Trial record 12 of 301 for:    "Multiple Sclerosis, Relapsing-Remitting"

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This study has been withdrawn prior to enrollment.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
  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:


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:
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, Relapsing-Remitting
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 April 17, 2014