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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: glatiramer acetate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glatiramer acetate<br>glatiramer acetate 20 mg s.c. daily for 1 year | Drug: glatiramer acetate<br>* 20 mg daily s.c. for 1 year<br>* Other names: Copaxone;|
| No Intervention: no treatment<br>No disease modifying treatment allowed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinically isolated syndrome, relapsing remitting multiple sclerosis, glatiramer acetate, Optical Coherence Tomography