Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (RADIANCE)

January 25, 2021 updated by: Celgene

A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

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.

Study Type

Interventional

Enrollment (Actual)

1320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246029
        • Gomel Regional Clinical Hospital
      • Gomel, Belarus, 246029
        • Receptos Study Site 904
      • Grodno, Belarus, 230017
        • Grodno Clinical Regional Hospital
      • Grodno, Belarus, 230017
        • Receptos Study Site 907
      • Minsk, Belarus, 220026
        • Minsk Municipal Clinical Hospital 5
      • Minsk, Belarus, 220114
        • Republican Scientific and Practical Centre of Neurology and Neurosurgery
      • Minsk, Belarus, 220116
        • Minsk City Clinical Hospital 9
      • Minsk, Belarus, 220026
        • Receptos Study Site 902
      • Minsk, Belarus, 220114
        • Receptos Study Site 901
      • Minsk, Belarus, 220116
        • Receptos Study Site 903
      • Vitebsk, Belarus, 210023
        • Vitebsk Regional Diagnostic Centre
      • Vitebsk, Belarus, 210023
        • Receptos Study Site 905
      • Vitebsk, Belarus, 210037
        • Receptos Study Site 906
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan AV Brugge
      • Brugge, Belgium, 8000
        • Receptos Study Site 256
      • Brussels, Belgium, 1200
        • Receptos Study Site 255
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St Luc
      • Montegnee, Belgium, 4420
        • Centre Hospitalier Chretien Clinique Saint Joseph
      • Montegnée, Belgium, 4420
        • Receptos Study Site 252
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
      • Ottignies, Belgium, 1340
        • Receptos Study Site 254
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Receptos Study Site 911
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
      • Sofia, Bulgaria, 1113
        • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
      • Sofia, Bulgaria, 1527
        • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
      • Sofia, Bulgaria, 1113
        • Receptos Study Site 453
      • Sofia, Bulgaria, 1113
        • Receptos Study Site 454
      • Sofia, Bulgaria, 1309
        • Receptos Study Site 452
      • Sofia, Bulgaria, 1407
        • Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
      • Sofia, Bulgaria, 1407
        • Receptos Study Site 456
      • Sofia, Bulgaria, 1431
        • Receptos Study Site 457
      • Sofia, Bulgaria, 1527
        • Receptos Study Site 451
      • Sofia, Bulgaria, 1606
        • Receptos Study Site 455
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta MS Clinic
      • Edmonton, Alberta, Canada, T6G2B7
        • Receptos Study Site 154
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Center Osijek
      • Osijek, Croatia, 31000
        • Receptos Study Site 923
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh
      • Zagreb, Croatia, 10 000
        • Receptos Study Site 921
      • Zagreb, Croatia, 10 000
        • Receptos Study Site 922
      • Zagreb, Croatia, 10 000
        • Receptos Study Site 924
      • Zagreb, Croatia, 10000
        • Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases
  • Georgia
      • Tbilisi, Georgia, 0160
        • LTD MediClubGeorgia
      • Tbilisi, Georgia, 0179
        • Khechinashvili University Hospital
      • Tbilisi, Georgia, 0112
        • Receptos Study Site 301
      • Tbilisi, Georgia, 0160
        • Receptos Study Site 302
      • Tbilisi, Georgia, 0179
        • Receptos Study Site 303
      • Tbilisi, Georgia, 112
        • Sarajishvili Institute of Neurology
  • Greece
      • Athens, Greece, 115 21
        • Navy Hospital of Athens
      • Athens, Greece, 11525
        • 401 Military Hospital of Athens
      • Athens, Greece, 10676
        • Evaggelismos General Hospital
      • Athens, Greece, 10676
        • Receptos Study Site 552
      • Athens, Greece, 10676
        • Receptos Study Site 554
      • Athens, Greece, 11521
        • Receptos Study Site 553
      • Athens, Greece, 11525
        • Receptos Study Site 551
      • Thessaloniki, Greece, 546 36
        • AHEPA University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 57010
        • Georgios Papanikolaou General Hospital of Thessaloniki
      • Thessaloniki, Greece, 54636
        • Receptos Study Site 557
      • Thessaloniki, Greece, 57010
