Multiple SclerosisBREAKNCT01184833
Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Poland.
Trial summary
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients. Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- Type of treatment
- Injection or infusion
- How many people
- 852 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2008to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Who may be able to join
- Relapsing-remitting multiple sclerosis
- Age >/= 18 years
- Start of treatment with Betaferon not earlier than 60 days prior to inclusion
Who cannot join
- Synonymous with contraindications to Betaferon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.
Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.
This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Multiple sclerosis, Interferon beta-1b, Compliance to treatment, Premature treatment discontinuation
- 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
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
| 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.
Rate of discontinuation of Betaferon
Measured: 24 months
Secondary outcomes (4)
Number of missed doses of Betaferon
Measured: 24 months
Depression score as measured by CES-D questionnaire
Measured: 24 months
Neurological disability score as measured by EDSS scale
Measured: 24 months
Overall tolerability of treatment as measured by rate of adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2008
- Study completionAug 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.
- 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
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184833
- Sponsor's protocol ID
- 14323
- Other IDs
- BF0813PL
- Acronym
- BREAK
- Status last verified
- Jun 2013
- First submitted
- 18 Aug 2010
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01184833
- Acronym / sponsor ID
- BREAK / 14323
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Interferon beta-1b, Compliance to treatment, Premature treatment discontinuation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Aug 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.
Non-adherence to the treatment regimen is a common problem associated with injectable drugs (e.g. Betaferon) that are used in multiple sclerosis patients.
Certain patients omit single injections or even totally discontinue therapy that normally should be long-term. It is therefore crucial to identify the factors which have the most significant effect on regularity of administration of Betaferon and the risk of premature discontinuation of treatment in order to undertake appropriate preventive measures.
This study is conducted in routine practice setting and aims to identify those risks. Pre-defined risk factors associated with technical aspects of the treatment, support provided to the patient, stage of the disease and possible adverse effects of the medication are checked on a quarterly basis with a questionnaire method. Monitoring of omitted doses of the prescribed medication (Betaferon) is carried out by the study nurse.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Key inclusion criteria (3 listed)
- Relapsing-remitting multiple sclerosis
- Age >/= 18 years
- Start of treatment with Betaferon not earlier than 60 days prior to inclusion
Key exclusion criteria (1 listed)
- Synonymous with contraindications to Betaferon
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)Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting. | Drug | Group 1 |
Primary outcome
Rate of discontinuation of Betaferon
Time frame: 24 months
4 secondary outcomes
Number of missed doses of Betaferon
Time frame: 24 months
Depression score as measured by CES-D questionnaire
Time frame: 24 months
Neurological disability score as measured by EDSS scale
Time frame: 24 months
Overall tolerability of treatment as measured by rate of adverse events
Time frame: 24 months
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 25 Jun 2013.
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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 Poland.
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 25 Jun 2013. 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 Poland. 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?
Rate of discontinuation of Betaferon (time frame: 24 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 25 Jun 2013.