Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
NCT ID: NCT02047734
Last Updated: 2021-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1320 participants
INTERVENTIONAL
2013-12-03
2017-04-13
Brief Summary
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The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).
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Detailed Description
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Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.
Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ozanimod 0.5 mg
Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Ozanimod
Oral capsule, daily for 24 months
Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months
Ozanimod1 mg
Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Ozanimod
Oral capsule, daily for 24 months
Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months
Interferon β-1a
interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
Ozanimod placebo
Oral capsule, daily for 24 months
Interferon beta-1a
Intramuscular injection, 30 µg, weekly for 24 months
Interventions
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Ozanimod
Oral capsule, daily for 24 months
Ozanimod placebo
Oral capsule, daily for 24 months
Interferon beta-1a
Intramuscular injection, 30 µg, weekly for 24 months
Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Locations
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Receptos Study Site 115
Phoenix, Arizona, United States
Xenoscience
Phoenix, Arizona, United States
Receptos Study Site 118
Phoenix, Arizona, United States
Saint Josephs Hosptial and Medical Center
Phoenix, Arizona, United States
Territory Neurology and Research Institute
Tucson, Arizona, United States
Receptos Study Site 119
Tucson, Arizona, United States
Alta Bates Summit Medical Center
Berkeley, California, United States
Receptos Study Site 110
Berkeley, California, United States
Receptos Study Site 122
Long Beach, California, United States
Receptos Study Site 112
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Multiple Sclerosis Center at UCSF
San Francisco, California, United States
Receptos Study Site 120
San Francisco, California, United States
Denver Neurological Research LLC
Denver, Colorado, United States
Receptos Study Site 127
Denver, Colorado, United States
Neurology Associates PA
Maitland, Florida, United States
Receptos Study Site 114
Maitland, Florida, United States
Receptos Study Site 124
Pompano Beach, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Receptos Study Site 123
Port Charlotte, Florida, United States
Infinity Clinical Research LLC
Sunrise, Florida, United States
West Georgia Sleep Disorder Center and Neurology Associates
Douglasville, Georgia, United States
Consultants In Neurology
Northbrook, Illinois, United States
Receptos Study Site 113
Northbrook, Illinois, United States
Receptos Study Site 121
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Receptos Study Site 101
Charlotte, North Carolina, United States
The Neurological Institute PA
Charlotte, North Carolina, United States
Neurology and Neuroscience Associates Inc.
Akron, Ohio, United States
Receptos Study Site 107
Akron, Ohio, United States
Receptos Study Site 104
Cleveland, Ohio, United States
Receptos Study Site 109
Philadelphia, Pennsylvania, United States
Receptos Study Site 102
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
Receptos Study Site 125
Tacoma, Washington, United States
Grodno Clinical Regional Hospital
Grodno, , Belarus
Receptos Study Site 907
Grodno, , Belarus
Gomel Regional Clinical Hospital
Homyel, , Belarus
Receptos Study Site 904
Homyel, , Belarus
Minsk Municipal Clinical Hospital 5
Minsk, , Belarus
Receptos Study Site 902
Minsk, , Belarus
Receptos Study Site 901
Minsk, , Belarus
Republican Scientific and Practical Centre of Neurology and Neurosurgery
Minsk, , Belarus
Minsk City Clinical Hospital 9
Minsk, , Belarus
Receptos Study Site 903
Minsk, , Belarus
Receptos Study Site 905
Vitebsk, , Belarus
Vitebsk Regional Diagnostic Centre
Vitebsk, , Belarus
Receptos Study Site 906
Vitebsk, , Belarus
AZ Sint-Jan AV Brugge
Bruges, , Belgium
Receptos Study Site 256
Bruges, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
Receptos Study Site 255
Brussels, , Belgium
Centre Hospitalier Chretien Clinique Saint Joseph
Montegnée, , Belgium
