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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

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ClinicalTrials.gov Identifier: NCT04356339
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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. 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : February 3, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BETASERON
Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled
Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)
Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in patient-reported health-related quality of life (HRQOL) [ Time Frame: Up to 6 months ]
    Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.

  2. Patient satisfaction with the myBETAapp [ Time Frame: Up to 6 months ]
    Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.

  3. Change in health status evaluated by EQ-5D-5L descriptive system [ Time Frame: Up to 6 months ]
    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).

  4. Change in EQ-Visual Analog Score (EQ-VAS) [ Time Frame: Up to 6 months ]
    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.

  5. Change in prescription and non-prescription medication usage [ Time Frame: Up to 6 months ]
    Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.

  6. Number of relapses [ Time Frame: Up to 6 months ]
  7. Number of participants with treatment with corticosteroids due to relapses [ Time Frame: Up to 6 months ]
  8. Number of emergency room visits due to relapse [ Time Frame: Up to 6 months ]
  9. Number of hospitalizations due to relapse [ Time Frame: Up to 6 months ]
  10. Patient self-assessment [ Time Frame: Up to 6 months ]
    Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.

  11. Change in dose of BETASERON prescription [ Time Frame: Up to 6 months ]
  12. Change in frequency of BETASERON prescription [ Time Frame: Up to 6 months ]
  13. Patient satisfaction with the BETACONNECT autoinjector [ Time Frame: Up to 6 months ]
    Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
US patients aged ≥18 years diagnosed with Multiple Sclerosis (MS) and treated with BETASERON using the BETACONNECT autoinjector and registered with myBETAapp
Criteria

Inclusion Criteria:

  • Aged ≥18 years
  • Treated with BETASERON using the BETACONNECT autoinjector
  • Registered with myBETAapp
  • Provided electronic informed consent

Exclusion Criteria:

- There are no exclusion criteria for participation in this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356339


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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United States, New Jersey
myBETAapp
Whippany, New Jersey, United States, 07981
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04356339    
Other Study ID Numbers: 20756
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic