- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811290
A Pilot Study Assessing the Impact of Gilenya Therapy on Bone Density Change in Relapsing Forms of Multiple Sclerosis (MS-BMD)
January 30, 2018 updated by: Virginia I. Simnad, MD, Simnad, Virginia, M.D.
A Single Center Prospective, Open Label, Pilot Study to Assess Change in Bone Mass Density and Select Bone Turnover Biomarkers in Gilenya Treated Versus Non-Gilenya Treated Ambulatory Subjects With a Relapsing Form of Multiple Sclerosis
The purpose of this study is to assess whether Multiple Sclerosis patients treated with Gilenya show a beneficial change over time in bone mass density and bone turnover markers as compared to matched controls treated with alternative FDA approved therapy or no therapy.
Study Overview
Status
Unknown
Conditions
Detailed Description
To assess the effect of Gilenya on the rate of decline in bone mass density and expression of selected bone turnover biomarkers in ambulatory subject with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, race, gender, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy at 24 months compared to baseline.
Study Type
Observational
Enrollment (Anticipated)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Kirkland, Washington, United States, 98034
- MS Center at Evergreen Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Men and women aged 21 or older diagnosed with a relapsing form of Multiple Sclerosis.
Minimum age was defined due to the limitations of site's current DXA bone scan software in scanning any person under 21 years of age.
A total of 36 subjects will be recruited, with estimated 20% screen failure/early termination to allow for 30 subjects enrolled to complete the study.
Racial composition of the regional population (Puget Sound of the Pacific Northwest, USA) from which study candidates will be recruited over-represents Caucasian individuals, and thus this pilot study may not be balanced for race.
Description
Inclusion Criteria:
• Male and female subjects, 21 years of age or older.
- Subjects must be able to give consent by signing and dating an informed consent form (written in English) prior to any study assessments being performed.
- Ambulatory with an Expanded Disability Status Scale(EDSS) between 2.5 - 6.5 inclusive.
- Must meet McDonald criteria for a relapsing form (relapsing remitting and secondary progressive) of Multiple Sclerosis.
- Gilenya therapy group subjects must have been treated with Gilenya a minimum of 3 months uninterrupted prior to screening visit, and approved by the principal investigator to continue on this agent.
- Control therapy group subjects must have been consistently on an FDA approved disease modifying therapy other than Gilenya or off such therapy a minimum of 6 months prior to screening visit.
- Subjects must be neurologically stable and have not received any form of steroid therapy for 4 weeks prior to screening visit.
- Subjects must abide by safety surveillance monitoring studies appropriate to their disease modifying therapy and considered standard of care. Such monitoring will be considered outside the scope of this study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Exclusion Criteria:
• Subjects must not have been treated with Fingolimod, Gilenya or other experimental Sphingosine 1-phosphate receptor agonist therapy in a clinical trial prior to enrollment in this study.
- Subjects on an FDA approved disease modifying therapy other than Gilenya, or on no therapy, must not have received Gilenya therapy within 12 months of screening visit.
- Current or previous use of bisphosphonate therapy, estrogen replacement, calcitonin, Depo-Provera, dehydroepiandrosterone, or methotrexate within 12 months of screening visit.
- Medical contraindication to daily calcium intake of at least 1000 mg daily, and vitamin D3 supplementation of 800 IU daily.
- Vitamin D insufficiency (25-hydroxy vitamin D level <=30 ng/ml) at the time of baseline visit.
- Meeting National Osteoporosis Foundation criteria for osteoporosis requiring treatment with study prohibited therapies:
- History of osteoporosis with baseline Dexa bone scan T score <-1.5 but >-2.0 with one or more risk factors for fracture (age >50 years, current smoking, low Body Mass Index (i.e. < 18.5), previous fragility fracture, parental history of osteoporosis or of fragility fracture of hip, femur, or vertebrae , alcohol consumption greater than 3 units per day, daily glucocorticoid usage).
- Dexa bone scan T score < -2.0 with or without additional risk factors.
- Subjects with Body Mass Index >=40 kg/m2 due to artifacts in Body mass density measurement with Dexa unit used.
- Subjects with anatomical deformities or vertebral fractures that would potentially distort Body mass density measurements.
- Current diagnosis of parathyroid disorder, untreated hyperthyroidism or hypothyroidism, renal insufficiency (Glomerular filtration rate- (GFR) <= 55), history of renal calculi or stones, uncontrolled mood disorder, drug or alcohol abuse.
- Current use of "first generation" anticonvulsant medication (barbiturate, phenytoin, carbamazepine, valproate), or of "second generation" anticonvulsant levetiracetam (implicated recently in accelerated bone density loss). Stable use of "second generation" anticonvulsant medication (gabapentin, pregabalin, lamotrigine, topiramate, lacosamide, zonisamide, oxcarbazepine) for symptoms management will be acceptable. Stable use of dopamine reuptake inhibitor class, Serotonin Norepinephrine Reuptake Inhibitors, Selective serotonin re-uptake inhibitor antidepressant therapies will be allowed.
- Continuous or "pulsed" treatment with a corticosteroid for any medical condition. Brief therapy with intravenous methylprednisolone 1 gram for 3-5 days with no oral taper, for a confirmed neurological relapse will be allowed.
- Subjects must not have any unstable medical or psychiatric condition per the judgment of the principal investigator which would risk safety or completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Gilenya Subjects
Gilenya therapy group subjects must have been treated with Gilenya a minimum of 3 months uninterrupted prior to screening visit, and approved by the principal investigator to continue on this agent.
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Controlled Therapy Group
Control therapy group subjects must have been consistently on an FDA approved disease modifying therapy other than Gilenya or off such therapy a minimum of 6 months prior to screening visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess change in bone mass density in subjects taking Gilenya versus subjects taking alternative disease modifying therapy or no therapy.
Time Frame: baseline and 22 months (96 weeks)
|
The primary objective of this pilot study will be to assess the effect of Gilenya (fingolimod) on the rate of decline in bone mass density and expression of selected bone turnover biomarkers over 2 years in ambulatory subjects with a relapsing form of Multiple Sclerosis compared to control subjects matched for age, gender, race, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy.
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baseline and 22 months (96 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interim analysis of primary outcome measures
Time Frame: baseline and 11 months (48 weeks)
|
Assessment at week 48 of the change from baseline in bone mass density in ambulatory subjects with a relapsing form of MS treated with Gilenya compared to control subjects matched for age, gender, race, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy.
|
baseline and 11 months (48 weeks)
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Interim analysis of secondary outcome measures
Time Frame: baseline and 11 months (48 weeks)
|
expression of selected bone turnover biomarkers in ambulatory subjects with a relapsing form of Multiple Sclerosis treated with Gilenya compared to control subjects matched for age, gender, race, duration of disease, and disability on an alternative FDA approved disease modifying therapy or no therapy.
|
baseline and 11 months (48 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Virginia I Simnad, MD, Evergreen Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
March 8, 2013
First Submitted That Met QC Criteria
March 12, 2013
First Posted (Estimate)
March 14, 2013
Study Record Updates
Last Update Posted (Actual)
February 1, 2018
Last Update Submitted That Met QC Criteria
January 30, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-BMD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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