Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01592097
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2012-05-01
Brief Title:
Exploratory Study to Assess Clinical Response to Gilenya Fingolimod in Hispanics With RRMS
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Non-randomized Exploratory Study to Assess Clinical Response to Gilenya Fingolimod in a Cohort of Relapsing Remitting Hispanic MS Forms
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 fingolimodin 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
1 Number of relapse-free patients over the investigational period
2 Site of relapse defined as brain or spinal cord
3 Sustained Disability progression will be defined as a one point 1 increase from baseline in patients with baseline EDSS score from 0 to 50 or half a point 05 increase in patients with baseline EDSS score of 5-55 or above after 3 months
4 MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions after 12 months from baseline
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
1 Number of relapse-free patients over the investigational period
2 Site of relapse defined as brain or spinal cord
3 Sustained Disability progression will be defined as a one point 1 increase from baseline in patients with baseline EDSS score from 0 to 50 or half a point 05 increase in patients with baseline EDSS score of 5-55 or above after 3 months
4 MRI changes as described as number of new T2 lesions and number of Gd-enhancing lesions after 12 months from baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None