Teriflunomide Tecfidera LMCE

U

University at Buffalo

Status

Completed

Conditions

Teriflunomide
Tecfidera

Treatments

Drug: Dimethyl Fumarate
Drug: Teriflunomide

Study type

Observational

Funder types

Other

Identifiers

NCT03526224
STUDY00002359

Details and patient eligibility

About

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®)

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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