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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04338022
Registration number
NCT04338022
Ethics application status
Date submitted
6/04/2020
Date registered
8/04/2020
Date last updated
29/04/2024
Titles & IDs
Public title
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
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Scientific title
A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)
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Secondary ID [1]
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2019-004972-20
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Secondary ID [2]
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MS200527_0080
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing 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 - Evobrutinib
Treatment: Drugs - Placebo (match to Teriflunomide)
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Placebo (match to Evobrutinib)
Experimental: Evobrutinib + Teriflunomide matched Placebo: DB Period -
Active Comparator: Teriflunomide + Evobrutinib matched Placebo: DB Period -
Treatment: Drugs: Evobrutinib
Evobrutinib twice daily (BID) in DBTP.
Treatment: Drugs: Placebo (match to Teriflunomide)
Placebo match to Teriflunomide once daily in DBTP.
Treatment: Drugs: Teriflunomide
Teriflunomide once daily in DBTP.
Treatment: Drugs: Placebo (match to Evobrutinib)
Placebo match to Evobrutinib BID in DBTP.
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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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DBTP: Annualized Relapse Rate (ARR)
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Assessment method [1]
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The annualized relapse rates up to 156 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
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Timepoint [1]
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Up to 156 weeks
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Primary outcome [2]
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DBE Period: ARR
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Assessment method [2]
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The annualized relapse rates up to 96 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
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Timepoint [2]
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Up to 96 weeks
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Primary outcome [3]
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OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s
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Assessment method [3]
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0
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Timepoint [3]
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Baseline OLE up to 96 weeks
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Secondary outcome [1]
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DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression
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Assessment method [1]
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0
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Timepoint [1]
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Up to 156 weeks
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Secondary outcome [2]
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DBTP: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression
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Assessment method [2]
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0
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Timepoint [2]
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Up to 156 weeks
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Secondary outcome [3]
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DBTP: Time to First Occurrence of 24-Week Confirmed Disability Improvement (CDI) as measured by EDSS Improvement
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Assessment method [3]
0
0
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Timepoint [3]
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Up to 156 weeks
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Secondary outcome [4]
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DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score
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Assessment method [4]
0
0
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Timepoint [4]
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Baseline up to 96 weeks
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Secondary outcome [5]
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DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score
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Assessment method [5]
0
0
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Timepoint [5]
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Baseline up to 96 weeks
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Secondary outcome [6]
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DBTP: Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans
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Assessment method [6]
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0
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Timepoint [6]
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Up to Week 156
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Secondary outcome [7]
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DBTP: Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan Relative to Baseline MRI Scan
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Assessment method [7]
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0
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Timepoint [7]
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Up to Week 156
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Secondary outcome [8]
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DBTP: Neurofilament light chain (NfL) Serum Concentration
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Assessment method [8]
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0
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Timepoint [8]
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At Week 12
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Secondary outcome [9]
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DBTP: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
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Assessment method [9]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.
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Timepoint [9]
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Baseline up to 156 weeks
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Secondary outcome [10]
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DBTP: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
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Assessment method [10]
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Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.