        • Receptos Study Site 555
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1204
        • Jahn Ferenc DelPesti Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • Receptos Study Site 352
      • Budapest, Hungary, 1204
        • Receptos Study Site 356
      • Esztergom, Hungary, 2500
        • Vaszary Kolos Kórház
      • Esztergom, Hungary, 2500
        • Receptos Study Site 354
      • Kistarcsa, Hungary, 2143
        • Pest Megyei Flor Ferenc Korhaz
      • Kistarcsa, Hungary, 2143
        • Receptos Study Site 358
      • Nyiregyhaza, Hungary, 4400
        • SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz
      • Nyíregyháza, Hungary, 4400
        • Receptos Study Site 351
      • Szekesfehervar, Hungary, 8000
        • Receptos Study Site 355
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Catania, Italy, 95123
        • Receptos Study Site 654
      • Cefalu, Italy, 90015
        • Fondazione Istituto San Raffaele G Giglio di Cefalu
      • Cefalù, Italy, 90015
        • Receptos Study Site 653
      • Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20122
        • Receptos Study Site 655
      • Milano, Italy, 20132
        • Receptos Study Site 652
      • Montichiari, Italy, 25018
        • Presidio Ospedaliero di Montichiari
      • Montichiari, Italy, 25018
        • Receptos Study Site 659
      • Napoli, Italy
        • Receptos Study Site 656
      • Pavia, Italy, 27100
        • Receptos Study Site 658
      • Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata
      • Roma, Italy, 00133
        • Receptos Study Site 651
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
      • Siena, Italy, 53100
        • Receptos Study Site 657
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2004
        • IMSP Institutul de Medicina Urgenta
      • Chisinau, Moldova, Republic of, 2028
        • Institutul de Neurologie si Neurochirurgie
      • Chisinau, Moldova, Republic of, 2004
        • Receptos Study Site 932
      • Chisinau, Moldova, Republic of, 2028
        • Receptos Study Site 931
      • Chisinau, Moldova, Republic of, 2028
        • Receptos Study Site 933
  • Poland
      • Bialystok, Poland, 15-402
        • Receptos Study Site 401
      • Bydgoszcz, Poland, 85-654
        • Receptos Study Site 423
      • Bydgoszcz, Poland, 85-654
        • Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek
      • Czeladz, Poland, 41-250
        • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
      • Czeladz, Poland, 41-250
        • Receptos Study Site 406
      • Gdansk, Poland, 80-083
        • Receptos Study Site 405
      • Gdansk, Poland, 80-299
        • Receptos Study Site 425
      • Gdansk, Poland, 80-803
        • Copernicus PL Sp. z. o.o.
      • Katowice, Poland, 40-555
        • NEUROMEDIC Janusz Zbrojkiewicz
      • Katowice, Poland, 40-595
        • MA LEK AM Maciejowscy SC Centrum Terapii SM
      • Katowice, Poland, 40-595
        • Receptos Study Site 427
      • Katowice, Poland, 40-650
        • NovoMed Zielinski i Wspolnicy Spolka Jawna
      • Katowice, Poland, 40-650
        • Receptos Study Site 426
      • Katowice, Poland, 40-749
        • NEUROCARE Site Management Organization Gabriela KlodowskaDuda
      • Katowice, Poland, 40-749
        • Receptos Study Site 407
      • Katowice, Poland, 40-752
        • Receptos Study Site 417
      • Kielce, Poland, 25-726
        • RESMEDICA Spolka z o.o.
      • Kielce, Poland, 25-726
        • Receptos Study Site 424
      • Konstancin Jeziorna, Poland, 05-510
        • Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
      • Konstancin-Jeziorna, Poland, 05-510
        • Receptos Study Site 404
      • Krakow, Poland, 31-305
        • Krakowska Akademia Neurologii Sp. z. o.o.
      • Krakow, Poland, 31-305
        • Receptos Study Site 414
      • Lodz, Poland, 93-121
        • Centrum Neurologii Krzysztof Selmaj
      • Lodz, Poland, 93-121
        • Receptos Study Site 411
      • Lublin, Poland, 20-718
        • Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
      • Lublin, Poland, 20-718
        • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
      • Lublin, Poland, 20-718
        • Receptos Study Site 412
      • Lublin, Poland, 20-718
        • Receptos Study Site 420
      • Olsztyn, Poland, 10-561
        • Wojewodzki Szpital Specjalistyczny
      • Olsztyn, Poland, 10-443
        • Receptos Study Site 402
      • Olsztyn, Poland, 10-561
