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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02294058
Other study ID # RPC01-301
Secondary ID 2014-002320-27
Status Completed
Phase Phase 3
First received
Last updated
Start date December 3, 2014
Est. completion date December 22, 2016

Study information

Verified date November 2020
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1346
Est. completion date December 22, 2016
Est. primary completion date December 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ozanimod
Capsules for oral administration once a day
Interferon beta-1a
Administered by intramuscular injection once a week
Placebo to ozanimod
Matching placebo capsules administered orally once a day
Placebo to interferon beta-1a
Placebo intramuscular injection once a week

Locations

Country Name City State
Belarus Grodno Clinical Regional Hospital Grodno
Belarus Minsk City Clinical Hospital 9 Minsk
Belarus Minsk Municipal Clinical Hospital 5 Minsk
Belarus Republican Scientific and Practical Centre of Neurology and Neurosurgery Minsk
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belarus Vitebsk Regional Diagnostic Centre Vitebsk
Bosnia and Herzegovina Clinical Center Banja Luka Banja Luka
Bosnia and Herzegovina Clinical Center University of Sarajevo Sarajevo
Bosnia and Herzegovina University Clinical Center Tuzla Tuzla
Bulgaria Military Medical Academy HBAT Pleven
Bulgaria Military Medical Academy - MHAT Sofia
Bulgaria Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD Sofia
Bulgaria Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD Sofia
Bulgaria Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Aleksandrovska EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD Sofia
Bulgaria Multiprofile Hospital for Active Treatment Sveta Marina EAD Varna
Canada Clinique Neuro Outaouais Gatineau Quebec
Croatia Clinical Hospital Osijek Osijek
Croatia General Hospital Varazdin Varazdin
Croatia Clinical Hospital Center Zagreb Zagreb
Croatia Clinical Hospital Dubrava Zagreb
Croatia Clinical Hospital Sestre Milosrdnice Zagreb
Croatia Clinical Hospital Sveti duh Zagreb
Czechia Fakultni nemocnice u sv Anny v Brne Brno
Czechia University Hospital Brno Brno
Czechia Private Neurological Practice Radomir Talab MD Hradec Kralove
Czechia University Hospital Hradec Kralove Hradec Kralove
Czechia Nemocnice Jihlava prispevkova organizace Jihlava
Czechia Fakultni Nemocnice Olomouc Olomouc
Czechia Vseobecna Fakultni Nemocnice v Praze Praha 2
Czechia Krajska zdravotni as Nemocnice Teplice oz Teplice
Estonia East Tallinn Central Hospital Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
Georgia Aversi Clinic LTD Tbilisi
Georgia Curatio JSC Tbilisi
Georgia Khechinashvili University Hospital Tbilisi
Georgia Ltd DEKA Tbilisi
Georgia LTD MediClubGeorgia Tbilisi
Georgia Sarajishvili Institute of Neurology Tbilisi
Germany Praxis Dr. Wilfried Luer Berlin
Germany St. Joseph Krankenhaus Berlin Berlin
Germany Asklepios Fachklinikum Teupitz Brandenburg
Germany Universitatsklinikum Carl Gustav Carus an der TU Dresden Dresden
Germany Heinrich Heine Universitat Dusseldorf Düsseldorf
Germany DataMed GmbH Köln
Germany Universitatsklinikum Leipzig Leipzig
Germany Klinikum der Stadt Ludwigshafen gGmbH Ludwigshafen am Rhein
Germany Klinikum der Philipps Universitat Marburg Marburg
Germany St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH Potsdam
Germany Krankenhaus der Barmherzigen Brueder Trier
Germany NeuroPoint Akademie Ulm
Hungary Kenezy Gyula Korhaz es Rendelointezet Debrecen
Hungary Pest Megyei Flor Ferenc Korhaz Kistarcsa
Latvia Latvian Maritime Medicine Centre Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Latvia Riga East Clinical University Hospital clinic Gailezers Riga
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Kaunas
Lithuania Klaipeda University Hospital Klaipeda
Moldova, Republic of IMSP Institutul de Medicina Urgenta Chisinau
Moldova, Republic of Institutul de Neurologie si Neurochirurgie Chisinau
Moldova, Republic of Municipal Clinical Hospital Sf Arhanghel Mihail Chisinau
Netherlands Zuyderland Medisch Centrum Sittard-Geleen
New Zealand Auckland City Hospital Auckland
New Zealand Christchurch Hospital Christchurch
New Zealand Waikato Hospital Hamilton
Poland B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna Bydgoszcz
Poland Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi Czeladz
Poland Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk
Poland Akson Clinical Research Maciejowski Bielecki Sp. Jawna Jaroslaw
Poland M.A.- Lek A.M.Maciejowscy Spolka Cywilna Katowice
Poland NEURO- CARE Site Management Organization Gabriela Klodowska-Duda Katowice
Poland Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC Katowice
