Clinical trial NCT02047734: Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Annualized Relapse Rate (ARR) at the End of Month 24
timeFrame: At the end of month 24
Secondary outcomes:
measure: Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months
timeFrame: 24 month treatment period; MRI scans were performed at Months 12 and 24
measure: Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24
timeFrame: Month 24
measure: Time to Onset of Disability Progression Confirmed After 3 Months
timeFrame: From first dose to the end of the 24-month treatment period
measure: Time to Onset of Disability Progression Confirmed After 6 Months
timeFrame: From first dose to the end of the 24-month treatment period
measure: Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24
timeFrame: Month 24
measure: Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24
timeFrame: Month 24
measure: Percent Change From Baseline in Normalized Brain Volume to Month 24
timeFrame: Baseline and Month 24
measure: Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
timeFrame: Baseline to Month 24
measure: Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
timeFrame: Baseline to Month 24
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Receptos Study Site 115
state: Arizona
city: Phoenix
country: United States
facility: Xenoscience
state: Arizona
city: Phoenix
country: United States
facility: Receptos Study Site 118
state: Arizona
city: Phoenix
country: United States
facility: Saint Josephs Hosptial and Medical Center
state: Arizona
city: Tucson
country: United States
facility: Territory Neurology and Research Institute
state: Arizona
city: Tucson
country: United States
facility: Receptos Study Site 119
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Berkeley
country: United States
facility: Receptos Study Site 110
state: California
city: Long Beach
country: United States
facility: Receptos Study Site 122
state: California
city: Sacramento
country: United States
facility: Receptos Study Site 112
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: Multiple Sclerosis Center at UCSF
state: California
city: San Francisco
country: United States
facility: Receptos Study Site 120
state: California
city: Denver
country: United States
facility: Denver Neurological Research LLC
state: Colorado
city: Denver
country: United States
facility: Receptos Study Site 127
state: Colorado
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Maitland
country: United States
facility: Receptos Study Site 114
state: Florida
city: Pompano Beach
country: United States
facility: Receptos Study Site 124
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies Inc
state: Florida
city: Port Charlotte
country: United States
facility: Receptos Study Site 123
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research LLC
state: Florida
city: Douglasville
country: United States
facility: West Georgia Sleep Disorder Center and Neurology Associates
state: Georgia
city: Northbrook
country: United States
facility: Consultants In Neurology
state: Illinois
city: Northbrook
country: United States
facility: Receptos Study Site 113
state: Illinois
city: Saint Louis
country: United States
facility: Receptos Study Site 121
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Charlotte
country: United States
facility: Receptos Study Site 101
state: North Carolina
city: Charlotte
country: United States
facility: The Neurological Institute PA
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates Inc.
state: Ohio
city: Akron
country: United States
facility: Receptos Study Site 107
state: Ohio
city: Cleveland
country: United States
facility: Receptos Study Site 104
state: Ohio
city: Philadelphia
country: United States
facility: Receptos Study Site 109
state: Pennsylvania
city: Seattle
country: United States
facility: Receptos Study Site 102
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Tacoma
country: United States
facility: Receptos Study Site 125
state: Washington
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Hospital
city: Gomel
country: Belarus
facility: Receptos Study Site 904
city: Grodno
country: Belarus
facility: Grodno Clinical Regional Hospital
city: Grodno
country: Belarus
facility: Receptos Study Site 907
city: Minsk
country: Belarus
facility: Minsk Municipal Clinical Hospital 5
city: Minsk
country: Belarus
facility: Receptos Study Site 902
city: Minsk
country: Belarus
facility: Receptos Study Site 901
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Centre of Neurology and Neurosurgery
city: Minsk
country: Belarus
facility: Minsk City Clinical Hospital 9
city: Minsk
country: Belarus
facility: Receptos Study Site 903
city: Vitebsk
country: Belarus
facility: Receptos Study Site 905
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Diagnostic Centre
city: Vitebsk
country: Belarus
facility: Receptos Study Site 906
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV Brugge
city: Brugge
country: Belgium
facility: Receptos Study Site 256
city: Brussels
country: Belgium
facility: Receptos Study Site 255
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Montegnee