        • Receptos Study Site 415
      • Plewiska, Poland, 62-064
        • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
      • Plewiska, Poland, 62-064
        • Receptos Study Site 421
      • Podlaskie, Poland, 15-402
        • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
      • Pomorskie, Poland, 80-299
        • Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
      • Poznan, Poland, 60-355
        • Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
      • Poznan, Poland, 61-853
        • Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
      • Poznan, Poland, 60-355
        • Receptos Study Site 408
      • Poznan, Poland, 61-853
        • Receptos Study Site 418
      • Szczecin, Poland, 70-111
        • EUROMEDIS Sp. z.o.o.
      • Szczecin, Poland, 70-111
        • Receptos Study Site 419
      • Warminsko-mazurskie, Poland, 10-443
        • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
      • Warsaw, Poland, 00-739
        • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 02-957
        • Instytut Psychiatrii i Neurologii
      • Warszawa, Poland, 04-141
        • Wojskowy Instytut Medyczny
      • Warszawa, Poland, 01-697
        • Centrum Medyczne NeuroProtect
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSW w Warszawie
      • Warszawa, Poland, 00-739
        • Receptos Study Site 410
      • Warszawa, Poland, 01-697
        • Receptos Study Site 428
      • Warszawa, Poland, 02-507
        • Receptos Study Site 422
      • Warszawa, Poland, 02-957
        • Receptos Study Site 403
      • Warszawa, Poland, 04-141
        • Receptos Study Site 413
  • Romania
      • Brasov, Romania, 500123
        • Clinical Hospital of Psychiatry and Neurology Brasov
      • Brasov, Romania, 500123
        • Receptos Study Site 503
      • Campulung, Romania, 115100
        • Health Club Medical Center S.R.L.
      • Campulung, Romania, 115100
        • Receptos Study Site 502
      • Cluj-Napoca, Romania, 400347
        • Rehabilitation Clinical Hospital
      • Cluj-Napoca, Romania, 400347
        • Receptos Study Site 501
      • Sibiu, Romania, 550166
        • Receptos Study Site 505
      • Sibiu, Romania, 550166
        • Sibiu Emergency County Clinical Hospital
      • Timisoara, Romania, 300736
        • Timisoara Emergency County Clinical Hospital
      • Timisoara, Romania, 300736
        • Receptos Study Site 506
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454136
        • Chelyabinsk City Clinical Hospital 3
      • Chelyabinsk, Russian Federation, 454136
        • Receptos Study Site 701
      • Kazan, Russian Federation, 420021
        • Republican Clinical Hospital For Rehabilitation Treatment
      • Kazan, Russian Federation, 420021
        • Receptos Study Site 704
      • Kazan, Russian Federation, 420101
        • Receptos Study Site 713
      • Kazan, Russian Federation, 420101
        • Research Medical Complex Vashe Zdorovie
      • Moscow, Russian Federation, 107150
        • Central Clinical Hospital 2 na NA Semashko OAO RZhD
      • Moscow, Russian Federation, 119049
        • City Clinical Hospital 1 na NIPirogov
      • Moscow, Russian Federation, 107150
        • Receptos Study Site 712
      • Moscow, Russian Federation, 119049
        • Receptos Study Site 709
      • Novosibirsk, Russian Federation, 630091
        • City Neurology Center Sibneuromed LLC
      • Novosibirsk, Russian Federation, 630091
        • Receptos Study Site 703
      • Perm, Russian Federation, 614990
        • Perm State Medical Academy
      • Perm, Russian Federation, 614990
        • Receptos Study Site 710
      • Samara, Russian Federation, 443095
        • Samara Regional Clinical Hospital named after MI Kalinin
      • Samara, Russian Federation, 443095
        • Receptos Study Site 716
      • Saransk, Russian Federation, 430032
        • City Clinical Hospital 4
      • Saransk, Russian Federation, 430032
        • Receptos Study Site 715
      • Saratov, Russian Federation, 410054
        • Saratov State Medical University
      • Saratov, Russian Federation, 410012
        • Receptos Study Site 714
      • Smolensk, Russian Federation, 214018
        • Smolensk State Medical Academy
      • Smolensk, Russian Federation, 214018
        • Receptos Study Site 707
      • St. Petersburg, Russian Federation, 194044
        • Receptos Study Site 708
      • St. Petersburg, Russian Federation, 194044
