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Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) (SUNBEAM)

Primary Purpose

Multiple Sclerosis

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

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, RMS, Multiple Sclerosis, 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
  • EDSS score between 0 and 5.0 at baseline

Exclusion Criteria:

• Primary progressive multiple sclerosis

Sites / Locations

  • Xenosciences Inc
  • St Josephs Hospital and Medical Center
  • Northwest Neuro Specialists PLLC
  • Alta Bates Summit Medical Center
  • Collaborative Neuroscience Network Inc
  • University of California Davis Medical Center
  • Multiple Sclerosis Center at UCSF
  • Denver Neurological Clinic
  • Neurology Associates PA
  • Neurology Associates of Ormond Beach
  • Infinity Clinical Research LLC
  • Neurostudies Inc
  • Roskamp Institute
  • Axiom Clinical Research of Florida
  • Meridien Research
  • West Georgia Sleep Disorder Center and Neurology Associates
  • Consultants In Neurology
  • University of Kansas Medical Center
  • MidAmerica Neuroscience Research Foundation
  • Associates In Neurology
  • Norton Healthcare
  • Henry Ford Health System
  • Michigan State University
  • Minneapolis Clinic of Neurology
  • Washington University
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • Neurology Specialists of Monmouth County PA
  • Neuro Medical Care Associates PLLC
  • Raleigh Neurology Associates PA
  • Neurology and Neuroscience Associates Inc.
  • Neurological Research Institute Inc
  • Providence Multiple Sclerosis Center
  • University of Pennsylvania
  • Hope Neurology MS Center
  • University of Texas Health Science Center at Houston
  • Bhupesh Dihenia MD PA
  • EvergreenHealth
  • The Polyclinic
  • Neurology of Neurosurgery Associates of Tacoma
  • Center for Neurological Disorders
  • Grodno Clinical Regional Hospital
  • Minsk Municipal Clinical Hospital 5
  • Republican Scientific and Practical Centre of Neurology and Neurosurgery
  • Minsk City Clinical Hospital 9
  • Vitebsk Regional Diagnostic Centre
  • Vitebsk Regional Clinical Hospital
  • Clinical Center Banja Luka
  • Clinical Center University of Sarajevo
  • University Clinical Center Tuzla
  • Military Medical Academy HBAT
  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
  • Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD
  • Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia
  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
  • Military Medical Academy - MHAT
  • Multiprofile Hospital for Active Treatment Sveta Marina EAD
  • Clinique Neuro Outaouais
  • Clinical Hospital Osijek
  • General Hospital Varazdin
  • Clinical Hospital Center Zagreb
  • Clinical Hospital Dubrava
  • Clinical Hospital Sestre Milosrdnice
  • Clinical Hospital Sveti duh
  • University Hospital Brno
  • Fakultni nemocnice u sv Anny v Brne
  • Private Neurological Practice Radomir Talab MD
  • University Hospital Hradec Kralove
  • Nemocnice Jihlava prispevkova organizace
  • Fakultni Nemocnice Olomouc
  • Vseobecna Fakultni Nemocnice v Praze
  • Krajska zdravotni as Nemocnice Teplice oz
  • East Tallinn Central Hospital
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • Aversi Clinic LTD
  • Khechinashvili University Hospital
  • LTD MediClubGeorgia
  • Sarajishvili Institute of Neurology
  • Curatio JSC
  • Ltd DEKA
  • Praxis Dr. Wilfried Luer
  • St. Joseph Krankenhaus Berlin
  • Asklepios Fachklinikum Teupitz
  • Universitatsklinikum Carl Gustav Carus an der TU Dresden
  • Heinrich Heine Universitat Dusseldorf
  • DataMed GmbH
  • Universitatsklinikum Leipzig
  • Klinikum der Stadt Ludwigshafen gGmbH
  • Klinikum der Philipps Universitat Marburg
  • St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH
  • Krankenhaus der Barmherzigen Brueder
  • NeuroPoint Akademie
  • Kenezy Gyula Korhaz es Rendelointezet
  • Pest Megyei Flor Ferenc Korhaz
  • Latvian Maritime Medicine Centre
  • Riga East Clinical University Hospital clinic Gailezers
  • Pauls Stradins Clinical University Hospital
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda University Hospital
  • IMSP Institutul de Medicina Urgenta
  • Municipal Clinical Hospital Sf Arhanghel Mihail
  • Institutul de Neurologie si Neurochirurgie
  • Zuyderland Medisch Centrum
  • Auckland City Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna
  • Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
  • Copernicus Podmiot Leczniczy Sp. z o.o.
  • Akson Clinical Research Maciejowski Bielecki Sp. Jawna
  • Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
  • M.A.- Lek A.M.Maciejowscy Spolka Cywilna
