BAY86-5046 (Betaseron), Non Interventional Studies

Multiple Sclerosis Clinical Trial

— BETAEVAL  

Official title:

BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121444
• Other study ID #: 17101
• Secondary ID: BF1414DE
• Status: Completed
• Phase: N/A
• First received: April 22, 2014
• Last updated: October 16, 2017
• Start date: June 23, 2014
• Est. completion date: June 1, 2016

Study information

• Verified date: October 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 1, 2016
• Est. primary completion date: March 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaferon, BAY 86-5046)

Device:
• BETACONNECT auto-injector.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 weeks
Secondary	Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire		up to 24 weeks
Secondary	Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire		up to 24 weeks
Secondary	Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)		up to 24 weeks
Secondary	Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)		up to 24 weeks
Secondary	Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)		up to 24 weeks
Secondary	Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)		up to 24 weeks
Secondary	Local skin reactions recorded by Health Care Provider (HCP) evaluation		up to 24 weeks
Secondary	Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device		up to 24 weeks
Secondary	Number of Treatment-emergent Adverse Events (TEAE)		up to 24 weeks

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