Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months

NCT02017808 | Completed

• 1 other identifier: GA-OCT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.

Conditions

Multiple Sclerosis

Keywords

OCT; Copaxone; Multiple sclerosis; relapsing-remitting

Outcome Measures

Primary Outcomes (1)

• Retinal health in multiple sclerosis patients prescribed copaxone

  Participants will have an OCT retinal health will be determined by degree of axonal loss.

  24 months

Secondary Outcomes (1)

• Measuring disability progression

  24 months

Study Arms (2)

Copaxone

Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)

OCT

Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsing remitting multiple sclerosis Healthy controls without known neurological problems.

You may qualify if:

• MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
• Starting GA monotherapy (20mg/day sc) at the time of the OCT scan
• Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA
• Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)
• MS patients having a RR disease course (Lublin and Reingold, 1996)
• Age 18-65 (healthy controls will be matched to MS patients for age and sex)
• Signed informed consent at the 24-month follow-up

You may not qualify if:

• Patients who had a relapse within 30 days prior to OCT scan date
• Patients who received steroid treatment within 30 days prior to OCT scan date
• Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
• MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Sponsors & Collaborators

• University at Buffalo: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Buffalo Neuroimaging Analysis Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Zivadinov, MD, PhD

  SUNY University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Buffalo Neuroimaging Analysis Center, Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 23, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)