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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01592097

Run by

University of Southern California

People needed

51

Starts

2012-06-01

Expected to finish

2018-04-01

Last updated by the study team

2018-05-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically definite multiple sclerosis defined by McDonald Criteria (8) with a score of 0 to 5.5 on the Expanded Disability Status Scale (EDSS)(9). Inclusion will also be determined by PI if clinically indicated. Relapsing remitting form of MS.
• Between 18-65 years of age (This age range is selected so as to capture the vast majority of patients who are seen in the clinics with a confirmed diagnosed of MS. This age range also allows for exclusion of co-morbid conditions that may be associated with aging as well as pediatric cases where their disease characteristics have been shown to be different).
• 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.

Where it is running

• Keck School of Medicine of the University of Southern Calfornia — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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