clinical isolated syndrome MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome
Conditions
Interventions
Trade Name: Copaxone
Product Name: Copaxone
Pharmaceutical Form: Solution for injection
CAS Number: 147245929
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Amphia Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age: 18 – 45 years • Early RRMS, defined as a disease course less than 3 years • CIS other than ON • Expanded disability status scale (EDSS) score 0-4 • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Clinical definite multiple sclerosis (CDMS) with a disease course more than 3 years • Acute ON or a history of ON • Primary progressive multiple sclerosis • Secondary progressive multiple sclerosis • Current use of any approved or investigational disease modifying agents for the treatment of MS. • Neuromyelitis Optica (Devic’s disease) • Any condition that may interfere with the quality of the OCT scan: clouding of the media, e.i. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of optical coherence tomography (OCT) measurement in patient with CIS other than optic neuritis (ON) or in patients with early MS in the Dutch clinical setting by qualitative evaluation;Secondary Objective: To assess the efficacy of GA on the Retinal Nerve Fiber Layer (RNFL) and visual function in patients with CIS as determined by the mean change in RNFL;Primary end point(s): • Feasibility of OCT measurement in patient with CIS other than ON or with early RRMS in the Dutch clinical setting. • Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12. | — |
Countries
Netherlands
Outcome results
None listed