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Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (RADIANCE)

Primary Purpose

Relapsing Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ozanimod
Ozanimod placebo
Interferon beta-1a
Interferon beta-1a placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ozanimod 0.5 mg

Ozanimod1 mg

Interferon β-1a

Arm Description

Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.

interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 26, 2014
Last Updated
January 25, 2021
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02047734
Brief Title
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2013 (Actual)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozanimod 0.5 mg
Arm Type
Experimental
Arm Description
Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Arm Title
Ozanimod1 mg
Arm Type
Experimental
Arm Description
Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.
Arm Title
Interferon β-1a
Arm Type
Active Comparator
Arm Description
interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
RPC1063, Zeposia®
Intervention Description
Oral capsule, daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Ozanimod placebo
Intervention Description
Oral capsule, daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Avonex
Intervention Description
Intramuscular injection, 30 µg, weekly for 24 months
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a placebo
Intervention Description
Intramuscular injection, weekly for 24 months
Primary Outcome Measure Information:
Title
Adjusted Annualized Relapse Rate (ARR) at the End of Month 24
Description
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.
Time Frame
At the end of month 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months
Description
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.
Time Frame
24 month treatment period; MRI scans were performed at Months 12 and 24
Title
Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24
Description
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).
Time Frame
Month 24
Title
Time to Onset of Disability Progression Confirmed After 3 Months
Description
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.
Time Frame
From first dose to the end of the 24-month treatment period
Title
Time to Onset of Disability Progression Confirmed After 6 Months
Description
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.
Time Frame
From first dose to the end of the 24-month treatment period
Title
Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24
Description
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.
Time Frame
Month 24
Title
Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24
Description
MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
Time Frame
Month 24
Title
Percent Change From Baseline in Normalized Brain Volume to Month 24
Description
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.
Time Frame
Baseline and Month 24
Title
Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
Description
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.
Time Frame
Baseline to Month 24
Title
Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
Description
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.
Time Frame
Baseline to Month 24
Title
Number of Participants With Treatment Emergent Adverse Events
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Receptos Study Site 115
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Receptos Study Site 118
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Saint Josephs Hosptial and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Territory Neurology and Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Receptos Study Site 119
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Receptos Study Site 110
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Receptos Study Site 122
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Receptos Study Site 112
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Multiple Sclerosis Center at UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Receptos Study Site 120
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Denver Neurological Research LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Receptos Study Site 127
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Neurology Associates PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Receptos Study Site 114
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Receptos Study Site 124
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Neurostudies Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Receptos Study Site 123
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Infinity Clinical Research LLC
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
West Georgia Sleep Disorder Center and Neurology Associates
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Consultants In Neurology
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Receptos Study Site 113
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Receptos Study Site 121
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Receptos Study Site 101
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Neurological Institute PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Neurology and Neuroscience Associates Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Receptos Study Site 107
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Receptos Study Site 104
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Receptos Study Site 109
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Receptos Study Site 102
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Receptos Study Site 125
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Receptos Study Site 904
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Grodno Clinical Regional Hospital
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Receptos Study Site 907
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Minsk Municipal Clinical Hospital 5
City
Minsk
ZIP/Postal Code
220026
Country
Belarus
Facility Name
Receptos Study Site 902
City
Minsk
ZIP/Postal Code
220026
Country
Belarus
Facility Name
Receptos Study Site 901
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Facility Name
Republican Scientific and Practical Centre of Neurology and Neurosurgery
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Facility Name
Minsk City Clinical Hospital 9
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Receptos Study Site 903
City
Minsk
ZIP/Postal Code
220116
Country
Belarus
Facility Name
Receptos Study Site 905
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Vitebsk Regional Diagnostic Centre
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Receptos Study Site 906
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
AZ Sint-Jan AV Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Receptos Study Site 256
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Receptos Study Site 255
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Centre Hospitalier Chretien Clinique Saint Joseph
City
Montegnee
ZIP/Postal Code
4420
Country
Belgium
Facility Name
Receptos Study Site 252
City
Montegnée
ZIP/Postal Code
4420
Country
Belgium
Facility Name
Clinique Saint Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Receptos Study Site 254
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Receptos Study Site 911
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Receptos Study Site 453
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Receptos Study Site 454
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Receptos Study Site 452
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Receptos Study Site 456
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Receptos Study Site 457
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Receptos Study Site 451
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Receptos Study Site 455
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
University of Alberta MS Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Receptos Study Site 154
