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.|
|ClinicalTrials.gov Identifier: NCT02307877|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : October 26, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||157 participants|
|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 :||September 2018|
|Estimated Study Completion Date :||December 2018|
Subjects currently taking Fingolimod for a minimum of 2 years
Subjects currently taking glatiramer acetate for a minimum of 2 years
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT02307877
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Kavita Nair, PhD||University of Colorado, Denver|