multiple sclerosis MedDRA version: 15.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Gilenya
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Concentration unit: mg milligram(s)
Conc
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill the following criteria: • Written informed consent must be obtained before any assessment is performed • Male and female patients aged 18-55 years inclusive • A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsingremitting course • MS disease duration of more than one year (from diagnosis of MS) before study entry (Screening) Participants of the reference group eligible for inclusion have to fulfill the following criteria: • Written informed consent must be obtained before any assessment is performed • Male and female subjects aged 18-55 years inclusive • Matched to MS patients recruited in terms of age (±3 years), ethnicity, gender and visual refraction (±2 diopters) with the MS patients recruited. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. HIV or any other known immunodeficiency syndrome (disease or drug-induced) 2. Any ophthalmologic reason for RNFL pathology other than MS, such as: optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist’s clinical judgment or • history or presence of severe myopia: a. in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma c. in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm 3. Acute optic neuritis within the past 6 months before Baseline 4. Evidence of advanced, non-proliferative or proliferative diabetic retinopathy 5. Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc. 6. History of a severe head trauma 7. Any of the following neurologic/psychiatric disorders: • history of substance abuse (drug or alcohol) in the past five years or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures • specific MRI findings (tumor, subdural haematoma, post-contusional changes, territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation, evidence of past macroscopic haemorrhage, or other relevant MRI findings that would interfere with evaluation) • progressive neurological disorder, other than MS, which may affect participation in the study 8. Concomitant use of drugs that may directly affect retinal structure and function (e.g. chronic systemic corticosteroids [>30 consecutive days; doses higher than Cushing threshold e.g. prednisone 7.5mg/d], intraocular anti-angiogenic drugs [ranibizumab, bevacizumab], intraocular steroids etc.) 9. Any medically unstable condition, progressive disease (other than MS) or other condition that would preclude reliable participation in the study as assessed by the investigator 10. Patients unable to undergo MRI scans including gadolinium enhancement: • reduced renal clearance (eGFR <45 ml/min) • history of severe hypersensitivity to gadolinium-DTPA • claustrophobia that cannot be overcome otherwise 11. Patients who have received an investigational drug or therapy within 30 days or 5 half lives, which ever is longer, of the baseline visit. No additional exclusions may be applied by the investigator, in order to ensure that the population will be representative of all eligible patients. Participants of the reference group fulfilling any of the following criteria are not eligible for inclusion in this study: 1. HIV or any other known immunodeficiency syndrome (disease or drug-induced) 2. Any ophthalmologic reason for RNFL pathology other than MS, such as: • optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist’s clinical judgment or • history or presence of severe myopia: a. in subjects who have not had refractive surgery, a refractive error of greater than 6.00 diopters b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma c. in subjects that have had previous refractive surgery, an axial eye length of greater than 26 mm 3. Acute optic neuritis within the past 6 months before Baseline 4. Evidence of advanced, non-proli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate change in RNFL thickness in RRMS patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the optical coherence tomography (OCT) technology is sufficiently sensitive to disease and to change over time.;Secondary Objective: To evaluate the correlation of change in RNFL thickness and macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months. To evaluate the correlation of change in RNFL thickness and macular volume with change in disability (as assessed by the EDSS and visual function) in RRMS patients followed for up to 36 months. To evaluate short-team reproducibility of the RNFL thickness measure at study start by test/re-test estimation after a 4–week interval in RRMS patients and reference subjects (without neurologic or ophthalmic disease). To evaluate short-term reproducibility (4-week interval) in macular volume measure (as above). To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease).;Primary end point(s): The primary objective of the study is to evaluate the change in RNFL thickness in MS patients followed for up to 36 months compared to a group of reference subjects (without ophthalmic and neurologic disease).;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the correlation of change in RNFL thickness and macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months. To evaluate the correlation of change in RNFL thickness and macular volume with change in disability (as assessed by the EDSS and visual function) in RRMS patients followed for up to 36 months. To evaluate short-team reproducibility of the RNFL thickness measure at study start by test/re-test estimation after a 4–week interval in RRMS patients and reference subjects (without neurologic or ophthalmic disease). To evaluate short-term reproducibility (4-week interval) in macular volume measure (as above). To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease).;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Australia, Austria, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH
Outcome results
None listed