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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02294058
Registration number
NCT02294058
Ethics application status
Date submitted
5/08/2014
Date registered
19/11/2014
Date last updated
25/11/2020
Titles & IDs
Public title
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
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Scientific 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
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Secondary ID [1]
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2014-002320-27
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Secondary ID [2]
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RPC01-301
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Universal Trial Number (UTN)
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Trial acronym
SUNBEAM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Treatment: Drugs - Interferon beta-1a
Treatment: Drugs - Placebo to ozanimod
Treatment: Drugs - Placebo to interferon beta-1a
Active comparator: Interferon beta-1a - 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.
Experimental: Ozanimod 0.5 mg - 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.
Experimental: Ozanimod 1 mg - 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.
Treatment: Drugs: Ozanimod
Capsules for oral administration once a day
Treatment: Drugs: Interferon beta-1a
Administered by intramuscular injection once a week
Treatment: Drugs: Placebo to ozanimod
Matching placebo capsules administered orally once a day
Treatment: Drugs: Placebo to interferon beta-1a
Placebo intramuscular injection once a week
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months
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Assessment method [1]
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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.
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Timepoint [1]
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12 month treatment period; MRI scans were assessed at Month 6 and Month 12
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Secondary outcome [2]
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Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12
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Assessment method [2]
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Timepoint [2]
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Month 12
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Secondary outcome [3]
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Time to Onset of Disability Progression Confirmed After 3 Months
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose to the end of the 12-month treatment period
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Secondary outcome [4]
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Time to Onset of Disability Progression Confirmed After 6 Months
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose to the end of the 12-month treatment period
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Secondary outcome [5]
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Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12
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Assessment method [5]
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MRI scans were analyzed by blinded centralized reading facility.
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Timepoint [5]
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Month 12
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Secondary outcome [6]
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Percentage of Participants Who Were T2 Lesion-Free at Month 12
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Assessment method [6]
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MRI scans were analyzed by blinded centralized reading facility.
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Timepoint [6]
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Month 12
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Secondary outcome [7]
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Percent Change From Baseline in Normalized Brain Volume at Month 12
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Assessment method [7]
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Brain volume (a measure of brain atrophy) was analyzed by MRI.
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Timepoint [7]
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Baseline to Month 12
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Secondary outcome [8]
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Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to Month 12
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Secondary outcome [9]
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Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to Month 12
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Secondary outcome [10]
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Number of Participants With Treatment Emergent Adverse Events
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Assessment method [10]
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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.
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Timepoint [10]
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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.
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Eligibility
Key inclusion criteria
* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* EDSS score between 0 and 5.0 at baseline
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Primary progressive multiple sclerosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/12/2016
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Sample size
Target
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Accrual to date
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Final
1346
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Recruitment in Australia
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Khanty-mansiysk
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Russian Federation
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Kirov
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Penza
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Russian Federation
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Perm
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Russian Federation
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Petrozavodsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Rostov on Don
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tver
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Russian Federation
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Tyumen
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Barcelona
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Lleida
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Spain
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Spain
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Sant Joan Despí
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Spain
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Valencia
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Sweden
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Goteborg
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Sweden
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Stockholm
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Ukraine
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Cherkasy
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Ukraine
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Chernihiv
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Poltava
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Ukraine
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Uzhhorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhya
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Ukraine
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Zaporizhzhia
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Ukraine
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Zhytomyr
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United Kingdom
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Cardiff
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United Kingdom
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Inverness
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United Kingdom
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celgene
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
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Trial website
https://clinicaltrials.gov/study/NCT02294058
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Trial related presentations / publications
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. 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 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.
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Public notes
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Contacts
Principal investigator
Name
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0
James Sheffiled, MD
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Address
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Celgene
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Contact person for scientific queries
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Citations or Other Details
Journal
Cree B, et al. The RADIANCE and SUNBEAM phase 3 st...
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https://clinicaltrials.gov/study/NCT02294058
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