Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome (TERIS)
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|ClinicalTrials.gov Identifier: NCT03122652|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : October 14, 2020
Multiple sclerosis (MS) is a common cause of severe neurological disability in young adults, resulting from an autoimmune interruption of both myelin and axons within the central nervous system (CNS). The diagnosis is made by fulfilling both spatial criteria, by meeting the requisite number of lesions within the brain or spinal cord, along with criteria for time, by demonstrating a history of at least a second clinical attack or the development of a new MS lesion on MRI after the seminal neurological event. In the case of MS, healthy individuals who do not exhibit signs of neurological dysfunction commonly have brain MRI studies performed for a reason other than an evaluation for MS that reveal unexpected anomalies highly suggestive of demyelinating plaques given their size, location, and morphology. These healthy subjects lack symptomatology suggestive of MS and fulfill formal criteria for radiologically isolated syndrome (RIS), a recently described MS subtype that expands upon the phenotype of at-risk individuals for future demyelinating events. The discovery of such anomalies creates intersecting neuro-ethical, legal, social, and practical medical management quandaries and is, therefore, of both immediate and long-term clinical significance. Despite advancements in the characterization of RIS subjects, and in our understanding of risk factors for initial symptom development, the effect of treatment on such cases remain unclear.
The purpose of this investigation is to systematically study the efficacy of Teriflunomide in those individuals who possess incidental white matter anomalies within the brain and following a MRI study that is performed for a reason other than for the evaluation of MS.
RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.
The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.
This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Teriflunomide 14 MG Oral Tablet [Aubagio] Drug: Placebo Oral Tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study|
|Actual Study Start Date :||September 25, 2017|
|Actual Primary Completion Date :||February 5, 2019|
|Estimated Study Completion Date :||October 24, 2022|
Drug: Teriflunomide 14 MG Oral Tablet [Aubagio]
1 tablet once a day
|Placebo Comparator: Placebo||
Drug: Placebo Oral Tablet
1 tablet once a day
- Time to the first acute or progressive neurological event resulting from CNS demyelination. [ Time Frame: Week 96 ]
Acute neurological event: The development of an acute neurological episode localized to the optic nerve, brainstem, cerebellum, spinal cord, or long sensory or motor tracts, lasting > 24 hours followed by a period of symptom improvement.
Progressive event: The onset of a clinical symptom (e.g. leg weakness) with the temporal profile revealing at least a 12-month progression of neurological deficits.
- New or enlarging T2 lesions [ Time Frame: Week 48 ]Number of new or enlarging T2 lesions on MRI
- New or enlarging T2 lesions [ Time Frame: Week 96 ]Number of new or enlarging T2 lesions on MRI
- New contrast enhancing lesions [ Time Frame: Week 48 ]New contrast enhancing lesions on MRI
- New contrast enhancing lesions [ Time Frame: Week 96 ]New contrast enhancing lesions on MRI
- New T2-lesion volumes [ Time Frame: Week 48 ]New T2-lesion volumes on MRI
- New T2-lesion volumes [ Time Frame: Week 96 ]New T2-lesion volumes on MRI
- Brain atrophy [ Time Frame: Week 96 ]Brain atrophy on MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122652
|Principal Investigator:||Christine LEBRUN-FRENAY, MD||Centre Hospitalier Universitaire de Nice|