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

NCT02307877 | Completed

• 2 other identifiers: 14-0774UL1TR001082
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline; Year 1; Year 2.

Study Arms (2)

Fingolimod

Subjects currently taking Fingolimod for a minimum of 2 years

glatiramer acetate

Subjects currently taking glatiramer acetate for a minimum of 2 years

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

MS patients who have been taking either fingolimod or glatiramer acetate for at least 2 years

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kavita Nair, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: December 4, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

US (1)