Multiple SclerosisGZANCT01881191
Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
An observational study of Multiple Sclerosis, run by University at Buffalo at 1 site in United States.
Trial summary
This study will evaluate the effects of Aubagio on changes in the brain using MRI. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MRI
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their disease modifying therapy. Healthy controls from the general population.
Who may be able to join
- Subjects aged 18-65
- Clinically definite MS according to the Polman criteria, 52
- Relapsing MS or Healthy Control (no neurological disorders)
- Expanded Disability Status Scale (EDSS) scores ≤5.5
- Disease duration <30 years
- Normal kidney function (creatinine clearance >59 mL/min) (patients only)
- Signed informed consent
- None of the exclusion criteria
Who cannot join
- MS patients with hepatic impairment
- Nursing mothers or pregnant women who will need to undergo 12 months follow-up
- Women of childbearing potential not using reliable contraception
- Patients currently treated with leflunomide
- Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
- A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
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- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
- Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
- Other pathology related to MRI abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo Neuroimaging Analysis Center
Buffalo, New York, 14203
About this study
Official title: Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
This study will evaluate the effects of Aubagio on changes in the brain using MRI.
Read the detailed description
Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.
- Conditions
- Multiple Sclerosis
- Being tested
- MRI
- Keywords
- multiple sclerosis, relapsing remitting, MRI, teriflunomide, aubagio, gray matter atrophy, gray matter pathology
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Aubagio MRI | Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire. Receives: Other: MRI | |
| Healthy controls | Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.
Measured: baseline, 6 month and 12 month
Secondary outcomes (1)
The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.
Measured: baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD,PhD,FAAN, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881191
- Sponsor's protocol ID
- GZ-2013-10958
- Acronym
- GZA
- Status last verified
- Feb 2016
- First submitted
- 17 Jun 2013
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
- ClinicalTrials.gov ID
- NCT01881191
- Acronym / sponsor ID
- GZA / GZ-2013-10958
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing remitting, MRI, teriflunomide, aubagio, gray matter atrophy, gray matter pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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 evaluate the effects of Aubagio on changes in the brain using MRI.
Detailed description
Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aubagio MRI | – | Other: MRIPatients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire. |
| Healthy controls | – | Other: MRISubjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their disease modifying therapy. Healthy controls from the general population.
Key inclusion criteria (8 listed)
- Subjects aged 18-65
- Clinically definite MS according to the Polman criteria, 52
- Relapsing MS or Healthy Control (no neurological disorders)
- Expanded Disability Status Scale (EDSS) scores ≤5.5
- Disease duration <30 years
Key exclusion criteria (9 listed)
- MS patients with hepatic impairment
- Nursing mothers or pregnant women who will need to undergo 12 months follow-up
- Women of childbearing potential not using reliable contraception
- Patients currently treated with leflunomide
- Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
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 |
|---|---|---|
| MRI | Other | Aubagio MRI, Healthy controls |
Primary outcome
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI.
Time frame: baseline, 6 month and 12 month
1 secondary outcome
The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months.
Time frame: baseline, month 6 and month 12
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 12 Feb 2016.
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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.
Robert Zivadinov, MD,PhD,FAAN principal investigator
University at Buffalo
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 Multiple Sclerosis, 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 12 Feb 2016. 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?
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI. (time frame: baseline, 6 month and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016.