Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
SUNBEAM
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
2 other identifiers
interventional
1,346
23 countries
213
Brief Summary
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-sclerosis
Started Dec 2014
213 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedStudy Start
First participant enrolled
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedResults Posted
Study results publicly available
November 25, 2020
CompletedNovember 25, 2020
November 1, 2020
2.1 years
August 5, 2014
December 22, 2017
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months
12 month treatment period; MRI scans were assessed at Month 6 and Month 12
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
Month 12
Time to Onset of Disability Progression Confirmed After 3 Months
From first dose to the end of the 12-month treatment period
Time to Onset of Disability Progression Confirmed After 6 Months
From first dose to the end of the 12-month treatment period
Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12
Month 12
- +5 more secondary outcomes
Study Arms (3)
Interferon beta-1a
ACTIVE COMPARATORParticipants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.
Ozanimod 0.5 mg
EXPERIMENTALParticipants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.
Ozanimod 1 mg
EXPERIMENTALParticipants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.
Interventions
Capsules for oral administration once a day
Administered by intramuscular injection once a week
Placebo intramuscular injection once a week
Eligibility Criteria
You may qualify if:
- Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- EDSS score between 0 and 5.0 at baseline
You may not qualify if:
- Primary progressive multiple sclerosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (224)
Xenosciences Inc
Phoenix, Arizona, 85004, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Northwest Neuro Specialists PLLC
Tucson, Arizona, 85712, United States
Alta Bates Summit Medical Center
Berkeley, California, 94705, United States
Collaborative Neuroscience Network Inc
Long Beach, California, 90806, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Multiple Sclerosis Center at UCSF
San Francisco, California, 94158, United States
Denver Neurological Clinic
Denver, Colorado, 80210, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Infinity Clinical Research LLC
Pompano Beach, Florida, 33060, United States
Neurostudies Inc
Port Charlotte, Florida, 33952, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Meridien Research
Tampa, Florida, 33634, United States
West Georgia Sleep Disorder Center and Neurology Associates
Douglasville, Georgia, 30134, United States
Consultants In Neurology
Northbrook, Illinois, 60062, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MidAmerica Neuroscience Research Foundation
Lenexa, Kansas, 66214, United States
Associates In Neurology
Lexington, Kentucky, 40513, United States
Norton Healthcare
Louisville, Kentucky, 40207, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422, United States
Washington University
St Louis, Missouri, 63110, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
Neurology Specialists of Monmouth County PA
West Long Branch, New Jersey, 07764, United States
Neuro Medical Care Associates PLLC
Johnson City, New York, 13790, United States
Raleigh Neurology Associates PA
Raleigh, North Carolina, 27607, United States
Neurology and Neuroscience Associates Inc.
Akron, Ohio, 44320, United States
Neurological Research Institute Inc
Columbus, Ohio, 43221, United States
Providence Multiple Sclerosis Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Hope Neurology MS Center
Knoxville, Tennessee, 37922, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Bhupesh Dihenia MD PA
Lubbock, Texas, 79410, United States
EvergreenHealth
Kirkland, Washington, 98034, United States
The Polyclinic
Seattle, Washington, 98104, United States
Neurology of Neurosurgery Associates of Tacoma
Tacoma, Washington, 98405, United States
Center for Neurological Disorders
Milwaukee, Wisconsin, 53215, United States
Grodno Clinical Regional Hospital
Grodno, 230017, Belarus
Minsk Municipal Clinical Hospital 5
Minsk, 220026, Belarus
Republican Scientific and Practical Centre of Neurology and Neurosurgery
Minsk, 220114, Belarus
Minsk City Clinical Hospital 9
Minsk, 220116, Belarus
Vitebsk Regional Diagnostic Centre
Vitebsk, 210023, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, 210037, Belarus
Clinical Center Banja Luka
Banja Luka, 51000, Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, 75000, Bosnia and Herzegovina
Military Medical Academy HBAT
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
Sofia, 1113, Bulgaria
Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD
Sofia, 1309, Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
Sofia, 1407, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
Sofia, 1527, Bulgaria
Military Medical Academy - MHAT
Sofia, 1606, Bulgaria
Multiprofile Hospital for Active Treatment Sveta Marina EAD
Varna, 9010, Bulgaria
Clinique Neuro Outaouais
Gatineau, Quebec, J9J 0A5, Canada
Clinical Hospital Osijek
Osijek, 31000, Croatia
General Hospital Varazdin