        • Russian Medical Military Academy na SMKirov
      • Tyumen, Russian Federation, 625048
        • Neftyanik Medical and Sanitary Unit
      • Tyumen, Russian Federation, 625000
        • Receptos Study Site 717
      • Yaroslavl, Russian Federation, 150030
        • Yaroslavl Clinical Hospital 8
      • Yaroslavl, Russian Federation, 150030
        • Receptos Study Site 711
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Centar Zvezdara
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Zemun
      • Belgrade, Serbia, 11000
        • Receptos Study Site 602
      • Belgrade, Serbia, 11000
        • Receptos Study Site 603
      • Belgrade, Serbia, 11000
        • Receptos Study Site 604
      • Belgrade, Serbia, 11080
        • Receptos Study Site 601
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Kragujevac, Serbia, 34000
        • Receptos Study Site 605
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic
      • Bratislava, Slovakia, 83305
        • Receptos Study Site 946
      • Lucenec, Slovakia, 984 01
        • Receptos Study Site 942
      • Trnava, Slovakia, 917 75
        • Receptos Study Site 945
  • South Africa
      • KwaZulu-Natal, South Africa, 4321
        • Receptos Study Site 956
      • Pretoria, South Africa, 0040
        • Neurology Practice
      • Pretoria, South Africa, 0041
        • Receptos Study Site 953
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Receptos Study Site 758
      • Barcelona, Spain, 28040
        • Hospital Universitario Vall D hebron
      • Bilbao, Spain, 48013
        • Organización Sanitaria Integrada Bilbao Basurto
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr Josep Trueta
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28006
        • Receptos Study Site 757
      • Madrid, Spain, 28040
        • Receptos Study Site 751
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Majadahonda (Madrid), Spain, 28222
        • Receptos Study Site 754
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Andalucía
      • Sevilla, Andalucía, Spain, 41009
        • Receptos Study Site 755
    • Canarias
      • Santa Cruz de Tenerife, Canarias, Spain, 38010
        • Receptos Study Site 763
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Receptos Study Site 756
      • Girona, Cataluña, Spain, 17007
        • Receptos Study Site 760
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Receptos Study Site 762
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Receptos Study Site 752
    • País Vasco
      • Bilbao, País Vasco, Spain, 48013
        • Receptos Study Site 761
      • San Sebastián, País Vasco, Spain, 20014
        • Receptos Study Site 759
  • Ukraine
      • Chernigiv, Ukraine, 14033
        • Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
      • Chernihiv, Ukraine, 14033
        • Receptos Study Site 805
      • Chernivtsi, Ukraine, 58018
        • Municipal Institution Chernivtsi Regional Psychiatric Hospital
      • Chernivtsi, Ukraine, 58018
        • Receptos Study Site 813
      • Dnipropetrovsk, Ukraine, 49027
        • Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
      • Dnipropetrovsk, Ukraine, 49027
        • Receptos Study Site 802
      • Dnipropetrovsk, Ukraine, 49027
        • State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
      • Dnipropetrovsk, Ukraine, 49095
        • Receptos Study Site 815
      • Ivano Frankivsk, Ukraine, 76008
        • Regional Clinical Hospital
      • Ivano-Frankivsk, Ukraine, 76008
        • Receptos Study Site 801
      • Kharkiv, Ukraine, 61103
        • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
      • Kharkiv, Ukraine, 61103
        • Receptos Study Site 814
      • Kherson, Ukraine, 73000
        • Municipal Institution Kherson City Clinical Hospital
      • Kherson, Ukraine, 73003
        • Receptos Study Site 811
      • Kyiv, Ukraine, 04107
        • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
      • Kyiv, Ukraine, 3110
        • Kyiv City Clinical Hospital 4
      • Kyiv, Ukraine, 03110
        • Receptos Study Site 818
      • Kyiv, Ukraine, 04107
        • Receptos Study Site 803
      • Lutsk, Ukraine, 43024
        • Volyn Regional Clinical Hospital
      • Lutsk, Ukraine, 43024
        • Municipal Institution Lutsk City Clinical Hospital
      • Lutsk, Ukraine, 43024
        • Receptos Study Site 816
      • Lutsk, Ukraine, 43024
        • Receptos Study Site 817
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital
