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

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046); Device: BETACONNECT device

• Registration Number: NCT02652091
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Study Start: 2016-02-05
• Primary Completion: 2017-08-11
• Study Completion: 2017-09-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interferon beta-1b	BETACONNECT device	Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
Interferon beta-1b	Interferon beta-1b (Betaseron, BAY86-5046)	Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient reported satisfaction by a questionnaire	At 6 weeks