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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02907281
Other study ID # CFTY720D2319
Secondary ID 2011-001437-16
Status Completed
Phase N/A
First received September 8, 2016
Last updated November 15, 2017
Start date May 29, 2012
Est. completion date July 24, 2017

Study information

Verified date November 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 414
Est. completion date July 24, 2017
Est. primary completion date July 24, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Multiple sclerosis patients

- A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsing-remitting course

- MS disease duration of more than one year (from diagnosis of MS) before study entry

Healthy volunteers

- Matched to MS patients based on age, gender, ethnicity and visual refraction

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
Observational

Locations

Country Name City State
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Parkville, Victoria
Canada Novartis Investigative Site Calgary Alberta
Canada Novartis Investigative Site Greenfield Park Quebec
Czechia Novartis Investigative Site Praha 2
Denmark Novartis Investigative Site Copenhagen
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Magdeburg
Italy Novartis Investigative Site Bari
Italy Novartis Investigative Site Cagliari CA
Italy Novartis Investigative Site Genova
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Montichiari
Italy Novartis Investigative Site Padova
Italy Novartis Investigative Site Roma
Netherlands Novartis Investigative Site Amsterdam
Poland Novartis Investigative Site Lodz Lódzkie
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Cataluña
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Switzerland Novartis Investigative Site Zürich
United Kingdom Novartis Investigative Site London
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Iowa City Iowa
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Denmark,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Assess reproducibility of RNFL thickness on optical coherence tomography 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
Secondary 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
Secondary 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
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