Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Relapsing Remitting Hispanic Multiple Sclerosis Forms

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Southern California
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Lilyana Amezcua, University of Southern California
ClinicalTrials.gov Identifier:
NCT01592097
First received: May 1, 2012
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 50
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)
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® (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:

  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 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5-5.5 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592097

Contacts
Contact: Pat Gutierrez 323-342-6817 fgutierr@usc.edu
Contact: Jose Aparicio 323-442-6833 joseapar@usc.edu

Locations
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    fgutierr@usc.edu   
Contact: Jose Aparicio    323-442-6833    joseapar@usc.edu   
Sponsors and Collaborators
University of Southern California
Novartis Pharmaceuticals
Investigators
Principal Investigator: Lilyana Amezcua, MD University of Southern California
  More Information

Additional Information:
No publications provided

Responsible Party: Lilyana Amezcua, Assistant Professor of Neurology, University of Southern California
ClinicalTrials.gov Identifier: NCT01592097     History of Changes
Other Study ID Numbers: CFTY720DUS04T
Study First Received: May 1, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Multiple Sclerosis
MS
Autoimmune

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014