  • Novo-Med Zielinski i wsp. Sp.J.
  • NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
  • RESMEDICA Spolka z o.o.
  • Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji
  • NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
  • Centrum Neurologii Krzysztof Selmaj
  • Samodzielny Publiczny Centralny Szpital Kliniczny
  • Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n med Hanka Hertmanowska
  • Niepubliczny Zaklad Opieki Zdrowotnej KENDRON
  • Indywidualna Specjalistyczna Praktyka Lekarska dr nmed Monika Lyczak
  • Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
  • Centrum Medyczne Medyk
  • Indywidualna Specjalistyczna Praktyka Lekarska Zbigniew Cebulski
  • Szpital Czerniakowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Centrum Medyczne NeuroProtect
  • Instytut Psychiatrii i Neurologii
  • Centrum Medyczne doktorA
  • Hospital Garcia de Orta
  • Hospital de Braga
  • Centro Hospitalar E Universitario de Coimbra EPE
  • Hospital Beatriz Angelo
  • Campus Neurologico Senior
  • Fundeni Clinical Institute
  • Colentina Clinical Hospital
  • Cluj Clinical County Hospital
  • Cai Ferate Clinical Hospital
  • Sibiu Emergency County Clinical Hospital
  • Timisoara Emergency County Clinical Hospital
  • Arkhangelsk Regional Clinical Hospital
  • Regional Clinical Hospital
  • Belgorod Regional Clinical Hospital
  • Bryansk Regional Hospital 1
  • Chelyabinsk City Clinical Hospital 3
  • Sverdlovsk Regional Clinical Hospital 1
  • Research Medical Complex Vashe Zdorovie
  • Kemerovo Regional Clinical Hospital
  • Regional Clinical Hospital
  • Kirov City Clinical Hospital 1
  • Krasnoyarsk State Medical Academy
  • Kursk Regional Clinical Hospital
  • Central Clinical Hospital 2 na NA Semashko OAO RZhD
  • City Clinical Hospital 24
  • City Clinical Hospital 1 na NIPirogov
  • Research Center of Neurology of RAMS
  • City Clinical Hospital 11
  • Nizhniy Novgorod City Hospital 33
  • City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre
  • Siberian Regional Medical Center
  • Novosibirsk State Medical University
  • Penza Regional Clinical Hospital na NN Burdenko
  • Perm State Medical Academy
  • Republican Hospital na VA Baranov
  • Pyatigorsk City Hospital 2
  • Rostov Regional Clinical Hospital
  • Samara Regional Clinical Hospital named after MI Kalinin
  • Smolensk State Medical Academy
  • City Hospital 31
  • City Hospital Nikolaevskaya Bolnitsa
  • St. Petersburg Multi Field City Hospital 2
  • First St Petersburg State Medical University na IP Pavlov
  • Institute of Human Brain RAN
  • City Clinical Hospital 40
  • Siberian State Medical University
  • Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
  • Neftyanik Medical and Sanitary Unit
  • Kuvatov Republican Clinical Hospital
  • Yaroslavl Clinical Hospital 8
  • Clinical Center of Serbia
  • Clinical Hospital Centar Zvezdara
  • Military Medical Academy
  • Clinical Hospital Centre Zemun
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Hospital Universitario Vall D hebron
  • Hospital Arnau de Vilanova
  • Complejo Hospitalario de Navarra
  • Hospital Moises Broggi
  • Hospital Clinico Universitario de Valencia
  • Sahlgrenska Universitetssjukhuset
  • Karolinska Universitetssjukhuset Solna
  • MI Cherkasy Regional Hospital of Cherkasy Regional Council
  • Hospital 4 of Chernihiv City Council
  • Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital
  • Municipal Institution Chernivtsi Regional Psychiatric Hospital
  • Municipal Institution Dnipropetrovsk Regional Clinical Hospital na I.I. Mechnykov
  • Ivano Frankivsk City Clinical Hospital 1
  • Regional Clinical Hospital.
  • State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
  • Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine
  • Municipal Institution of Health Care Kharkiv Clinical City Hospital 7
  • National Research Center for Radiation Medicine, Institute of Clinical Radiology
  • Kyiv City Clinical Hospital 4
  • Volyn Regional Clinical Hospital
  • Lviv Regional Clinical Hospital
  • Municipal City Clinical Hospital 5
  • Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
  • Municipal Institution Odesa Regional Clinical Hospital
  • Regional Clinical Hospital na NV Sklifosovskyi
  • Regional Clinical Center of Neurosurgery and Neurology
  • Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko
  • Municipal Institution City Clinical Hospital 2
  • Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
  • Municipal Institution Zaporizhzhia
  • Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council
  • University Hospital of Wales
  • Raigmore Hospital
  • Kings College Hospital
  • Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Interferon beta-1a