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Timepoint [10]
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Baseline up to 156 weeks
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Secondary outcome [11]
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DBTP: Absolute Concentrations of Immunoglobulin (Ig) Levels
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Assessment method [11]
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0
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Timepoint [11]
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Baseline up to 156 weeks
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Secondary outcome [12]
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DBTP: Change From Baseline in Immunoglobulin (Ig) Levels
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Baseline up to 156 weeks
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Secondary outcome [13]
0
0
DBE Period: Time to First Occurrence of 12-Week CDP as measured by EDSS Progression
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Assessment method [13]
0
0
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Timepoint [13]
0
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Up to 96 weeks
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Secondary outcome [14]
0
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DBE Period: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression
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Assessment method [14]
0
0
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Timepoint [14]
0
0
Up to 96 weeks
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Secondary outcome [15]
0
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DBE Period: Time to First Occurrence of 24-Week CDI as measured by EDSS Improvement
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Assessment method [15]
0
0
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Timepoint [15]
0
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Up to 96 weeks
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Secondary outcome [16]
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DBE Period: Change From Baseline in PROMIS MS PF Short Form Score
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Assessment method [16]
0
0
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Timepoint [16]
0
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Baseline up to 96 weeks
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Secondary outcome [17]
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DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score
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Assessment method [17]
0
0
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Timepoint [17]
0
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Baseline up to 96 weeks
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Secondary outcome [18]
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DBE Period: Total Number of Gd+ T1 Lesions Assessed by all Available MRI Scans
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Assessment method [18]
0
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Timepoint [18]
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Up to Week 96
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Secondary outcome [19]
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DBE Period: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available MRI Scans Relative to Baseline MRI Scan
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Assessment method [19]
0
0
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Timepoint [19]
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Up to Week 96
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Secondary outcome [20]
0
0
DBE Period: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
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Assessment method [20]
0
0
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.
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Timepoint [20]
0
0
Baseline up to 96 weeks
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Secondary outcome [21]
0
0
DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
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Assessment method [21]
0
0
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.
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Timepoint [21]
0
0
Baseline up to 96 weeks
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Secondary outcome [22]
0
0
DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels
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Assessment method [22]
0
0
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Timepoint [22]
0
0
Baseline up to 96 weeks
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Secondary outcome [23]
0
0
DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels
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Assessment method [23]
0
0
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Timepoint [23]
0
0
Baseline up to 96 weeks
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Secondary outcome [24]
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OLE Period: ARR based on protocol-defined qualified relapses
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Assessment method [24]
0
0
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Timepoint [24]
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Baseline OLE up to 96 weeks
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Secondary outcome [25]
0
0
OLE Period: Time to first occurrence of 24-week CDP as measured by EDSS
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Assessment method [25]
0
0
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Timepoint [25]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [26]
0
0
OLE Period: Time to first occurrence of 24-week CDI as measured by EDSS
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Assessment method [26]
0
0
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Timepoint [26]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [27]
0
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OLE Period: Symbol Digital Modalities Test Over time
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Assessment method [27]
0
0
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Timepoint [27]
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0
Baseline OLE up to 96 weeks
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Secondary outcome [28]
0
0
OLE Period: PROMISnq PF (MS) 15a score change over time
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Assessment method [28]
0
0
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Timepoint [28]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [29]
0
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OLE Period: PROMIS Fatigue (MS) 8a Score Change Over Time
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Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [30]
0
0
OLE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings
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Assessment method [30]
0
0
Query!
Timepoint [30]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [31]
0
0
OLE: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available Magnetic Resonance Imaging (MRI) Scans
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Assessment method [31]
0
0
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Timepoint [31]
0
0
Baseline OLE up to 96 weeks
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Secondary outcome [32]
0
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OLE: Change from Baseline in T2 lesion Volume Over Time
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Assessment method [32]
0
0
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Timepoint [32]
0
0
Baseline OLE up to 96 weeks
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Eligibility
Key inclusion criteria
- Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or
secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017
Revised McDonald criteria (Thompson 2018)
- Participants with one or more documented relapses within the 2 years before Screening
with either: a. one relapse which occurred within the last year prior to
randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion
within 6 months prior to randomization
- Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at
Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and
Baseline (Day 1) are only eligible for participation if their disease duration (time
since onset of symptoms) is no more than 10 years
- Participants are neurologically stable for >= 30 days prior to both screening and
baseline (Day 1)
- Female participants must be neither pregnant nor breast-feeding or must lack
child-bearing potential (as defined by either: post-menopausal or surgically sterile),
or use an effective method of contraception for the duration of the study and at least
2 years after study intervention due to the long elimination period for teriflunomide
of 2 years, unless the participant undergoes an accelerated elimination procedure
- Male participants must refrain from donating sperm and/or abstain from intercourse
with women of child-bearing potential or use an effective method of contraception for
the duration of the study and at least 2 years after study intervention due to the
long elimination period for teriflunomide of 2 years, unless the participant undergoes
an accelerated elimination procedure
- Participants have given written informed consent prior to any study-related procedure
- Other protocol defined inclusion criteria could apply.
