Teriflunomide Tecfidera LMCE

January 4, 2021 updated by: Robert Zivadinov, MD, PhD, University at Buffalo

Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study

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®)

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo Neuroimaging Analysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aubagio
Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
Individuals with MS treated with teriflunomide (Aubagio)
Other Names:
  • 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
Individuals with MS treated with dimethyl fumarate (Tecfidera)
Other Names:
  • Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
24 months
CGM atrophy and LM inflammation
Time Frame: 24 months
Association between the development of CGM atrophy and LM inflammation
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

July 10, 2019

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No data will be shared with other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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