Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
1 other identifier
observational
146
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
February 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedSeptember 6, 2018
September 1, 2018
1.5 years
January 5, 2016
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of BETASERON injections as captured by the BETACONNECT device
At 6 months
Time (days) between BETASERON injections as captured by BETACONNECT device
At 6 months
Secondary Outcomes (1)
Patient reported satisfaction by a questionnaire
At 6 weeks
Study Arms (1)
Interferon beta-1b
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
Interventions
Applied via the BETACONNECT device. Dose as prescribed by physician.
Eligibility Criteria
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Cullman, Alabama, 35058, United States
Unknown Facility
Boca Raton, Florida, 33428, United States
Unknown Facility
New Port Richey, Florida, 34653, United States
Unknown Facility
Tampa, Florida, 33609, United States
Unknown Facility
Atlanta, Georgia, 30309-1465, United States
Unknown Facility
Fulton, Maryland, 20759, United States
Unknown Facility
Foxborough, Massachusetts, 02035, United States
Unknown Facility
Deckerville, Michigan, 48427, United States
Unknown Facility
St Louis, Missouri, 63131, United States
Unknown Facility
Stratford, New Jersey, 08084, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Staten Island, New York, 10306, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, 19004, United States
Unknown Facility
Lititz, Pennsylvania, 17543, United States
Unknown Facility
Franklin, Tennessee, 37064, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Nashville, Tennessee, 37212, United States
Unknown Facility
Lubbock, Texas, 79430, United States
Unknown Facility
Round Rock, Texas, 78681, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Virginia Beach, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2016
First Posted
January 11, 2016
Study Start
February 5, 2016
Primary Completion
August 11, 2017
Study Completion
September 13, 2017
Last Updated
September 6, 2018
Record last verified: 2018-09