Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis (OCTIMS)

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ClinicalTrials.gov Identifier: NCT02907281

Recruitment Status : Completed

First Posted : September 20, 2016

Last Update Posted : November 17, 2017

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Multiple Sclerosis RRMS	Other: Observational

Study Design

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Study Type :	Observational
Actual Enrollment :	414 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
Actual Study Start Date :	May 29, 2012
Actual Primary Completion Date :	July 24, 2017
Actual Study Completion Date :	July 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Multiple sclerosis patients Multiple sclerosis patients	Other: Observational Observational
Healthy volunteers Healthy volunteers	Other: Observational Observational

Outcome Measures

Primary Outcome Measures :

Change in Retinal Nerve Fiber Layer Thickness (RNFL) [ Time Frame: 36 months ]
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.

Secondary Outcome Measures :

Correlation of change in macular volume with change in brain volume [ Time Frame: 36 months ]
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.
Assess reproducibility of RNFL thickness on optical coherence tomography [ Time Frame: 4 weeks ]
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).
Change in macular volume over 36 months [ Time Frame: 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).
Correlation of change in RNFL thickness with change in brain volume [ Time Frame: 36 months ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Multiple Sclerosis patients and healthy volunteers

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907281

Locations

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United States, California
Novartis Investigative Site
San Francisco, California, United States, 94143-0359
Novartis Investigative Site
Torrance, California, United States, 90509-2004
United States, Iowa
Novartis Investigative Site
Iowa City, Iowa, United States, 52242
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104-4283
Australia, New South Wales
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Novartis Investigative Site
Parkville,, Victoria, Australia, 3065
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4Z1
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
Czechia
Novartis Investigative Site
Praha 2, Czechia, 128 08
Denmark
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Magdeburg, Germany, 39120
Italy
Novartis Investigative Site
Cagliari, CA, Italy, 09126
Novartis Investigative Site
Milano, MI, Italy, 20132
Novartis Investigative Site
Bari, Italy, 70124
Novartis Investigative Site
Genova, Italy, 16132
Novartis Investigative Site
Montichiari, Italy, 25018
Novartis Investigative Site
Padova, Italy, 35128
Novartis Investigative Site
Roma, Italy, 189
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081
Poland
Novartis Investigative Site
Lodz, Lódzkie, Poland, 90-153
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Cataluña, Spain, 8036
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site
Madrid, Spain, 28040
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
London, United Kingdom, EC1V 2PD

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02907281
Other Study ID Numbers:	CFTY720D2319 2011-001437-16 ( EudraCT Number )
First Posted:	September 20, 2016 Key Record Dates
Last Update Posted:	November 17, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Multiple sclerosis, MS, Optical coherence tomography OCT, RRMS

Additional relevant MeSH terms:

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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System	Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases

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