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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01074346 |
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Date of registration:
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22/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis
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Scientific title:
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A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01074346 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Interferon-ß-1a
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Annual relapse rate
[Time Frame: Baseline to 12 months observation period]
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Change in EDSS
[Time Frame: Baseline to 12 months observation period]
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Time to first relapse
[Time Frame: Baseline to 12 months observation period]
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Change in MSTCQ
[Time Frame: Baseline to 12 months observation period]
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Incidence of side effects associated with Rebif therapy
[Time Frame: Baseline to 12 months observation period]
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Secondary ID(s)
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EMR 701068-511
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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