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Eligibility
for people ages 18–65
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official Title

A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis

Keywords

Multiple Sclerosis RRMS MS Optical coherence tomography OCT

Eligibility

For people ages 18–65

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

Locations

  • Novartis Investigative Site
    Torrance, California, 90509-2004, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02907281
Phase
Phase 3
Study Type
Observational
Last Updated
October 1, 2016