Betaferon® Regulatory Post-Marketing Surveillance

Multiple Sclerosis Clinical Trial

Official title:

Betaferon® Regulatory Post-Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414816
• Other study ID #: 14839
• Secondary ID: BF0814KR
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: August 20, 2014
• Start date: April 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clinically Isolated System
• Multiple Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
EOD, dosage frequency and duration will be decide by physicians.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables will be summarized using descriptive statistics based on adverse events.		Up to 6 months	Yes
Secondary	The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.		During 6 month	No
Secondary	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	No

External Links

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