Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
NCT ID: NCT01628393
Last Updated: 2021-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
258 participants
INTERVENTIONAL
2012-09-18
2016-05-11
Brief Summary
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The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).
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Detailed Description
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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
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.
Ozanimod
Oral capsule taken once a day
Ozanimod 1 mg
Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.
Ozanimod
Oral capsule taken once a day
Placebo
Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.
Ozanimod
Oral capsule taken once a day
Placebo
Oral capsule taken once a day
Interventions
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Ozanimod
Oral capsule taken once a day
Placebo
Oral capsule taken once a day
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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Alta Bates Summit Medical Center
Berkeley, California, United States
Neuro Pain Medical Center
Fresno, California, United States
University of California Davis Medical Center
Sacramento, California, United States
The Neurological Institute PA
Charlotte, North Carolina, United States
Neurology and Neuroscience Associates Inc.
Akron, Ohio, United States
The Polyclinic
Seattle, Washington, United States
Cliniques Universitaires St-Luc
Brussels, , Belgium
Centre Hospitalier Chretien Clinique Saint Joseph
Montegnée, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, , Bulgaria
Sarajishvili Institute of Neurology
Tbilisi, , Georgia
LTD MediClubGeorgia
Tbilisi, , Georgia
Khechinashvili University Hospital
Tbilisi, , Georgia
Evaggelismos General Hospital
Athens, , Greece
401 Military Hospital of Athens
Athens, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, , Greece
Vaszary Kolos Korhaz
Esztergom, , Hungary
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Cantania, , Italy
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
Czeladź, , Poland
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziądz, , Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice, , Poland
NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, , Poland
NEURO MEDIC Janusz Zbrojkiewicz
Katowice, , Poland
RESMEDICA Spolka z o.o.
Kielce, , Poland
Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
Konstancin-Jeziorna, , Poland
Centrum Neurologii Krzysztof Selmaj
Lódzkie, , Poland
Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny
Olsztyn, , Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
Plewiska, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
Podlaskie, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, , Poland
EUROMEDIS Sp. z.o.o.
Szczecin, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
Warminsko-mazurskie, , Poland
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Centralny Szpital Kliniczny MSWIA
Warsaw, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Health Club Medical Center S.R.L.
Campulung Muscel, , Romania
Colentina Clinical Hospital
Cluj-Napoca, , Romania
Rehabilitation Clinical Hospital
Cluj-Napoca, , Romania
Timisoara Emergency County Clinical Hospital
Timișoara, , Romania
Republican Clinical Hospital for Rehabilitation Treatment
Kazan', , Russia
Research Medical Complex Vashe Zdorovie
Kazan', , Russia
City Clinical Hospital 4
Saransk, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Centar Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Hospital Centre Zemun
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Hospital Donostia
Donostia / San Sebastian, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
Chernihiv, , Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
Dnipropetrovsk, , Ukraine
Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, , Ukraine
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Volyn Regional Clinical Hospital
Lutsk, , Ukraine
Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
Vinnytsia, , Ukraine
Countries
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References
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Cohen JA, Arnold DL, Comi G, Bar-Or A, Gujrathi S, Hartung JP, Cravets M, Olson A, Frohna PA, Selmaj KW; RADIANCE Study Group. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):373-81. doi: 10.1016/S1474-4422(16)00018-1. Epub 2016 Feb 12.
Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdova EK, Cree BA, Montalban X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study. Mult Scler. 2019 Aug;25(9):1255-1262. doi: 10.1177/1352458518789884. Epub 2018 Jul 25.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2012-002714-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RPC01-201-PartA
Identifier Type: -
Identifier Source: org_study_id
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