Teriflunomide Tecfidera LMCE

• ClinicalTrials.gov Identifier: NCT03526224
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2018
• Last Update Posted: October 15, 2018
• Sponsor: University at Buffalo
• Information provided by (Responsible Party): Robert Zivadinov, MD, PhD, University at Buffalo

Tracking Information

• First Submitted Date: May 3, 2018
• First Posted Date: May 16, 2018
• Last Update Posted Date: October 15, 2018
• Actual Study Start Date: June 4, 2018
• Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2018)

• 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
• 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
• CGM atrophy and LM inflammation [ Time Frame: 24 months ]
  Association between the development of CGM atrophy and LM inflammation

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03526224 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Teriflunomide Tecfidera LMCE
• Official Title: Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Tecfidera
• Teriflunomide

Intervention

• Drug: Dimethyl Fumarate
  Individuals with MS treated with dimethyl fumarate (Tecfidera)
  Other Name: Tecfidera
• Drug: Teriflunomide
  Individuals with MS treated with teriflunomide (Aubagio)
  Other Name: Aubagio

Study Groups/Cohorts

• Aubagio
  Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
  Intervention: 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
  Intervention: Drug: Dimethyl Fumarate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 15, 2018): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2019
• Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03526224
• Other Study ID Numbers: STUDY00002359
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No data will be shared with other researchers

• Responsible Party: Robert Zivadinov, MD, PhD, University at Buffalo
• Study Sponsor: University at Buffalo
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University at Buffalo
• Verification Date: October 2018