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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Amphia Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sanofi
TEVA Pharmachemie
Information provided by:
Amphia Hospital
ClinicalTrials.gov Identifier:
NCT00910598
First received: May 29, 2009
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: glatiramer acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amphia Hospital:

Primary Outcome Measures:
  • Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Other ophthalmological parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Copaxone
No Intervention: no treatment
No disease modifying treatment allowed

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910598

Contacts
Contact: E.C.A.M. Sanders, MD +31 76 5258246 rsc@rsconsultancy.nl
Contact: Raymond J. Schmidt, MD +31 575 441001 rsc@rsconsultancy.nl

Locations
Netherlands
Amphia Ziekenhuis Recruiting
Breda, Netherlands, 4818 CK
Contact: E.C.A.M. Sanders, MD    +31 76 5258246      
Principal Investigator: E.C.A.M. Sanders, MD         
Maasland Ziekenhuis Recruiting
Sittard, Netherlands
Contact: R.M.M. Hupperts, MD PhD    +31 88 4597811      
Principal Investigator: R.M.M. Hupperts, MD PhD         
Sub-Investigator: S.A.M. Knippenberg, MD         
Sponsors and Collaborators
Amphia Hospital
Sanofi
TEVA Pharmachemie
Investigators
Study Chair: E.C.A.M. Sanders, MD Amphia Ziekenhuis
  More Information

Additional Information:
No publications provided

Responsible Party: E.C.A.M. Sanders, Amphia Ziekenhuis
ClinicalTrials.gov Identifier: NCT00910598     History of Changes
Other Study ID Numbers: OCT
Study First Received: May 29, 2009
Last Updated: February 9, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Amphia Hospital:
clinically isolated syndrome
relapsing remitting multiple sclerosis
glatiramer acetate
Optical Coherence Tomography

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014