Varaždin, 42000, Croatia
Clinical Hospital Center Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Clinical Hospital Sestre Milosrdnice
Zagreb, 10000, Croatia
Clinical Hospital Sveti duh
Zagreb, 10000, Croatia
University Hospital Brno
Brno, 625 00, Czechia
Fakultni nemocnice u sv Anny v Brne
Brno, 656 91, Czechia
Private Neurological Practice Radomir Talab MD
Hradec KrĂ¡lovĂ©, 500 05, Czechia
University Hospital Hradec Kralove
Hradec KrĂ¡lovĂ©, 500 05, Czechia
Nemocnice Jihlava prispevkova organizace
Jihlava, 586 33, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 775 20, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, 128 21, Czechia
Krajska zdravotni as Nemocnice Teplice oz
Teplice, 415 29, Czechia
East Tallinn Central Hospital
Tallinn, 10138, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital
Tartu, EE-51014, Estonia
Aversi Clinic LTD
Tbilisi, 0160, Georgia
Khechinashvili University Hospital
Tbilisi, 179, Georgia
LTD MediClubGeorgia
Tbilisi, ¿0112, Georgia
Sarajishvili Institute of Neurology
Tbilisi, ¿0112, Georgia
Curatio JSC
Tbilisi, ¿0186, Georgia
Ltd DEKA
Tbilisi, ¿0186, Georgia
Praxis Dr. Wilfried Luer
Berlin, 12163, Germany
St. Joseph Krankenhaus Berlin
Berlin, 13088, Germany
Asklepios Fachklinikum Teupitz
Brandenburg, 15755, Germany
DataMed GmbH
Cologne, 50935, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Heinrich Heine Universitat Dusseldorf
DĂ¼sseldorf, 40225, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen am Rhein, 67063, Germany
Klinikum der Philipps Universitat Marburg
Marburg, 35043, Germany
St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH
Potsdam, 14471, Germany
Krankenhaus der Barmherzigen Brueder
Trier, 54292, Germany
NeuroPoint Akademie
Ulm, 89079, Germany
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, 4043, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Latvian Maritime Medicine Centre
Riga, LV-1015, Latvia
Riga East Clinical University Hospital clinic Gailezers
Riga, LV-1038, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Klaipeda University Hospital
KlaipÄ—da, LT-5808, Lithuania
IMSP Institutul de Medicina Urgenta
Chisinau, 2004, Moldova
Municipal Clinical Hospital Sf Arhanghel Mihail
Chisinau, 2005, Moldova
Institutul de Neurologie si Neurochirurgie
Chisinau, 2028, Moldova
Zuyderland Medisch Centrum
Sittard-Geleen, 6162 BG, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Waikato Hospital
Hamilton, 2001, New Zealand
B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna
Bydgoszcz, 85-795, Poland
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
Czeladź, 41-250, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, 80-803, Poland
Akson Clinical Research Maciejowski Bielecki Sp. Jawna
Jarosław, 37-500, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
Katowice, 40-555, Poland
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
Katowice, 40-595, Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice, 40-650, Poland
NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, 40-749, Poland
RESMEDICA Spolka z o.o.
Kielce, 25-726, Poland
Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji
Konstancin-Jeziorna, 05-510, Poland
Centrum Neurologii Krzysztof Selmaj
LĂ³dzkie, 90-324, Poland
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
Lublin, 20-059, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
Lublin, 20-718, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Mazowieckie, 02-097, Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
Plewiska, 62-064, Poland
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
Podlaskie, 15-402, Poland
Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
Pomorskie, 80-299, Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, 61-853, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
Rybnik, 44-200, Poland
Centrum Medyczne Medyk
RzeszĂ³w, 35-055, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
Warminsko-mazurskie, 10-443, Poland
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Warsaw, 00-739, Poland
Centrum Medyczne NeuroProtect
Warsaw, 01-697, Poland
Instytut Psychiatrii i Neurologii
Warsaw, 02-957, Poland
Centrum Medyczne doktorA
Warsaw, 05-077, Poland
Hospital Garcia de Orta
Almada, 2805-267, Portugal
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075, Portugal
Hospital Beatriz Angelo
Loures, 2674-514, Portugal
Campus Neurologico Senior
Torres Vedras, 2560-280, Portugal
Fundeni Clinical Institute
Bucharest, 022328, Romania
Colentina Clinical Hospital
Bucharest, 20125, Romania
Cluj Clinical County Hospital
Cluj-Napoca, 400012, Romania
Cai Ferate Clinical Hospital
Constanța, 900123, Romania
Sibiu Emergency County Clinical Hospital
Sibiu, 550166, Romania
Timisoara Emergency County Clinical Hospital
Timișoara, 300736, Romania
Arkhangelsk Regional Clinical Hospital
Arkhangelsk, 163045, Russia
Regional Clinical Hospital
Barnaul, 656024, Russia
Belgorod Regional Clinical Hospital
Belgorod, 308007, Russia
Bryansk Regional Hospital 1
Bryansk, 241033, Russia
Chelyabinsk City Clinical Hospital 3
Chelyabinsk, 454136, Russia
Research Medical Complex Vashe Zdorovie
Kazan', 420097, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, 650066, Russia
Regional Clinical Hospital
Khanty-Mansiysk, 628012, Russia
