Trial Condition(s):
Multiple Sclerosis
BAY86-5046 (Betaseron), Non Interventional Studies (BETAEVAL)
Bayer Identifier:
17101
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
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.
Trial Summary
Enrollment Goal
151
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Adherence measure to Betaferon therapy based on the real BETACONNECT injectionsAdherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.Timeframe: up to 24 weeks
Secondary Outcome
- Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaireTimeframe: up to 24 weeks
- Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaireTimeframe: up to 24 weeks
- Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)Timeframe: up to 24 weeks
- Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)Timeframe: up to 24 weeks
- Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)Timeframe: up to 24 weeks
- Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)Timeframe: up to 24 weeks
- Local skin reactions recorded by Health Care Provider (HCP) evaluationTimeframe: up to 24 weeks
- Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT deviceTimeframe: up to 24 weeks
- Number of Treatment-emergent Adverse Events (TEAE)Timeframe: up to 24 weeks
Additional Information
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