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This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-β-1a | Drug | Interferon-β-1a according to the standard practice |
|
| Measure | Description | 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 | After 3, 6 and 12 months of Rebif treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Annual relapse rate | Baseline to 12 months observation period | |
| Change in EDSS | Baseline to 12 months observation period | |
| Change in MSTCQ |
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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:
Subjects who sign the informed consent form.
Exclusion Criteria:
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Subjects with MS undergoing treatment with Rebif in Korea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul, 50 Ilwon-dong, Gangnam-gu | South Korea |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |