Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04338022
Registration number
NCT04338022
Ethics application status
Date submitted
6/04/2020
Date registered
8/04/2020
Date last updated
12/06/2025
Titles & IDs
Public title
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
Query!
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)
Query!
Secondary ID [1]
0
0
2019-004972-20
Query!
Secondary ID [2]
0
0
MS200527_0080
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Evobrutinib
Active comparator: Teriflunomide -
Experimental: Evobrutinib -
Treatment: Drugs: Teriflunomide
Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period and followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in open label extension (OLE) period.
Treatment: Drugs: Evobrutinib
Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period and followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in open label extension (OLE) period.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Double Blind Treatment Period (DBTP) and Double Blind Extension (DBE) Period: Annualized Relapse Rate (ARR)
Query!
Assessment method [1]
0
0
The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs,) and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).
Query!
Timepoint [1]
0
0
From baseline to 172 weeks
Query!
Primary outcome [2]
0
0
Open Label Extension (OLE) Period: Number of Participants With Adverse Events (AEs) and Serious AEs
Query!
Assessment method [2]
0
0
Adverse event (AE): Any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
Query!
Timepoint [2]
0
0
From OLE Baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [1]
0
0
DBTP and DBE Period: Percentage of Participants Without 12-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)
Query!
Assessment method [1]
0
0
Disability progression was defined as increase in EDSS of greater than or equal to \[\>=\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 12 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 12-week CDP.
Query!
Timepoint [1]
0
0
Week 96 and Week 156 (combined DBTP and DBE period)
Query!
Secondary outcome [2]
0
0
DBTP and DBE Period: Percentage of Participants Without 24-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)
Query!
Assessment method [2]
0
0
Disability progression was defined as increase in EDSS of greater than or equal to \[\>=\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 24 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 24-week CDP.
Query!
Timepoint [2]
0
0
Week 96 and Week 156 (combined DBTP and DBE periods)
Query!
Secondary outcome [3]
0
0
DBTP and DBE Period: Percentage of Participants With 24-Week Confirmed Disability Improvement (CDI) as Measured by Expanded Disability Status Scale (EDSS)
Query!
Assessment method [3]
0
0
Disability improvement was defined as a reduction of 1 point from Baseline EDSS score when the Baseline score is \>= 2 and less than or equal to \[\<=\] 6 and a reduction of 0.5 point from Baseline EDSS score when the Baseline score is \>= 6.5 and \<= 9.5. Disability improvement is considered sustained when the initial reduction in the EDSS score is confirmed at a regularly scheduled visit at least 24 weeks after the initial reduction. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants with 12-week CDI.
Query!
Timepoint [3]
0
0
Week 96 and Week 156 (combined DBTP and DBE periods)
Query!
Secondary outcome [4]
0
0
DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 48, Week 96, Week 120, Week 144 and Week 156
Query!
Assessment method [4]
0
0
Physical function was assessed with PROMISnq Short Form v2.0 - Physical Function - Multiple Sclerosis 15a (PROMISnq PF(MS) 15a). PROMISnq PF(MS) 15a assesses a participant's abilities and limitations with respect to everyday physical activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 10 to 65. Higher T-scores represent higher physical function. Change from baseline in PROMIS PF score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE).
Query!
Timepoint [4]
0
0
Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 (combined DBTP and DBE periods)
Query!
Secondary outcome [5]
0
0
DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score at Week 48, Week 96, Week 120, Week 144 and Week 156
Query!
Assessment method [5]
0
0
PROMIS Fatigue score was assessed with PROMIS Short Form v1.0 - Fatigue - Multiple Sclerosis 8a (PROMIS Fatigue (MS) 8a). PROMIS Fatigue (MS) 8a assesses level of fatigue and its interference on daily activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33 to 85. Higher T-scores represent higher fatigue. Change from baseline in PROMIS fatigue score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE).
Query!
Timepoint [5]
0
0
Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 (combined DBTP and DBE periods)
Query!
Secondary outcome [6]
0
0
DBTP and DBE Period: Total Number of T1 Gadolinium-positive (Gd+) Lesions
Query!
Assessment method [6]
0
0
Analysis of Gadolinium-positive T1 lesions was done using magnetic resonance imaging (MRI) scans.
Query!
Timepoint [6]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [7]
0
0
DBTP and DBE Period: New or Enlarging T2 Lesions Rate
Query!
