Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,320

Participants

Timeline

Start Date

December 3, 2013

Primary Completion Date

March 27, 2017

Study Completion Date

April 13, 2017

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Ozanimod

Oral capsule, 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

DRUG

Interferon beta-1a placebo

Intramuscular injection, weekly for 24 months

Trial Locations (299)

112

Sarajishvili Institute of Neurology, Tbilisi

1113

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD, Sofia

Receptos Study Site 453, Sofia

Receptos Study Site 454, Sofia

1145

Receptos Study Site 352, Budapest

Uzsoki Utcai Korhaz, Budapest

1200

Cliniques Universitaires St Luc, Brussels

Receptos Study Site 255, Brussels

1204

Jahn Ferenc DelPesti Korhaz es Rendelointezet, Budapest

Receptos Study Site 356, Budapest

1309

Receptos Study Site 452, Sofia

1340

Clinique Saint Pierre, Ottignies

Receptos Study Site 254, Ottignies

1407

Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia, Sofia

Receptos Study Site 456, Sofia

1431

Receptos Study Site 457, Sofia

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD, Sofia

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia

1527

Receptos Study Site 451, Sofia

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD, Sofia

1606

Receptos Study Site 455, Sofia

2004

IMSP Institutul de Medicina Urgenta, Chisinau

Receptos Study Site 932, Chisinau

2028

Institutul de Neurologie si Neurochirurgie, Chisinau

Receptos Study Site 931, Chisinau

Receptos Study Site 933, Chisinau

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

Receptos Study Site 358, Kistarcsa

2500

Receptos Study Site 354, Esztergom

Vaszary Kolos Korhaz, Esztergom

3110

Kyiv City Clinical Hospital 4, Kyiv

4321

Receptos Study Site 956, KwaZulu-Natal

4400

Receptos Study Site 351, Nyíregyháza

SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4420

Centre Hospitalier Chretien Clinique Saint Joseph, Montegnée

Receptos Study Site 252, Montegnée

8000

AZ Sint-Jan AV Brugge, Bruges

Receptos Study Site 256, Bruges

Receptos Study Site 355, Székesfehérvár

10000

"Clinical Hospital Center Sestre milosrdnice, Clinic of Internal Diseases", Zagreb

Clinical Hospital Centre Zagreb, Zagreb

Clinical Hospital Sveti duh, Zagreb

10676

Evaggelismos General Hospital, Athens

Receptos Study Site 552, Athens

Receptos Study Site 554, Athens

11000

Clinical Center of Serbia, Belgrade

Clinical Hospital Centar Zvezdara, Belgrade

Military Medical Academy, Belgrade

Receptos Study Site 602, Belgrade

Receptos Study Site 603, Belgrade

Receptos Study Site 604, Belgrade

11080

Clinical Hospital Centre Zemun, Belgrade

Receptos Study Site 601, Belgrade

11521

Receptos Study Site 553, Athens

11525

401 Military Hospital of Athens, Athens

Receptos Study Site 551, Athens

14033

Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital, Chernihiv

Receptos Study Site 805, Chernihiv

17007

Receptos Study Site 760, Girona

Hospital Universitari de Girona Dr Josep Trueta, Girona

19104

Receptos Study Site 109, Philadelphia

20014

Receptos Study Site 759, Donostia / San Sebastian

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

Receptos Study Site 655, Milan

20132

Receptos Study Site 652, Milan

21005

Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko, Vinnytsia

Receptos Study Site 809, Vinnytsia

25018

Presidio Ospedaliero di Montichiari, Montichiari

Receptos Study Site 659, Montichiari

27100

Receptos Study Site 658, Pavia

28006

Hospital Universitario de la Princesa, Madrid

Receptos Study Site 757, Madrid

28040

Hospital Universitario Vall D hebron, Barcelona

Receptos Study Site 751, Madrid

28204

Receptos Study Site 101, Charlotte

The Neurological Institute PA, Charlotte

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

Receptos Study Site 754, Majadahonda (Madrid)

