TecfideraNCT03526224

Teriflunomide Tecfidera LMCE

An observational study of Tecfidera and Teriflunomide, run by University at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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®) Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Tecfidera, Teriflunomide
What is being tested?: Dimethyl Fumarate and Teriflunomide
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2018to 10 Jul 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Buffalo Neuroimaging Analysis Center
Buffalo, New York, 14203

Other trials in United States

About this study

Official title: 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®)

Conditions: Tecfidera, Teriflunomide
Being tested: Dimethyl Fumarate, Teriflunomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dimethyl FumarateDrug
Also called Tecfidera
Individuals with MS treated with dimethyl fumarate (Tecfidera)
TeriflunomideDrug
Also called Aubagio
Individuals with MS treated with teriflunomide (Aubagio)

Study groups in NCT03526224
Study group	Role	What they receive
Aubagio		Individuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio). Receives: 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 Receives: Drug: Dimethyl Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change in CGM between teriflunomide and dimethyl fumarate
Percent change in cortical gray matter (CGM) between those on teriflunomide and dimethyl fumarate
Measured: 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
Measured: 24 months
CGM atrophy and LM inflammation
Association between the development of CGM atrophy and LM inflammation
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 201810 Jul 2019

First posted16 May 2018
Study start14 Jun 2018
Primary completion10 Jul 2019
Study completion10 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TecfideraStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03526224
Sponsor's protocol ID: STUDY00002359
Status last verified: Jan 2021
First submitted: 3 May 2018
Last updated: 6 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No data will be shared with other researchers

Publications

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.
PubMed 30870983

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis (RRMS)
Active, not recruitingObservational study
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Multiple Sclerosis (MS) Relapsing Remitting
RecruitingObservational study
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
RecruitingPhase 2/3
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
Type 1 Diabetes Mellitus

All Tecfidera trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study
ClinicalTrials.gov ID: NCT03526224
Acronym / sponsor ID: STUDY00002359
Conditions: Tecfidera, Teriflunomide
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University at BuffaloUniversity, hospital or other
Study start: 14 Jun 2018 (actual)
Primary completion: 10 Jul 2019 (actual)
Study completion: 10 Jul 2019 (actual)
First posted: 16 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Aubagio	–	Drug: TeriflunomideIndividuals diagnosed with multiple sclerosis (MS) who have been treated with teriflunomide (Aubagio).
Tecfidera	–	Drug: Dimethyl FumarateIndividuals 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dimethyl FumarateAlso: TecfideraIndividuals with MS treated with dimethyl fumarate (Tecfidera)	Drug	Tecfidera
TeriflunomideAlso: AubagioIndividuals with MS treated with teriflunomide (Aubagio)	Drug	Aubagio

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
Results publication: PubMed 30870983Zivadinov 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.
Individual participant dataSharing planned: No. No data will be shared with other researchers

Related trials for Tecfidera

Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis (RRMS)
Active, not recruitingObservational study
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Multiple Sclerosis (MS) Relapsing Remitting
RecruitingObservational study
A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
RecruitingPhase 2/3
Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes
Type 1 Diabetes Mellitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tecfidera and Teriflunomide, run by University at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in CGM between teriflunomide and dimethyl fumarate (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526224, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.