Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction

September 5, 2018 updated by: Bayer

The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).

The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
    • Florida
      • Boca Raton, Florida, United States, 33428
      • New Port Richey, Florida, United States, 34653
      • Tampa, Florida, United States, 33609
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
    • Maryland
      • Fulton, Maryland, United States, 20759
    • Massachusetts
      • Foxboro, Massachusetts, United States, 02035
    • Michigan
      • Deckerville, Michigan, United States, 48427
    • Missouri
      • Saint Louis, Missouri, United States, 63131
    • New Jersey
      • Stratford, New Jersey, United States, 08084
      • Teaneck, New Jersey, United States, 07666
    • New York
      • Staten Island, New York, United States, 10306
    • Oregon
      • Medford, Oregon, United States, 97504
      • Medford, Oregon, United States
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Lititz, Pennsylvania, United States, 17543
    • Tennessee
      • Franklin, Tennessee, United States, 37064
      • Memphis, Tennessee, United States, 38104
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Lubbock, Texas, United States, 79430
      • Round Rock, Texas, United States, 78681
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Virginia Beach, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS)

Description

Inclusion Criteria:

  • Male and females greater than or equal to 18 years of age
  • Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS)
  • Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study)
  • Confirmation of insurance coverage for BETASERON treatment
  • Access to a personal computer to complete online patient satisfaction survey at Week 6

Exclusion Criteria:

  • Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment
  • Documented substance abuse within the previous 6 months prior to study enrollment
  • Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study
  • Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study
  • Pregnant or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interferon beta-1b
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Applied via the BETACONNECT device. Dose as prescribed by physician.
Device: BETACONNECT device
Used to apply Betaseron.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of BETASERON injections as captured by the BETACONNECT device
Time Frame: At 6 months
At 6 months
Time (days) between BETASERON injections as captured by BETACONNECT device
Time Frame: At 6 months
At 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient reported satisfaction by a questionnaire
Time Frame: At 6 weeks
At 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2016

Primary Completion (Actual)

August 11, 2017

Study Completion (Actual)

September 13, 2017

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17942

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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