Betaferon® Regulatory Post-Marketing Surveillance

Completed

• Conditions: Clinically Isolated System; Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT01414816
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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.

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse events.	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.	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.	0, 6 month