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NCT Number: NCT02247310

BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon

Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias.

To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.

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Key information

Conditions

Multiple Sclerosis, Relapsing Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome.
  • Patients must be on treatment with Betaferon or the decision to treat a patient with Betaferon has been made by the attending physician.
  • Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device.
  • Written informed consent must be obtained.

Exclusion criteria

  • Patients receiving any other disease modifying drug.
  • Contraindications of Betaferon described in the Summary of Product Characteristics.

Treatment and study plan

Interferon beta-1b (Betaferon®, BAY 86-5046)

Drug

Patients will be treated with Betaferon

BETACONNECT

Device

Auto-injector device to support the injection of Betaferon

Primary outcomes

  1. Adherence to therapy at the final visit.

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Satisfaction with and evaluation of the BETACONNECT auto-injector

    Time frame: At baseline,4 weeks,12 weeks and 24 weeks

    Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire

  2. Injection site pain and prophylactic analgesic use

    Time frame: At baseline,4 weeks,12 weeks and 24 weeks

    Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire

  3. Health related quality of life

    Time frame: At baseline,12 weeks and 24 weeks

    Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.

  4. Anxiety

    Time frame: At baseline,12 weeks and 24 weeks

    Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).

  5. Depression

    Time frame: At baseline,12 weeks and 24 weeks

    Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).

  6. Fatigue

    Time frame: At baseline,12 weeks and 24 weeks

    Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).

  7. Cognition

    Time frame: At baseline,12 weeks and 24 weeks

    Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).

  8. Local skin reactions

    Time frame: At baseline,4 weeks,12 weeks and 24 weeks

    Local skin reactions will be recorded by HCP evaluation (local inspection).

  9. Injection-related specifics

    Time frame: At 4 weeks,12 weeks and 24 weeks

    Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Nov 7, 2017

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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