      • Lviv, Ukraine, 79010
        • Receptos Study Site 812
      • Odesa, Ukraine, 65025
        • Municipal Institution Odesa Regional Clinical Hospital
      • Odesa, Ukraine, 65009
        • Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
      • Odesa, Ukraine, 65009
        • Receptos Study Site 810
      • Odesa, Ukraine, 65025
        • Receptos Study Site 804
      • Vinnytsya, Ukraine, 21005
        • Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
      • Vinnytsya, Ukraine, 21005
        • Receptos Study Site 809
      • Zaporizhzhya, Ukraine, 69035
        • Municipal Institution City Clinical Hospital 6
      • Zaporizhzhya, Ukraine, 69035
        • Receptos Study Site 806
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Receptos Study Site 965
      • Brighton East Sussex, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Inverness, United Kingdom, IV2 3UJ
        • Raigmore Hospital
      • Inverness, United Kingdom, IV2 3UJ
        • Receptos Study Site 963
      • London, United Kingdom, WC1N 3BG
        • National Hospital For Neurology and Neurosurgery
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, SE5 9RS
        • Receptos Study Site 961
      • London, United Kingdom, WC1N 3BG
        • Receptos Study Site 967
      • Romford, United Kingdom, RM7 0AG
        • Receptos Study Site 966
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
      • Sheffield, United Kingdom, S10 2JF
        • Receptos Study Site 964
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience
      • Phoenix, Arizona, United States, 85004
        • Receptos Study Site 115
      • Phoenix, Arizona, United States, 85013
        • Receptos Study Site 118
      • Phoenix, Arizona, United States, 85013
        • Saint Josephs Hosptial and Medical Center
      • Tucson, Arizona, United States, 85704
        • Territory Neurology and Research Institute
      • Tucson, Arizona, United States, 85741
        • Receptos Study Site 119
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center
      • Berkeley, California, United States, 94705
        • Receptos Study Site 110
      • Long Beach, California, United States, 90806
        • Receptos Study Site 122
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • Sacramento, California, United States, 95817
        • Receptos Study Site 112
      • San Francisco, California, United States, 94158
        • Multiple Sclerosis Center at UCSF
      • San Francisco, California, United States, 94158
        • Receptos Study Site 120
    • Colorado
      • Denver, Colorado, United States, 80210
        • Denver Neurological Research LLC
      • Denver, Colorado, United States, 80210
        • Receptos Study Site 127
    • Florida
      • Maitland, Florida, United States, 32751
        • Neurology Associates PA
      • Maitland, Florida, United States, 32751
        • Receptos Study Site 114
      • Pompano Beach, Florida, United States, 33060
        • Receptos Study Site 124
      • Port Charlotte, Florida, United States, 33952
        • Neurostudies Inc
      • Port Charlotte, Florida, United States, 33952
        • Receptos Study Site 123
      • Sunrise, Florida, United States, 33351
        • Infinity Clinical Research LLC
    • Georgia
      • Douglasville, Georgia, United States, 30134
        • West Georgia Sleep Disorder Center and Neurology Associates
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology
      • Northbrook, Illinois, United States, 60062
        • Receptos Study Site 113
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • Receptos Study Site 121
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • The Neurological Institute PA
      • Charlotte, North Carolina, United States, 28204
        • Receptos Study Site 101
    • Ohio
      • Akron, Ohio, United States, 44320
        • Neurology and Neuroscience Associates Inc.
      • Akron, Ohio, United States, 44320
        • Receptos Study Site 107
      • Cleveland, Ohio, United States, 44195
        • Receptos Study Site 104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Receptos Study Site 109
    • Washington
      • Seattle, Washington, United States, 98104
        • The Polyclinic
      • Seattle, Washington, United States, 98104
        • Receptos Study Site 102
      • Tacoma, Washington, United States, 98405
        • Receptos Study Site 125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria:

