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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001437-16 | EudraCT Number |
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This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS).
Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple sclerosis patients | Multiple sclerosis patients |
| |
| Healthy volunteers | Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Retinal Nerve Fiber Layer Thickness (RNFL) | evaluate change in RNFL thickness in relapsing remitting multiple sclerosis (RRMS) patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the technology is sufficiently sensitive to disease and to change over time. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of change in macular volume with change in brain volume | To evaluate the correlation of change in macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months. | 36 months |
| Assess reproducibility of RNFL thickness on optical coherence tomography |
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Multiple sclerosis patients
Healthy volunteers
- Matched to MS patients based on age, gender, ethnicity and visual refraction
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Multiple Sclerosis patients and healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | San Francisco | California | 94143-0359 | United States | ||
| Novartis Investigative Site |
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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). |
| 4 weeks |
| Change in macular volume over 36 months | To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease). | 36 months |
| Correlation of change in RNFL thickness with change in brain volume | To evaluate the correlation of change in RNFL thickness with change in brain volume as measured by magnetic resonance imaging (MRI) in RRMS patients followed for up to 36 months. | 36 months |
| Torrance |
| California |
| 90509-2004 |
| United States |
| Novartis Investigative Site | Iowa City | Iowa | 52242 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21287 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Novartis Investigative Site | Camperdown | New South Wales | 2050 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3065 | Australia |
| Novartis Investigative Site | Calgary | Alberta | T2N 4Z1 | Canada |
| Novartis Investigative Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Novartis Investigative Site | Prague | 128 08 | Czechia |
| Novartis Investigative Site | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Cagliari | CA | 09126 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Bari | 70124 | Italy |
| Novartis Investigative Site | Genova | 16132 | Italy |
| Novartis Investigative Site | Montichiari | 25018 | Italy |
| Novartis Investigative Site | Padova | 35128 | Italy |
| Novartis Investigative Site | Roma | 189 | Italy |
| Novartis Investigative Site | Amsterdam | 1081 | Netherlands |
| Novartis Investigative Site | Lodz | Lódzkie | 90-153 | Poland |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 8036 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | London | EC1V 2PD | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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