Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis

February 16, 2014 updated by: Merck KGaA, Darmstadt, Germany

A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present observational study is being conducted to assess the safety information from a target of 100 Korean subjects with MS treated with Rebif. Various parameters like subjects' background (age, sex, BMI), MS history, MS status (MS type, Expanded Disability Status Score [EDSS] and others), MS Treatment Concern Questionnaire (MSTCQ), Rebif treatment status, concomitant disease modifying agents (DMA) therapy and Rebif related adverse events will be collected. Subjects will be followed for 12 months. Proportion of subjects with moderate to severe (Grade 3-5) injection site reactions after 3, 6, 12 months of Rebif treatment will be determined. Secondary outcomes like annual relapse rate, change in EDSS, changes in MSTCQ, time to first relapse and incidence of side effects associated with Rebif therapy will also be determined and presented descriptively.

OBJECTIVES

Primary objectives

  • To assess the tolerability of Rebif treatment in Korean MS subjects in a non-interventional setting Secondary Objectives
  • To evaluate subject's satisfaction, clinical data and disease characteristics of the population of MS subjects undergoing Rebif treatment.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, 50 Ilwon-dong, Gangnam-gu, Korea, Republic of
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with MS undergoing treatment with Rebif in Korea.

Description

Inclusion Criteria:

  • 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:

    1. Subjects with relapsing MS with two or more acute exacerbations in the previous two years
    2. Subjects with secondary progressive MS with ongoing relapsing activity
  • Subjects who sign the informed consent form.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: After 3, 6 and 12 months of Rebif treatment
After 3, 6 and 12 months of Rebif treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Annual relapse rate
Time Frame: Baseline to 12 months observation period
Baseline to 12 months observation period
Change in EDSS
Time Frame: Baseline to 12 months observation period
Baseline to 12 months observation period
Change in MSTCQ
Time Frame: Baseline to 12 months observation period
Baseline to 12 months observation period
Time to first relapse
Time Frame: Baseline to 12 months observation period
Baseline to 12 months observation period
Incidence of side effects associated with Rebif therapy
Time Frame: Baseline to 12 months observation period
Baseline to 12 months observation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 16, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 701068-511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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