Assessment method [7]
0
0
Analysis of new or enlarging T2 lesions rate was done using magnetic resonance imaging (MRI) scans. Negative binomial model for lesion count (summed over scans) includes treatment and covariates based on randomization strata and baseline volume of T2 lesion (continuous), with offset equal to the log of the time in years between the last available MRI scan and the baseline scan.
Query!
Timepoint [7]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [8]
0
0
DBTP Period: Neurofilament Light Chain Concentration (NfL) at Week 12
Query!
Assessment method [8]
0
0
NfL is a biomarker of neuro-axonal damage whose concentration was assessed in blood at Week 12.
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Query!
Assessment method [9]
0
0
Adverse event (AE): Any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: those AEs with an onset date on or after the date of first study intervention administration, or AEs present prior to any study intervention administration but exacerbating after. TEAEs included both Serious TEAEs and non-serious TEAEs. AESIs included liver AEs (possible drug-induced, non-infectious, non-alcoholic, and immune-mediated), infections (serious and opportunistic infections), lipase and amylase elevation, and seizure.
Query!
Timepoint [9]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [10]
0
0
DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Query!
Assessment method [10]
0
0
Severity of adverse events (AE) were assessed by the investigator per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with Grades 1, 2, 3, 4 and 5 were reported.
Query!
Timepoint [10]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [11]
0
0
DBTP and DBE Periods: Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
Query!
Assessment method [11]
0
0
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: diastolic blood pressure and systolic blood pressure from baseline up to 176 weeks were reported.
Query!
Timepoint [11]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [12]
0
0
DBTP and DBE Periods: Change From Baseline in Vital Signs: Pulse Rate
Query!
Assessment method [12]
0
0
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: pulse rate from baseline up to baseline up to 176 weeks was reported.
Query!
Timepoint [12]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [13]
0
0
DBTP and DBE Periods: Change From Baseline in Vital Signs: Respiratory Rate
Query!
Assessment method [13]
0
0
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: respiratory rate from baseline up to 176 weeks was reported.
Query!
Timepoint [13]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [14]
0
0
DBTP and DBE Periods: Change From Baseline in Vital Signs: Weight
Query!
Assessment method [14]
0
0
Changes in vital signs: weight from baseline up to 176 weeks was reported.
Query!
Timepoint [14]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [15]
0
0
DBTP and DBE Periods: Change From Baseline in Vital Signs: Temperature
Query!
Assessment method [15]
0
0
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: Temperature from baseline up to 176 weeks was reported.
Query!
Timepoint [15]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [16]
0
0
DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs) Parameter: Heart Rate
Query!
Assessment method [16]
0
0
Heart rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in ECG parameter: heart rate from baseline up to 176 weeks was reported.
Query!
Timepoint [16]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [17]
0
0
DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs) Parameters: QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration
Query!
Assessment method [17]
0
0
QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in ECG parameter: QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration from baseline up to 176 weeks were reported.
Query!
Timepoint [17]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [18]
0
0
DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Query!
Assessment method [18]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Changes in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin from baseline up to 176 weeks were reported.
Query!
Timepoint [18]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [19]
0
0
DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes
Query!
Assessment method [19]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes. Changes in hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes from baseline up to 176 weeks were reported.
Query!
Timepoint [19]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [20]
0
0
DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Hematocrit
Query!
Assessment method [20]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Hematocrit. Changes in hematology parameter: Hematocrit from baseline up to 176 weeks was reported.
Query!
Timepoint [20]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [21]
0
0
DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Query!
Assessment method [21]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Changes in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin from baseline up to 176 weeks was reported.
Query!
Timepoint [21]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [22]
0
0
DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Query!
Assessment method [22]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Changes in hematology parameter: Erythrocytes Mean Corpuscular Volume from baseline up to 176 weeks was reported.
Query!
Timepoint [22]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [23]
0
0
DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Bilirubin and Creatinine
Query!
Assessment method [23]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Bilirubin and Creatinine. Changes in biochemistry parameters: Bilirubin and Creatinine from baseline up to 176 weeks were reported.
Query!
Timepoint [23]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [24]
0
0
DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase
Query!
Assessment method [24]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase. Changes in biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase from baseline up to 176 weeks were reported.
Query!