30134

West Georgia Sleep Disorder Center and Neurology Associates, Douglasville

31000

Clinical Hospital Center Osijek, Osijek

Receptos Study Site 923, Osijek

32751

Neurology Associates PA, Maitland

Receptos Study Site 114, Maitland

33060

Receptos Study Site 124, Pompano Beach

33351

Infinity Clinical Research LLC, Sunrise

33952

Neurostudies Inc, Port Charlotte

Receptos Study Site 123, Port Charlotte

34000

Clinical Center Kragujevac, Kragujevac

Receptos Study Site 605, Kragujevac

38010

Receptos Study Site 763, Santa Cruz de Tenerife

41009

Receptos Study Site 755, Seville

Hospital Universitario Vírgen Macarena, Seville

43024

Municipal Institution Lutsk City Clinical Hospital, Lutsk

Receptos Study Site 816, Lutsk

Receptos Study Site 817, Lutsk

Volyn Regional Clinical Hospital, Lutsk

44195

Receptos Study Site 104, Cleveland

44320

Neurology and Neuroscience Associates Inc., Akron

Receptos Study Site 107, Akron

46026

Receptos Study Site 752, Valencia

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48013

Receptos Study Site 761, Bilbao

Organizacion Sanitaria Integrada Bilbao Basurto, Bilbao

49027

Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov, Dnipropetrovsk

Receptos Study Site 802, Dnipropetrovsk

State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine, Dnipropetrovsk

49095

Receptos Study Site 815, Dnipropetrovsk

53100

Azienda Ospedaliera Universitaria Senese, Siena

Receptos Study Site 657, Siena

54636

Receptos Study Site 557, Thessaloniki

57010

Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki

Receptos Study Site 555, Thessaloniki

58018

Municipal Institution Chernivtsi Regional Psychiatric Hospital, Chernivtsi

Receptos Study Site 813, Chernivtsi

60062

Consultants In Neurology, Northbrook

Receptos Study Site 113, Northbrook

61103

Receptos Study Site 814, Kharkiv

State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya, Kharkiv

63110

Receptos Study Site 121, St Louis

Washington University, St Louis

65009

Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU, Odesa

Receptos Study Site 810, Odesa

65025

Municipal Institution Odesa Regional Clinical Hospital, Odesa

Receptos Study Site 804, Odesa

69035

Municipal Institution City Clinical Hospital 6, Zaporizhzhya

Receptos Study Site 806, Zaporizhzhya

71000

Clinical Center University of Sarajevo, Sarajevo

Receptos Study Site 911, Sarajevo

73000

Municipal Institution Kherson City Clinical Hospital, Kherson

73003

Receptos Study Site 811, Kherson

76008

Receptos Study Site 801, Ivano-Frankivsk

Regional Clinical Hospital, Ivano-Frankivsk

79010

Lviv Regional Clinical Hospital, Lviv

