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

NCT ID: NCT02652091

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-05

Study Completion Date

2017-09-13

Brief Summary

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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

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Interferon beta-1b

Patients 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)

Intervention Type DRUG

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

BETACONNECT device

Intervention Type DEVICE

Used to apply Betaseron.

Interventions

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

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

Intervention Type DRUG

BETACONNECT device

Used to apply Betaseron.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Foxborough, Massachusetts, United States

Site Status

Deckerville, Michigan, United States

Site Status

St Louis, Missouri, United States

Site Status

Stratford, New Jersey, United States

Site Status

Teaneck, New Jersey, United States

Site Status

Staten Island, New York, United States

Site Status

Medford, Oregon, United States

Site Status

Medford, Oregon, United States

Site Status

Bala-Cynwyd, Pennsylvania, United States

Site Status

Lititz, Pennsylvania, United States

Site Status

Franklin, Tennessee, United States

Site Status

Memphis, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Lubbock, Texas, United States

Site Status

Round Rock, Texas, United States

Site Status

Fairfax, Virginia, United States

Site Status

Virginia Beach, Virginia, United States

Site Status

Cullman, Alabama, United States

Site Status

Boca Raton, Florida, United States

Site Status

New Port Richey, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Fulton, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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17942

Identifier Type: -

Identifier Source: org_study_id

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