Timepoint [24]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [25]
0
0
DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium
Query!
Assessment method [25]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium. Changes in biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium from baseline up to 176 weeks were reported.
Query!
Timepoint [25]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [26]
0
0
DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Total Protein and Albumin
Query!
Assessment method [26]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Total Protein and Albumin. Changes in biochemistry parameters: Total Protein and Albumin from baseline up to 176 weeks were reported.
Query!
Timepoint [26]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [27]
0
0
DBTP and DBE Periods: Change From Baseline in Biochemistry Parameter: Glomerular Filtration Rate
Query!
Assessment method [27]
0
0
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameter: Glomerular Filtration Rate. Changes in biochemistry parameter: Glomerular Filtration Rate from baseline up to 176 weeks was reported. The Glomerular Filtration Rate will be measured as milliliter per minute per 1.73 square meter (mL/min/1.73m\^2).
Query!
Timepoint [27]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [28]
0
0
DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
Query!
Assessment method [28]
0
0
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Changes in urinalyses parameter: pH from baseline up to 176 weeks was reported.
Query!
Timepoint [28]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [29]
0
0
DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
Query!
Assessment method [29]
0
0
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: Specific Gravity of Urine. Changes in urinalyses parameter: Specific Gravity of Urine from baseline up to 176 weeks was reported.
Query!
Timepoint [29]
0
0
From baseline to 176 weeks
Query!
Secondary outcome [30]
0
0
DBTP and DBE Periods: Absolute Concentrations of Immunoglobulin (Ig) Levels
Query!
Assessment method [30]
0
0
Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.
Query!
Timepoint [30]
0
0
At Week 176
Query!
Secondary outcome [31]
0
0
DBTP and DBE Periods: Change From Baseline in Immunoglobulin (Ig) Levels
Query!
Assessment method [31]
0
0
Change from baseline serum levels of IgG, IgA, IgM were assessed.
Query!
Timepoint [31]
0
0
Baseline to 176 weeks
Query!
Secondary outcome [32]
0
0
OLE Period: Annualized Relapse Rate (ARR)
Query!
Assessment method [32]
0
0
The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, AEs, and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).
Query!
Timepoint [32]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [33]
0
0
OLE Period: Percentage of Participants Without 24-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)
Query!
Assessment method [33]
0
0
Disability progression was defined as increase in EDSS of greater than or equal to \[\>=\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 24 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis).
Query!
Timepoint [33]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [34]
0
0
OLE Period: Percentage of Participants With 24-Week Confirmed Disability Improvement (CDI) as Measured by Expanded Disability Status Scale (EDSS)
Query!
Assessment method [34]
0
0
Disability improvement was defined as a reduction of 1 point from Baseline EDSS score when the Baseline score is \>= 2 and less than or equal to \[\<=\] 6 and a reduction of 0.5 point from Baseline EDSS score when the Baseline score is \>= 6.5 and \<= 9.5. Disability improvement is considered sustained when the initial reduction in the EDSS score is confirmed at a regularly scheduled visit at least 24 weeks after the initial reduction. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis).
Query!
Timepoint [34]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [35]
0
0
OLE Period: Symbol Digit Modalities Test (SDMT)
Query!
Assessment method [35]
0
0
The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening. Participant wise data was reported for this outcome measure.
Query!
Timepoint [35]
0
0
Assessed from OLE baseline to OLE Week 96; OLE Week 48 were reported for Participants 1 and 2 and OLE Week 12 were reported for Participant 3
Query!
Secondary outcome [36]
0
0
OLE Period: Change From Baseline in PROMISnq Physical Function (PF) Multiple Sclerosis (MS) 15a at Week 52
Query!
Assessment method [36]
0
0
Physical function was assessed with PROMISnq Short Form v2.0 - Physical Function - Multiple Sclerosis 15a (PROMISnq PF(MS) 15a). PROMISnq PF(MS) 15a assesses a participant's abilities and limitations with respect to everyday physical activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and ranges from 10 to 65. Higher T-scores represent higher physical function. Participant wise data was reported for this outcome measure.
Query!
Timepoint [36]
0
0
OLE Baseline (DBTP Week 96), OLE Week 52
Query!
Secondary outcome [37]
0
0
OLE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (MS) 8a Score at Week 52
Query!
