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

Bayer

Status: Completed

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Interferon beta-1b (Betaseron, BAY86-5046); Device: BETACONNECT device

Study type: Observational

Funder types: Industry

Identifiers

NCT02652091

17942

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

146 participants in 1 patient group

Interferon beta-1b

Description:

Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.

Treatment:

Device: BETACONNECT device

Drug: Interferon beta-1b (Betaseron, BAY86-5046)