NCT01414816

Brief Summary

To identify problems/questions about following items in the clinical practice using Betaferon

  1. 1.Unknown adverse event (especially serious adverse event)
  2. 2.Identification of adverse event occurred in the real practice
  3. 3.Factors that may affect the safety of drug
  4. 4.Factors that may affect the effectiveness of the drug

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

4.3 years

First QC Date

July 13, 2011

Last Update Submit

August 20, 2014

Conditions

Multiple SclerosisClinically Isolated System

Keywords

Multiple SclerosisClinical Isolated Syndrome (CIS)

Outcome Measures

Primary Outcomes (1)

  • Safety variables will be summarized using descriptive statistics based on adverse events.

    Up to 6 months

Secondary Outcomes (2)

  • The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.

    During 6 month

  • Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome.

    0, 6 month

Study Arms (1)

Group 1

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

Interventions

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

EOD, dosage frequency and duration will be decide by physicians.

Group 1

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome who have been or will be treated with Betaferon.

You may qualify if:

  • Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
  • Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Multiple 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

August 11, 2011

Study Start

April 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

KR(1)