Assessment method [37]
0
0
PROMIS Fatigue score was assessed with PROMIS Short Form v1.0 - Fatigue - Multiple Sclerosis 8a (PROMIS Fatigue (MS) 8a). PROMIS Fatigue (MS) 8a assesses level of fatigue and its interference on daily activities. Results are reported as a T-score. In general, T-scores have a mean of 50, standard deviation of 10, and range from 33 to 85. Higher T-scores represent higher fatigue. Participant wise data was reported for this outcome measure.
Query!
Timepoint [37]
0
0
OLE baseline (DBTP Week 96), OLE Week 52
Query!
Secondary outcome [38]
0
0
OLE Period: Number of Participants With Abnormalities in Laboratory Parameters
Query!
Assessment method [38]
0
0
Laboratory investigation included hematology, biochemistry and coagulation. The number of participants with abnormalities in laboratory parameters were reported.
Query!
Timepoint [38]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [39]
0
0
OLE Period: Number of Participants With Abnormalities in Vital Signs
Query!
Assessment method [39]
0
0
Vital signs included temperature, pulse rate, respiration rate and blood pressure and weight (taken after 5 minutes in the sitting position). The number of participants with abnormalities in vital signs were reported.
Query!
Timepoint [39]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [40]
0
0
OLE Period: Number of Participants With Abnormalities in Electrocardiograms (ECGs) Findings
Query!
Assessment method [40]
0
0
ECG recordings included, heart rate, PR interval and QRS duration. ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position. The number of participants with abnormalities in ECG findings were reported.
Query!
Timepoint [40]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [41]
0
0
OLE Period: Number of New or Enlarging T2 Lesions
Query!
Assessment method [41]
0
0
Analysis of number of new or enlarging T2 lesions was done using magnetic resonance imaging (MRI) scans. Negative binomial model for lesion count (summed over scans) includes treatment and covariates based on randomization strata and baseline volume of T2 lesion (continuous), with offset equal to the log of the time in years between the last available MRI scan and the baseline scan. Participant wise data was reported for this outcome measure.
Query!
Timepoint [41]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
Secondary outcome [42]
0
0
OLE Period: Change From Baseline in T2 Lesion Volume
Query!
Assessment method [42]
0
0
Change from baseline in T2 lesion volume was reported. Participant wise data was reported for this outcome measure.
Query!
Timepoint [42]
0
0
From OLE baseline (DBTP Week 96) to OLE Week 52
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/06/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/03/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1124
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site 104 - Auchenflower
Query!
Recruitment hospital [2]
0
0
Research Site 107 - Concord
Query!
Recruitment hospital [3]
0
0
Research Site 109 - Hobart
Query!
Recruitment hospital [4]
0
0
Research Site 101 - Liverpool
Query!
Recruitment hospital [5]
0
0
Research Site 102 - New Lambton Heights
Query!
Recruitment hospital [6]
0
0
Research Site 103 - St Leonards
Query!
Recruitment postcode(s) [1]
0
0
- Auchenflower
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- Hobart
Query!
Recruitment postcode(s) [4]
0
0
- Liverpool
Query!
Recruitment postcode(s) [5]
0
0
- New Lambton Heights
Query!
Recruitment postcode(s) [6]
0
0
- St Leonards
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oklahoma
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Wisconsin
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Cordoba
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Godoy Cruz
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Guaymallen
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Rosario
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Salta
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
San Juan
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
San Miguel de Tucuman
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Innsbruck
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Linz
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Salzburg
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Vienna
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Bruxelles
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Kortrijk
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
La Louvière
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Liège
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Overpelt
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Roeselare
Query!
Country [47]
0
0
Bosnia and Herzegovina
Query!
State/province [47]
0
0
Bihac
Query!
Country [48]
0
0
Bosnia and Herzegovina
Query!
State/province [48]
0
0
Mostar
Query!
Country [49]
0
0
Bosnia and Herzegovina
Query!
State/province [49]
0
0
Sarajevo
Query!
Country [50]
0
0
Bulgaria
Query!
State/province [50]
0
0
Pleven
Query!
Country [51]
0
0
Bulgaria
Query!
State/province [51]
0
0
Plovdiv
Query!
Country [52]
0
0
Bulgaria
Query!
State/province [52]
0
0
Sofia
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Greenfield Park
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Levis
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Moncton
Query!
Country [56]
0
0
Canada
Query!
