NCT01074346

Brief Summary

This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Typical duration 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

August 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

February 22, 2010

Last Update Submit

February 16, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisInterferon-beta 1-a

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with moderate to severe (grade 3-5) injection site reactions based on pain, bruising and/or transient (<24 hours) erythema; inflammation alone and with induration; necrosis at injection site; plastic surgery required for necrosis

    After 3, 6 and 12 months of Rebif treatment

Secondary Outcomes (5)

  • Annual relapse rate

    Baseline to 12 months observation period

  • Change in EDSS

    Baseline to 12 months observation period

  • Change in MSTCQ

    Baseline to 12 months observation period

  • Time to first relapse

    Baseline to 12 months observation period

  • Incidence of side effects associated with Rebif therapy

    Baseline to 12 months observation period

Interventions

Interferon-β-1aDRUG

Interferon-β-1a according to the standard practice

Also known as: Rebif®

Eligibility Criteria

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

Subjects with MS undergoing treatment with Rebif in Korea.

You may qualify if:

  • Subjects, who are eligible for Rebif treatment according to the indication in the national label of Rebif in Korean subjects with MS. The national labels approved by Korean Regulatory Authority are:
  • Subjects with relapsing MS with two or more acute exacerbations in the previous two years
  • Subjects with secondary progressive MS with ongoing relapsing activity
  • Subjects who sign the informed consent form.

You may not qualify if:

  • Initiation of treatment in pregnancy.
  • Subjects with a history of hypersensitivity to natural or recombinant interferon-ß, or to any excipients.
  • Subjects with current severe depression and/or suicidal ideation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 50 Ilwon-dong, Gangnam-gu, South Korea

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

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 Design

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

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

August 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)