Ozanimod 0.5 mg

Ozanimod 1 mg

Arm Description

Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.

Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Outcomes

Primary Outcome Measures

Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
The relapse rate was based on confirmed relapses. 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 relapses divided by the total number of days in the study * 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included 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 12 Months
The 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 treatment period.
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
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 6 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 Lesion-Free at Month 12
MRI scans were analyzed by blinded centralized reading facility.
Percentage of Participants Who Were T2 Lesion-Free at Month 12
MRI scans were analyzed by blinded centralized reading facility.
Percent Change From Baseline in Normalized Brain Volume at Month 12
Brain volume (a measure of brain atrophy) was analyzed by MRI.
Change From Baseline to Month 12 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). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.

Full Information

First Posted
August 5, 2014
Last Updated
November 23, 2020
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02294058
Brief Title
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Acronym
SUNBEAM
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, 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
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2014 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (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
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
MS, RMS, Multiple Sclerosis, 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
1346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon beta-1a
Arm Type
Active Comparator
Arm Description
Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.
Arm Title
Ozanimod 0.5 mg
Arm Type
Experimental
Arm Description
Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.
Arm Title
Ozanimod 1 mg
Arm Type
Experimental
Arm Description
Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.
Intervention Type
Drug
Intervention Name(s)
Ozanimod
Other Intervention Name(s)
RPC1063, Zeposia®
Intervention Description
Capsules for oral administration once a day
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Avonex®, IFN β-1a
Intervention Description
Administered by intramuscular injection once a week
Intervention Type
Drug
Intervention Name(s)
Placebo to ozanimod
Intervention Description
Matching placebo capsules administered orally once a day
Intervention Type
Drug
Intervention Name(s)
Placebo to interferon beta-1a
Intervention Description
Placebo intramuscular injection once a week
Primary Outcome Measure Information:
Title
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
Description
The relapse rate was based on confirmed relapses. 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 relapses divided by the total number of days in the study * 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months
Description
The 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 treatment period.
Time Frame
12 month treatment period; MRI scans were assessed at Month 6 and Month 12
Title
Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
Time Frame
Month 12
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 12-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 6 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 12-month treatment period
Title
Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12
Description
MRI scans were analyzed by blinded centralized reading facility.
Time Frame
Month 12
Title
Percentage of Participants Who Were T2 Lesion-Free at Month 12
Description
MRI scans were analyzed by blinded centralized reading facility.
Time Frame
Month 12
Title
Percent Change From Baseline in Normalized Brain Volume at Month 12
Description
Brain volume (a measure of brain atrophy) was analyzed by MRI.
Time Frame
Baseline to Month 12
Title
Change From Baseline to Month 12 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 12
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 12
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). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.
Time Frame
From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.