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Minimum age
18
Years
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Maximum age
55
Years
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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
- Participants diagnosed with Progressive MS, in accordance with the 2017 Revised
McDonald criteria as follows: a). Participants with Primary Progressive MS. b).
Participants with secondary progressive MS without evidence of relapse
- Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at
screening and Baseline (Day 1)
- Immunologic disorder other than MS, or any other condition requiring oral, intravenous
(IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of
well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
- Other protocol defined exclusion criteria could apply.
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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
Terminated
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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
12/06/2020
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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
8/03/2024
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Sample size
Target
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Accrual to date
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Final
1124
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site 104 - Auchenflower
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Recruitment hospital [2]
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Research Site 107 - Concord
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Recruitment hospital [3]
0
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Research Site 109 - Hobart
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Recruitment hospital [4]
0
0
Research Site 101 - Liverpool
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Recruitment hospital [5]
0
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Research Site 102 - New Lambton Heights
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Recruitment hospital [6]
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Research Site 103 - St Leonards
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Recruitment postcode(s) [1]
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- Auchenflower
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Recruitment postcode(s) [2]
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- Concord
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Recruitment postcode(s) [3]
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- Hobart
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Recruitment postcode(s) [4]
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- Liverpool
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Recruitment postcode(s) [5]
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- New Lambton Heights
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Recruitment postcode(s) [6]
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- St Leonards
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kansas
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Louisiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Maryland
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Massachusetts
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Michigan
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Missouri
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Country [15]
0
0
United States of America
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State/province [15]
0
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Nebraska
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Nevada
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Country [17]
0
0
United States of America
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State/province [17]
0
0
New Jersey
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Country [18]
0
0
United States of America
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State/province [18]
0
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New York
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Ohio
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Country [20]
0
0
United States of America
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State/province [20]
0
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Oklahoma
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Country [21]
0
0
United States of America
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State/province [21]
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Oregon
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Country [22]
0
0
United States of America
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State/province [22]
0
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Pennsylvania
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Country [23]
0
0
United States of America
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0
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Tennessee
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Country [24]
0
0
United States of America
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State/province [24]
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Texas
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Country [25]
0
0
United States of America
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Utah
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Country [26]
0
0
United States of America
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Virginia
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Country [27]
0
0
United States of America
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0
0
Wisconsin
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Country [28]
0
0
Argentina
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0
0
Ciudad Autonoma Buenos Aires
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Country [29]
0
0
Argentina
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State/province [29]
0
0
Ciudad Autonoma de Buenos Aires
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Country [30]
0
0
Argentina
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State/province [30]
0
0
Cordoba
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Country [31]
0
0
Argentina
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State/province [31]
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0
Godoy Cruz
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Country [32]
0
0
Argentina
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State/province [32]
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Guaymallen
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Country [33]
0
0
Argentina
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State/province [33]
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Rosario
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Country [34]
0
0
Argentina
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0
Salta
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0
0
Argentina
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San Juan
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Country [36]
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Argentina
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State/province [36]
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San Miguel de Tucuman
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Country [37]
0
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Austria
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0
Innsbruck
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0
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Austria
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Linz
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Austria
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Salzburg
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Country [40]
0
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Austria
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Vienna
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Country [41]
0
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Belgium
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0
Bruxelles
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0
Belgium
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State/province [42]
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0
Kortrijk
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0
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Belgium
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0
La Louvière
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0
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Belgium
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0
0
Liège
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0
0
Belgium
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0
0
Overpelt
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Country [46]
0
0
Belgium
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0
0
Roeselare
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Country [47]
0
0
Bosnia and Herzegovina
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Bihac
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Country [48]
0
0
Bosnia and Herzegovina
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State/province [48]
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Mostar
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Country [49]
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Bosnia and Herzegovina
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Sarajevo
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Greenfield Park
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0
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Canada
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Levis
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0
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Canada
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Moncton
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0
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Canada
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0
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Montreal
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0
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Canada
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Toronto
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Country [58]
0
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Colombia
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0
Barranquilla
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Colombia
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State/province [59]
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Medellin
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0
0
Croatia
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State/province [60]
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0
Osijek
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Country [61]
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0
Croatia
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0
Rijeka
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0
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Croatia
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0
Varazdin
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0
0
Croatia
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0
0
Zagreb
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Country [64]
0
0
Czechia
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State/province [64]
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Jihlava
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Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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Plzen-Bory
