stop_circleTerminated/Withdrawn

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

15110

ClinicalTrials.gov Identifier:

NCT01071694

EudraCT Number:

Not Available

EU CT Number:

Not Available
QOLBET Quality Of Life in patients with early relapsing-remitting multiple sclerosis treated with BETaferon® in Korea

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - Age lower than 18

Trial summary

Enrollment Goal
0
Trial Dates
January 2011 - December 2012
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many locations, Korea, Republic Of

Primary Outcome

  • Quality of life evaluated by several validated questionnaire
    date_rangeTime Frame:
    Baseline, 3, 6, 9, 12 months (+/- 1 month)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Information about safety of Betaferon in routine clinical use
    date_rangeTime Frame:
    Baseline, 3, 6, 9, 12 months (+/- 1 month)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

QOLBET Quality Of Life in patients with early relapsing-remitting multiple sclerosis treated with BETaferon® in Korea
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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