Multiple Sclerosis Clinical Trial
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
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).
Full 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
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There are 163 Locations for this study
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85013, United States
Tucson Arizona, 85704, United States
Tucson Arizona, 85741, United States
Berkeley California, 94705, United States
Berkeley California, 94705, United States
Long Beach California, 90806, United States
Sacramento California, 95817, United States
Sacramento California, 95817, United States
San Francisco California, 94158, United States
San Francisco California, 94158, United States
Denver Colorado, 80210, United States
Denver Colorado, 80210, United States
Maitland Florida, 32751, United States
Maitland Florida, 32751, United States
Pompano Beach Florida, 33060, United States
Port Charlotte Florida, 33952, United States
Port Charlotte Florida, 33952, United States
Sunrise Florida, 33351, United States
Douglasville Georgia, 30134, United States
Northbrook Illinois, 60062, United States
Northbrook Illinois, 60062, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Charlotte North Carolina, 28204, United States
Charlotte North Carolina, 28204, United States
Akron Ohio, 44320, United States
Akron Ohio, 44320, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Tacoma Washington, 98405, United States
Gomel , 24602, Belarus
Gomel , 24602, Belarus
Grodno , 23001, Belarus
Grodno , 23001, Belarus
Minsk , 22002, Belarus
Minsk , 22002, Belarus
Minsk , 22011, Belarus
Minsk , 22011, Belarus
Minsk , 22011, Belarus
Minsk , 22011, Belarus
Vitebsk , 21002, Belarus
Vitebsk , 21002, Belarus
Vitebsk , 21003, Belarus
Brugge , 8000, Belgium
Brugge , 8000, Belgium
Brussels , 1200, Belgium
Bruxelles , 1200, Belgium
Montegnee , 4420, Belgium
Montegnée , 4420, Belgium
Ottignies , 1340, Belgium
Ottignies , 1340, Belgium
Sarajevo , 71000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Sofia , 1113, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1606, Bulgaria
Edmonton Alberta, T6G 2, Canada
Edmonton Alberta, T6G2B, Canada
Osijek , 31000, Croatia
Osijek , 31000, Croatia
Zagreb , 10 00, Croatia
Zagreb , 10 00, Croatia
Zagreb , 10 00, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Tbilisi , 0112, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0179, Georgia
Tbilisi , 0179, Georgia
Tbilisi , 112, Georgia
Athens , 10676, Greece
Athens , 10676, Greece
Athens , 10676, Greece
Athens , 115 2, Greece
Athens , 11521, Greece
Athens , 11525, Greece
Athens , 11525, Greece
Thessaloniki , 546 3, Greece
Thessaloniki , 54636, Greece
Thessaloniki , 57010, Greece
Thessaloniki , 57010, Greece
Budapest , 1145, Hungary
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Budapest , 1204, Hungary
Esztergom , 2500, Hungary
Esztergom , 2500, Hungary
Kistarcsa , 2143, Hungary
Kistarcsa , 2143, Hungary
Nyiregyhaza , 4400, Hungary
NyÃregyháza , 4400, Hungary
Szekesfehervar , 8000, Hungary
Catania , 95123, Italy
Catania , 95123, Italy
Cefalu , 90015, Italy
Cefalù , 90015, Italy
Milano , 20122, Italy
Milano , 20132, Italy
Milan , 20122, Italy
Montichiari , 25018, Italy
Montichiari , 25018, Italy
Napoli , , Italy
Pavia , 27100, Italy
Roma , 00133, Italy
Roma , 00133, Italy
Siena , 53100, Italy
Siena , 53100, Italy
Chisinau , 2004, Moldova, Republic of
Chisinau , 2004, Moldova, Republic of
Chisinau , 2028, Moldova, Republic of
Chisinau , 2028, Moldova, Republic of
Chisinau , 2028, Moldova, Republic of
Bialystok , 15-40, Poland
Bydgoszcz , 85-65, Poland
Bydgoszcz , 85-65, Poland
Czeladz , 41-25, Poland
Czeladz , 41-25, Poland
Gdansk , 80-08, Poland
Gdansk , 80-29, Poland
Gdansk , 80-80, Poland
Katowice , 40-55, Poland
Katowice , 40-59, Poland
Katowice , 40-59, Poland
Katowice , 40-65, Poland
Katowice , 40-65, Poland
Katowice , 40-74, Poland
Katowice , 40-74, Poland
Katowice , 40-75, Poland
Kielce , 25-72, Poland
Kielce , 25-72, Poland
Konstancin Jeziorna , 05-51, Poland
Konstancin-Jeziorna , 05-51, Poland
Krakow , 31-30, Poland
Krakow , 31-30, Poland
Lodz , 93-12, Poland
