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OpenTrials
Completed

NCT Number: NCT02652091

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Health Behavior Immune System Diseases Multiple Sclerosis Nervous System Diseases Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cullman, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

BETACONNECT device

Device

Used to apply Betaseron.

Primary outcomes

  1. Number of BETASERON injections as captured by the BETACONNECT device

    Time frame: At 6 months

  2. Time (days) between BETASERON injections as captured by BETACONNECT device

    Time frame: At 6 months

Secondary outcomes

  1. Patient reported satisfaction by a questionnaire

    Time frame: At 6 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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