Multiple Sclerosis Clinical Trial

Teriflunomide Tecfidera LMCE

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®)

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

120

Study ID:

NCT03526224

Recruitment Status:

Completed

Sponsor:

University at Buffalo

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

120

Study ID:

NCT03526224

Recruitment Status:

Completed

Sponsor:


University at Buffalo

How clear is this clinincal trial information?

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