A Study Comparing the Effectiveness and Safety of Teriflu... | NCT00883337 | Trialant
NCT00883337
Sponsor
Sanofi
Status
Completed
Last Update Posted
Jun 13, 2016Estimated
Enrollment
324Actual
Phase
Phase 3
Conditions
Multiple Sclerosis
Interventions
Interferon β-1a
Teriflunomide
Countries
Belgium
Canada
Czechia
France
Germany
Greece
Hungary
Italy
Poland
Spain
Switzerland
Tunisia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00883337
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EFC10891
Secondary IDs
ID
Type
Description
Link
2008-006226-34
EudraCT Number
Brief Title
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
Official Title
A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period
Acronym
TENERE
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
May 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2009
Primary Completion Date
Sep 2011Actual
Completion Date
May 2015Actual
First Submitted Date
Apr 16, 2009
First Submission Date that Met QC Criteria
Apr 16, 2009
First Posted Date
Apr 17, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 3, 2012
Results First Submitted that Met QC Criteria
Oct 3, 2012
Results First Posted Date
Nov 6, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 4, 2016
Last Update Posted Date
Jun 13, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis [MS].
Secondary objectives were:
To assess the effect of the two doses in comparison to interferon beta-1a on:
Frequency of relapses,
Fatigue,
Participant's satisfaction with treatment.
To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.
The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.
Detailed Description
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind fashion, whereas interferon beta-1a (Rebif®) was open-label.
The opportunity to continue with the highest dose of teriflunomide in open-label fashion was offered to the participants who successfully completed treatment in the core study.
The overall treatment period was followed by a 4-week elimination follow-up period.
Conditions Module
Conditions
Multiple Sclerosis
Keywords
Relapsing-remitting multiple sclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
324Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Teriflunomide 7 mg / 14 mg
Experimental
Teriflunomide 7 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extended treatment period).
Drug: Teriflunomide
Teriflunomide 14 mg / 14 mg
Experimental
Teriflunomide 14 mg once daily (core treatment period) and teriflunomide 14 mg once daily (extension treatment period).
Drug: Teriflunomide
IFN-β-1a / 14 mg
Active Comparator
Interferon β-1a 3 times a week (core treatment period) and teriflunomide 14 mg once daily (extended treatment period).
Drug: Interferon β-1a
Drug: Teriflunomide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Interferon β-1a
Drug
Sterile preservative-free solution packaged in graduated pre-filled syringes
Subcutaneous injection
Ascending doses from 8.8 to 44 mcg according to local standard for Rebif®
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Treatment Period: Overview of Failures
Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints
Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale [EDSS] score ≤5.5 at screening visit.
Exclusion Criteria:
Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia;
Persistent significant or severe infection.
Liver function impairment or known history of hepatitis.
Use of adrenocorticotrophic hormone [ACTH] or systemic corticosteroids for 2 weeks prior to randomization.
Human immunodeficiency virus [HIV] positive.
Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months prior to randomization.
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab.
Pregnant or breast-feeding woman.
Extension criteria:
The participants who met all the following criteria at the end of the core study period were eligible for enrolment into the open-label extension phase:
Participants who had not discontinued treatment in the core period and who had a minimum treatment of 48 weeks and completed the EOT visit (Visit 18).
Participants who had not met criteria for treatment withdrawal.
An informed consent must be obtained in writing from the participant for this open-label extension phase prior to entering and prior to completion of any extension phase procedure.
Participants who demonstrated a willingness and ability to roll over to the extension phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under open-label.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Randomization was stratified by country and baseline disability (Expanded Disability Status Scale [EDSS] score ≤3.5 or >3.5).
Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria. 324 participants were randomized at 53 sites.
Recruitment Details
The recruitment initiated in April 2009 was completed in July 2010. A total of 369 participants were screened at 54 sites in 13 countries.
The common end date of core treatment period was 14 September 2011 (maximum treatment duration of 115 weeks).
The end date of extension was 13 May 2015 (maximum treatment duration of 197 weeks)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Teriflunomide 7 mg/14 mg
Core treatment period: Teriflunomide 7 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily.
FG001
Teriflunomide 14 mg/14 mg
Periods
Title
Milestones
Reasons Not Completed
Core Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Outcomes Assessor
IFN-β-1a / 14 mg
Rebif®
Teriflunomide
Drug
Film-coated tablet
Oral administration
IFN-β-1a / 14 mg
Teriflunomide 14 mg / 14 mg
Teriflunomide 7 mg / 14 mg
HMR1726
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors).
