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

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ClinicalTrials.gov Identifier: NCT02247310
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing Remitting Drug: Interferon beta-1b (Betaferon®, BAY 86-5046) Device: BETACONNECT

Study Design
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Study Type : Observational
Actual Enrollment : 498 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Actual Study Start Date : October 20, 2014
Actual Primary Completion Date : July 19, 2016
Actual Study Completion Date : November 8, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.
 Drug: Interferon beta-1b (Betaferon®, BAY 86-5046)
Patients will be treated with Betaferon

Device: BETACONNECT
Auto-injector device to support the injection of Betaferon


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to therapy at the final visit. [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon® according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device.

The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.

Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247310


Locations
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Austria
Many locations, Austria
Belgium
Many locations, Belgium
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Croatia
Many locations, Croatia
Czechia
Many Locations, Czechia
France
Many locations, France
Greece
Many locations, Greece
Hungary
Many locations, Hungary
Italy
Many locations, Italy
Spain
Many locations, Spain
Switzerland
Many locations, Switzerland
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02247310    
Other Study ID Numbers: 17591
BF1401 ( Other Identifier: Company Internal )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic