeFrame: From first dose to the end of the 12-month treatment period
measure: Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12
timeFrame: Month 12
measure: Percentage of Participants Who Were T2 Lesion-Free at Month 12
timeFrame: Month 12
measure: Percent Change From Baseline in Normalized Brain Volume at Month 12
timeFrame: Baseline to Month 12
measure: Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
timeFrame: Baseline to Month 12
measure: Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
timeFrame: Baseline to Month 12
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenosciences Inc
state: Arizona
city: Phoenix
country: United States
facility: St Josephs Hospital and Medical Center
state: Arizona
city: Tucson
country: United States
facility: Northwest Neuro Specialists PLLC
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network Inc
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: Multiple Sclerosis Center at UCSF
state: California
city: Denver
country: United States
facility: Denver Neurological Clinic
state: Colorado
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Pompano Beach
country: United States
facility: Infinity Clinical Research LLC
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Douglasville
country: United States
facility: West Georgia Sleep Disorder Center and Neurology Associates
state: Georgia
city: Northbrook
country: United States
facility: Consultants In Neurology
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Research Foundation
state: Kansas
city: Lexington
country: United States
facility: Associates In Neurology
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County PA
state: New Jersey
city: Johnson City
country: United States
facility: Neuro Medical Care Associates PLLC
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates PA
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates Inc.
state: Ohio
city: Columbus
country: United States
facility: Neurological Research Institute Inc
state: Ohio
city: Portland
country: United States
facility: Providence Multiple Sclerosis Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Knoxville
country: United States
facility: Hope Neurology MS Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Lubbock
country: United States
facility: Bhupesh Dihenia MD PA
state: Texas
city: Kirkland
country: United States
facility: EvergreenHealth
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Tacoma
country: United States
facility: Neurology of Neurosurgery Associates of Tacoma
state: Washington
city: Milwaukee
country: United States
facility: Center for Neurological Disorders
state: Wisconsin
city: Grodno
country: Belarus
facility: Grodno Clinical Regional Hospital
city: Minsk
country: Belarus
facility: Minsk Municipal Clinical Hospital 5
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Centre of Neurology and Neurosurgery
city: Minsk
country: Belarus
facility: Minsk City Clinical Hospital 9
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Diagnostic Centre
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Center Banja Luka
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
city: Pleven
country: Bulgaria
facility: Military Medical Academy HBAT
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD
city: Gatineau
country: Canada
facility: Clinique Neuro Outaouais
state: Quebec
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti duh
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Private Neurological Practice Radomir Talab MD
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava prispevkova organizace
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze
city: Teplice
country: Czechia
facility: Krajska zdravotni as Nemocnice Teplice oz
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Tbilisi
country: Georgia
facility: Aversi Clinic LTD
city: Tbilisi
country: Georgia
facility: Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: Sarajishvili Institute of Neurology
city: Tbilisi
country: Georgia
facility: Curatio JSC
city: Tbilisi
country: Georgia
facility: Ltd DEKA
city: Berlin
country: Germany
facility: Praxis Dr. Wilfried Luer
city: Berlin
country: Germany
facility: St. Joseph Krankenhaus Berlin
city: Brandenburg
country: Germany
facility: Asklepios Fachklinikum Teupitz
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden
city: Düsseldorf
country: Germany
facility: Heinrich Heine Universitat Dusseldorf
city: Köln
country: Germany
facility: DataMed GmbH
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Marburg
country: Germany
facility: Klinikum der Philipps Universitat Marburg
city: Potsdam
country: Germany
facility: St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brueder
city: Ulm
country: Germany
facility: NeuroPoint Akademie
city: Debrecen
country: Hungary
facility: Kenezy Gyula Korhaz es Rendelointezet
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Riga
country: Latvia
facility: Latvian Maritime Medicine Centre
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital clinic Gailezers
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul de Medicina Urgenta
city: Chisinau
country: Moldova, Republic of
facility: Municipal Clinical Hospital Sf Arhanghel Mihail
city: Chisinau
country: Moldova, Republic of
facility: Institutul de Neurologie si Neurochirurgie
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bydgoszcz
country: Poland
facility: B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna
city: Czeladz
country: Poland
facility: Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o.
city: Jaroslaw
country: Poland
facility: Akson Clinical Research Maciejowski Bielecki Sp. Jawna
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
city: Katowice
country: Poland
facility: M.A.- Lek A.M.Maciejowscy Spolka Cywilna
city: Katowice
country: Poland
facility: Novo-Med Zielinski i wsp. Sp.J.
city: Katowice
country: Poland
facility: NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
city: Kielce
country: Poland
facility: RESMEDICA Spolka z o.o.
