Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

NCT02907281 | Completed

• 2 other identifiers: CFTY720D23192011-001437-16
• Study Type: observational
• Target: 414
• Locations: 12 countries
• Sites: 28

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.

Conditions

Multiple Sclerosis; RRMS

Keywords

Multiple sclerosis,; MS,; Optical coherence tomography; OCT,; RRMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation of change in macular volume with change in brain volume

  36 months

• Assess reproducibility of RNFL thickness on optical coherence tomography

  4 weeks

• Change in macular volume over 36 months

  36 months

• Correlation of change in RNFL thickness with change in brain volume

  36 months

Study Arms (2)

Multiple sclerosis patients

Multiple sclerosis patients

Other: Observational

Healthy volunteers

Healthy volunteers

Other: Observational

Interventions

Observational OTHER

Observational

Healthy volunteers; Multiple sclerosis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis patients and healthy volunteers

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

San Francisco, California, 94143-0359, United States

Location

Novartis Investigative Site

Torrance, California, 90509-2004, United States

Location

Novartis Investigative Site

Iowa City, Iowa, 52242, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21287, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Novartis Investigative Site

Camperdown, New South Wales, 2050, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3065, Australia

Location

Novartis Investigative Site

Calgary, Alberta, T2N 4Z1, Canada

Location

Novartis Investigative Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Novartis Investigative Site

Prague, 128 08, Czechia

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Magdeburg, 39120, Germany

Location

Novartis Investigative Site

Cagliari, CA, 09126, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Bari, 70124, Italy

Location

Novartis Investigative Site

Genova, 16132, Italy

Location

Novartis Investigative Site

Montichiari, 25018, Italy

Location

Novartis Investigative Site

Padua, 35128, Italy

Location

Novartis Investigative Site

Roma, 189, Italy

Location

Novartis Investigative Site

Amsterdam, 1081, Netherlands

Location

Novartis Investigative Site

Lodz, Lódzkie, 90-153, Poland

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 8036, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 20, 2016
• Study Start: May 29, 2012
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1); DK (1); IT (7); DE (2); AU (2); GB (1); CA (2); PL (1); NL (1); US (5); CH (1); ES (4)