Baseline (before randomization) and 48 weeks
Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores
TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).
48 weeks
Core Treatment Period: Overview of Adverse Events [AE]
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
Extension Treatment Period: Overview of AEs
AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period
ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrolment and baseline EDSS stratum as covariates).
Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.
Core treatment period: Teriflunomide 14 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily.
FG002
IFN-β-1a / Teriflunomide 14 mg
Core treatment period: Interferon β-1a 3 times a week.
Extension treatment period: Teriflunomide 14 mg once daily.
FG000109 subjects
FG001111 subjects
FG002104 subjects
Treated
FG000109 subjects
FG001111 subjectsOne participant received teriflunomide 7 mg instead of teriflunomide 14 mg
FG002101 subjects3 participants refused treatment with Rebif®
COMPLETED
FG00089 subjects
FG00189 subjects
FG00271 subjects
NOT COMPLETED
FG00020 subjects
FG00122 subjects
FG00233 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG00112 subjects
FG00222 subjects
Lack of Efficacy
FG0007 subjects
FG0014 subjects
FG0022 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0026 subjects
Wish to be pregnant
FG0001 subjects
FG0012 subjects
FG0021 subjects
Poor compliance to protocol
FG0000 subjects
FG0010 subjects
FG0021 subjects
Other than above
FG0000 subjects
FG0011 subjects
FG0021 subjects
Extension Treatment Period
Type
Comment
Milestone Data
STARTED
FG00089 subjects
FG00189 subjects
FG00259 subjects12 participants completed the core period but didn't enter the extension period.
COMPLETED
FG00061 subjects
FG00166 subjects
FG00240 subjects
NOT COMPLETED
FG00028 subjects
FG00123 subjects
FG00219 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0015 subjects
FG0025 subjects
Lack of Efficacy
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Teriflunomide 7 mg / 14 mg
Core treatment period: Teriflunomide 7 mg once daily
Extension treatment period: Teriflunomide 14 mg once daily
BG001
Teriflunomide 14 mg/14 mg
Core treatment period: Teriflunomide 14 mg once daily.
Extension treatment period: Teriflunomide 14 mg once daily.
BG002
IFNβ1a / Teriflunomide 14 mg
Core treatment period: Interferon β-1a 3 times a week.
Extension treatment period: Teriflunomide 14 mg once daily.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000109
BG001111
BG002104
BG003324
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00032.5± 9.2
BG00136.8± 10.3
BG00237.0± 10.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00070
BG00178
BG002
Region of enrollment
Due the small sample size in some countries, the countries were pooled as follows:
North America: Canada;
Eastern Europe: Czech Republic, Greece, Hungary and Poland;
Western Europe: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdon;
'*' the only participant in Tunisia was included in the Western Europe group.
Number
participants
Title
Denominators
Categories
North America
Title
Measurements
BG0008
BG001
Time since first diagnosis of Multiple Sclerosis [MS]
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0003.72± 5.19
BG0013.68± 6.24
BG002
Number of MS relapses
Median
Full Range
relapses
Title
Denominators
Categories
Within the past year
Title
Measurements
BG0001(0 to 3)
BG0011(0 to 4)
BG002
Time since most recent MS relapse onset
The information was not available for one participant in the Teriflunomide 14 mg group
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG0009.00± 13.96
BG0017.90± 10.34
MS subtype
Number
participants
Title
Denominators
Categories
Relapsing Remitting
Title
Measurements
BG000109
BG001108
BG002
Baseline EDSS score
EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.
EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).
Number
participants
Title
Denominators
Categories
≤3.5
Title
Measurements
BG00096
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Core Treatment Period: Overview of Failures
Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.
Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.
Intent-to-treat population: all randomized participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.
Posted
Number
participants
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
ID
Title
Description
OG000
Teriflunomide 7 mg
Teriflunomide 7 mg once daily
OG001
Teriflunomide 14 mg
Teriflunomide 14 mg once daily
OG002
IFN-β-1a
Interferon β-1a 3 times a week
Units
Counts
Participants
OG000109
OG001111
OG002104
Title
Denominators
Categories
Failure
Title
Measurements
OG00053
OG00142
OG00244
Free of failure
Primary
Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints
Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.
Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.
ITT population.
Posted
Number
95% Confidence Interval
percent probability
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.
To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).
ITT population.
