Multiple SclerosisNCT01074346
Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
Trial summary
This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon-β-1a
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with MS undergoing treatment with Rebif in Korea.
Who may be able to join
- 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 with relapsing MS with two or more acute exacerbations in the previous two years
- Subjects with secondary progressive MS with ongoing relapsing activity
- Subjects who sign the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon-β-1a
- Keywords
- Multiple sclerosis, Interferon-beta 1-a
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-β-1aDrug
Also called Rebif®
Interferon-β-1a according to the standard practice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 3, 6 and 12 months of Rebif treatment
Secondary outcomes (5)
Annual relapse rate
Measured: Baseline to 12 months observation period
Change in EDSS
Measured: Baseline to 12 months observation period
Change in MSTCQ
Measured: Baseline to 12 months observation period
Time to first relapse
Measured: Baseline to 12 months observation period
Incidence of side effects associated with Rebif therapy
Measured: Baseline to 12 months observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startAug 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074346
- Sponsor's protocol ID
- EMR 701068-511
- Status last verified
- Feb 2014
- First submitted
- 22 Feb 2010
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01074346
- Acronym / sponsor ID
- EMR 701068-511
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Interferon-beta 1-a
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with MS undergoing treatment with Rebif in Korea.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-β-1aAlso: Rebif®Interferon-β-1a according to the standard practice | Drug | – |
Primary outcome
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
5 secondary outcomes
Annual relapse rate
Time frame: Baseline to 12 months observation period
Change in EDSS
Time frame: Baseline to 12 months observation period
Change in MSTCQ
Time frame: Baseline to 12 months observation period
Time to first relapse
Time frame: Baseline to 12 months observation period
Incidence of side effects associated with Rebif therapy
Time frame: Baseline to 12 months observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.