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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02307877
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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 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.

Condition or disease
Multiple Sclerosis

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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : September 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Subjects currently taking Fingolimod for a minimum of 2 years
glatiramer acetate
Subjects currently taking glatiramer acetate for a minimum of 2 years

Primary Outcome Measures :
  1. 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,

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS patients who have been taking either fingolimod or glatiramer acetate for at least 2 years

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02307877

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Kavita Nair, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT02307877     History of Changes
Other Study ID Numbers: 14-0774
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathological Conditions, Anatomical
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antirheumatic Agents