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

Multiple Sclerosis, Relapsing Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247310
• Other study ID #: 17591
• Secondary ID: BF1401
• Status: Completed
• Phase: N/A
• First received: September 19, 2014
• Last updated: November 5, 2017
• Start date: October 20, 2014
• Est. completion date: November 8, 2016

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: November 8, 2016
• Est. primary completion date: July 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A 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 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing Remitting
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Bosnia and Herzegovina,  Croatia,  Czechia,  France,  Greece,  Hungary,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to therapy at the final visit.		Up to 24 weeks
Secondary	Satisfaction with and evaluation of the BETACONNECT auto-injector	Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire	At baseline,4 weeks,12 weeks and 24 weeks
Secondary	Injection site pain and prophylactic analgesic use	Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire	At baseline,4 weeks,12 weeks and 24 weeks
Secondary	Health related quality of life	Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.	At baseline,12 weeks and 24 weeks
Secondary	Anxiety	Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).	At baseline,12 weeks and 24 weeks
Secondary	Depression	Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).	At baseline,12 weeks and 24 weeks
Secondary	Fatigue	Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).	At baseline,12 weeks and 24 weeks
Secondary	Cognition	Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).	At baseline,12 weeks and 24 weeks
Secondary	Local skin reactions	Local skin reactions will be recorded by HCP evaluation (local inspection).	At baseline,4 weeks,12 weeks and 24 weeks
Secondary	Injection-related specifics	Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device	At 4 weeks,12 weeks and 24 weeks

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