Receptos Study Site 252
Montegnée, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Receptos Study Site 254
Ottignies, , Belgium
Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
Receptos Study Site 911
Sarajevo, , Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
Sofia, , Bulgaria
Receptos Study Site 453
Sofia, , Bulgaria
Receptos Study Site 454
Sofia, , Bulgaria
Receptos Study Site 452
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
Sofia, , Bulgaria
Receptos Study Site 456
Sofia, , Bulgaria
Receptos Study Site 457
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, , Bulgaria
Receptos Study Site 451
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
Sofia, , Bulgaria
Receptos Study Site 455
Sofia, , Bulgaria
University of Alberta MS Clinic
Edmonton, Alberta, Canada
Receptos Study Site 154
Edmonton, Alberta, Canada
Clinical Hospital Center Osijek
Osijek, , Croatia
Receptos Study Site 923
Osijek, , Croatia
Receptos Study Site 921
Zagreb, , Croatia
Receptos Study Site 922
Zagreb, , Croatia
Receptos Study Site 924
Zagreb, , Croatia
Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases
Zagreb, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Clinical Hospital Sveti duh
Zagreb, , Croatia
Receptos Study Site 301
Tbilisi, , Georgia
LTD MediClubGeorgia
Tbilisi, , Georgia
Receptos Study Site 302
Tbilisi, , Georgia
Khechinashvili University Hospital
Tbilisi, , Georgia
Receptos Study Site 303
Tbilisi, , Georgia
Sarajishvili Institute of Neurology
Tbilisi, , Georgia
Evaggelismos General Hospital
Athens, , Greece
Receptos Study Site 552
Athens, , Greece
Receptos Study Site 554
Athens, , Greece
Navy Hospital of Athens
Athens, , Greece
Receptos Study Site 553
Athens, , Greece
401 Military Hospital of Athens
Athens, , Greece
Receptos Study Site 551
Athens, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Receptos Study Site 557
Thessaloniki, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, , Greece
Receptos Study Site 555
Thessaloniki, , Greece
Receptos Study Site 352
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Jahn Ferenc DelPesti Korhaz es Rendelointezet
Budapest, , Hungary
Receptos Study Site 356
Budapest, , Hungary
Receptos Study Site 354
Esztergom, , Hungary
Vaszary Kolos Korhaz
Esztergom, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Receptos Study Site 358
Kistarcsa, , Hungary
Receptos Study Site 351
Nyíregyháza, , Hungary
SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
Receptos Study Site 355
Székesfehérvár, , Hungary
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, , Italy
Receptos Study Site 654
Catania, , Italy
Fondazione Istituto San Raffaele G Giglio di Cefalu
Cefalù, , Italy
Receptos Study Site 653
Cefalù, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Receptos Study Site 655
Milan, , Italy
Receptos Study Site 652
Milan, , Italy
Presidio Ospedaliero di Montichiari
Montichiari, , Italy
Receptos Study Site 659
Montichiari, , Italy
Receptos Study Site 656
Napoli, , Italy
Receptos Study Site 658
Pavia, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Receptos Study Site 651
Roma, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Receptos Study Site 657
Siena, , Italy
IMSP Institutul de Medicina Urgenta
Chisinau, , Moldova
Receptos Study Site 932
Chisinau, , Moldova
Institutul de Neurologie si Neurochirurgie
Chisinau, , Moldova
Receptos Study Site 931
Chisinau, , Moldova
Receptos Study Site 933
Chisinau, , Moldova
Receptos Study Site 401
Bialystok, , Poland
Receptos Study Site 423
Bydgoszcz, , Poland
Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek
Bydgoszcz, , Poland
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
Czeladź, , Poland
Receptos Study Site 406
Czeladź, , Poland
Receptos Study Site 405
Gdansk, , Poland
Receptos Study Site 425
Gdansk, , Poland
Copernicus PL Sp. z. o.o.
Gdansk, , Poland
NEUROMEDIC Janusz Zbrojkiewicz
Katowice, , Poland
MA LEK AM Maciejowscy SC Centrum Terapii SM
Katowice, , Poland
Receptos Study Site 427
Katowice, , Poland
NovoMed Zielinski i Wspolnicy Spolka Jawna
Katowice, , Poland
Receptos Study Site 426
Katowice, , Poland
NEUROCARE Site Management Organization Gabriela KlodowskaDuda
Katowice, , Poland
Receptos Study Site 407
Katowice, , Poland
Receptos Study Site 417
Katowice, , Poland
Receptos Study Site 424
Kielce, , Poland
RESMEDICA Spolka z o.o.