Posted
Number
95% Confidence Interval
relapses per year
Core treatment period between 48 and 118 weeks depending on when the participant was enrolled
ID
Title
Description
OG000
Teriflunomide 7 mg
Teriflunomide 7 mg once daily
OG001
Teriflunomide 14 mg
Teriflunomide 14 mg once daily
OG002
IFN-β-1a
Interferon β-1a 3 times a week
Units
Counts
Secondary
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score
FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.
FIS total score ranges from 0 (no problem) to 160 (extreme problem).
Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors).
ITT population.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline (before randomization) and 48 weeks
ID
Title
Description
OG000
Teriflunomide 7 mg
Teriflunomide 7 mg once daily
OG001
Teriflunomide 14 mg
Teriflunomide 14 mg once daily
OG002
IFN-β-1a
Interferon β-1a 3 times a week
Secondary
Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores
TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).
ITT population.
Posted
Least Squares Mean
Standard Error
units on a scale
48 weeks
ID
Title
Description
OG000
Teriflunomide 7 mg
Teriflunomide 7 mg once daily
OG001
Teriflunomide 14 mg
Teriflunomide 14 mg once daily
OG002
IFN-β-1a
Interferon β-1a 3 times a week
Units
Counts
Secondary
Core Treatment Period: Overview of Adverse Events [AE]
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Safety population: all randomized and treated participants. Participants were considered according to the drug actually received.
The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group.
Posted
Number
participants
from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first
ID
Title
Description
OG000
Teriflunomide 7 mg
Teriflunomide 7 mg once daily
OG001
Teriflunomide 14 mg
Teriflunomide 14 mg once daily
OG002
IFN-β-1a
Interferon β-1a 3 times a week
Units
Counts
Secondary
Extension Treatment Period: Overview of AEs
AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Safety population. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.
Posted
Number
participants
From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period
ID
Title
Description
OG000
Teriflunomide 7 mg / 14 mg
Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
OG001
Teriflunomide 14 mg / 14 mg
Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
OG002
IFN-β-1a / 14 mg
Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrolment and baseline EDSS stratum as covariates).
ITT population.
Posted
Number
95% Confidence Interval
relapses per year
Extension treatment period (Maximum: 197 weeks)
ID
Title
Description
OG000
Teriflunomide 7 mg / 14 mg
Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
OG001
Teriflunomide 14 mg / 14 mg
Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
OG002
IFN-β-1a / 14 mg
Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
Time Frame
AEs were collected from signature of the Informed Consent Form up to the last visit (197 weeks) in the study.
Description
The analysis was performed on the safety population as previously defined and included all AE that developed or worsened from first intake of study drug in extension treatment period up to 28 days after the last intake in the extension study treatment period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Core Treatment Period: Teriflunomide 7 mg
Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
12
110
85
110
EG001
Core Treatment:Teriflunomide 14 mg
Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
6
110
92
110
EG002
Core Treatment: IFN-β-1a
Interferon β-1a 3 times a week (mean exposure of 405.18 days).
Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
12
59
48
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis perforated
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG0030 affected90 at risk
EG0041 affected88 at risk
EG0050 affected59 at risk
Bacterial pyelonephritis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Peritonitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Pneumonia
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Tuberculosis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0011 affected110 at risk
EG0020 affected101 at risk
EG003
Anal abscess
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Appendicitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Bacterial infection
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Cellulitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Cervicitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Chronic sinusitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0011 affected110 at risk
EG0020 affected101 at risk
EG003
Meningitis bacterial
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Pyelonephritis acute
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Urinary tract infection
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Urosepsis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Uterine leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0011 affected110 at risk
EG0020 affected101 at risk
EG003
Drug hypersensitivity
Immune system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Suicide attempt
Psychiatric disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Hypomania
Psychiatric disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Optic neuritis
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Sciatica
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Syncope
