Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Relapsing Remitting Hispanic Multiple Sclerosis Forms
Gilenya (fingolimod) is approved for multiple sclerosis. However, it is unclear of its clinical effect in the Hispanics with MS given that clinical studies had limited representation of this population. It is also unclear if Gilenya would be as effective in individuals with disease predominantly affecting the optic nerve and spinal cord (OSMS) commonly seen in Asian populations.
Objectives: To compare the clinical response of Gilenya® (fingolimod) in relapsing remitting OSMS and MS of Hispanic descent using ancestral markers as a biomarker of treatment response and clinical disease state.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms|
DNA will be extracted from isolated cells; the remaining cells will be cryopreserved for any duplicate analyses.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
The primary objective of this study is to determine the success of Gilenya® (fingolimod) treatment in patients with MS of Hispanic descent relative to their ancestral background. Therapeutic success will be determined by annualized relapse rate (ARR; defined as the number of relapses divided by the person years followed) after initiation of treatment with Gilenya® (fingolimod)in comparison to the relapse rate in the previous 12 months. This will be determined based on medical chart extraction, in-person assessment and regular clinical follow-up.
A secondary objective of this study is to investigate whether the efficacy of Gilenya® (fingolimod) is superior or equal in HW which have higher loads of Amerindian versus Caucasian background with opticospinal MS (OSMS-NMO neg) versus classical MS (CMS) in the first 12 months using radiological and clinical parameters. The following measures will be obtained:
- Number of relapse-free patients over the investigational period
- Site of relapse defined as brain or spinal cord.
- Sustained Disability progression will be defined as a one point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5-5.5 or above after 3 months.
- MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions after 12 months from baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592097
|Contact: Pat Gutierrezemail@example.com|
|Contact: Jose Apariciofirstname.lastname@example.org|
|United States, California|
|Keck School of Medicine of the University of Southern Calfornia||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Pat Gutierrez 323-442-6817 email@example.com|
|Contact: Jose Aparicio 323-442-6833 firstname.lastname@example.org|
|Principal Investigator:||Lilyana Amezcua, MD||University of Southern California|