Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
NCT ID: NCT02652091
Last Updated: 2018-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
146 participants
OBSERVATIONAL
2016-02-05
2017-09-13
Brief Summary
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The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Interferon beta-1b
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
Interferon beta-1b (Betaseron, BAY86-5046)
Applied via the BETACONNECT device. Dose as prescribed by physician.
BETACONNECT device
Used to apply Betaseron.
Interventions
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Interferon beta-1b (Betaseron, BAY86-5046)
Applied via the BETACONNECT device. Dose as prescribed by physician.
BETACONNECT device
Used to apply Betaseron.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Foxborough, Massachusetts, United States
Deckerville, Michigan, United States
St Louis, Missouri, United States
Stratford, New Jersey, United States
Teaneck, New Jersey, United States
Staten Island, New York, United States
Medford, Oregon, United States
Medford, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Lititz, Pennsylvania, United States
Franklin, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Lubbock, Texas, United States
Round Rock, Texas, United States
Fairfax, Virginia, United States
Virginia Beach, Virginia, United States
Cullman, Alabama, United States
Boca Raton, Florida, United States
New Port Richey, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Fulton, Maryland, United States
Countries
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Other Identifiers
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17942
Identifier Type: -
Identifier Source: org_study_id
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