Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome (TERIS)
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ClinicalTrials.gov Identifier: NCT03122652 |
Recruitment Status :
Completed
First Posted : April 21, 2017
Last Update Posted : March 17, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | April 12, 2017 | ||||
First Posted Date ICMJE | April 21, 2017 | ||||
Last Update Posted Date | March 17, 2023 | ||||
Actual Study Start Date ICMJE | September 25, 2017 | ||||
Actual Primary Completion Date | February 5, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome | ||||
Official Title ICMJE | Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study | ||||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
125 | ||||
Original Estimated Enrollment ICMJE |
200 | ||||
Actual Study Completion Date ICMJE | October 4, 2022 | ||||
Actual Primary Completion Date | February 5, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Fertile male subjects participating in the study who are sexually active with WOCBP: - Must agree to use condom during the treatment period and for an additional 6 weeks after the first oft wo tests showing teriflunomide plasma level <0.02 mg/L. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, Switzerland, Turkey | ||||
Removed Location Countries | Germany, Martinique, Sweden, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03122652 | ||||
Other Study ID Numbers ICMJE | 14-PP-11 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Genzyme, a Sanofi Company | ||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Nice | ||||
Verification Date | March 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |