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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This study has been withdrawn prior to enrollment.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.)
Information provided by:
Bayer Identifier:
First received: February 18, 2010
Last updated: April 12, 2012
Last verified: April 2012
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:

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) ]

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

Biospecimen Retention:   None Retained

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary hospital

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
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Please refer to this study by its identifier: NCT01071694

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

Additional Information:
Responsible Party: Global Medical Affairs Therapeutic area Head, Bayer HealthCare AG Identifier: NCT01071694     History of Changes
Other Study ID Numbers: 15110
Qolbet ( Other Identifier: Company internal )
BF1010KR ( Other Identifier: Company internal )
Study First Received: February 18, 2010
Last Updated: April 12, 2012

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

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
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-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on May 25, 2017