Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

(OCTIMS Trial)

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion 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

Treatment Details

Interventions

• Observational (Other)

Participant Groups

Group I: Multiple sclerosis patients Experimental Treatment 1 Intervention

Multiple sclerosis patients

Group II: Healthy volunteers Experimental Treatment 1 Intervention

Healthy volunteers

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Novartis Investigative Site Philadelphia, PA

Novartis Investigative Site Greenfield Park, Canada

Novartis Investigative Site Baltimore, MD

Novartis Investigative Site Calgary, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals Lead Sponsor

References