Poland Novo-Med Zielinski i wsp. Sp.J. Katowice
Poland RESMEDICA Spolka z o.o. Kielce
Poland Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji Konstancin Jeziorna
Poland Centrum Neurologii Krzysztof Selmaj Lódzkie
Poland NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska Lublin
Poland Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego Lublin
Poland Samodzielny Publiczny Centralny Szpital Kliniczny Mazowieckie
Poland Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska Plewiska
Poland Niepubliczny Zaklad Opieki Zdrowotnej KENDRON Podlaskie
Poland Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak Pomorskie
Poland Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy Poznan
Poland SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku Rybnik
Poland Centrum Medyczne Medyk Rzeszow
Poland Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski Warminsko-mazurskie
Poland Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej Warsaw
Poland Centrum Medyczne doktorA Warszawa
Poland Centrum Medyczne NeuroProtect Warszawa
Poland Instytut Psychiatrii i Neurologii Warszawa
Portugal Hospital Garcia de Orta Almada
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar E Universitario de Coimbra EPE Coimbra
Portugal Hospital Beatriz Angelo Loures
Portugal Campus Neurologico Senior Torres Vedras
Romania Colentina Clinical Hospital Bucharest
Romania Fundeni Clinical Institute Bucharest
Romania Cluj Clinical County Hospital Cluj Napoca
Romania Cai Ferate Clinical Hospital Constanta
Romania Sibiu Emergency County Clinical Hospital Sibiu
Romania Timisoara Emergency County Clinical Hospital Timisoara
Russian Federation Arkhangelsk Regional Clinical Hospital Arkhangelsk
Russian Federation Regional Clinical Hospital Barnaul
Russian Federation Belgorod Regional Clinical Hospital Belgorod
Russian Federation Bryansk Regional Hospital 1 Bryansk
Russian Federation Chelyabinsk City Clinical Hospital 3 Chelyabinsk
Russian Federation Sverdlovsk Regional Clinical Hospital 1 Ekaterinburg
Russian Federation Research Medical Complex Vashe Zdorovie Kazan
Russian Federation Kemerovo Regional Clinical Hospital Kemerovo
Russian Federation Regional Clinical Hospital Khanty-mansiysk
Russian Federation Kirov City Clinical Hospital 1 Kirov
Russian Federation Krasnoyarsk State Medical Academy Krasnoyarsk
Russian Federation Kursk Regional Clinical Hospital Kursk
Russian Federation Central Clinical Hospital 2 na NA Semashko OAO RZhD Moscow
Russian Federation City Clinical Hospital 1 na NIPirogov Moscow
Russian Federation City Clinical Hospital 11 Moscow
Russian Federation City Clinical Hospital 24 Moscow
Russian Federation Research Center of Neurology of RAMS Moscow
Russian Federation City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre Nizhny Novgorod
Russian Federation Nizhniy Novgorod City Hospital 33 Nizhny Novgorod
Russian Federation Novosibirsk State Medical University Novosibirsk
Russian Federation Siberian Regional Medical Center Novosibirsk
Russian Federation Penza Regional Clinical Hospital na NN Burdenko Penza
Russian Federation Perm State Medical Academy Perm
Russian Federation Republican Hospital na VA Baranov Petrozavodsk
Russian Federation Pyatigorsk City Hospital 2 Pyatigorsk
Russian Federation Rostov Regional Clinical Hospital Rostov on Don
Russian Federation Samara Regional Clinical Hospital named after MI Kalinin Samara
Russian Federation Smolensk State Medical Academy Smolensk
Russian Federation City Clinical Hospital 40 St. Petersburg
Russian Federation City Hospital 31 St. Petersburg
Russian Federation City Hospital Nikolaevskaya Bolnitsa St. Petersburg
Russian Federation First St Petersburg State Medical University na IP Pavlov St. Petersburg
Russian Federation Institute of Human Brain RAN St. Petersburg
Russian Federation St. Petersburg Multi Field City Hospital 2 St. Petersburg
Russian Federation Siberian State Medical University Tomsk
Russian Federation Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital Tver
Russian Federation Neftyanik Medical and Sanitary Unit Tyumen
Russian Federation Kuvatov Republican Clinical Hospital Ufa
Russian Federation Yaroslavl Clinical Hospital 8 Yaroslavl
Serbia Clinical Center of Serbia Belgrade
Serbia Clinical Hospital Centar Zvezdara Belgrade
Serbia Clinical Hospital Centre Zemun Belgrade
Serbia Military Medical Academy Belgrade
Serbia Clinical Center Kragujevac Kragujevac
Serbia Clinical Center Nis Nis
Spain Hospital Universitario Vall D hebron Barcelona
Spain Hospital Arnau de Vilanova Lleida
Spain Complejo Hospitalario de Navarra Pamplona/ Navarra
Spain Hospital Moises Broggi Sant Joan Despí
Spain Hospital Clinico Universitario de Valencia Valencia