State/province [56]
0
0
Montreal
Query!
Country [57]
0
0
Canada
Query!
State/province [57]
0
0
Toronto
Query!
Country [58]
0
0
Colombia
Query!
State/province [58]
0
0
Barranquilla
Query!
Country [59]
0
0
Colombia
Query!
State/province [59]
0
0
Medellin
Query!
Country [60]
0
0
Croatia
Query!
State/province [60]
0
0
Osijek
Query!
Country [61]
0
0
Croatia
Query!
State/province [61]
0
0
Rijeka
Query!
Country [62]
0
0
Croatia
Query!
State/province [62]
0
0
Varazdin
Query!
Country [63]
0
0
Croatia
Query!
State/province [63]
0
0
Zagreb
Query!
Country [64]
0
0
Czechia
Query!
State/province [64]
0
0
Brno
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Hradec Kralove
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Jihlava
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Ostrava
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Pardubice
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Plzen-Bory
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Praha 10
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Praha 2
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Praha 4 - Krc
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Praha 5
Query!
Country [74]
0
0
Estonia
Query!
State/province [74]
0
0
Tallinn
Query!
Country [75]
0
0
Estonia
Query!
State/province [75]
0
0
Tartu
Query!
Country [76]
0
0
Finland
Query!
State/province [76]
0
0
Turku
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Bron cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Caen cedex 9
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Grenoble cedex 09
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Lille cedex
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Lille
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Montpellier
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Nantes cedex 1
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Nice Cedex 1
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Rennes cedex 09
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Rouen Cedex
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Toulouse cedex 9
Query!
Country [88]
0
0
Georgia
Query!
State/province [88]
0
0
Tbilisi
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Bamberg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Bayreuth
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Berlin
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Bochum
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Bonn
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Erbach
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Essen
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Frankfurt
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Hannover
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Mannheim
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Muenchen
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Muenster
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Potsdam
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Siegen
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Ulm
Query!
Country [104]
0
0
Hong Kong
Query!
State/province [104]
0
0
Hong Kong
Query!
Country [105]
0
0
Hong Kong
Query!
State/province [105]
0
0
Hongkong
Query!
Country [106]
0
0
Hong Kong
Query!
State/province [106]
0
0
Shatin
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Budapest
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Kistarcsa
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Pecs
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Tatabanya
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Vac
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Hyderabad
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Nashik
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
New Delhi
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Ashkelon
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Jerusalem
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Petah Tikva
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Ramat Gan
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Rechovot
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Safed
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Bologna
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Chieti
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Genova
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Messina
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Milano
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Montichiari
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Napoli
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Reggio Calabria
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Roma
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Salerno
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Verona
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Goyang-si
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Seoul
Query!
Country [134]
0
0
Mexico
Query!
State/province [134]
0
0
Aguascalientes
Query!
Country [135]
0
0
Mexico
Query!
State/province [135]
0
0
Culiacan
Query!
Country [136]
0
0
Netherlands
Query!
State/province [136]
0
0
Hoorn
Query!
Country [137]
0
0
Netherlands
Query!
State/province [137]
0
0
Nieuwegein
Query!
Country [138]
0
0
Netherlands
Query!
State/province [138]
0
0
Rotterdam
Query!
Country [139]
0
0
Netherlands
Query!
State/province [139]
0
0
Sittard-Geleen
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Bydgoszcz
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Gdansk
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Katowice
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Knurow
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Lodz
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Lublin
Query!
Country [146]
0
0
Poland
Query!
State/province [146]
0
0
Oswiecim
Query!
Country [147]
0
0
Poland
Query!
State/province [147]
0
0
Rzeszów
Query!
Country [148]
0
0
Poland
Query!
State/province [148]
0
0
Warszawa
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Barnaul
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Ekaterinburg
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Kaluga
Query!
Country [152]
0
0
Russian Federation
Query!
State/province [152]
0
0
Kazan
Query!
Country [153]
0
0
Russian Federation
Query!
State/province [153]
0
0
Kirov
Query!
Country [154]
0
0
Russian Federation
Query!
State/province [154]
0
0
Krasnoyarsk
Query!
Country [155]
0
0
Russian Federation
Query!
State/province [155]
0
0
Moscow
Query!
Country [156]
0
0
Russian Federation
Query!
State/province [156]
0
0
Nizhniy Novgorod
Query!