Kirov City Clinical Hospital 1
Kirov, 610014, Russia
Krasnoyarsk State Medical Academy
Krasnoyarsk, 660022, Russia
Kursk Regional Clinical Hospital
Kursk, 305007, Russia
Central Clinical Hospital 2 na NA Semashko OAO RZhD
Moscow, 107150, Russia
City Clinical Hospital 24
Moscow, 117997, Russia
City Clinical Hospital 1 na NIPirogov
Moscow, 119049, Russia
Research Center of Neurology of RAMS
Moscow, 125367, Russia
City Clinical Hospital 11
Moscow, 127018, Russia
Nizhniy Novgorod City Hospital 33
Nizhny Novgorod, 603076, Russia
City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre
Nizhny Novgorod, 603155, Russia
Siberian Regional Medical Center
Novosibirsk, 630007, Russia
Novosibirsk State Medical University
Novosibirsk, 630087, Russia
Penza Regional Clinical Hospital na NN Burdenko
Penza, 440026, Russia
Perm State Medical Academy
Perm, 614045, Russia
Republican Hospital na VA Baranov
Petrozavodsk, 185019, Russia
Pyatigorsk City Hospital 2
Pyatigorsk, 357538, Russia
Rostov Regional Clinical Hospital
Rostov-on-Don, 344015, Russia
City Hospital 31
Saint Petersburg, 194354, Russia
City Hospital Nikolaevskaya Bolnitsa
Saint Petersburg, 194354, Russia
St. Petersburg Multi Field City Hospital 2
Saint Petersburg, 194354, Russia
First St Petersburg State Medical University na IP Pavlov
Saint Petersburg, 197022, Russia
Institute of Human Brain RAN
Saint Petersburg, 197376, Russia
City Clinical Hospital 40
Saint Petersburg, 197706, Russia
Samara Regional Clinical Hospital named after MI Kalinin
Samara, 443095, Russia
Smolensk State Medical Academy
Smolensk, 214018, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
Tver', 125170, Russia
Neftyanik Medical and Sanitary Unit
Tyumen, 625000, Russia
Kuvatov Republican Clinical Hospital
Ufa, 450005, Russia
Yaroslavl Clinical Hospital 8
Yaroslavl, 150030, Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, 620102, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Centar Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Centre Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Hospital Universitario Vall D hebron
Barcelona, 08035, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Complejo Hospitalario de Navarra
Pamplona/ Navarra, 31008, Spain
Hospital Moises Broggi
Sant Joan DespĂ, 08970, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, SE-41345, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, SE-17176, Sweden
MI Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Hospital 4 of Chernihiv City Council
Chernihiv, 14001, Ukraine
Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital
Chernihiv, 14029, Ukraine
Municipal Institution Chernivtsi Regional Psychiatric Hospital
Chernivtsi, 58018, Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
Dnipropetrovsk, 49027, Ukraine
Ivano Frankivsk City Clinical Hospital 1
Ivano-Frankivsk, 76000, Ukraine
Regional Clinical Hospital.
Ivano-Frankivsk, 76008, Ukraine
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, 61018, Ukraine
Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine
Kharkiv, 61022, Ukraine
Municipal Institution of Health Care Kharkiv Clinical City Hospital 7
Kharkiv, 61176, Ukraine
National Research Center for Radiation Medicine, Institute of Clinical Radiology
Kyiv, 03115, Ukraine
Kyiv City Clinical Hospital 4
Kyiv, 3110, Ukraine
Volyn Regional Clinical Hospital
Lutsk, 43024, Ukraine
Lviv Regional Clinical Hospital
Lviv, 79010, Ukraine
Municipal City Clinical Hospital 5
Lviv, 79044, Ukraine
Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
Odesa, 65009, Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
Regional Clinical Hospital na NV Sklifosovskyi
Poltava, 36024, Ukraine
Regional Clinical Center of Neurosurgery and Neurology
Uzhhorod, 88018, Ukraine
Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko
Vinnytsia, 21005, Ukraine
Municipal Institution City Clinical Hospital 2
Zaporizhya, 6972, Ukraine
Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
Zaporizhzhia, 69035, Ukraine
Municipal Institution Zaporizhzhia
Zaporizhzhia, 69600, Ukraine
Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council
Zhytomyr, 10008, Ukraine
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Raigmore Hospital
Inverness, IV2 3UJ, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, S10 2JF, United Kingdom
Related Publications (4)
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.
PMID: 31492651BACKGROUNDCree 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
RESULTHarris S, Comi G, Cree BAC, Arnold DL, Steinman L, Sheffield JK, Maddux R, Southworth H, Kappos L, Cohen JA. Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. Eur J Neurol. 2025 Jun;32(6):e70222. doi: 10.1111/ene.70222.
PMID: 40462564DERIVEDDeLuca 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.
PMID: 33454584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain, Senior Manager
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
James Sheffiled, MD
Celgene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2014
First Posted
November 19, 2014
Study Start
December 3, 2014
Primary Completion
December 22, 2016
Study Completion
December 22, 2016
Last Updated
November 25, 2020
Results First Posted
November 25, 2020
Record last verified: 2020-11