Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Hispanics With RRMS

NCT01592097 | Completed

• 1 other identifier: CFTY720DUS04T
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; Autoimmune

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 50 individuals with MS who self identify Hispanic descent and are served at USC clinics. Hispanic patients with clinically definite MS, defined by the newly revised McDonald criteria, will be offered the opportunity to participate in this study and asked to give informed consent.

You may qualify if:

• Ability to understand and sign the IRB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol.
• Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and must be willing to practice a reliable birth-control method.
• Patient must be willing to discontinue and remain free from concomitant immunosuppressive or additional immunomodulatory treatment (including IFNβ1a, 1b, natalizumab and GA) for the duration of the study.
• Willing to answer a series of questions about disease, ancestry, residence history, socioeconomic status and ethnic background.
• Willing to donate 50cc of blood for genetic admixture and immunological testing on three occasions (O months, 6 months, 12 months).
• Willing to undergo MRI as standard of care at a 1.5 Tesla magnet strength at least.

You may not qualify if:

• Inability to understand nature of the study.
• Lack of a definite diagnosis of Multiple Sclerosis such as clinical isolated syndrome will be excluded.
• NMO Antibody positive.
• Primary progressive or secondary progressive MS.
• Inability to undergo an MRI study or receive contrast agent and GFR\<30.
• Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment.
• Lack of Varicella immunity.
• History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease.
• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
• Known history of human immunodeficiency virus infection, hematological malignancy, or organ transplantation, history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• Prior treatment history with the interferons, glatiramer acetate or natalizumab will be acceptable after drug clearance of 1 month. 1 month has been selected due to clinical experience of possible disease breakthrough if longer period is performed.

Sponsors & Collaborators

• University of Southern California: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Keck School of Medicine of the University of Southern Calfornia

Los Angeles, California, 90033, United States

Location

Related Links

• USC MS Comprehensive Care Center and Research Group

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from isolated cells; the remaining cells will be cryopreserved for any duplicate analyses.

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

• Lilyana Amezcua, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-04

Locations

US (1)