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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • myBETAapp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
Patient satisfaction with the myBETAapp	Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.	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).	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.	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.	Up to 6 months
Number of relapses		Up to 6 months
Number of participants with treatment with corticosteroids due to relapses		Up to 6 months
Number of emergency room visits due to relapse		Up to 6 months
Number of hospitalizations due to relapse		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.	Up to 6 months
Change in dose of BETASERON prescription		Up to 6 months
Change in frequency of BETASERON prescription		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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 20756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No