city: Konstancin Jeziorna
country: Poland
facility: Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji
city: Lublin
country: Poland
facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
city: Lódzkie
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Mazowieckie
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
city: Podlaskie
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
city: Pomorskie
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Warminsko-mazurskie
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
city: Warsaw
country: Poland
facility: Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Warszawa
country: Poland
facility: Centrum Medyczne doktorA
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitario de Coimbra EPE
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Torres Vedras
country: Portugal
facility: Campus Neurologico Senior
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Cluj Napoca
country: Romania
facility: Cluj Clinical County Hospital
city: Constanta
country: Romania
facility: Cai Ferate Clinical Hospital
city: Sibiu
country: Romania
facility: Sibiu Emergency County Clinical Hospital
city: Timisoara
country: Romania
facility: Timisoara Emergency County Clinical Hospital
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Hospital
city: Barnaul
country: Russian Federation
facility: Regional Clinical Hospital
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Clinical Hospital
city: Bryansk
country: Russian Federation
facility: Bryansk Regional Hospital 1
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk City Clinical Hospital 3
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital 1
city: Kazan
country: Russian Federation
facility: Research Medical Complex Vashe Zdorovie
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Khanty-mansiysk
country: Russian Federation
facility: Regional Clinical Hospital
city: Kirov
country: Russian Federation
facility: Kirov City Clinical Hospital 1
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical Academy
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital 2 na NA Semashko OAO RZhD
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 24
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 1 na NIPirogov
city: Moscow
country: Russian Federation
facility: Research Center of Neurology of RAMS
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 11
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod City Hospital 33
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre
city: Novosibirsk
country: Russian Federation
facility: Siberian Regional Medical Center
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital na NN Burdenko
city: Perm
country: Russian Federation
facility: Perm State Medical Academy
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital na VA Baranov
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk City Hospital 2
city: Rostov on Don
country: Russian Federation
facility: Rostov Regional Clinical Hospital
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital named after MI Kalinin
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: City Hospital 31
city: St. Petersburg
country: Russian Federation
facility: City Hospital Nikolaevskaya Bolnitsa
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Multi Field City Hospital 2
city: St. Petersburg
country: Russian Federation
facility: First St Petersburg State Medical University na IP Pavlov
city: St. Petersburg
country: Russian Federation
facility: Institute of Human Brain RAN
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital 40
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Tver
country: Russian Federation
facility: Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
city: Tyumen
country: Russian Federation
facility: Neftyanik Medical and Sanitary Unit
city: Ufa
country: Russian Federation
facility: Kuvatov Republican Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Clinical Hospital 8
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Pamplona/ Navarra
country: Spain
facility: Complejo Hospitalario de Navarra
city: Sant Joan Despí
country: Spain
facility: Hospital Moises Broggi
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Cherkasy
country: Ukraine
facility: MI Cherkasy Regional Hospital of Cherkasy Regional Council
city: Chernihiv
country: Ukraine
facility: Hospital 4 of Chernihiv City Council
city: Chernihiv
country: Ukraine
facility: Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital
city: Chernivtsi
country: Ukraine
facility: Municipal Institution Chernivtsi Regional Psychiatric Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
city: Ivano Frankivsk
country: Ukraine
facility: Ivano Frankivsk City Clinical Hospital 1
city: Ivano Frankivsk
country: Ukraine
facility: Regional Clinical Hospital.
city: Kharkiv
country: Ukraine
facility: State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
city: Kharkiv
country: Ukraine
facility: Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care Kharkiv Clinical City Hospital 7
city: Kyiv
country: Ukraine
facility: National Research Center for Radiation Medicine, Institute of Clinical Radiology
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital 4
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Municipal City Clinical Hospital 5
city: Odesa
country: Ukraine
facility: Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Poltava
country: Ukraine
facility: Regional Clinical Hospital na NV Sklifosovskyi
city: Uzhhorod
country: Ukraine
facility: Regional Clinical Center of Neurosurgery and Neurology
city: Vinnytsia
country: Ukraine
facility: Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko
city: Zaporizhya
country: Ukraine
facility: Municipal Institution City Clinical Hospital 2
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution Zaporizhzhia
city: Zhytomyr
country: Ukraine
facility: Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Study officials:
affiliation: Celgene
name: James Sheffiled, MD
role: STUDY_DIRECTOR
References:
citation: Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Ding N, Cohen JA; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1009-1020. doi: 10.1016/S1474-4422(19)30239-X. Epub 2019 Sep 3.
citation: Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344
citation: DeLuca J, Schippling S, Montalban X, Kappos L, Cree BAC, Comi G, Arnold DL, Hartung HP, Sheffield JK, Liu H, Silva D, Cohen JA. Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS. Mult Scler Relat Disord. 2021 Feb;48:102673. doi: 10.1016/j.msard.2020.102673. Epub 2020 Dec 10.