Multiple SclerosisINFLUENCENCT01706055
Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Poland.
Trial summary
This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). 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
- 629 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2012to Mar 2016
- 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 MS patients starting Betaferon therapy
Who may be able to join
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
- Age >/= 18 years old
- Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
- Minimum 6 months wash-out period from previous IFNβ
- Written Informed Consent signed
Who cannot join
- Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
- Patients receiving treatment with IFN beta other than Betaferon (Bayer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Multiple Sclerosis (MS), Interferon
- 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)Biological
Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Biological: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
Measured: 6 months
MS patient with Flu-Like Symptoms (FLS) demographic profile
For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.
Measured: Up to 1 month
Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
Measured: 6 months
Secondary outcomes (2)
The impact of FLS on patients daily activities as measured by current professional/educational status
Measured: From baseline up to 6 months
Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionMar 2016
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
- 629 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
- NCT01706055
- Sponsor's protocol ID
- 16400
- Other IDs
- BF1213PL
- Acronym
- INFLUENCE
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2012
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
- ClinicalTrials.gov ID
- NCT01706055
- Acronym / sponsor ID
- INFLUENCE / 16400
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis (MS), Interferon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Oct 2012 (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 will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: 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 MS patients starting Betaferon therapy
Key inclusion criteria (5 listed)
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
- Age >/= 18 years old
- Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
- Minimum 6 months wash-out period from previous IFNβ
- Written Informed Consent signed
Key exclusion criteria (2 listed)
- Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
- Patients receiving treatment with IFN beta other than Betaferon (Bayer)
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)Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic. | Biological | Group 1 |
Primary outcome
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
Time frame: 6 months
MS patient with Flu-Like Symptoms (FLS) demographic profile
Time frame: Up to 1 month
For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.
Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
Time frame: 6 months
2 secondary outcomes
The impact of FLS on patients daily activities as measured by current professional/educational status
Time frame: From baseline up to 6 months
Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period
Time frame: 6 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 14 Mar 2017.
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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 5 inclusion and 2 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 14 Mar 2017. 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?
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation (time frame: 6 months). The study lists 3 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 14 Mar 2017.