Sweden Sahlgrenska Universitetssjukhuset Goteborg
Sweden Karolinska Universitetssjukhuset Solna Stockholm
Ukraine MI Cherkasy Regional Hospital of Cherkasy Regional Council Cherkasy
Ukraine Hospital 4 of Chernihiv City Council Chernihiv
Ukraine Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital Chernihiv
Ukraine Municipal Institution Chernivtsi Regional Psychiatric Hospital Chernivtsi
Ukraine Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov Dnipropetrovsk
Ukraine Ivano Frankivsk City Clinical Hospital 1 Ivano Frankivsk
Ukraine Regional Clinical Hospital. Ivano Frankivsk
Ukraine Municipal Institution of Health Care Kharkiv Clinical City Hospital 7 Kharkiv
Ukraine Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine Kharkiv
Ukraine State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya Kharkiv
Ukraine Kyiv City Clinical Hospital 4 Kyiv
Ukraine National Research Center for Radiation Medicine, Institute of Clinical Radiology Kyiv
Ukraine Volyn Regional Clinical Hospital Lutsk
Ukraine Lviv Regional Clinical Hospital Lviv
Ukraine Municipal City Clinical Hospital 5 Lviv
Ukraine Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU Odesa
Ukraine Municipal Institution Odesa Regional Clinical Hospital Odesa
Ukraine Regional Clinical Hospital na NV Sklifosovskyi Poltava
Ukraine Regional Clinical Center of Neurosurgery and Neurology Uzhhorod
Ukraine Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko Vinnytsia
Ukraine Municipal Institution City Clinical Hospital 2 Zaporizhya
Ukraine Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council Zaporizhzhia
Ukraine Municipal Institution Zaporizhzhia Zaporizhzhia
Ukraine Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council Zhytomyr
United Kingdom University Hospital of Wales Cardiff
United Kingdom Raigmore Hospital Inverness
United Kingdom Kings College Hospital London
United Kingdom Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust Sheffield
United States Neurology and Neuroscience Associates Inc. Akron Ohio
United States Alta Bates Summit Medical Center Berkeley California
United States Neurological Research Institute Inc Columbus Ohio
United States Denver Neurological Clinic Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States West Georgia Sleep Disorder Center and Neurology Associates Douglasville Georgia
United States Michigan State University East Lansing Michigan
United States Minneapolis Clinic of Neurology Golden Valley Minnesota
United States University of Texas Health Science Center at Houston Houston Texas
United States Neuro Medical Care Associates PLLC Johnson City New York
United States University of Kansas Medical Center Kansas City Kansas
United States EvergreenHealth Kirkland Washington
United States Hope Neurology MS Center Knoxville Tennessee
United States Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada
United States MidAmerica Neuroscience Research Foundation Lenexa Kansas
United States Associates In Neurology Lexington Kentucky
United States Collaborative Neuroscience Network Inc Long Beach California
United States Norton Healthcare Louisville Kentucky
United States Bhupesh Dihenia MD PA Lubbock Texas
United States Neurology Associates PA Maitland Florida
United States Center for Neurological Disorders Milwaukee Wisconsin
United States Consultants In Neurology Northbrook Illinois
United States Neurology Associates of Ormond Beach Ormond Beach Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States St Josephs Hospital and Medical Center Phoenix Arizona
United States Xenosciences Inc Phoenix Arizona
United States Infinity Clinical Research LLC Pompano Beach Florida
United States Neurostudies Inc Port Charlotte Florida
United States Providence Multiple Sclerosis Center Portland Oregon
United States Raleigh Neurology Associates PA Raleigh North Carolina
United States University of California Davis Medical Center Sacramento California
United States Washington University Saint Louis Missouri
United States Multiple Sclerosis Center at UCSF San Francisco California
United States Roskamp Institute Sarasota Florida
United States The Polyclinic Seattle Washington
United States Neurology of Neurosurgery Associates of Tacoma Tacoma Washington
United States Axiom Clinical Research of Florida Tampa Florida
United States Meridien Research Tampa Florida
United States Northwest Neuro Specialists PLLC Tucson Arizona
United States Neurology Specialists of Monmouth County PA West Long Branch New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belarus,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  Georgia,  Germany,  Hungary,  Latvia,  Lithuania,  Moldova, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (2)

Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdová 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. — View 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.

Outcome

Type Measure Description Time frame Safety issue
Primary Adjusted Annualized Relapse Rate (ARR) During the Treatment Period The relapse rate was based on confirmed relapses. A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for > 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of = 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on = two functional system scale scores.
Relapse rate was calculated as the total number of relapses divided by the total number of days in the study * 365.25.
ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.
12 months
Secondary Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months The number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over treatment period. 12 month treatment period; MRI scans were assessed at Month 6 and Month 12
Secondary Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12 Month 12
Secondary Time to Onset of Disability Progression Confirmed After 3 Months EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.
The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.
Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.
From first dose to the end of the 12-month treatment period
Secondary Time to Onset of Disability Progression Confirmed After 6 Months EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.
The EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.
Disability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 6 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.
From first dose to the end of the 12-month treatment period
Secondary Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12 MRI scans were analyzed by blinded centralized reading facility. Month 12
Secondary Percentage of Participants Who Were T2 Lesion-Free at Month 12 MRI scans were analyzed by blinded centralized reading facility. Month 12
Secondary Percent Change From Baseline in Normalized Brain Volume at Month 12 Brain volume (a measure of brain atrophy) was analyzed by MRI. Baseline to Month 12
Secondary Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test The MSFC-LCLA is a battery including the following 4 individual scales:
Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds
9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function
Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability
Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly
Z-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A z-score represents the number of standard deviations a patient's test result is higher (z > 0) or lower (z < 0) than the average test result (z = 0) of the reference population. A positive change indicates improvement.
Baseline to Month 12
Secondary Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures.
The two summary scores - physical health and mental health - are derived from a weighted combination of scale scores.
The physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress.
The mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function.
Each composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Baseline to Month 12
Secondary Number of Participants With Treatment Emergent Adverse Events An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe. 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.
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