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Czechia
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Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 4 - Krc
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Czechia
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Praha 5
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Estonia
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Tallinn
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Estonia
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Turku
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France
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Caen cedex 9
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France
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Grenoble cedex 09
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France
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Lille cedex
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France
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Lille
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France
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Montpellier
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France
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Nantes cedex 1
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France
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Nice Cedex 1
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France
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Rennes cedex 09
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France
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Rouen Cedex
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France
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Toulouse cedex 9
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Georgia
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Tbilisi
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Germany
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Germany
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Bayreuth
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Erbach
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Mannheim
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Germany
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Muenchen
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Germany
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Muenster
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Germany
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Potsdam
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Country [102]
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Germany
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State/province [102]
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Siegen
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Country [103]
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Germany
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Ulm
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Hong Kong
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State/province [104]
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Hong Kong
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Hong Kong
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State/province [105]
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Hongkong
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Hong Kong
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State/province [106]
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Shatin
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Country [107]
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Hungary
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Budapest
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Country [108]
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Hungary
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Kistarcsa
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Country [109]
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Hungary
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Pecs
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Country [110]
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Hungary
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Tatabanya
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Hungary
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Vac
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Country [112]
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India
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Hyderabad
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India
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Nashik
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India
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New Delhi
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Israel
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Ashkelon
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Country [119]
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Israel
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Rechovot
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Country [120]
0
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Israel
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Safed
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Country [121]
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Italy
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Bologna
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Italy
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Chieti
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Italy
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Genova
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Italy
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Messina
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Italy
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Milano
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Italy
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Montichiari
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Italy
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Napoli
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Italy
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Reggio Calabria
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Italy
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Roma
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Italy
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Salerno
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Italy
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Verona
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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0
0
Mexico
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Aguascalientes
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Mexico
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Culiacan
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Netherlands
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Hoorn
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Netherlands
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Knurow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Poland
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Rzeszów
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Poland
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Warszawa
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kaluga
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Russian Federation
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Kazan
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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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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Perm
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Russian Federation
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Pyatigorsk
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Country [159]
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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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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Ufa
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Russian Federation
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Ulyanovsk
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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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Serbia
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Novi Sad
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Serbia
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Uzice
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Serbia
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Valjevo
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Barcelona
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Spain
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Cadiz
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Pozuelo de Alarcon
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Spain
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Salt
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Spain
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San Sebastian
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Spain
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Sevilla
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Kaohsiung
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Taiwan
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Taichung
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Ukraine
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Ukraine
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Kharkiv
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Ukraine
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Kropyvnytskyi
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Ukraine
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Kyiv
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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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Sumy
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Exeter
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United Kingdom
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Glasgow
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United Kingdom
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Newcastle
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United Kingdom
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State/province [197]
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
EMD Serono Research & Development Institute, Inc.
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is to evaluate the efficacy and safety of evobrutinib administered orally twice
daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with
Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment
period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate
long-term follow-up study in their country will get an option for evobrutinib treatment
continuation through a 96-week open-label extension (OLE) period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04338022
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Responsible
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Address
0
0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Country
0
0
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Phone
0
0
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Fax
0
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Email
0
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04338022
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