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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652091
• Other study ID #: 17942
• Status: Completed
• Start date: February 5, 2016
• Est. completion date: September 13, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 13, 2017
• Est. primary completion date: August 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Applied via the BETACONNECT device. Dose as prescribed by physician.

Device:
• BETACONNECT device
Used to apply Betaseron.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of BETASERON injections as captured by the BETACONNECT device		At 6 months
Primary	Time (days) between BETASERON injections as captured by BETACONNECT device		At 6 months
Secondary	Patient reported satisfaction by a questionnaire		At 6 weeks

External Links

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