Multiple SclerosisNCT03577977
Betaferon Use in Children and Adolescents With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Russia.
Trial summary
The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2008to 15 Apr 2009
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.
Who may be able to join
- patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
- patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
- recorded use of at least one dose of Betaferon before January 1, 2008
Who cannot join
- Diagnosis other then MS or a demyelinating CNS disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis
The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)
- Keywords
- Multiple sclerosis (MS), Betaseron, Betaferon
- 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, Betaferon, BAY86-5046)Drug
Betaferon was injected subcutaneously as prescribed by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Betaferon | Patients with very early onset of MS, who received at least one injection of interferon beta-1b as prescribed by the treating physician, before the age of 18. Receives: Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean expanded disability status scale (EDSS) score at the end of trial participation
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Measured: Up to 2 years
Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Measured: Up to 2 years
Mean frequency of complications recorded after start of betaferon therapy
Measured: Up to 2 years
Mean EDSS score on the exacerbations recorded after start of betaferon therapy
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Measured: Up to 2 years
Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug
Measured: Up to 2 years
Number of mild, moderate, or severe adverse events
Measured: Up to 2 years
Number of serious adverse events described during the trial
Measured: Up to 2 years
Number of adverse events described during the trial and classified as an flu-like syndrome
Measured: Up to 2 years
Number of adverse events described during the trial and classified as a local reaction
Measured: Up to 2 years
Number of cases of betaferon discontinuation due to adverse events
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Jun 2008
- Primary completion15 Apr 2009
- Study completion15 Apr 2009
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
- Retrospective
- Enrolment
- 70 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
- NCT03577977
- Sponsor's protocol ID
- 2008/01743
- Other IDs
- 2008
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03577977
- Acronym / sponsor ID
- 2008/01743
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis (MS), Betaseron, Betaferon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 15 Apr 2009 (actual)
- Study completion
- 15 Apr 2009 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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.
The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Betaferon | – | Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)Patients with very early onset of MS, who received at least one injection of interferon beta-1b as prescribed by the treating physician, before the age of 18. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.
Key inclusion criteria (3 listed)
- patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
- patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
- recorded use of at least one dose of Betaferon before January 1, 2008
Key exclusion criteria (1 listed)
- Diagnosis other then MS or a demyelinating CNS disease
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, Betaferon, BAY86-5046)Betaferon was injected subcutaneously as prescribed by the treating physician. | Drug | Patients treated with Betaferon |
Primary outcome
Mean expanded disability status scale (EDSS) score at the end of trial participation
Time frame: Up to 2 years
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial
Time frame: Up to 2 years
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Mean frequency of complications recorded after start of betaferon therapy
Time frame: Up to 2 years
Mean EDSS score on the exacerbations recorded after start of betaferon therapy
Time frame: Up to 2 years
The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug
Time frame: Up to 2 years
Number of mild, moderate, or severe adverse events
Time frame: Up to 2 years
Number of serious adverse events described during the trial
Time frame: Up to 2 years
Number of adverse events described during the trial and classified as an flu-like syndrome
Time frame: Up to 2 years
Number of adverse events described during the trial and classified as a local reaction
Time frame: Up to 2 years
Number of cases of betaferon discontinuation due to adverse events
Time frame: Up to 2 years
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 11 Jul 2018.
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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, run by Bayer at 1 site in Russia.
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 3 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 11 Jul 2018. 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 Russia. 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?
Mean expanded disability status scale (EDSS) score at the end of trial participation (time frame: Up to 2 years). The study lists 10 primary outcomes in all. 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 11 Jul 2018.