Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Interferon-beta 1-a
Brief summary
This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.
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.
Interventions
DRUGInterferon-β-1a
Interferon-β-1a according to the standard practice
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 | After 3, 6 and 12 months of Rebif treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed