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Teriflunomide Tecfidera LMCE

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ClinicalTrials.gov Identifier: NCT03526224
Recruitment Status : Active, not recruiting
First Posted : May 16, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Brief Summary:
This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)

Condition or disease Intervention/treatment
Tecfidera Teriflunomide Drug: Dimethyl Fumarate Drug: Teriflunomide

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Aubagio
Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
Drug: Teriflunomide
Individuals with MS treated with teriflunomide (Aubagio)
Other Name: Aubagio

Tecfidera
Individuals diagnosed with multiple sclerosis (MS) who have been treated with dimethyl fumarate (Tecfidera) and matched with the teriflunomide (Aubagio) patients on age, sex, disease duration, and disability level
Drug: Dimethyl Fumarate
Individuals with MS treated with dimethyl fumarate (Tecfidera)
Other Name: Tecfidera




Primary Outcome Measures :
  1. Percent change in CGM between teriflunomide and dimethyl fumarate [ Time Frame: 24 months ]
    Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate

  2. LM CE lesions at 24 months [ Time Frame: 24 months ]
    Frequency of leptomeningeal (LM) lesions as measured by presence (number) of LM contrast enhancing (CE) lesions foci on three-dimensional fluid-attenuated-inversion recovery (3D_FLAIR) MRI performed 10 minutes post-contrast injection between those on teriflunomide and dimethyl fumarate

  3. CGM atrophy and LM inflammation [ Time Frame: 24 months ]
    Association between the development of CGM atrophy and LM inflammation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with MS who have used dimethyl fumarate or teriflunomide and had magnetic resonance imaging at baseline (before starting disease modifying therapy (DMT) in question), 12 months after starting DMT, and 24 months after starting DMT.
Criteria

Inclusion Criteria:

  • Diagnosed with MS according to McDonald criteria
  • Age 18-65 years
  • Relapsing disease course
  • Expanded Disability Status Scale (EDSS) score of ≤ 5.5
  • MRI obtained at baseline (medication start date), 12 months, and 24 months
  • Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label
  • Clinical information available over the 24 month follow-up
  • None of the exclusion criteria

Exclusion Criteria:

  • Diagnosis of non-relapsing MS
  • Use of experimental drug or investigational procedure during the study period
  • Pregnancy during study period
  • Severe hepatic impairment
  • Relapse within 30 days prior to any of the 3 MRIs
  • Corticosteroid use within 30 days prior to the MRIs
  • Teriflunomide patients who have used leflunomide
  • Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone
  • Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation

Information from the National Library of Medicine

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): NCT03526224


Locations
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United States, New York
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States, 14203
Sponsors and Collaborators
University at Buffalo

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Responsible Party: Robert Zivadinov, MD, PhD, Director, Principal Investigator, University at Buffalo
ClinicalTrials.gov Identifier: NCT03526224     History of Changes
Other Study ID Numbers: STUDY00002359
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs