Betaferon® Regulatory Post-Marketing Surveillance

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

Completed

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon beta-1b (Betaseron, BAY86-5046)

Drug

EOD, dosage frequency and duration will be decide by physicians.

Primary outcomes

Safety variables will be summarized using descriptive statistics based on adverse events.

Time frame: Up to 6 months

Secondary outcomes

The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.

Time frame: 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.

Time frame: 0, 6 month

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Aug 11, 2011
Registry last updated: Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed