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BAY86-5046 (Betaseron), Non Interventional Studies (BETAEVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121444
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

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

Study Design
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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Actual Study Start Date : June 23, 2014
Actual Primary Completion Date : March 9, 2016
Actual Study Completion Date : June 1, 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
 Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
Device: BETACONNECT auto-injector.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence measure to Betaferon therapy based on the real BETACONNECT injections [ Time Frame: up to 24 weeks ]
    Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.


Secondary Outcome Measures :
  1. Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire [ Time Frame: up to 24 weeks ]
  2. Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire [ Time Frame: up to 24 weeks ]
  3. Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) [ Time Frame: up to 24 weeks ]
  4. Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: up to 24 weeks ]
  5. Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) [ Time Frame: up to 24 weeks ]
  6. Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) [ Time Frame: up to 24 weeks ]
  7. Local skin reactions recorded by Health Care Provider (HCP) evaluation [ Time Frame: up to 24 weeks ]
  8. Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device [ Time Frame: up to 24 weeks ]
  9. Number of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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 patients 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): NCT02121444


Locations
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Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02121444    
Other Study ID Numbers: 17101
BF1414DE ( Other Identifier: Company internal )
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Keywords provided by Bayer:
RRMS
CIS
Additional relevant MeSH terms:
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Multiple Sclerosis
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