country: Belgium
facility: Centre Hospitalier Chretien Clinique Saint Joseph
city: Montegnée
country: Belgium
facility: Receptos Study Site 252
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Ottignies
country: Belgium
facility: Receptos Study Site 254
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: Receptos Study Site 911
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
city: Sofia
country: Bulgaria
facility: Receptos Study Site 453
city: Sofia
country: Bulgaria
facility: Receptos Study Site 454
city: Sofia
country: Bulgaria
facility: Receptos Study Site 452
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
city: Sofia
country: Bulgaria
facility: Receptos Study Site 456
city: Sofia
country: Bulgaria
facility: Receptos Study Site 457
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: Receptos Study Site 451
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
city: Sofia
country: Bulgaria
facility: Receptos Study Site 455
city: Edmonton
country: Canada
facility: University of Alberta MS Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Receptos Study Site 154
state: Alberta
city: Osijek
country: Croatia
facility: Clinical Hospital Center Osijek
city: Osijek
country: Croatia
facility: Receptos Study Site 923
city: Zagreb
country: Croatia
facility: Receptos Study Site 921
city: Zagreb
country: Croatia
facility: Receptos Study Site 922
city: Zagreb
country: Croatia
facility: Receptos Study Site 924
city: Zagreb
country: Croatia
facility: Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti duh
city: Tbilisi
country: Georgia
facility: Receptos Study Site 301
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: Receptos Study Site 302
city: Tbilisi
country: Georgia
facility: Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: Receptos Study Site 303
city: Tbilisi
country: Georgia
facility: Sarajishvili Institute of Neurology
city: Athens
country: Greece
facility: Evaggelismos General Hospital
city: Athens
country: Greece
facility: Receptos Study Site 552
city: Athens
country: Greece
facility: Receptos Study Site 554
city: Athens
country: Greece
facility: Navy Hospital of Athens
city: Athens
country: Greece
facility: Receptos Study Site 553
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Receptos Study Site 551
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Receptos Study Site 557
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Receptos Study Site 555
city: Budapest
country: Hungary
facility: Receptos Study Site 352
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Budapest
country: Hungary
facility: Jahn Ferenc DelPesti Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Receptos Study Site 356
city: Esztergom
country: Hungary
facility: Receptos Study Site 354
city: Esztergom
country: Hungary
facility: Vaszary Kolos Korhaz
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Kistarcsa
country: Hungary
facility: Receptos Study Site 358
city: Nyiregyhaza
country: Hungary
facility: SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz
city: Nyíregyháza
country: Hungary
facility: Receptos Study Site 351
city: Szekesfehervar
country: Hungary
facility: Receptos Study Site 355
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
city: Catania
country: Italy
facility: Receptos Study Site 654
city: Cefalu
country: Italy
facility: Fondazione Istituto San Raffaele G Giglio di Cefalu
city: Cefalù
country: Italy
facility: Receptos Study Site 653
city: Milano
country: Italy
facility: Receptos Study Site 655
city: Milano
country: Italy
facility: Receptos Study Site 652
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Montichiari
country: Italy
facility: Presidio Ospedaliero di Montichiari
city: Montichiari
country: Italy
facility: Receptos Study Site 659
city: Napoli
country: Italy
facility: Receptos Study Site 656
city: Pavia
country: Italy
facility: Receptos Study Site 658
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
city: Roma
country: Italy
facility: Receptos Study Site 651
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Siena
country: Italy
facility: Receptos Study Site 657
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul de Medicina Urgenta
city: Chisinau
country: Moldova, Republic of
facility: Receptos Study Site 932
city: Chisinau
country: Moldova, Republic of
facility: Institutul de Neurologie si Neurochirurgie
city: Chisinau
country: Moldova, Republic of
facility: Receptos Study Site 931
city: Chisinau
country: Moldova, Republic of
facility: Receptos Study Site 933
city: Bialystok
country: Poland
facility: Receptos Study Site 401
city: Bydgoszcz
country: Poland
facility: Receptos Study Site 423
city: Bydgoszcz
country: Poland
facility: Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek
city: Czeladz
country: Poland
facility: Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
city: Czeladz
country: Poland
facility: Receptos Study Site 406
city: Gdansk
country: Poland
facility: Receptos Study Site 405
city: Gdansk
country: Poland
facility: Receptos Study Site 425
city: Gdansk
country: Poland
facility: Copernicus PL Sp. z. o.o.
