check_circleStudy Completed
Multiple Sclerosis, Clinically Isolated System
Bayer Identifier:
14839
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Betaferon® regulatory Post-Marketing Surveillance
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
(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
Key Participants Requirements
Sex
BothAge
12 - N/ATrial summary
Enrollment Goal
355Trial Dates
April 2008 - July 2012Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events.date_rangeTime Frame:Up to 6 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.date_rangeTime Frame:During 6 monthenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:0, 6 monthenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A