Teriflunomide Tecfidera LMCE

NCT03526224 | Completed FDA Drug

• 1 other identifier: STUDY00002359
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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®)

Conditions

Tecfidera; Teriflunomide

Outcome Measures

Primary Outcomes (3)

• Percent change in CGM between teriflunomide and dimethyl fumarate

  Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate

  24 months

• LM CE lesions at 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

  Association between the development of CGM atrophy and LM inflammation

  24 months

Study Arms (2)

Aubagio

Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).

Drug: Teriflunomide

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

Interventions

Dimethyl Fumarate DRUG

Individuals with MS treated with dimethyl fumarate (Tecfidera)

Also known as: Tecfidera

Tecfidera

Teriflunomide DRUG

Individuals with MS treated with teriflunomide (Aubagio)

Also known as: Aubagio

Aubagio

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Clinical information available over the 24 month follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• Zivadinov R, Bergsland N, Carl E, Ramasamy DP, Hagemeier J, Dwyer MG, Lizarraga AA, Kolb C, Hojnacki D, Weinstock-Guttman B. Effect of Teriflunomide and Dimethyl Fumarate on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective, Observational, Case-Control Pilot Study. J Clin Med. 2019 Mar 12;8(3):344. doi: 10.3390/jcm8030344.

  PMID: 30870983 RESULT

MeSH Terms

Interventions

Dimethyl Fumarate; teriflunomide

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: June 14, 2018
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)