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Teriflunomide Tecfidera LMCE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526224
Recruitment Status : Active, not recruiting
First Posted : May 16, 2018
Last Update Posted : October 15, 2018
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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