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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02652091
Enrollment
146
Registered
2016-01-11
Start date
2016-02-05
Completion date
2017-09-13
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Adherence, Persistence, Patient satisfaction

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.

Interventions

Applied via the BETACONNECT device. Dose as prescribed by physician.

DEVICEBETACONNECT device

Used to apply Betaseron.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of BETASERON injections as captured by the BETACONNECT deviceAt 6 months
Time (days) between BETASERON injections as captured by BETACONNECT deviceAt 6 months

Secondary

MeasureTime frame
Patient reported satisfaction by a questionnaireAt 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026