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Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study (PROmyBETAapp)

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ClinicalTrials.gov Identifier: NCT03134573
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaferon, BAY86-5046) Device: Betaconnect auto-injector Device: myBETAapp

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Multiple Sclerosis
Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp
Drug: Interferon beta-1b (Betaferon, BAY86-5046)
Solution for injection
Device: Betaconnect auto-injector
Auto-injector for application of Betaferon solution which automatically covers injection related data
Device: myBETAapp
Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker



Primary Outcome Measures :
  1. Compliance to therapy (%) [ Time Frame: 6 months ]
    Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100

  2. Persistence of therapy (yes, no) [ Time Frame: 6 months ]
    Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)

  3. Adherence to therapy (yes, no) [ Time Frame: 6 months ]

    Patients will be defined as being adherent to therapy if they fulfill the following criteria:

    1. They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and
    2. They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)


Secondary Outcome Measures :
  1. Proportion of patients consenting to participate in this study among those using the myBETAapp [ Time Frame: 3 months ]
    All patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.

  2. Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp [ Time Frame: 3 months ]
    Wellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habits



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years.
  • Patients on treatment with Betaferon (every Betaferon box contains a "Mixject" number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study).
  • Patients must be using the myBETAapp.
  • Electronic informed consent must be obtained.

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): NCT03134573


Contacts
Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com

Locations
Germany
Many locations Recruiting
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03134573     History of Changes
Other Study ID Numbers: 18462
BF1504 ( Other Identifier: IMPACT )
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Relapsing Remitting Multiple Sclerosis (RRMS),
Clinically isolated Syndrome (CIS),
Secondary Progressive Multiple Sclerosis (SPMS)

Additional relevant MeSH terms:
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