disease of the central nervous system multiple sclerosis
Conditions
Interventions
Investigational Medicinal Product:
- Rebif New Formulation 44 mcg sc tiw.
- Rebif New Formulation 44 mcg sc ow (+ placebo twice weekly to ensure
appropriate blinding).
- Matching placebo sc tiw.
All
the following 2 weeks
clip-on spacers that will allow for 50% of the dose to be dispensed will be
provided. When subjects reached CDMS they will be re-titrated to 44 mcg tiw
For patients who have no
Sponsors
Clinical Research Assistance
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject with a single, first clinical event suggestive of MS within the last 60 days (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono-polysymptomatic, other than a paresthesia, vegetative or cerebral dysfunction
Exclusion criteria
Exclusion criteria: Subject has a diagnosis of Multiple Sclerosis ( per Mc Donald creteria 2005)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time to conversion to MS (from randomization), according to the revised McDonald criteria (2005). | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to conversie to CDMS Number of combined unique active MS lesions Number of new T2 lesions Number of new T1 lesions Number of new Gd-enhancing lesions Cognition by means of PASAT Relapse rate EDSS MSFC Development of BAbs and NAbs safety including AE's, SAE's and laboratory parameters | — |
Countries
Netherlands
Outcome results
None listed