Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS) (OCTIMS)

A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMS

This is a study in patients with clinically isolated syndrome (CIS) and early relapsing remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA) subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging (MRI) scanning for follow-up of these patients.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: glatiramer acetate

Detailed Description

Multiple sclerosis (MS) is a progressive and demyelinating disease of the central nervous system characterized by inflammation and neurodegeneration. It is characterized by an ongoing process of demyelination and axonal loss, even at the beginning of the disease course, which will result in brain atrophy. A first manifestation of clinical definite MS, is called a clinically isolated syndrome (CIS). Brain atrophy occurs even in patients with a CIS. Optic neuritis (ON) is a common feature of a CIS. The axons in the retina represent the most proximal part of the optic nerve which is devoid of myelin. Because the retina is part of the central nervous system (CNS), measurement of the Retinal Nerve Fiber Layer (RFLN) by Optical Coherence Tomography (OCT) offers the opportunity to visualize the unmyelinated axons of the CNS directly. OCT is a non-invasive method to measure the thickness of the optical layer. The thickness of the RNFL is reduced in MS patients with or without ON history.

Glatiramer acetate (GA), an immunomodulatory drug for RRMS and CIS, reduces brain atrophy and stimulates the production of brain-derived neurotrophic factor, which in turn could stimulate neuroregeneration.

In this pilot study we would like to assess the feasibility of OCT measurement in patient with CIS other than ON in the Dutch clinical setting and to assess the effect of GA on the RNFL and visual function in patients with CIS or in early relapsing remitting MS patients.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: E.C.A.M. Sanders, MD; Phone Number: +31 76 5258246; Email: rsc@rsconsultancy.nl
• Study Contact Backup: Name: Raymond J. Schmidt, MD; Phone Number: +31 575 441001; Email: rsc@rsconsultancy.nl

Study Locations

• Netherlands
  • Breda, Netherlands, 4818 CK
    • Recruiting
    • Amphia Ziekenhuis
    • Contact: E.C.A.M. Sanders, MD; Phone Number: +31 76 5258246
    • Principal Investigator: E.C.A.M. Sanders, MD
  • Sittard, Netherlands
    • Recruiting
    • Maasland Ziekenhuis
    • Contact: R.M.M. Hupperts, MD PhD; Phone Number: +31 88 4597811
    • Principal Investigator: R.M.M. Hupperts, MD PhD
    • Sub-Investigator: S.A.M. Knippenberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18 - 55 years
• Early relapsing remitting MS, defined as a disease course less than 3 years
• clinically isolated syndrome , defined as optic neuritis (ON) or other than ON
• Currently treated with glatiramer (GA) or currently not treated for MS
• Expanded disability status scale (EDSS) score 0-5
• Able and willing to provide written informed consent prior to enrolment
• Willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria:

• Clinical definite multiple sclerosis with a disease course more than 3 years
• Primary progressive multiple sclerosis
• Secondary progressive multiple sclerosis
• Current use of any approved or investigational disease modifying agents for the treatment of MS other than GA.
• Neuromyelitis Optica (Devic's disease)
• Any condition that may interfere with the quality of the OCT scan: clouding of the media, i.e. cataract, pupil which are hard to dilate.
• Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics (SPC) text
• Hypersensitivity to GA or mannitol
• Subject's inability to complete the study or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: glatiramer acetate; glatiramer acetate 20 mg s.c. daily for 1 year	Drug: glatiramer acetate; 20 mg daily s.c. for 1 year; Other Names: Copaxone
No Intervention: no treatment; No disease modifying treatment allowed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12	1 year
Other ophthalmological parameters	1 year

Collaborators and Investigators

• Sponsor: Amphia Hospital
• Collaborators: Sanofi; TEVA Pharmachemie
• Investigators: Study Chair: E.C.A.M. Sanders, MD, Amphia Ziekenhuis

Publications and helpful links

Helpful Links

• Amphia Hospital Breda Netherlands

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2010
• Last Update Submitted That Met QC Criteria: February 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; glatiramer acetate; relapsing remitting multiple sclerosis; clinically isolated syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: OCT