Betaferon® Regulatory Post-Marketing Surveillance
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01414816
First received: July 13, 2011
Last updated: August 27, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To identify problems/questions about following items in the clinical practice using Betaferon
- Unknown adverse event (especially serious adverse event)
- Identification of adverse event occurred in the real practice
- Factors that may affect the safety of drug
- 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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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: | 363 |
| 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01414816 History of Changes |
| Other Study ID Numbers: | 14839, BF0814KR |
| Study First Received: | July 13, 2011 |
| Last Updated: | August 27, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Bayer:
|
Multiple Sclerosis Clinical Isolated Syndrome (CIS) |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta-1b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 17, 2013