Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— SUNBEAM  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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.