Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis Clinical Trial

— RADIANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047734
• Other study ID #: RPC01-201-PartB
• Secondary ID: 2012-002714-40
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2013
• Est. completion date: April 13, 2017

Study information

• Verified date: January 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1320
• Est. completion date: April 13, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Ozanimod
Oral capsule, daily for 24 months
• Ozanimod placebo
Oral capsule, daily for 24 months
• Interferon beta-1a
Intramuscular injection, 30 µg, weekly for 24 months
• Interferon beta-1a placebo
Intramuscular injection, weekly for 24 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Georgia,  Greece,  Hungary,  Italy,  Moldova, Republic of,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

References & Publications (2)

Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdová E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon be — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Annualized Relapse Rate (ARR) 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	Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months	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
Secondary	Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at 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
Secondary	Time to Onset of Disability Progression Confirmed After 3 Months	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
Secondary	Time to Onset of Disability Progression Confirmed After 6 Months	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
Secondary	Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at 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
Secondary	Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24	MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.	Month 24
Secondary	Percent Change From Baseline in Normalized Brain Volume to 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
Secondary	Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test	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
Secondary	Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores	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
Secondary	Number of Participants With Treatment Emergent Adverse Events	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.