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 EDSS score between 0 and 5.0 at baseline Exclusion Criteria: • Primary progressive multiple sclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Sheffiled, MD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Xenosciences Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
St Josephs Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Northwest Neuro Specialists PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Collaborative Neuroscience Network Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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
Denver Neurological Clinic
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
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Infinity Clinical Research LLC
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
Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
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
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MidAmerica Neuroscience Research Foundation
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Associates In Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Neurology Specialists of Monmouth County PA
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Neuro Medical Care Associates PLLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Raleigh Neurology Associates PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Neurology and Neuroscience Associates Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Neurological Research Institute Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Providence Multiple Sclerosis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hope Neurology MS Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Bhupesh Dihenia MD PA
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
EvergreenHealth
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Neurology of Neurosurgery Associates of Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Grodno Clinical Regional Hospital
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
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
Vitebsk Regional Diagnostic Centre
City
Vitebsk
ZIP/Postal Code
210023
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Clinical Center Banja Luka
City
Banja Luka
ZIP/Postal Code
51000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Military Medical Academy HBAT
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment National Cardiology Hospital EAD
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
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Military Medical Academy - MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sveta Marina EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Clinique Neuro Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J9J 0A5
Country
Canada
Facility Name
Clinical Hospital Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Clinical Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sveti duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Private Neurological Practice Radomir Talab MD
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava prispevkova organizace
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 21
Country
Czechia
Facility Name
Krajska zdravotni as Nemocnice Teplice oz
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
EE-51014
Country
Estonia
Facility Name
Aversi Clinic LTD
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
179
Country
Georgia
Facility Name
LTD MediClubGeorgia
City
Tbilisi
ZIP/Postal Code
¿0112
Country
Georgia
Facility Name
Sarajishvili Institute of Neurology
City
Tbilisi
ZIP/Postal Code
¿0112
Country
Georgia
Facility Name
Curatio JSC
City
Tbilisi
ZIP/Postal Code
¿0186
Country
Georgia
Facility Name
Ltd DEKA
City
Tbilisi
ZIP/Postal Code
¿0186
Country
Georgia
Facility Name
Praxis Dr. Wilfried Luer
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
St. Joseph Krankenhaus Berlin
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Asklepios Fachklinikum Teupitz
City
Brandenburg
ZIP/Postal Code
15755
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich Heine Universitat Dusseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
DataMed GmbH
City
Köln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen gGmbH
City
Ludwigshafen am Rhein
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum der Philipps Universitat Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
St. Josefs-Krankenhaus Potsdam-Sanssouci GmbH
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brueder
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
NeuroPoint Akademie
City
Ulm
ZIP/Postal Code
89079
Country
Germany
Facility Name
Kenezy Gyula Korhaz es Rendelointezet
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Latvian Maritime Medicine Centre
City
Riga
ZIP/Postal Code
LV-1015
Country
Latvia
Facility Name
Riga East Clinical University Hospital clinic Gailezers
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
LT-5808
Country
Lithuania
Facility Name
IMSP Institutul de Medicina Urgenta
City
Chisinau
ZIP/Postal Code
2004
Country
Moldova, Republic of
Facility Name
Municipal Clinical Hospital Sf Arhanghel Mihail
City
Chisinau
ZIP/Postal Code
2005
Country
Moldova, Republic of
Facility Name
Institutul de Neurologie si Neurochirurgie
City
Chisinau
ZIP/Postal Code
2028
Country
Moldova, Republic of
Facility Name
Zuyderland Medisch Centrum
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
B&B Robert Bonek, Pawel Bochniak, Spolka Cywilna
City
Bydgoszcz
ZIP/Postal Code
85-795
Country
Poland
Facility Name
Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Akson Clinical Research Maciejowski Bielecki Sp. Jawna
City
Jaroslaw
ZIP/Postal Code
37-500
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-MEDIC
City
Katowice
ZIP/Postal Code
40-555
Country
Poland
Facility Name
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
Novo-Med Zielinski i wsp. Sp.J.
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
NEURO- CARE Site Management Organization Gabriela Klodowska-Duda
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
RESMEDICA Spolka z o.o.
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Niepubliczny Zespol Leczniczo-Rehabilitacyjny Centrum Kompleksowej Rehabilitacji
City
Konstancin Jeziorna
ZIP/Postal Code
05-510
Country
Poland
Facility Name
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska
City
Lublin
ZIP/Postal Code
20-059
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lódzkie
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Mazowieckie
ZIP/Postal Code
02-097
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
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
Niepubliczny Zaklad Opieki Zdrowotnej NEUROKARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
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