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Eye oedema
Eye disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Vertigo
Ear and labyrinth disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0011 affected110 at risk
EG0020 affected101 at risk
EG003
Coronary artery disease
Cardiac disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Pericarditis
Cardiac disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Sinus tachycardia
Cardiac disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Varicose vein
Vascular disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Deep vein thrombosis
Vascular disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Haematoma
Vascular disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Venous stenosis
Vascular disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Crohn's disease
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Diarrhoea
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Cholecystitis
Hepatobiliary disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0011 affected110 at risk
EG0020 affected101 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Acute kidney injury
Renal and urinary disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Gait disturbance
General disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Alanine aminotransferase increased
Investigations
meddra-18.0
Systematic Assessment
EG0003 affected110 at risk
EG0011 affected110 at risk
EG0021 affected101 at risk
EG003
Contusion
Injury, poisoning and procedural complications
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0021 affected101 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0010 affected110 at risk
EG0020 affected101 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG00026 affected110 at risk
EG00124 affected110 at risk
EG00217 affected101 at risk
EG00311 affected90 at risk
EG0049 affected88 at risk
EG0053 affected59 at risk
Urinary tract infection
Infections and infestations
meddra-18.0
Systematic Assessment
EG0008 affected110 at risk
EG0013 affected110 at risk
EG0026 affected101 at risk
EG003
Bronchitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0008 affected110 at risk
EG0014 affected110 at risk
EG0022 affected101 at risk
EG003
Upper respiratory tract infection
Infections and infestations
meddra-18.0
Systematic Assessment
EG0008 affected110 at risk
EG00111 affected110 at risk
EG0029 affected101 at risk
EG003
Oral herpes
Infections and infestations
meddra-18.0
Systematic Assessment
EG0009 affected110 at risk
EG0010 affected110 at risk
EG0022 affected101 at risk
EG003
Pharyngitis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0008 affected110 at risk
EG0011 affected110 at risk
EG0023 affected101 at risk
EG003
Influenza
Infections and infestations
meddra-18.0
Systematic Assessment
EG0008 affected110 at risk
EG0019 affected110 at risk
EG0025 affected101 at risk
EG003
Ear infection
Infections and infestations
meddra-18.0
Systematic Assessment
EG0003 affected110 at risk
EG0012 affected110 at risk
EG0022 affected101 at risk
EG003
Gastroenteritis
Infections and infestations
meddra-18.0
Systematic Assessment
EG0005 affected110 at risk
EG0016 affected110 at risk
EG0023 affected101 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0012 affected110 at risk
EG0024 affected101 at risk
EG003
Insomnia
Psychiatric disorders
meddra-18.0
Systematic Assessment
EG0007 affected110 at risk
EG0011 affected110 at risk
EG0025 affected101 at risk
EG003
Hypoaesthesia
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG0013 affected110 at risk
EG0022 affected101 at risk
EG003
Dizziness
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0004 affected110 at risk
EG0011 affected110 at risk
EG0026 affected101 at risk
EG003
Headache
Nervous system disorders
meddra-18.0
Systematic Assessment
EG00023 affected110 at risk
EG00117 affected110 at risk
EG00226 affected101 at risk
EG003
Sciatica
Nervous system disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG0023 affected101 at risk
EG003
Paraesthesia
Nervous system disorders
meddra-18.0
Systematic Assessment
EG00014 affected110 at risk
EG00111 affected110 at risk
EG0028 affected101 at risk
EG003
Vertigo
Ear and labyrinth disorders
meddra-18.0
Systematic Assessment
EG0001 affected110 at risk
EG0011 affected110 at risk
EG0022 affected101 at risk
EG003
Hypertension
Vascular disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0015 affected110 at risk
EG0024 affected101 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
meddra-18.0
Systematic Assessment
EG0007 affected110 at risk
EG0014 affected110 at risk
EG0021 affected101 at risk
EG003
Diarrhoea
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG00019 affected110 at risk
EG00117 affected110 at risk
EG0029 affected101 at risk
EG003
Abdominal pain
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0005 affected110 at risk
EG0017 affected110 at risk
EG0022 affected101 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0007 affected110 at risk
EG0017 affected110 at risk
EG0023 affected101 at risk
EG003
Nausea
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG00010 affected110 at risk
EG00110 affected110 at risk
EG0024 affected101 at risk
EG003
Dyspepsia
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0004 affected110 at risk
EG0014 affected110 at risk
EG0020 affected101 at risk
EG003
Vomiting
Gastrointestinal disorders