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Clinical Hospital Center Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Receptos Study Site 923
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Receptos Study Site 921
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Receptos Study Site 922
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Receptos Study Site 924
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Clinical Hospital Center "Sestre milosrdnice", Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sveti duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Receptos Study Site 301
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD MediClubGeorgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Receptos Study Site 302
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Receptos Study Site 303
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Sarajishvili Institute of Neurology
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Facility Name
Evaggelismos General Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Receptos Study Site 552
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Receptos Study Site 554
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Navy Hospital of Athens
City
Athens
ZIP/Postal Code
115 21
Country
Greece
Facility Name
Receptos Study Site 553
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Receptos Study Site 551
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
AHEPA University General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Receptos Study Site 557
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Georgios Papanikolaou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Receptos Study Site 555
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Receptos Study Site 352
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc DelPesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Receptos Study Site 356
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Receptos Study Site 354
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Vaszary Kolos Korhaz
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Receptos Study Site 358
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
SzabolcsSzatmarBereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Receptos Study Site 351
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Receptos Study Site 355
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Receptos Study Site 654
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fondazione Istituto San Raffaele G Giglio di Cefalu
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Receptos Study Site 653
City
Cefalù
ZIP/Postal Code
90015
Country
Italy
Facility Name
Receptos Study Site 655
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Receptos Study Site 652
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Presidio Ospedaliero di Montichiari
City
Montichiari
ZIP/Postal Code
25018
Country
Italy
Facility Name
Receptos Study Site 659
City
Montichiari
ZIP/Postal Code
25018
Country
Italy
Facility Name
Receptos Study Site 656
City
Napoli
Country
Italy
Facility Name
Receptos Study Site 658
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Receptos Study Site 651
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Receptos Study Site 657
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
IMSP Institutul de Medicina Urgenta
City
Chisinau
ZIP/Postal Code
2004
Country
Moldova, Republic of
Facility Name
Receptos Study Site 932
City
Chisinau
ZIP/Postal Code
2004
Country
Moldova, Republic of
Facility Name
Institutul de Neurologie si Neurochirurgie
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Receptos Study Site 931
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Receptos Study Site 933
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Receptos Study Site 401
City
Bialystok
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Receptos Study Site 423
City
Bydgoszcz
ZIP/Postal Code
85-654
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska Lek Med Robert Bonek
City
Bydgoszcz
ZIP/Postal Code
85-654
Country
Poland
Facility Name
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Receptos Study Site 406
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Receptos Study Site 405
City
Gdansk
ZIP/Postal Code
80-083
Country
Poland
Facility Name
Receptos Study Site 425
City
Gdansk
ZIP/Postal Code
80-299
Country
Poland
Facility Name
Copernicus PL Sp. z. o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
NEUROMEDIC Janusz Zbrojkiewicz
City
Katowice
ZIP/Postal Code
40-555
Country
Poland
Facility Name
MA LEK AM Maciejowscy SC Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Receptos Study Site 427
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
NovoMed Zielinski i Wspolnicy Spolka Jawna
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
Receptos Study Site 426
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
NEUROCARE Site Management Organization Gabriela KlodowskaDuda
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
Receptos Study Site 407
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
Receptos Study Site 417
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Receptos Study Site 424
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
RESMEDICA Spolka z o.o.
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Centrum Kompleksowej Rehabilitacji Sp.z.o.o. Szpital Wielospecjalistyczny
City
Konstancin Jeziorna
ZIP/Postal Code
05-510
Country
Poland
Facility Name
Receptos Study Site 404
City
Konstancin-Jeziorna
ZIP/Postal Code
05-510
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp. z. o.o.
City
Krakow
ZIP/Postal Code
31-305
Country
Poland
Facility Name
Receptos Study Site 414
City
Krakow
ZIP/Postal Code
31-305
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
93-121
Country
Poland
Facility Name
Receptos Study Site 411
City
Lodz
ZIP/Postal Code
93-121
Country
Poland
Facility Name
Prof. dr med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Receptos Study Site 412
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Receptos Study Site 420
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Receptos Study Site 402
City
Olsztyn
ZIP/Postal Code
10-443
Country
Poland
Facility Name
Receptos Study Site 415
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Receptos Study Site 421
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
City
Podlaskie
ZIP/Postal Code
15-402
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
City
Pomorskie
ZIP/Postal Code
80-299
Country
Poland
Facility Name
Receptos Study Site 408
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Szpital Kliniczny im HSwiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Receptos Study Site 418
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
EUROMEDIS Sp. z.o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Receptos Study Site 419
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
City
Warminsko-mazurskie
ZIP/Postal Code
10-443
Country
Poland
Facility Name
Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Warsaw
ZIP/Postal Code
00-739
Country
Poland
Facility Name
Receptos Study Site 410
City
Warszawa
ZIP/Postal Code
00-739
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Receptos Study Site 428
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Receptos Study Site 422
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Receptos Study Site 403
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Receptos Study Site 413
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Clinical Hospital of Psychiatry and Neurology Brasov
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Receptos Study Site 503
City
Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Health Club Medical Center S.R.L.
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Receptos Study Site 502
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Receptos Study Site 501
City
Cluj-Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Rehabilitation Clinical Hospital
City
Cluj-Napoca
ZIP/Postal Code
400347
Country
Romania
Facility Name
Receptos Study Site 505
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
Sibiu Emergency County Clinical Hospital
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