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Centrum Medyczne doktorA
City
Warszawa
ZIP/Postal Code
05-077
Country
Poland
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar E Universitario de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
Cluj Clinical County Hospital
City
Cluj Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Cai Ferate Clinical Hospital
City
Constanta
ZIP/Postal Code
900123
Country
Romania
Facility Name
Sibiu Emergency County Clinical Hospital
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
Timisoara Emergency County Clinical Hospital
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Belgorod Regional Clinical Hospital
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Bryansk Regional Hospital 1
City
Bryansk
ZIP/Postal Code
241033
Country
Russian Federation
Facility Name
Chelyabinsk City Clinical Hospital 3
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Medical Complex Vashe Zdorovie
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Khanty-mansiysk
ZIP/Postal Code
628012
Country
Russian Federation
Facility Name
Kirov City Clinical Hospital 1
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical Academy
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Kursk Regional Clinical Hospital
City
Kursk
ZIP/Postal Code
305007
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
City Clinical Hospital 24
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
City Clinical Hospital 1 na NIPirogov
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Research Center of Neurology of RAMS
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
City Clinical Hospital 11
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Nizhniy Novgorod City Hospital 33
City
Nizhny Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
City Clinical Hospital 3 Nizhniy Novgorod Geriatrics Centre
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Siberian Regional Medical Center
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital na NN Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Perm State Medical Academy
City
Perm
ZIP/Postal Code
614045
Country
Russian Federation
Facility Name
Republican Hospital na VA Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Pyatigorsk City Hospital 2
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Rostov Regional Clinical Hospital
City
Rostov on Don
ZIP/Postal Code
344015
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital named after MI Kalinin
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Smolensk State Medical Academy
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
City Hospital 31
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
City Hospital Nikolaevskaya Bolnitsa
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St. Petersburg Multi Field City Hospital 2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
First St Petersburg State Medical University na IP Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Institute of Human Brain RAN
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
City Clinical Hospital 40
City
St. Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital
City
Tver
ZIP/Postal Code
125170
Country
Russian Federation
Facility Name
Neftyanik Medical and Sanitary Unit
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Kuvatov Republican Clinical Hospital
City
Ufa
ZIP/Postal Code
450005
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
Clinical Hospital Centre Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Hospital Universitario Vall D hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona/ Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Moises Broggi
City
Sant Joan Despí
ZIP/Postal Code
08970
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
SE-41345
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
MI Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Hospital 4 of Chernihiv City Council
City
Chernihiv
ZIP/Postal Code
14001
Country
Ukraine
Facility Name
Municipal Treatment and Preventive Institution Chernihiv Regional Clinical Hospital
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Municipal Institution Chernivtsi Regional Psychiatric Hospital
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
Ivano Frankivsk City Clinical Hospital 1
City
Ivano Frankivsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Regional Clinical Hospital.
City
Ivano Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
State Treatment and Prevention Institution Central Clinical Hospital of Ukrzaliznytsya
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Regional Clinical Hospital Center for Emergency Medical Care and Disaster Medicine
City
Kharkiv
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
Municipal Institution of Health Care Kharkiv Clinical City Hospital 7
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
National Research Center for Radiation Medicine, Institute of Clinical Radiology
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 4
City
Kyiv
ZIP/Postal Code
3110
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
Municipal City Clinical Hospital 5
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Center for Reconstructive and Rehabilitation Medicine University Clinic of ONMedU
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
Regional Clinical Hospital na NV Sklifosovskyi
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine
Facility Name
Regional Clinical Center of Neurosurgery and Neurology
City
Uzhhorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Municipal Institution Vinnytsia Regional Psychoneurological Hospital na OI Yushchenko
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Institution City Clinical Hospital 2
City
Zaporizhya
ZIP/Postal Code
6972
Country
Ukraine
Facility Name
Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Regional Clinical Hospital na OFHerbachevskyi of Zhytomyr Regional Council
City
Zhytomyr
ZIP/Postal Code
10008
Country
Ukraine
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Raigmore Hospital
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
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31492651
Citation
Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Ding N, Cohen JA; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1009-1020. doi: 10.1016/S1474-4422(19)30239-X. Epub 2019 Sep 3.
Results Reference
background
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
33454584
Citation
DeLuca J, Schippling S, Montalban X, Kappos L, Cree BAC, Comi G, Arnold DL, Hartung HP, Sheffield JK, Liu H, Silva D, Cohen JA. Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS. Mult Scler Relat Disord. 2021 Feb;48:102673. doi: 10.1016/j.msard.2020.102673. Epub 2020 Dec 10.
Results Reference
derived

Learn more about this trial

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

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