Country [157]
0
0
Russian Federation
Query!
State/province [157]
0
0
Perm
Query!
Country [158]
0
0
Russian Federation
Query!
State/province [158]
0
0
Pyatigorsk
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
Saint-Petersburg
Query!
Country [160]
0
0
Russian Federation
Query!
State/province [160]
0
0
Saratov
Query!
Country [161]
0
0
Russian Federation
Query!
State/province [161]
0
0
Smolensk
Query!
Country [162]
0
0
Russian Federation
Query!
State/province [162]
0
0
St.Petersburg
Query!
Country [163]
0
0
Russian Federation
Query!
State/province [163]
0
0
Tomsk
Query!
Country [164]
0
0
Russian Federation
Query!
State/province [164]
0
0
Ufa
Query!
Country [165]
0
0
Russian Federation
Query!
State/province [165]
0
0
Ulyanovsk
Query!
Country [166]
0
0
Russian Federation
Query!
State/province [166]
0
0
Yaroslavl
Query!
Country [167]
0
0
Serbia
Query!
State/province [167]
0
0
Belgrade
Query!
Country [168]
0
0
Serbia
Query!
State/province [168]
0
0
Kragujevac
Query!
Country [169]
0
0
Serbia
Query!
State/province [169]
0
0
Nis
Query!
Country [170]
0
0
Serbia
Query!
State/province [170]
0
0
Novi Sad
Query!
Country [171]
0
0
Serbia
Query!
State/province [171]
0
0
Uzice
Query!
Country [172]
0
0
Serbia
Query!
State/province [172]
0
0
Valjevo
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
Barcelona
Query!
Country [174]
0
0
Spain
Query!
State/province [174]
0
0
Cadiz
Query!
Country [175]
0
0
Spain
Query!
State/province [175]
0
0
Lleida
Query!
Country [176]
0
0
Spain
Query!
State/province [176]
0
0
Madrid
Query!
Country [177]
0
0
Spain
Query!
State/province [177]
0
0
Pozuelo de Alarcon
Query!
Country [178]
0
0
Spain
Query!
State/province [178]
0
0
Salt
Query!
Country [179]
0
0
Spain
Query!
State/province [179]
0
0
San Sebastian
Query!
Country [180]
0
0
Spain
Query!
State/province [180]
0
0
Sevilla
Query!
Country [181]
0
0
Taiwan
Query!
State/province [181]
0
0
Kaohsiung
Query!
Country [182]
0
0
Taiwan
Query!
State/province [182]
0
0
Taichung
Query!
Country [183]
0
0
Taiwan
Query!
State/province [183]
0
0
Taipei
Query!
Country [184]
0
0
Ukraine
Query!
State/province [184]
0
0
Chernivtsi
Query!
Country [185]
0
0
Ukraine
Query!
State/province [185]
0
0
Kharkiv
Query!
Country [186]
0
0
Ukraine
Query!
State/province [186]
0
0
Kropyvnytskyi
Query!
Country [187]
0
0
Ukraine
Query!
State/province [187]
0
0
Kyiv
Query!
Country [188]
0
0
Ukraine
Query!
State/province [188]
0
0
Lviv
Query!
Country [189]
0
0
Ukraine
Query!
State/province [189]
0
0
Odesa
Query!
Country [190]
0
0
Ukraine
Query!
State/province [190]
0
0
Poltava
Query!
Country [191]
0
0
Ukraine
Query!
State/province [191]
0
0
Sumy
Query!
Country [192]
0
0
Ukraine
Query!
State/province [192]
0
0
Vinnytsia
Query!
Country [193]
0
0
Ukraine
Query!
State/province [193]
0
0
Zaporizhzhia
Query!
Country [194]
0
0
United Kingdom
Query!
State/province [194]
0
0
Exeter
Query!
Country [195]
0
0
United Kingdom
Query!
State/province [195]
0
0
Glasgow
Query!
Country [196]
0
0
United Kingdom
Query!
State/province [196]
0
0
Newcastle
Query!
Country [197]
0
0
United Kingdom
Query!
State/province [197]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
EMD Serono Research & Development Institute, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04338022
Query!
Trial related presentations / publications
Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Responsible
Query!
Address
0
0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Query!
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/22/NCT04338022/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT04338022/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cre...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT04338022
Download to PDF