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QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea

This study has been withdrawn prior to enrollment.
(Study Manager could not embark on it during the timeline.)
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01071694
First received: February 18, 2010
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

This study is to describe the quality of life of Korean patients with early relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon with several validated questionnaires.


Condition Intervention
Multiple Sclerosis, Relapsing-Remitting
 Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Quality of life evaluated by several validated questionnaire [ Time Frame: Baseline, 3, 6, 9, 12 months (+/- 1 month) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Information about safety of Betaferon in routine clinical use [ Time Frame: Baseline, 3, 6, 9, 12 months (+/- 1 month) ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)
Patients receiving Betaferon according to routine clinical practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tertiary hospital

Criteria

Inclusion Criteria:

  • Relapsing-remitting MS (RRMS) patients within the first two years after diagnosis according to Poser or McDonald criteria, starting Betaferon treatment, including patients switching from other DMDs
  • Patients who signed informed consent form

Exclusion Criteria:

  • Age lower than 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071694

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Medical Affairs Therapeutic area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01071694     History of Changes
Other Study ID Numbers: 15110, Qolbet, BF1010KR
Study First Received: February 18, 2010
Last Updated: April 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Multiple Sclerosis,
Relapsing-Remitting,
Interferon beta-1b,
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 May 23, 2013