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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00622700
Registration number
NCT00622700
Ethics application status
Date submitted
14/02/2008
Date registered
25/02/2008
Date last updated
13/03/2017
Titles & IDs
Public title
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
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Scientific title
An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period
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Secondary ID [1]
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HMR1726D-3005
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Secondary ID [2]
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EFC6260
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Universal Trial Number (UTN)
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Trial acronym
TOPIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Placebo
Placebo Comparator: Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg - Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
Extension treatment period: Re-randomized in 1:1 ratio to either teriflunomide 7 mg or 14 mg once daily orally.
Experimental: Teriflunomide 7 mg/7 mg - Core treatment period: Teriflunomide 7 mg tablet once daily orally.
Extension treatment period: Teriflunomide 7 mg tablet once daily orally.
Experimental: Teriflunomide 14 mg/14 mg - Core treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Treatment: Drugs: Teriflunomide
Film-coated tablet Oral administration
Treatment: Drugs: Placebo
Film-coated tablet Oral administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Core Treatment Period: Time to Conversion to Clinically De?nite Multiple Sclerosis (CDMS)
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Assessment method [1]
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Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
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Timepoint [1]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [1]
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Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)
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Assessment method [1]
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Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
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Timepoint [1]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [2]
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Core Treatment Period: Annualized Relapse Rate (ARR)
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Assessment method [2]
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ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. 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 EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).
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Timepoint [2]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [3]
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Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108
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Assessment method [3]
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The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.
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Timepoint [3]
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Baseline, Week 108
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Secondary outcome [4]
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Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)
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Assessment method [4]
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Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
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Timepoint [4]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [5]
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Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan
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Assessment method [5]
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Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
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Timepoint [5]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [6]
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Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component
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Assessment method [6]
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Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction
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Timepoint [6]
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Baseline, Week 108
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Secondary outcome [7]
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Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component
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Assessment method [7]
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Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.
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Timepoint [7]
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Baseline, Week 108
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Secondary outcome [8]
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Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy
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Assessment method [8]
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Atrophy was measured by MRI scan.
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Timepoint [8]
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Baseline, Week 108
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Secondary outcome [9]
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Core Treatment Period: Time to 12-Week Sustained Disability Progression
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Assessment method [9]
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The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
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Timepoint [9]
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Up to a maximum of 108 weeks depending on time of enrollment
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Secondary outcome [10]
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Core Treatment Period: Change From Baseline in EDSS at Week 108
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Assessment method [10]
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EDSS is an ordinal scale in half-point increments that qualifies disability in participants 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). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction
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Timepoint [10]
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Baseline, Week 108
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Secondary outcome [11]
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Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108
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Assessment method [11]
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FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants 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 adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.
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Timepoint [11]
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Baseline, Week 108
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Secondary outcome [12]
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Core Treatment Period: Overview of Adverse Events (AEs)
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Assessment method [12]
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AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
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Timepoint [12]
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From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
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Secondary outcome [13]
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Extension Treatment Period: Time to Conversion to Clinically De?nite Multiple Sclerosis (CDMS)
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Assessment method [13]
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Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.
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Timepoint [13]
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From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])
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Secondary outcome [14]
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Extension Treatment Period: Overview of Adverse Events (AEs)
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Assessment method [14]
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AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.
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Timepoint [14]
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From re-randomization up to 283 Weeks
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Eligibility
Key inclusion criteria
- First acute or subacute, well-defined neurological event consistent with demyelination
(that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome,
brainstem/cerebellar syndromes)
- Onset of MS symptoms occurring within 90 days of randomization
- A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter
that are characteristic of MS
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease
- Significantly impaired bone marrow function
- Pregnancy or nursing
- Alcohol or drug abuse
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
enrollment
- Any known condition or circumstance that would prevent in the investigator's opinion
compliance or completion of the study
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
618
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 1405 - Geelong
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Recruitment hospital [2]
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Investigational Site Number 1404 - Heidelberg
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Recruitment hospital [3]
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Investigational Site Number 1407 - Hobart
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Recruitment hospital [4]
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Investigational Site Number 1401 - Parkville
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment postcode(s) [2]
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3081 - Heidelberg
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Recruitment postcode(s) [3]
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7001 - Hobart
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Recruitment postcode(s) [4]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Florida
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Indiana
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Louisiana
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Tennessee
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Washington
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Austria
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Innsbruck
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Austria
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Linz
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Wien
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Pleven
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Sofia
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Greenfield Park
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Canada
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London
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Canada
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Montreal
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Ottawa
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Sherbrooke
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Toronto
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Santiago
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Brno
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Hradec Kralove
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Aarhus C
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Tallinn
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Tartu
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Helsinki
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Kuopio
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Klaipeda
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Lodz
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Warszawa 44
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Warszawa
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Romania
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Bucuresti
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Romania
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Timisoara
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Kazan
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Izmit
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Turkey
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Trabzon
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Ukraine
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Chernihiv
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donets'K
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Poltava
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhya
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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United Kingdom
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Salford
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Summary
Brief summary
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram
per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of
participants presenting with their first clinical episode consistent with multiple sclerosis
(MS) to clinically definite multiple sclerosis (CDMS).
The secondary objectives were:
- To demonstrate the effect of teriflunomide, in comparison to placebo, on:
- Reducing conversion to definite multiple sclerosis (DMS)
- Reducing annualized relapse rate (ARR)
- Reducing disease activity/progression as measured by Magnetic Resonance Imaging
(MRI)
- Reducing accumulation of disability for at least 12 weeks as measured by the
Expanded Disability Status Scale (EDSS)
- Proportion of disability-free participants as assessed by the EDSS
- Reducing participant-reported fatigue
- To evaluate the safety and tolerability of teriflunomide
- To evaluate the pharmacokinetics (PK) of teriflunomide
- Optional pharmacogenomic testing aimed at assessing the association between the main
enzyme systems of teriflunomide metabolism and hepatic safety, and other potential
associations between gene variations and clinical outcomes
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00622700
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Trial related presentations / publications
Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.
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Public notes
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Contacts
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Clinical Sciences & Operations
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Sanofi
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00622700
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