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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.