check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:
17942
ClinicalTrials.gov Identifier:
NCT02652091
EudraCT Number:
Not Available
EU CT Number:
Not Available
Impact of the BETACONNECT auto-injector on BETASERON therapy adherence and patient satisfaction

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
146
Trial Dates
February 2016 - September 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Lubbock, 79430, United States
Completed
Stratford, 08084, United States
Completed
Deckerville, 48427, United States
Completed
Memphis, 38104, United States
Completed
Tampa, 33609, United States
Completed
Boca Raton, 33428, United States
Completed
Teaneck, 07666, United States
Completed
Round Rock, 78681, United States
Completed
Fulton, 20759, United States
Completed
Franklin, 37064, United States
Completed
Cullman, 35058, United States
Completed
Lititz, 17543, United States
Completed
Nashville, 37212, United States
Completed
Foxboro, 02035, United States
Completed
Staten Island, 10306, United States
Completed
New Port Richey, 34653, United States
Completed
Fairfax, 22031, United States
Completed
St. Louis, 63131, United States
Completed
Bala Cynwyd, 19004, United States
Completed
Atlanta, 30309-1465, United States
Completed
Medford, 97504, United States
Completed
Virginia Beach, United States
Completed
Medford, United States

Primary Outcome

  • Number of BETASERON injections as captured by the BETACONNECT device
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Time (days) between BETASERON injections as captured by BETACONNECT device
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Patient reported satisfaction by a questionnaire
    date_rangeTime Frame:
    At 6 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Impact of the BETACONNECT auto-injector on BETASERON therapy adherence and patient satisfaction
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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