NCT01071694

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

February 18, 2010

Last Update Submit

April 12, 2012

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis,Relapsing-Remitting,Interferon beta-1b,Quality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life evaluated by several validated questionnaire

    Baseline, 3, 6, 9, 12 months (+/- 1 month)

Secondary Outcomes (1)

  • Information about safety of Betaferon in routine clinical use

    Baseline, 3, 6, 9, 12 months (+/- 1 month)

Study Arms (1)

Group 1

Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)

Interventions

Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)DRUG

Patients receiving Betaferon according to routine clinical practice

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary hospital

You may qualify if:

  • 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

You may not qualify if:

  • Age lower than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

KR(1)