Multiple SclerosisNCT01592097
Exploratory Study to Assess Clinical Response to Gilenya® (Fingolimod) in Hispanics With RRMS
An observational study of Multiple Sclerosis, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of the University of Southern Calfornia
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Autoimmune
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Lilyana Amezcua, University of Southern California
- Investigators
- Lilyana Amezcua, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592097
- Sponsor's protocol ID
- CFTY720DUS04T
- Status last verified
- Apr 2018
- First submitted
- 1 May 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Exploratory, Study to Assess Clinical Response to Gilenya® (Fingolimod) in a Cohort of Relapsing Remitting Hispanic MS Forms
- ClinicalTrials.gov ID
- NCT01592097
- Acronym / sponsor ID
- CFTY720DUS04T
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Autoimmune
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jun 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- USC MS Comprehensive Care Center and Research GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilyana Amezcua, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.