Multiple SclerosisNCT01414816
Betaferon® Regulatory Post-Marketing Surveillance
An observational study of Multiple Sclerosis and Clinically Isolated System, run by Bayer at 1 site in South Korea.
Trial summary
To identify problems/questions about following items in the clinical practice using Betaferon 1. Unknown adverse event (especially serious adverse event) 2. Identification of adverse event occurred in the real practice 3. Factors that may affect the safety of drug 4. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated System
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- How many people
- 355 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Jul 2012
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome who have been or will be treated with Betaferon.
Who may be able to join
- Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
- Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.
Who cannot join
- Exclusion criteria must be read in conjunction with local product information
Trial locations and contacts
1 site in 1 country.
About this study
To identify problems/questions about following items in the clinical practice using Betaferon
- Unknown adverse event (especially serious adverse event)
- Identification of adverse event occurred in the real practice
- Factors that may affect the safety of drug
- Factors that may affect the effectiveness of the drug
- Conditions
- Multiple Sclerosis, Clinically Isolated System
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Multiple Sclerosis, Clinical Isolated Syndrome (CIS)
- 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 beta-1b (Betaseron, BAY86-5046)Drug
EOD, dosage frequency and duration will be decide by physicians.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables will be summarized using descriptive statistics based on adverse events.
Measured: Up to 6 months
Secondary outcomes (2)
The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.
Measured: During 6 month
Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome.
Measured: 0, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2008
- Primary completionJul 2012
- Study completionJul 2012
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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414816
- Sponsor's protocol ID
- 14839
- Other IDs
- BF0814KR
- Status last verified
- Aug 2014
- First submitted
- 13 Jul 2011
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betaferon® Regulatory Post-Marketing Surveillance
- ClinicalTrials.gov ID
- NCT01414816
- Acronym / sponsor ID
- 14839
- Conditions
- Multiple Sclerosis, Clinically Isolated System
- Keywords
- Multiple Sclerosis, Clinical Isolated Syndrome (CIS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Aug 2011 (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.
To identify problems/questions about following items in the clinical practice using Betaferon
- Unknown adverse event (especially serious adverse event)
- Identification of adverse event occurred in the real practice
- Factors that may affect the safety of drug
- Factors that may affect the effectiveness of the drug
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diagnosis of Multiple Sclerosis or Clinically Isolated Syndrome who have been or will be treated with Betaferon.
Key inclusion criteria (2 listed)
- Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
- Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with local product information
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 beta-1b (Betaseron, BAY86-5046)EOD, dosage frequency and duration will be decide by physicians. | Drug | Group 1 |
Primary outcome
Safety variables will be summarized using descriptive statistics based on adverse events.
Time frame: Up to 6 months
2 secondary outcomes
The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.
Time frame: During 6 month
Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome.
Time frame: 0, 6 month
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 21 Aug 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.
Bayer Study Director study director
Bayer
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 and Clinically Isolated System, run by Bayer 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 2 inclusion and 1 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 21 Aug 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?
Safety variables will be summarized using descriptive statistics based on adverse events. (time frame: Up to 6 months). 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 21 Aug 2014.