Betaferon® Regulatory Post-Marketing Surveillance
What it found
We found no results in the registry or in papers.
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
Safety variables will be summarized using descriptive statistics based on adverse events.
Up to 6 months
Safety
Other measures (2)
The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.
During 6 month
RelapsesProgression 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
Disability progressionMRI lesions
Who could take part
Early (CIS/RIS) · 12 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Apr 2008
Main results due
Jul 2012
Finished
Jul 2012
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