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

NCT02652091 — Completed, 146 participants, Bayer

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RegistryNCT02652091
StatusCompleted
Study typeObservational
Enrollment146 (Actual)
SponsorBayer (Industry)
ConditionsMultiple Sclerosis, Relapsing-Remitting
InterventionsInterferon beta-1b (Betaseron, BAY86-5046), BETACONNECT device (Drug, device)
Datesstart 2016-02-05, primary completion 2017-08-11, completion 2017-09-13, first posted 2016-01-11, last updated 2018-09-06
Locations23 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Sclerosis, Relapsing-Remitting All trials of Interferon beta-1b (Betaseron, BAY86-5046) All trials of BETACONNECT device

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Interferon beta-1bDrug: Interferon beta-1b (Betaseron, BAY86-5046); Device: BETACONNECT devicePatients 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) (Drug): Applied via the BETACONNECT device. Dose as prescribed by physician.
  • BETACONNECT device (Device): Used to apply Betaseron.

+Outcome measures

Primary outcomes

  • 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

  • Patient reported satisfaction by a questionnaire [At 6 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (23)

FacilityCityCountryStatus
Cullman, AlabamaUnited States
Boca Raton, FloridaUnited States
New Port Richey, FloridaUnited States
Tampa, FloridaUnited States
Atlanta, GeorgiaUnited States
Fulton, MarylandUnited States
Foxborough, MassachusettsUnited States
Deckerville, MichiganUnited States
St Louis, MissouriUnited States
Stratford, New JerseyUnited States
Teaneck, New JerseyUnited States
Staten Island, New YorkUnited States
Medford, OregonUnited States
Medford, OregonUnited States
Bala-Cynwyd, PennsylvaniaUnited States
Lititz, PennsylvaniaUnited States
Franklin, TennesseeUnited States
Memphis, TennesseeUnited States
Nashville, TennesseeUnited States
Lubbock, TexasUnited States
Round Rock, TexasUnited States
Fairfax, VirginiaUnited States
Virginia Beach, VirginiaUnited States

+Investigators

  • Bayer Study Director, Study director, Bayer