Multiple SclerosisPhase 4OCTIMSNCT00910598
Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)
A Phase 4 study testing glatiramer acetate in people with Multiple Sclerosis, run by Amphia Hospital at 2 sites in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- glatiramer acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2009to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia Ziekenhuis
Breda, 4818 CK
E.C.A.M. Sanders, MD, +31 76 5258246
E.C.A.M. Sanders, MD
- Recruiting
Maasland Ziekenhuis
Sittard
R.M.M. Hupperts, MD PhD, +31 88 4597811
R.M.M. Hupperts, MD PhD
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- glatiramer acetate
- Keywords
- clinically isolated syndrome, relapsing remitting multiple sclerosis, glatiramer acetate, Optical Coherence Tomography
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glatiramer acetateDrug
Also called Copaxone
20 mg daily s.c. for 1 year
| Study group | Role | What they receive |
|---|---|---|
| glatiramer acetate | Experimental | glatiramer acetate 20 mg s.c. daily for 1 year Receives: Drug: glatiramer acetate |
| no treatment | No intervention | No disease modifying treatment allowed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting
Measured: 1 year
Secondary outcomes (2)
Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12
Measured: 1 year
Other ophthalmological parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, TEVA Pharmachemie
- Investigators
- E.C.A.M. Sanders, MD, Study chair, Amphia ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910598
- Sponsor's protocol ID
- OCT
- Acronym
- OCTIMS
- Status last verified
- Feb 2010
- First submitted
- 29 May 2009
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00910598
- Acronym / sponsor ID
- OCTIMS / OCT
- Conditions
- Multiple Sclerosis
- Keywords
- clinically isolated syndrome, relapsing remitting multiple sclerosis, glatiramer acetate, Optical Coherence Tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Collaborators
- Sanofi, TEVA Pharmachemie
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glatiramer acetate | Experimental | Drug: glatiramer acetateglatiramer acetate 20 mg s.c. daily for 1 year |
| no treatment | No intervention | –No disease modifying treatment allowed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glatiramer acetateAlso: Copaxone20 mg daily s.c. for 1 year | Drug | glatiramer acetate |
Primary outcome
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
2 secondary outcomes
Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12
Time frame: 1 year
Other ophthalmological parameters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
- Amphia Hospital Breda NetherlandsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.C.A.M. Sanders, MD study chair
Amphia ziekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glatiramer acetate in people with Multiple Sclerosis, run by Amphia Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact E.C.A.M. Sanders, MD (+31 76 5258246, rsc@rsconsultancy.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.