Clinically Isolated System, Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Clinical Isolated Syndrome (CIS)
Brief summary
To identify problems/questions about following items in the clinical practice using Betaferon 1. Unknown adverse event (especially serious adverse event) 2. Identification of adverse event occurred in the real practice 3. Factors that may affect the safety of drug 4. Factors that may affect the effectiveness of the drug
Interventions
EOD, dosage frequency and duration will be decide by physicians.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon * Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events. | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse. | During 6 month |
| Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome. | 0, 6 month |
Countries
South Korea
Outcome results
None listed