Betaferon® Regulatory Post-Marketing Surveillance

Bayer355 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

355

Conditions

Multiple Sclerosis Clinically Isolated System

Interventions

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

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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Many Locations, South Korea

Outcomes

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

Data from ClinicalTrials.gov

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