Teriflunomide Tecfidera LMCE

Completed

• Conditions: Tecfidera; Teriflunomide
• Interventions: Drug: Teriflunomide; Drug: Dimethyl Fumarate

• Registration Number: NCT03526224
• Lead Sponsor: 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®)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-16
• Study Start: 2018-06-14
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aubagio	Teriflunomide	Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
Tecfidera	Dimethyl Fumarate	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

Primary Outcome Measures

Name	Time	Method
LM CE lesions at 24 months	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
Percent change in CGM between teriflunomide and dimethyl fumarate	24 months	Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate
CGM atrophy and LM inflammation	24 months	Association between the development of CGM atrophy and LM inflammation

Trial Locations

Locations (1)

Buffalo Neuroimaging Analysis Center; 🇺🇸 Buffalo, New York, United States