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG0019 affected110 at risk
EG0024 affected101 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG00122 affected110 at risk
EG0021 affected101 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG00010 affected110 at risk
EG00111 affected110 at risk
EG0027 affected101 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG00011 affected110 at risk
EG0017 affected110 at risk
EG0024 affected101 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG0017 affected110 at risk
EG0024 affected101 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG0015 affected110 at risk
EG0023 affected101 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
meddra-18.0
Systematic Assessment
EG0002 affected110 at risk
EG0013 affected110 at risk
EG0027 affected101 at risk
EG003
Micturition urgency
Renal and urinary disorders
meddra-18.0
Systematic Assessment
EG0002 affected110 at risk
EG0013 affected110 at risk
EG0021 affected101 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
meddra-18.0
Systematic Assessment
EG0003 affected110 at risk
EG0016 affected110 at risk
EG0021 affected101 at risk
EG003
Fatigue
General disorders
meddra-18.0
Systematic Assessment
EG0007 affected110 at risk
EG0016 affected110 at risk
EG0025 affected101 at risk
EG003
Asthenia
General disorders
meddra-18.0
Systematic Assessment
EG0003 affected110 at risk
EG0011 affected110 at risk
EG0029 affected101 at risk
EG003
Pyrexia
General disorders
meddra-18.0
Systematic Assessment
EG00010 affected110 at risk
EG0012 affected110 at risk
EG0023 affected101 at risk
EG003
Influenza like illness
General disorders
meddra-18.0
Systematic Assessment
EG0004 affected110 at risk
EG0014 affected110 at risk
EG00249 affected101 at risk
EG003
Injection site erythema
General disorders
meddra-18.0
Systematic Assessment
EG0000 affected110 at risk
EG0010 affected110 at risk
EG00210 affected101 at risk
EG003
Alanine aminotransferase increased
Investigations
meddra-18.0
Systematic Assessment
EG00012 affected110 at risk
EG0019 affected110 at risk
EG00230 affected101 at risk
EG003
Fall
Injury, poisoning and procedural complications
meddra-18.0
Systematic Assessment
EG0006 affected110 at risk
EG0012 affected110 at risk
EG0022 affected101 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If no publication has occurred within 12 months after trial completion, the Investigator can present or publish results. The investigator provides the sponsor with a copy of the presentation or publication for review and comment at least 30 days in advance of its submission.
The sponsor can delay the submission for a period not exceeding 90 days to allow for filing a patent application or such other measures as sponsor deems appropriate to establish and preserve its proprietary rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Trial Transparency Team
sanofi
Contact-US@sanofi.com
ID
Term
D009103
Multiple Sclerosis
D020529
Multiple Sclerosis, Relapsing-Remitting
Ancestor Terms
ID
Term
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068556
Interferon beta-1a
C527525
teriflunomide
Ancestor Terms
ID
Term
D016899
Interferon-beta
D007370
Interferon Type I
D007372
Interferons
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D011506
Proteins
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
8 subjects
FG0018 subjects
FG0028 subjects
Poor compliance to protocol
FG0001 subjects
FG0011 subjects
FG0021 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other than above
FG00010 subjects
FG0019 subjects
FG0025 subjects
36.3
± 10.0
71
BG003219
Male
BG00039
BG00133
BG00233
BG003105
6
BG0027
BG00321
Eastern Europe
Title
Measurements
BG00039
BG00141
BG00235
BG003115
Western Europe*
Title
Measurements
BG00062
BG00164
BG00262
BG003188
3.82
± 5.69
BG0033.74± 5.71
1
(0 to 5)
BG0031(0 to 5)
Within the past 2 years
Title
Measurements
BG0002(0 to 4)
BG0012(0 to 4)
BG0022(0 to 6)
BG0032(0 to 6)
BG0029.79± 10.72
BG0038.88± 11.79
104
BG003321
Secondary Progressive
Title
Measurements
BG0000
BG0011
BG0020
BG0031
Progressive Relapsing
Title
Measurements
BG0000
BG0012
BG0020
BG0032
95
BG00293
BG003284
>3.5
Title
Measurements
BG00013
BG00116
BG00211
BG00340
Title
Measurements
OG00056
OG00169
OG00260
Units
Counts
Participants
OG000109
OG001111
OG002104
Title
Denominators
Categories
Probability of failure at 24 weeks
Title
Measurements
OG00025.7(17.5 to 33.9)
OG00124.3(16.3 to 32.3)
OG00229.8(21.0 to 38.6)
Probability of failure at 48 weeks
Title
Measurements
OG00035.8(26.8 to 44.8)
OG00133.3(24.6 to 42.1)
OG00236.5(27.3 to 45.8)
Probability of failure at 96 weeks
Title
Measurements
OG00058.8(46.1 to 71.4)
OG00141.1(30.9 to 51.4)
OG00244.4(34.3 to 54.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.
Null hypothesis:
H1: No difference between Teriflunomide 14 mg and Rebif
H2: No difference between Teriflunomide 7 mg and Rebif
Log Rank
Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors
0.5953
Hochberg testing procedure:
a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons
a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value >0.05
95
No
Superiority or Other
OG000
OG002
Null hypothesis:
H1: No difference between Teriflunomide 14 mg and Rebif
H2: No difference between Teriflunomide 7 mg and Rebif
Log Rank
Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors
0.5190
Hochberg testing procedure:
a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons
a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value >0.05