Receptos Study Site 812, Lviv

80210

Denver Neurological Research LLC, Denver

Receptos Study Site 127, Denver

83305

Receptos Study Site 946, Bratislava

85004

Receptos Study Site 115, Phoenix

Xenoscience, Phoenix

85013

Receptos Study Site 118, Phoenix

Saint Josephs Hosptial and Medical Center, Phoenix

85704

Territory Neurology and Research Institute, Tucson

85741

Receptos Study Site 119, Tucson

90015

Fondazione Istituto San Raffaele G Giglio di Cefalu, Cefalù

Receptos Study Site 653, Cefalù

90806

Receptos Study Site 122, Long Beach

94158

Multiple Sclerosis Center at UCSF, San Francisco

Receptos Study Site 120, San Francisco

94705

Alta Bates Summit Medical Center, Berkeley

Receptos Study Site 110, Berkeley

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

Receptos Study Site 654, Catania

95817

Receptos Study Site 112, Sacramento

University of California Davis Medical Center, Sacramento

98104

Receptos Study Site 102, Seattle

The Polyclinic, Seattle

98405

Receptos Study Site 125, Tacoma

107150

Central Clinical Hospital 2 na NA Semashko OAO RZhD, Moscow

Receptos Study Site 712, Moscow

115100

Health Club Medical Center S.R.L., Campulung Muscel

Receptos Study Site 502, Campulung Muscel

119049

City Clinical Hospital 1 na NIPirogov, Moscow

Receptos Study Site 709, Moscow

150030

Receptos Study Site 711, Yaroslavl

Yaroslavl Clinical Hospital 8, Yaroslavl

194044

Receptos Study Site 708, Saint Petersburg

Russian Medical Military Academy na SMKirov, Saint Petersburg

210023

Receptos Study Site 905, Vitebsk

Vitebsk Regional Diagnostic Centre, Vitebsk

210037

Receptos Study Site 906, Vitebsk

214018

Receptos Study Site 707, Smolensk

Smolensk State Medical Academy, Smolensk

220026

Minsk Municipal Clinical Hospital 5, Minsk

Receptos Study Site 902, Minsk

220114

Receptos Study Site 901, Minsk

Republican Scientific and Practical Centre of Neurology and Neurosurgery, Minsk

220116

Minsk City Clinical Hospital 9, Minsk

Receptos Study Site 903, Minsk

230017

Grodno Clinical Regional Hospital, Grodno

Receptos Study Site 907, Grodno

246029

Gomel Regional Clinical Hospital, Homyel

Receptos Study Site 904, Homyel

300736

Receptos Study Site 506, Timișoara

Timisoara Emergency County Clinical Hospital, Timișoara

400347

Receptos Study Site 501, Cluj-Napoca

Rehabilitation Clinical Hospital, Cluj-Napoca

410012

Receptos Study Site 714, Saratov

410054

Saratov State Medical University, Saratov

420021

Receptos Study Site 704, Kazan'

Republican Clinical Hospital for Rehabilitation Treatment, Kazan'

420101

Receptos Study Site 713, Kazan'

Research Medical Complex Vashe Zdorovie, Kazan'

