check_circleStudy Completed

Multiple Sclerosis, Clinically Isolated System

Bayer Identifier:

14839

ClinicalTrials.gov Identifier:

NCT01414816

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

Key Participants Requirements

Sex

Both

Age

12 - N/A
  • - 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 must be read in conjunction with local product information

Trial summary

Enrollment Goal
355
Trial Dates
April 2008 - July 2012
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 months
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    Safety Issue:
    Yes

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 month
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    Safety Issue:
    No
  • 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 month
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    Safety Issue:
    No

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
N/A

Additional Information

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