- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526224
Teriflunomide Tecfidera LMCE
January 4, 2021 updated by: Robert Zivadinov, MD, PhD, University at Buffalo
Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
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®)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Buffalo, New York, United States, 14203
- Buffalo Neuroimaging Analysis Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Aubagio
Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
|
Individuals with MS treated with teriflunomide (Aubagio)
Other Names:
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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
|
Individuals with MS treated with dimethyl fumarate (Tecfidera)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
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
|
24 months
|
CGM atrophy and LM inflammation
Time Frame: 24 months
|
Association between the development of CGM atrophy and LM inflammation
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24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2018
Primary Completion (Actual)
July 10, 2019
Study Completion (Actual)
July 10, 2019
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 15, 2018
First Posted (Actual)
May 16, 2018
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 4, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Dimethyl Fumarate
- Teriflunomide
Other Study ID Numbers
- STUDY00002359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No data will be shared with other researchers
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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