430032

City Clinical Hospital 4, Saransk

Receptos Study Site 715, Saransk

443095

Receptos Study Site 716, Samara

Samara Regional Clinical Hospital named after MI Kalinin, Samara

454136

Chelyabinsk City Clinical Hospital 3, Chelyabinsk

Receptos Study Site 701, Chelyabinsk

500123

Clinical Hospital of Psychiatry and Neurology Brasov, Brasov

Receptos Study Site 503, Brasov

550166

Receptos Study Site 505, Sibiu

Sibiu Emergency County Clinical Hospital, Sibiu

614990

Perm State Medical Academy, Perm

Receptos Study Site 710, Perm

625000

Receptos Study Site 717, Tyumen

625048

Neftyanik Medical and Sanitary Unit, Tyumen

630091

City neurology center Sibneuromed LLC, Novosibirsk

Receptos Study Site 703, Novosibirsk

T6G 2G3

University of Alberta MS Clinic, Edmonton

T6G2B7

Receptos Study Site 154, Edmonton

10 000

Receptos Study Site 921, Zagreb

Receptos Study Site 922, Zagreb

Receptos Study Site 924, Zagreb

0112

Receptos Study Site 301, Tbilisi

0160

LTD MediClubGeorgia, Tbilisi

Receptos Study Site 302, Tbilisi

0179

Khechinashvili University Hospital, Tbilisi

Receptos Study Site 303, Tbilisi

115 21

Navy Hospital of Athens, Athens

546 36

AHEPA University General Hospital of Thessaloniki, Thessaloniki

Unknown

Receptos Study Site 656, Napoli

00133

Fondazione PTV Policlinico Tor Vergata, Roma

Receptos Study Site 651, Roma

15-402

Receptos Study Site 401, Bialystok

Niepubliczny Zaklad Opieki Zdrowotnej KENDRON, Podlaskie

85-654

Receptos Study Site 423, Bydgoszcz

Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek, Bydgoszcz

41-250

Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi, Czeladź

Receptos Study Site 406, Czeladź

80-083

Receptos Study Site 405, Gdansk

80-299

Receptos Study Site 425, Gdansk

Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak, Pomorskie

80-803

Copernicus PL Sp. z. o.o., Gdansk

40-555

NEUROMEDIC Janusz Zbrojkiewicz, Katowice

40-595

MA LEK AM Maciejowscy SC Centrum Terapii SM, Katowice

Receptos Study Site 427, Katowice

40-650

NovoMed Zielinski i Wspolnicy Spolka Jawna, Katowice

Receptos Study Site 426, Katowice

40-749

NEUROCARE Site Management Organization Gabriela KlodowskaDuda, Katowice

Receptos Study Site 407, Katowice

40-752

Receptos Study Site 417, Katowice

25-726

Receptos Study Site 424, Kielce

RESMEDICA Spolka z o.o., Kielce

05-510

Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny, Konstancin-Jeziorna

Receptos Study Site 404, Konstancin-Jeziorna

31-305

Krakowska Akademia Neurologii Sp. z. o.o., Krakow

Receptos Study Site 414, Krakow

93-121

Centrum Neurologii Krzysztof Selmaj, Lodz

Receptos Study Site 411, Lodz

20-718

Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny, Lublin

Receptos Study Site 412, Lublin

Receptos Study Site 420, Lublin

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego, Lublin

10-443

Receptos Study Site 402, Olsztyn

Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski, Warminsko-mazurskie

10-561

Receptos Study Site 415, Olsztyn

Wojewodzki Szpital Specjalistyczny, Olsztyn

62-064

Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska, Plewiska

Receptos Study Site 421, Plewiska

60-355

Receptos Study Site 408, Poznan

Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu, Poznan

61-853

Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy, Poznan

Receptos Study Site 418, Poznan

70-111

EUROMEDIS Sp. z.o.o., Szczecin

Receptos Study Site 419, Szczecin

00-739

Receptos Study Site 410, Warsaw

Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Warsaw

01-697

Centrum Medyczne NeuroProtect, Warsaw

Receptos Study Site 428, Warsaw

02-507

Centralny Szpital Kliniczny MSW w Warszawie, Warsaw

Receptos Study Site 422, Warsaw

02-957

Instytut Psychiatrii i Neurologii, Warsaw

Receptos Study Site 403, Warsaw

04-141

Receptos Study Site 413, Warsaw

Wojskowy Instytut Medyczny, Warsaw

833 05

University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic, Bratislava

984 01

Receptos Study Site 942, Lučenec

917 75

Receptos Study Site 945, Trnava

0040

Neurology Practice, Pretoria

0041

Receptos Study Site 953, Pretoria

08003

Receptos Study Site 756, Barcelona

Hospital del Mar, Barcelona

03010

Receptos Study Site 762, Alicante

Hospital General Universitario de Alicante, Alicante

08035

Receptos Study Site 758, Barcelona

03110

Receptos Study Site 818, Kyiv

04107

Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv

Receptos Study Site 803, Kyiv

BN2 5BE

Receptos Study Site 965, Brighton

Royal Sussex County Hospital, Brighton East Sussex

IV2 3UJ

Raigmore Hospital, Inverness

Receptos Study Site 963, Inverness

SE5 9RS

Kings College Hospital, London

Receptos Study Site 961, London

WC1N 3BG

National Hospital for Neurology and Neurosurgery, London

Receptos Study Site 967, London

RM7 0AG

Receptos Study Site 966, Romford

S10 2JF

Receptos Study Site 964, Sheffield

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY