Trial Condition(s):
Multiple Sclerosis, Clinically Isolated System
Betaferon® regulatory Post-Marketing Surveillance
Bayer Identifier:
14839
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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
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
- Exclusion criteria must be read in conjunction with local product information
Trial Summary
Enrollment Goal
355
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Betaferon® regulatory Post-Marketing Surveillance
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events.Timeframe: Up to 6 months
Secondary Outcome
- The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.Timeframe: 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.Timeframe: 0, 6 month
Additional Information
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