  • Primary progressive multiple sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ozanimod
Oral capsule, daily for 24 months
Other Names:
  • RPC1063
  • Zeposia®
Drug: Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months
Experimental: Ozanimod1 mg
Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Drug: Ozanimod
Oral capsule, daily for 24 months
Other Names:
  • RPC1063
  • Zeposia®
Drug: Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months
Active Comparator: 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.
Drug: Ozanimod placebo
Oral capsule, daily for 24 months
Drug: Interferon beta-1a
Intramuscular injection, 30 µg, weekly for 24 months
Other Names:
  • Avonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Annualized Relapse Rate (ARR) at the End of Month 24
Time Frame: At the end of month 24

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 confirmed relapses divided by the total number of days in the study * 365.25.

ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.
At the end of month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months
Time Frame: 24 month treatment period; MRI scans were performed at Months 12 and 24

The adjusted mean 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 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

The adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term.
24 month treatment period; MRI scans were performed at Months 12 and 24
Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24
Time Frame: Month 24

MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

The number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant).
Month 24
Time to Onset of Disability Progression Confirmed After 3 Months
Time Frame: From first dose to the end of the 24-month treatment period

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 24-month treatment period
Time to Onset of Disability Progression Confirmed After 6 Months
Time Frame: From first dose to the end of the 24-month treatment period

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 24-month treatment period
Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24
Time Frame: Month 24

Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan.

MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Month 24
Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24
Time Frame: Month 24
MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Month 24
Percent Change From Baseline in Normalized Brain Volume to Month 24
Time Frame: Baseline and Month 24
Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Baseline and Month 24
Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
Time Frame: Baseline to Month 24

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 24
Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
Time Frame: Baseline to Month 24

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 24
Number of Participants With Treatment Emergent Adverse Events
Time Frame: From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months.

An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.

The investigator assessed the severity of AEs as mild, moderate, or severe and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.
From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2013

Primary Completion (Actual)

March 27, 2017

Study Completion (Actual)

April 13, 2017

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 26, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC01-201-PartB
  • 2012-002714-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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