Receptos Study Site 506
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Timisoara Emergency County Clinical Hospital
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Chelyabinsk City Clinical Hospital 3
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
Receptos Study Site 701
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
Receptos Study Site 704
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Republican Clinical Hospital for Rehabilitation Treatment
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Receptos Study Site 713
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Research Medical Complex Vashe Zdorovie
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Central Clinical Hospital 2 na NA Semashko OAO RZhD
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Receptos Study Site 712
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
City Clinical Hospital 1 na NIPirogov
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Receptos Study Site 709
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
City neurology center Sibneuromed LLC
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Receptos Study Site 703
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Perm State Medical Academy
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Receptos Study Site 710
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Receptos Study Site 716
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital named after MI Kalinin
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
City Clinical Hospital 4
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Receptos Study Site 715
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Receptos Study Site 714
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Receptos Study Site 707
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Smolensk State Medical Academy
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Receptos Study Site 708
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Russian Medical Military Academy na SMKirov
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Receptos Study Site 717
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Neftyanik Medical and Sanitary Unit
City
Tyumen
ZIP/Postal Code
625048
Country
Russian Federation
Facility Name
Receptos Study Site 711
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Yaroslavl Clinical Hospital 8
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centar Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Receptos Study Site 602
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Receptos Study Site 603
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Receptos Study Site 604
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centre Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Receptos Study Site 601
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Receptos Study Site 605
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
University Hospital Bratislava - Hospital ak. L. Derera, II Neurology Clinic
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Receptos Study Site 946
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
Facility Name
Receptos Study Site 942
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Receptos Study Site 945
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Receptos Study Site 956
City
KwaZulu-Natal
ZIP/Postal Code
4321
Country
South Africa
Facility Name
Neurology Practice
City
Pretoria
ZIP/Postal Code
0040
Country
South Africa
Facility Name
Receptos Study Site 953
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Facility Name
Receptos Study Site 755
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41009
Country
Spain
Facility Name
Receptos Study Site 763
City
Santa Cruz de Tenerife
State/Province
Canarias
ZIP/Postal Code
38010
Country
Spain
Facility Name
Receptos Study Site 756
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Facility Name
Receptos Study Site 760
City
Girona
State/Province
Cataluña
ZIP/Postal Code
17007
Country
Spain
Facility Name
Receptos Study Site 762
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Receptos Study Site 752
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Receptos Study Site 761
City
Bilbao
State/Province
País Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Receptos Study Site 759
City
San Sebastián
State/Province
País Vasco
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Receptos Study Site 758
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Vall D hebron
City
Barcelona
ZIP/Postal Code
28040
Country
Spain
Facility Name
Organizacion Sanitaria Integrada Bilbao Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Receptos Study Site 757
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Receptos Study Site 751
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Receptos Study Site 754
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Vírgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Municipal Medical & Preventive Institution Chernigiv Regional Clinical Hospital
City
Chernigiv
ZIP/Postal Code
14033
Country
Ukraine
Facility Name
Receptos Study Site 805
City
Chernihiv
ZIP/Postal Code
14033
Country
Ukraine
Facility Name
Municipal Institution Chernivtsi Regional Psychiatric Hospital
City
Chernivtsi
ZIP/Postal Code
58018
Country
Ukraine
Facility Name
Receptos Study Site 813
City
Chernivtsi
ZIP/Postal Code
58018
Country
Ukraine
Facility Name
Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Receptos Study Site 802
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
State Institution Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Receptos Study Site 815
City
Dnipropetrovsk
ZIP/Postal Code
49095
Country
Ukraine
Facility Name
Regional Clinical Hospital
City
Ivano Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Receptos Study Site 801
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Receptos Study Site 814
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Municipal Institution Kherson City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Receptos Study Site 811
City
Kherson
ZIP/Postal Code
73003
Country
Ukraine
Facility Name
Receptos Study Site 818
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Receptos Study Site 803
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 4
City
Kyiv
ZIP/Postal Code
3110
Country
Ukraine
Facility Name
Municipal Institution Lutsk City Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Receptos Study Site 816
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Receptos Study Site 817
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Receptos Study Site 812
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
City
Odesa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Receptos Study Site 810
City
Odesa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Receptos Study Site 804
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Municipal Institution Vinnytsya Regional Psychoneurological Hospital na OI Yushchenko
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Receptos Study Site 809
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Institution City Clinical Hospital 6
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Receptos Study Site 806
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Royal Sussex County Hospital
City
Brighton East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Receptos Study Site 965
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Receptos Study Site 963
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Receptos Study Site 961
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Receptos Study Site 967
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Receptos Study Site 966
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
Facility Name
Receptos Study Site 964
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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
Results Reference
result
PubMed Identifier
31492652
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.
Results Reference
result

Learn more about this trial

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

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