Multiple SclerosisNCT02307877
Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate
An observational study of Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: MS patients who have been taking either fingolimod or glatiramer acetate for at least 2 years
Who may be able to join
- Must be able to provide written informed consent
- Between 18-55 years of age at the time of informed consent.
- Diagnosis of any form of MS as defined by the 2010 revised McDonald criteria
- Currently taking fingolimod or glatiramer acetate for a minimum of two years at the time of the initial baseline visit
- Must be willing and able to comply with the protocol requirements for the duration of the study
Who cannot join
- Suffering from comorbidities that could confound the MRI outcomes or are (relative) contraindicated to receive treatment with fingolimod such as:
- diabetes,
- myocardial infarction,
- unstable angina,
- transient ischemic attack,
- decompensated heart failure,
Show all 19Show fewer
- history of Mobitz Type II 2nd or 3rd degree atrioventricular block,
- sick sinus syndrome,
- history of stroke,
- history of traumatic brain injury,
- history of encephalitis,
- dementia (not related to MS).
- Systemic steroid used (oral or IV) within 30 days of the baseline visit.
- Ever treated with chemotherapy.
- Ever having undergone cranial radiation, or intracranial surgery.
- Unable to tolerate an MRI scan.
- Is pregnant or breastfeeding or planning on pregnancy during the study period.
- Is decisionally challenged, illiterate or blind
- Is non-English speaking (as the PRO instruments are only validated in English)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Comparative Effectiveness of Long Term Fingolimod Versus Glatiramer Acetate on Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients With Multiple Sclerosis
Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into whether there is continued progression of MS in these patients. What remains unknown is whether patients on a particular therapy have a slower rate of brain atrophy. This would provide convincing evidence that central nervous system tissue injury is further suppressed. Such information would be of substantial clinical benefit when deciding between various therapies.
The investigators will estimate the impact of long term use of fingolimod therapy (defined as a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate.
Read more
The investigators secondary goal is to determine the correlation between brain atrophy and cognitive performance in treated patients with relapsing forms of MS.
The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical disability, work productivity, clinical assessments of cognitive functioning with whole brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and gender.
The investigators anticipate the findings of this study will generate relevant hypotheses about these relationships.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | Subjects currently taking Fingolimod for a minimum of 2 years | |
| glatiramer acetate | Subjects currently taking glatiramer acetate for a minimum of 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole Brain Atrophy (Rate of whole brain atrophy (T2 - T0): Two-time point percentage brain volume change (PBVC)
Rate of whole brain atrophy (T2 - T0): Two-time point percentage brain volume change (PBVC) over the two years of the study will be estimated from the 3D T-1 weighted acquisition with Structural Image Evaluation Using Normalization of Atrophy (SIENA) software, part of FSL (Functional MRI of the Brain [FMRIB] Software Library, http://www.fmrib.ox.ac.uk/fsl).
Measured: Baseline; Year 1; Year 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2018
- Study completionMay 2018
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kavita Nair, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307877
- Sponsor's protocol ID
- 14-0774
- Other IDs
- UL1TR001082
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2014
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Long Term Fingolimod Versus Glatiramer Acetate on Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02307877
- Acronym / sponsor ID
- 14-0774
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 4 Dec 2014 (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.
Rates of brain atrophy for long term users of fingolimod when compared to glatiramer acetate have not been examined in patients with relapsing forms of multiple sclerosis (MS). As patients on long term therapy typically have little or no overt signs of white matter inflammatory activity (T2, gad lesions), brain atrophy measures can provide insight into whether there is continued progression of MS in these patients. What remains unknown is whether patients on a particular therapy have a slower rate of brain atrophy. This would provide convincing evidence that central nervous system tissue injury is further suppressed. Such information would be of substantial clinical benefit when deciding between various therapies.
The investigators will estimate the impact of long term use of fingolimod therapy (defined as a minimum of two years on therapy) on whole brain atrophy in treated patients with relapsing forms of MS as compared to age and gender matched patients on Glatiramer Acetate.
The investigators secondary goal is to determine the correlation between brain atrophy and cognitive performance in treated patients with relapsing forms of MS.
The investigators will also examine the correlation between the NeuroQualityofLife (NeuroQOL) PROs, patient self-reports of disability, clinical assessment of physical disability, work productivity, clinical assessments of cognitive functioning with whole brain volume loss for patients on long term fingolimod vs. long term glatiramer acetate therapy matched on age and gender.
The investigators anticipate the findings of this study will generate relevant hypotheses about these relationships.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | – | –Subjects currently taking Fingolimod for a minimum of 2 years |
| glatiramer acetate | – | –Subjects currently taking glatiramer acetate for a minimum of 2 years |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- MS patients who have been taking either fingolimod or glatiramer acetate for at least 2 years
Key inclusion criteria (5 listed)
- Must be able to provide written informed consent
- Between 18-55 years of age at the time of informed consent.
- Diagnosis of any form of MS as defined by the 2010 revised McDonald criteria
- Currently taking fingolimod or glatiramer acetate for a minimum of two years at the time of the initial baseline visit
- Must be willing and able to comply with the protocol requirements for the duration of the study
Key exclusion criteria (19 listed)
- Suffering from comorbidities that could confound the MRI outcomes or are (relative) contraindicated to receive treatment with fingolimod such as:
- Systemic steroid used (oral or IV) within 30 days of the baseline visit.
- Ever treated with chemotherapy.
- Ever having undergone cranial radiation, or intracranial surgery.
- Unable to tolerate an MRI scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole Brain Atrophy (Rate of whole brain atrophy (T2 - T0): Two-time point percentage brain volume change (PBVC)
Time frame: Baseline; Year 1; Year 2.
Rate of whole brain atrophy (T2 - T0): Two-time point percentage brain volume change (PBVC) over the two years of the study will be estimated from the 3D T-1 weighted acquisition with Structural Image Evaluation Using Normalization of Atrophy (SIENA) software, part of FSL (Functional MRI of the Brain [FMRIB] Software Library, http://www.fmrib.ox.ac.uk/fsl).
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 8 Mar 2022.
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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.
Kavita Nair, PhD principal investigator
University of Colorado, Denver
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 of Colorado, Denver 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 5 inclusion and 19 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 8 Mar 2022. 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?
Whole Brain Atrophy (Rate of whole brain atrophy (T2 - T0): Two-time point percentage brain volume change (PBVC) (time frame: Baseline; Year 1; Year 2.). 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 8 Mar 2022.