Overview

This trial is active, not recruiting.

Conditions multiple sclerosis, rrms
Treatment observational
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2012
End date August 2017
Trial size 420 participants
Trial identifier NCT02907281, 2011-001437-16, CFTY720D2319

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Multiple sclerosis patients
observational
Observational
Healthy volunteers
observational
Observational

Primary Outcomes

Measure
Change in Retinal Nerve Fiber Layer Thickness (RNFL)
time frame: 36 months

Secondary Outcomes

Measure
Correlation of change in macular volume with change in brain volume
time frame: 36 months
Assess reproducibility of RNFL thickness on optical coherence tomography
time frame: 4 weeks
Change in macular volume over 36 months
time frame: 36 months
Correlation of change in RNFL thickness with change in brain volume
time frame: 36 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novartis.