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

NCT04356339 | Completed

• 1 other identifier: 20756
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

MS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Change in patient-reported health-related quality of life (HRQOL)

  Up to 6 months

• Patient satisfaction with the myBETAapp

  Up to 6 months

• Change in health status evaluated by EQ-5D-5L descriptive system

  Up to 6 months

• Change in EQ-Visual Analog Score (EQ-VAS)

  Up to 6 months

• Change in prescription and non-prescription medication usage

  Up to 6 months

Study Arms (1)

BETASERON

Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled

Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)

Interventions

Interferon-beta-1b (BETASERON, BAY 86-5046) DRUG

Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician

BETASERON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

myBETAapp

Whippany, New Jersey, 07981, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: November 24, 2020
• Primary Completion: August 29, 2021
• Study Completion: November 11, 2021
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)