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

Withdrawn

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)

• Registration Number: NCT01071694
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Study Start: 2011-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-12
• Last Update Posted: 2012-04-16
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Age lower than 18

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Quality of life evaluated by several validated questionnaire	Baseline, 3, 6, 9, 12 months (+/- 1 month)

Secondary Outcome Measures

Name	Time	Method
Information about safety of Betaferon in routine clinical use	Baseline, 3, 6, 9, 12 months (+/- 1 month)