check_circleStudy Completed

Multiple Sclerosis, Relapsing Remitting

Bayer Identifier:

17591

ClinicalTrials.gov Identifier:

NCT02247310

EudraCT Number:

Not Available

EU CT Number:

Not Available
BETAEVAL Global - The new BETACONNECT auto-injector : Adherence and EVALuation of Multiple Sclerosis patients treated with Betaferon

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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.

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

Trial summary

Enrollment Goal
498
Trial Dates
October 2014 - November 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, France
Completed
Many locations, Italy
Completed
Many locations, Spain
Completed
Many locations, Belgium
Completed
Many locations, Austria
Completed
Many locations, Hungary
Completed
Many locations, Greece
Completed
Many locations, Switzerland
Completed
Many locations, Croatia
Completed
Many Locations, Czech Republic
Completed
Many Locations, Bosnia And Herzegovina

Primary Outcome

  • Adherence to therapy at the final visit.
    date_rangeTime Frame:
    Up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Satisfaction with and evaluation of the BETACONNECT auto-injector
    Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
    date_rangeTime Frame:
    At baseline,4 weeks,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Injection site pain and prophylactic analgesic use
    Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
    date_rangeTime Frame:
    At baseline,4 weeks,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Health related quality of life
    Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
    date_rangeTime Frame:
    At baseline,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Anxiety
    Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
    date_rangeTime Frame:
    At baseline,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Depression
    Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
    date_rangeTime Frame:
    At baseline,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Fatigue
    Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
    date_rangeTime Frame:
    At baseline,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Cognition
    Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
    date_rangeTime Frame:
    At baseline,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Local skin reactions
    Local skin reactions will be recorded by HCP evaluation (local inspection).
    date_rangeTime Frame:
    At baseline,4 weeks,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Injection-related specifics
    Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
    date_rangeTime Frame:
    At 4 weeks,12 weeks and 24 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

BETAEVAL_Global- The new BETACONNECT® auto-injector: Adherence and EVALuation of MS patients treated with Betaferon®
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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