Lodz , 93-12, Poland
Lublin , 20-71, Poland
Lublin , 20-71, Poland
Lublin , 20-71, Poland
Lublin , 20-71, Poland
Olsztyn , 10-44, Poland
Olsztyn , 10-56, Poland
Olsztyn , 10-56, Poland
Plewiska , 62-06, Poland
Plewiska , 62-06, Poland
Podlaskie , 15-40, Poland
Pomorskie , 80-29, Poland
Poznan , 60-35, Poland
Poznan , 60-35, Poland
Poznan , 61-85, Poland
Poznan , 61-85, Poland
Szczecin , 70-11, Poland
Szczecin , 70-11, Poland
Warminsko-mazurskie , 10-44, Poland
Warsaw , 00-73, Poland
Warszawa , 00-73, Poland
Warszawa , 01-69, Poland
Warszawa , 01-69, Poland
Warszawa , 02-50, Poland
Warszawa , 02-50, Poland
Warszawa , 02-95, Poland
Warszawa , 02-95, Poland
Warszawa , 04-14, Poland
Warszawa , 04-14, Poland
Brasov , 50012, Romania
Brasov , 50012, Romania
Campulung , 11510, Romania
Campulung , 11510, Romania
Cluj-Napoca , 40034, Romania
Cluj-Napoca , 40034, Romania
Sibiu , 55016, Romania
Sibiu , 55016, Romania
Timisoara , 30073, Romania
Timisoara , 30073, Romania
Chelyabinsk , 45413, Russian Federation
Chelyabinsk , 45413, Russian Federation
Kazan , 42002, Russian Federation
Kazan , 42002, Russian Federation
Kazan , 42010, Russian Federation
Kazan , 42010, Russian Federation
Moscow , 10715, Russian Federation
Moscow , 10715, Russian Federation
Moscow , 11904, Russian Federation
Moscow , 11904, Russian Federation
Novosibirsk , 63009, Russian Federation
Novosibirsk , 63009, Russian Federation
Perm , 61499, Russian Federation
Perm , 61499, Russian Federation
Samara , 44309, Russian Federation
Samara , 44309, Russian Federation
Saransk , 43003, Russian Federation
Saransk , 43003, Russian Federation
Saratov , 41001, Russian Federation
Saratov , 41005, Russian Federation
Smolensk , 21401, Russian Federation
Smolensk , 21401, Russian Federation
St. Petersburg , 19404, Russian Federation
St. Petersburg , 19404, Russian Federation
Tyumen , 62500, Russian Federation
Tyumen , 62504, Russian Federation
Yaroslavl , 15003, Russian Federation
Yaroslavl , 15003, Russian Federation
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Belgrade , 11080, Serbia
Kragujevac , 34000, Serbia
Kragujevac , 34000, Serbia
Bratislava , 833 0, Slovakia
Bratislava , 83305, Slovakia
Lucenec , 984 0, Slovakia
Trnava , 917 7, Slovakia
KwaZulu-Natal , 4321, South Africa
Pretoria , 0040, South Africa
Pretoria , 0041, South Africa
Sevilla AndalucÃa, 41009, Spain
Santa Cruz de Tenerife Canarias, 38010, Spain
Barcelona Cataluña, 08003, Spain
Girona Cataluña, 17007, Spain
Alicante Comunidad Valenciana, 03010, Spain
Valencia Comunidad Valenciana, 46026, Spain
Bilbao PaÃs Vasco, 48013, Spain
San Sebastián PaÃs Vasco, 20014, Spain
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 28040, Spain
Bilbao , 48013, Spain
Girona , 17007, Spain
Madrid , 28006, Spain
Madrid , 28006, Spain
Madrid , 28040, Spain
Majadahonda (Madrid) , 28222, Spain
Majadahonda , 28222, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
Chernigiv , 14033, Ukraine
Chernihiv , 14033, Ukraine
Chernivtsi , 58018, Ukraine
Chernivtsi , 58018, Ukraine
Dnipropetrovsk , 49027, Ukraine
Dnipropetrovsk , 49027, Ukraine
Dnipropetrovsk , 49027, Ukraine
Dnipropetrovsk , 49095, Ukraine
Ivano Frankivsk , 76008, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Kharkiv , 61103, Ukraine
Kharkiv , 61103, Ukraine
Kherson , 73000, Ukraine
Kherson , 73003, Ukraine
Kyiv , 03110, Ukraine
Kyiv , 04107, Ukraine
Kyiv , 04107, Ukraine
Kyiv , 3110, Ukraine
Lutsk , 43024, Ukraine
Lutsk , 43024, Ukraine
Lutsk , 43024, Ukraine
Lutsk , 43024, Ukraine
Lviv , 79010, Ukraine
Lviv , 79010, Ukraine
Odesa , 65009, Ukraine
Odesa , 65009, Ukraine
Odesa , 65025, Ukraine
Odesa , 65025, Ukraine
Vinnytsya , 21005, Ukraine
Vinnytsya , 21005, Ukraine
Zaporizhzhya , 69035, Ukraine
Zaporizhzhya , 69035, Ukraine
Brighton East Sussex , BN2 5, United Kingdom
Brighton , BN2 5, United Kingdom
Inverness , IV2 3, United Kingdom
Inverness , IV2 3, United Kingdom
London , SE5 9, United Kingdom
London , SE5 9, United Kingdom
London , WC1N , United Kingdom
London , WC1N , United Kingdom
Romford , RM7 0, United Kingdom
Sheffield , S10 2, United Kingdom
Sheffield , S10 2, United Kingdom
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