city: Katowice
country: Poland
facility: NEUROMEDIC Janusz Zbrojkiewicz
city: Katowice
country: Poland
facility: MA LEK AM Maciejowscy SC Centrum Terapii SM
city: Katowice
country: Poland
facility: Receptos Study Site 427
city: Katowice
country: Poland
facility: NovoMed Zielinski i Wspolnicy Spolka Jawna
city: Katowice
country: Poland
facility: Receptos Study Site 426
city: Katowice
country: Poland
facility: NEUROCARE Site Management Organization Gabriela KlodowskaDuda
city: Katowice
country: Poland
facility: Receptos Study Site 407
city: Katowice
country: Poland
facility: Receptos Study Site 417
city: Kielce
country: Poland
facility: Receptos Study Site 424
city: Kielce
country: Poland
facility: RESMEDICA Spolka z o.o.
city: Konstancin Jeziorna
country: Poland
facility: Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
city: Konstancin-Jeziorna
country: Poland
facility: Receptos Study Site 404
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii Sp. z. o.o.
city: Krakow
country: Poland
facility: Receptos Study Site 414
city: Lodz
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Lodz
country: Poland
facility: Receptos Study Site 411
city: Lublin
country: Poland
facility: Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
city: Lublin
country: Poland
facility: Receptos Study Site 412
city: Lublin
country: Poland
facility: Receptos Study Site 420
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
city: Olsztyn
country: Poland
facility: Receptos Study Site 402
city: Olsztyn
country: Poland
facility: Receptos Study Site 415
city: Olsztyn
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Plewiska
country: Poland
facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
city: Plewiska
country: Poland
facility: Receptos Study Site 421
city: Podlaskie
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
city: Pomorskie
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
city: Poznan
country: Poland
facility: Receptos Study Site 408
city: Poznan
country: Poland
facility: Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
city: Poznan
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
city: Poznan
country: Poland
facility: Receptos Study Site 418
city: Szczecin
country: Poland
facility: EUROMEDIS Sp. z.o.o.
city: Szczecin
country: Poland
facility: Receptos Study Site 419
city: Warminsko-mazurskie
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
city: Warsaw
country: Poland
facility: Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Receptos Study Site 410
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Warszawa
country: Poland
facility: Receptos Study Site 428
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Receptos Study Site 422
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Warszawa
country: Poland
facility: Receptos Study Site 403
city: Warszawa
country: Poland
facility: Receptos Study Site 413
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Brasov
country: Romania
facility: Clinical Hospital of Psychiatry and Neurology Brasov
city: Brasov
country: Romania
facility: Receptos Study Site 503
city: Campulung
country: Romania
facility: Health Club Medical Center S.R.L.
city: Campulung
country: Romania
facility: Receptos Study Site 502
city: Cluj-Napoca
country: Romania
facility: Receptos Study Site 501
city: Cluj-Napoca
country: Romania
facility: Rehabilitation Clinical Hospital
city: Sibiu
country: Romania
facility: Receptos Study Site 505
city: Sibiu
country: Romania
facility: Sibiu Emergency County Clinical Hospital
city: Timisoara
country: Romania
facility: Receptos Study Site 506
city: Timisoara
country: Romania
facility: Timisoara Emergency County Clinical Hospital
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk City Clinical Hospital 3
city: Chelyabinsk
country: Russian Federation
facility: Receptos Study Site 701
city: Kazan
country: Russian Federation
facility: Receptos Study Site 704
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital for Rehabilitation Treatment
city: Kazan
country: Russian Federation
facility: Receptos Study Site 713
city: Kazan
country: Russian Federation
facility: Research Medical Complex Vashe Zdorovie
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital 2 na NA Semashko OAO RZhD
city: Moscow
country: Russian Federation
facility: Receptos Study Site 712
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 1 na NIPirogov
city: Moscow
country: Russian Federation
facility: Receptos Study Site 709
city: Novosibirsk
country: Russian Federation
facility: City neurology center Sibneuromed LLC
city: Novosibirsk
country: Russian Federation
facility: Receptos Study Site 703
city: Perm
country: Russian Federation
facility: Perm State Medical Academy
city: Perm
country: Russian Federation
facility: Receptos Study Site 710
city: Samara
country: Russian Federation
facility: Receptos Study Site 716
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital named after MI Kalinin
city: Saransk
country: Russian Federation
facility: City Clinical Hospital 4
city: Saransk
country: Russian Federation
facility: Receptos Study Site 715
city: Saratov
country: Russian Federation
facility: Receptos Study Site 714
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Smolensk
country: Russian Federation
facility: Receptos Study Site 707
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy
city: St. Petersburg
country: Russian Federation
facility: Receptos Study Site 708
city: St. Petersburg
country: Russian Federation
facility: Russian Medical Military Academy na SMKirov