Kielce, , Poland
Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
Konstancin-Jeziorna, , Poland
Receptos Study Site 404
Konstancin-Jeziorna, , Poland
Krakowska Akademia Neurologii Sp. z. o.o.
Krakow, , Poland
Receptos Study Site 414
Krakow, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
Receptos Study Site 411
Lodz, , Poland
Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
Lublin, , Poland
Receptos Study Site 412
Lublin, , Poland
Receptos Study Site 420
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
Lublin, , Poland
Receptos Study Site 402
Olsztyn, , Poland
Receptos Study Site 415
Olsztyn, , Poland
Wojewodzki Szpital Specjalistyczny
Olsztyn, , Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
Plewiska, , Poland
Receptos Study Site 421
Plewiska, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
Podlaskie, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
Pomorskie, , Poland
Receptos Study Site 408
Poznan, , Poland
Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, , Poland
Receptos Study Site 418
Poznan, , Poland
EUROMEDIS Sp. z.o.o.
Szczecin, , Poland
Receptos Study Site 419
Szczecin, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
Warminsko-mazurskie, , Poland
Receptos Study Site 410
Warsaw, , Poland
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Receptos Study Site 428
Warsaw, , Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, , Poland
Receptos Study Site 422
Warsaw, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Receptos Study Site 403
Warsaw, , Poland
Receptos Study Site 413
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Clinical Hospital of Psychiatry and Neurology Brasov
Brasov, , Romania
Receptos Study Site 503
Brasov, , Romania
Health Club Medical Center S.R.L.
Campulung Muscel, , Romania
Receptos Study Site 502
Campulung Muscel, , Romania
Receptos Study Site 501
Cluj-Napoca, , Romania
Rehabilitation Clinical Hospital
Cluj-Napoca, , Romania
Receptos Study Site 505
Sibiu, , Romania
Sibiu Emergency County Clinical Hospital
Sibiu, , Romania
Receptos Study Site 506
Timișoara, , Romania
Timisoara Emergency County Clinical Hospital
Timișoara, , Romania
Chelyabinsk City Clinical Hospital 3
Chelyabinsk, , Russia
Receptos Study Site 701
Chelyabinsk, , Russia
Receptos Study Site 704
Kazan', , Russia
Republican Clinical Hospital for Rehabilitation Treatment
Kazan', , Russia
Receptos Study Site 713
Kazan', , Russia
Research Medical Complex Vashe Zdorovie
Kazan', , Russia
Central Clinical Hospital 2 na NA Semashko OAO RZhD
Moscow, , Russia
Receptos Study Site 712
Moscow, , Russia
City Clinical Hospital 1 na NIPirogov
Moscow, , Russia
Receptos Study Site 709
Moscow, , Russia
City neurology center Sibneuromed LLC
Novosibirsk, , Russia
Receptos Study Site 703
Novosibirsk, , Russia
Perm State Medical Academy
Perm, , Russia
Receptos Study Site 710
Perm, , Russia
Receptos Study Site 708
Saint Petersburg, , Russia
Russian Medical Military Academy na SMKirov
Saint Petersburg, , Russia
Receptos Study Site 716
Samara, , Russia
Samara Regional Clinical Hospital named after MI Kalinin
Samara, , Russia
City Clinical Hospital 4
Saransk, , Russia
Receptos Study Site 715
Saransk, , Russia
Receptos Study Site 714
Saratov, , Russia
Saratov State Medical University
Saratov, , Russia
Receptos Study Site 707
Smolensk, , Russia
Smolensk State Medical Academy
Smolensk, , Russia
Receptos Study Site 717
Tyumen, , Russia
Neftyanik Medical and Sanitary Unit
Tyumen, , Russia
Receptos Study Site 711
Yaroslavl, , Russia
Yaroslavl Clinical Hospital 8
Yaroslavl, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Centar Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Receptos Study Site 602
Belgrade, , Serbia
Receptos Study Site 603
Belgrade, , Serbia
Receptos Study Site 604
Belgrade, , Serbia
Clinical Hospital Centre Zemun
Belgrade, , Serbia
Receptos Study Site 601
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Receptos Study Site 605
Kragujevac, , Serbia
University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic
