Multiple SclerosisNCT04356339
US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector
An observational study of Multiple Sclerosis, run by Bayer at 1 site in United States.
Trial summary
In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. 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, BAY 86-5046)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 11 Nov 2021
- 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: US patients aged ≥18 years diagnosed with Multiple Sclerosis (MS) and treated with BETASERON using the BETACONNECT autoinjector and registered with myBETAapp
Who may be able to join
- Aged ≥18 years
- Treated with BETASERON using the BETACONNECT autoinjector
- Registered with myBETAapp
- Provided electronic informed consent
Who cannot join
- There are no exclusion criteria for participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector
In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent
- taking medication matches the presciber's recommendation (adherence, compliance),
- treatment for the prescribed duration (persistence) is continued and
- injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon-beta-1b (BETASERON, BAY 86-5046)
- Keywords
- MS
- 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, BAY 86-5046)Drug
Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician
| Study group | Role | What they receive |
|---|---|---|
| BETASERON | Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled Receives: Drug: Interferon-beta-1b (BETASERON, BAY 86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to therapy
Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.
Measured: Up to 6 months
Persistence of therapy
Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.
Measured: Up to 6 months
Adherence to therapy
Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.
Measured: Up to 6 months
Secondary outcomes (13)
Change in patient-reported health-related quality of life (HRQOL)
Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.
Measured: Up to 6 months
Patient satisfaction with the myBETAapp
Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.
Measured: Up to 6 months
Change in health status evaluated by EQ-5D-5L descriptive system
EQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Measured: Up to 6 months
Change in EQ-Visual Analog Score (EQ-VAS)
The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' and provides a single quantitative measure of health.
Measured: Up to 6 months
Change in prescription and non-prescription medication usage
Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.
Measured: Up to 6 months
Number of relapses
Measured: Up to 6 months
Number of participants with treatment with corticosteroids due to relapses
Measured: Up to 6 months
Number of emergency room visits due to relapse
Measured: Up to 6 months
Number of hospitalizations due to relapse
Measured: Up to 6 months
Patient self-assessment
Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.
Measured: Up to 6 months
Change in dose of BETASERON prescription
Measured: Up to 6 months
Change in frequency of BETASERON prescription
Measured: Up to 6 months
Patient satisfaction with the BETACONNECT autoinjector
Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start24 Nov 2020
- Primary completion29 Aug 2021
- Study completion11 Nov 2021
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356339
- Sponsor's protocol ID
- 20756
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2020
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector
- ClinicalTrials.gov ID
- NCT04356339
- Acronym / sponsor ID
- 20756
- Conditions
- Multiple Sclerosis
- Keywords
- MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 22 Apr 2020 (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.
In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent
- taking medication matches the presciber's recommendation (adherence, compliance),
- treatment for the prescribed duration (persistence) is continued and
- injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BETASERON | – | Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- US patients aged ≥18 years diagnosed with Multiple Sclerosis (MS) and treated with BETASERON using the BETACONNECT autoinjector and registered with myBETAapp
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Treated with BETASERON using the BETACONNECT autoinjector
- Registered with myBETAapp
- Provided electronic informed consent
Key exclusion criteria (1 listed)
- There are no exclusion criteria for participation in this study
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, BAY 86-5046)Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician | Drug | BETASERON |
Primary outcome
Compliance to therapy
Time frame: Up to 6 months
Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.
Persistence of therapy
Time frame: Up to 6 months
Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.
Adherence to therapy
Time frame: Up to 6 months
Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.
13 secondary outcomes
Change in patient-reported health-related quality of life (HRQOL)
Time frame: Up to 6 months
Patient satisfaction with the myBETAapp
Time frame: Up to 6 months
Change in health status evaluated by EQ-5D-5L descriptive system
Time frame: Up to 6 months
Change in EQ-Visual Analog Score (EQ-VAS)
Time frame: Up to 6 months
Change in prescription and non-prescription medication usage
Time frame: Up to 6 months
Number of relapses
Time frame: Up to 6 months
Number of participants with treatment with corticosteroids due to relapses
Time frame: Up to 6 months
Number of emergency room visits due to relapse
Time frame: Up to 6 months
Number of hospitalizations due to relapse
Time frame: Up to 6 months
Patient self-assessment
Time frame: Up to 6 months
Change in dose of BETASERON prescription
Time frame: Up to 6 months
Change in frequency of BETASERON prescription
Time frame: Up to 6 months
Patient satisfaction with the BETACONNECT autoinjector
Time frame: Up to 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 24 Jul 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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 Bayer at 1 site in United States.
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 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 24 Jul 2023. 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 United States. 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?
Compliance to therapy (time frame: Up to 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 24 Jul 2023.