city: Tyumen
country: Russian Federation
facility: Receptos Study Site 717
city: Tyumen
country: Russian Federation
facility: Neftyanik Medical and Sanitary Unit
city: Yaroslavl
country: Russian Federation
facility: Receptos Study Site 711
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Clinical Hospital 8
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Receptos Study Site 602
city: Belgrade
country: Serbia
facility: Receptos Study Site 603
city: Belgrade
country: Serbia
facility: Receptos Study Site 604
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Belgrade
country: Serbia
facility: Receptos Study Site 601
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: Receptos Study Site 605
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic
city: Bratislava
country: Slovakia
facility: Receptos Study Site 946
city: Lucenec
country: Slovakia
facility: Receptos Study Site 942
city: Trnava
country: Slovakia
facility: Receptos Study Site 945
city: KwaZulu-Natal
country: South Africa
facility: Receptos Study Site 956
city: Pretoria
country: South Africa
facility: Neurology Practice
city: Pretoria
country: South Africa
facility: Receptos Study Site 953
city: Sevilla
country: Spain
facility: Receptos Study Site 755
state: Andalucía
city: Santa Cruz de Tenerife
country: Spain
facility: Receptos Study Site 763
state: Canarias
city: Barcelona
country: Spain
facility: Receptos Study Site 756
state: Cataluña
city: Girona
country: Spain
facility: Receptos Study Site 760
state: Cataluña
city: Alicante
country: Spain
facility: Receptos Study Site 762
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Receptos Study Site 752
state: Comunidad Valenciana
city: Bilbao
country: Spain
facility: Receptos Study Site 761
state: País Vasco
city: San Sebastián
country: Spain
facility: Receptos Study Site 759
state: País Vasco
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Receptos Study Site 758
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Bilbao
country: Spain
facility: Organizacion Sanitaria Integrada Bilbao Basurto
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Receptos Study Site 757
city: Madrid
country: Spain
facility: Receptos Study Site 751
city: Majadahonda (Madrid)
country: Spain
facility: Receptos Study Site 754
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Sevilla
country: Spain
facility: Hospital Universitario Vírgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Chernigiv
country: Ukraine
facility: Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
city: Chernihiv
country: Ukraine
facility: Receptos Study Site 805
city: Chernivtsi
country: Ukraine
facility: Municipal Institution Chernivtsi Regional Psychiatric Hospital
city: Chernivtsi
country: Ukraine
facility: Receptos Study Site 813
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
city: Dnipropetrovsk
country: Ukraine
facility: Receptos Study Site 802
city: Dnipropetrovsk
country: Ukraine
facility: State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
city: Dnipropetrovsk
country: Ukraine
facility: Receptos Study Site 815
city: Ivano Frankivsk
country: Ukraine
facility: Regional Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Receptos Study Site 801
city: Kharkiv
country: Ukraine
facility: Receptos Study Site 814
city: Kharkiv
country: Ukraine
facility: State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
city: Kherson
country: Ukraine
facility: Municipal Institution Kherson City Clinical Hospital
city: Kherson
country: Ukraine
facility: Receptos Study Site 811
city: Kyiv
country: Ukraine
facility: Receptos Study Site 818
city: Kyiv
country: Ukraine
facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: Receptos Study Site 803
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital 4
city: Lutsk
country: Ukraine
facility: Municipal Institution Lutsk City Clinical Hospital
city: Lutsk
country: Ukraine
facility: Receptos Study Site 816
city: Lutsk
country: Ukraine
facility: Receptos Study Site 817
city: Lutsk
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Receptos Study Site 812
city: Odesa
country: Ukraine
facility: Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
city: Odesa
country: Ukraine
facility: Receptos Study Site 810
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Odesa
country: Ukraine
facility: Receptos Study Site 804
city: Vinnytsya
country: Ukraine
facility: Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
city: Vinnytsya
country: Ukraine
facility: Receptos Study Site 809
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution City Clinical Hospital 6
city: Zaporizhzhya
country: Ukraine
facility: Receptos Study Site 806
city: Brighton East Sussex
country: United Kingdom
facility: Royal Sussex County Hospital
city: Brighton
country: United Kingdom
facility: Receptos Study Site 965
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Inverness
country: United Kingdom
facility: Receptos Study Site 963
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Receptos Study Site 961
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
city: London
country: United Kingdom
facility: Receptos Study Site 967
city: Romford
country: United Kingdom
facility: Receptos Study Site 966
city: Sheffield
country: United Kingdom
facility: Receptos Study Site 964
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Study officials:
References:
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. P6-344
citation: 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.