check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

17101

ClinicalTrials.gov Identifier:

NCT02121444

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY86-5046 (Betaseron), Non Interventional Studies

Trial purpose

This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

Key Participants Requirements

Sex

Both

Age

18 - 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 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.

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

Trial summary

Enrollment Goal
151
Trial Dates
June 2014 - June 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, Germany

Primary Outcome

  • Adherence measure to Betaferon therapy based on the real BETACONNECT injections
    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.
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Local skin reactions recorded by Health Care Provider (HCP) evaluation
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of Treatment-emergent Adverse Events (TEAE)
    date_rangeTime Frame:
    up to 24 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

BETAEVAL - 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

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.