Comparison of Brain Atrophy Rates, Cognition, and Patient-Reported Outcomes in MS Patients Using Long-term Fingolimod and Glatiramer Acetate

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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,
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)

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Comparative Effectiveness of Long Term Fingolimod Versus Glatiramer Acetate on Brain Atrophy Rates, Cognition and Patient Reported Outcomes in Patients With Multiple Sclerosis

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Dec 4, 2014
Registry last updated: Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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