Bratislava, , Slovakia
Receptos Study Site 946
Bratislava, , Slovakia
Receptos Study Site 942
Lučenec, , Slovakia
Receptos Study Site 945
Trnava, , Slovakia
Receptos Study Site 956
KwaZulu-Natal, , South Africa
Neurology Practice
Pretoria, , South Africa
Receptos Study Site 953
Pretoria, , South Africa
Receptos Study Site 755
Seville, Andalusia, Spain
Receptos Study Site 761
Bilbao, Basque Country, Spain
Receptos Study Site 759
Donostia / San Sebastian, Basque Country, Spain
Receptos Study Site 763
Santa Cruz de Tenerife, Canary Islands, Spain
Receptos Study Site 756
Barcelona, Catalonia, Spain
Receptos Study Site 760
Girona, Catalonia, Spain
Receptos Study Site 762
Alicante, Valencia, Spain
Receptos Study Site 752
Valencia, Valencia, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Receptos Study Site 758
Barcelona, , Spain
Hospital Universitario Vall D hebron
Barcelona, , Spain
Organizacion Sanitaria Integrada Bilbao Basurto
Bilbao, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Receptos Study Site 757
Madrid, , Spain
Receptos Study Site 751
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Receptos Study Site 754
Majadahonda (Madrid), , Spain
Hospital Universitario Vírgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
Chernihiv, , Ukraine
Receptos Study Site 805
Chernihiv, , Ukraine
Municipal Institution Chernivtsi Regional Psychiatric Hospital
Chernivtsi, , Ukraine
Receptos Study Site 813
Chernivtsi, , Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
Dnipropetrovsk, , Ukraine
Receptos Study Site 802
Dnipropetrovsk, , Ukraine
State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
Dnipropetrovsk, , Ukraine
Receptos Study Site 815
Dnipropetrovsk, , Ukraine
Receptos Study Site 801
Ivano-Frankivsk, , Ukraine
Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
Receptos Study Site 814
Kharkiv, , Ukraine
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, , Ukraine
Municipal Institution Kherson City Clinical Hospital
Kherson, , Ukraine
Receptos Study Site 811
Kherson, , Ukraine
Receptos Study Site 818
Kyiv, , Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Receptos Study Site 803
Kyiv, , Ukraine
Kyiv City Clinical Hospital 4
Kyiv, , Ukraine
Municipal Institution Lutsk City Clinical Hospital
Lutsk, , Ukraine
Receptos Study Site 816
Lutsk, , Ukraine
Receptos Study Site 817
Lutsk, , Ukraine
Volyn Regional Clinical Hospital
Lutsk, , Ukraine
Lviv Regional Clinical Hospital
Lviv, , Ukraine
Receptos Study Site 812
Lviv, , Ukraine
Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
Odesa, , Ukraine
Receptos Study Site 810
Odesa, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
Receptos Study Site 804
Odesa, , Ukraine
Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
Vinnytsia, , Ukraine
Receptos Study Site 809
Vinnytsia, , Ukraine
Municipal Institution City Clinical Hospital 6
Zaporizhzhya, , Ukraine
Receptos Study Site 806
Zaporizhzhya, , Ukraine
Receptos Study Site 965
Brighton, , United Kingdom
Royal Sussex County Hospital
Brighton East Sussex, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Receptos Study Site 963
Inverness, , United Kingdom
Kings College Hospital
London, , United Kingdom
Receptos Study Site 961
London, , United Kingdom
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Receptos Study Site 967
London, , United Kingdom
Receptos Study Site 966
Romford, , United Kingdom
Receptos Study Site 964
Sheffield, , United Kingdom
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, , United Kingdom
Countries
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References
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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
Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Epub 2019 Sep 3.
Harris 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-002714-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RPC01-201-PartB
Identifier Type: -
Identifier Source: org_study_id
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