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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Interferon-β-1a

Interferon-β-1a according to the standard practice

Intervention Type DRUG

Other Intervention Names

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Rebif®

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No