Betaferon® Regulatory Post-Marketing Surveillance

August 20, 2014 updated by: Bayer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome who have been or will be treated with Betaferon.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events.
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.
Time Frame: During 6 month
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
0, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (ESTIMATE)

August 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14839
  • BF0814KR (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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