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

May 1, 2012
June 29, 2012
June 2012
April 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01592097 on ClinicalTrials.gov Archive Site
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Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Relapsing Remitting Hispanic Multiple Sclerosis Forms
A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

Multiple Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Pat Gutierrez 323-342-6817 fgutierr@usc.edu
Contact: Jose Aparicio 323-442-6833 joseapar@usc.edu
United States
 
NCT01592097
CFTY720DUS04T
No
Lilyana Amezcua, University of Southern California
University of Southern California
Novartis Pharmaceuticals
Principal Investigator: Lilyana Amezcua, MD University of Southern California
University of Southern California
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP