Betaferon® Regulatory Post-Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01414816
First received: July 13, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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

Condition Intervention
Multiple Sclerosis
Clinically Isolated System
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon® Regulatory Post-Marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety variables will be summarized using descriptive statistics based on adverse events. [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse. [ Time Frame: During 6 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: April 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
EOD, dosage frequency and duration will be decide by physicians.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414816

Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01414816     History of Changes
Other Study ID Numbers: 14839, BF0814KR
Study First Received: July 13, 2011
Last Updated: August 20, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Multiple Sclerosis
Clinical Isolated Syndrome (CIS)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 15, 2014