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

Completed

• Conditions: Multiple Sclerosis, Relapsing Remitting
• Interventions: Drug: Interferon beta-1b (Betaferon®, BAY 86-5046); Device: BETACONNECT

• Registration Number: NCT02247310
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-25
• Study Start: 2014-10-20
• Primary Completion: 2016-07-19
• Study Completion: 2016-11-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-05
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Interferon beta-1b (Betaferon®, BAY 86-5046)	Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.
Cohort 1	BETACONNECT	Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device.

Primary Outcome Measures

Name	Time	Method
Adherence to therapy at the final visit.	Up to 24 weeks

Secondary Outcome Measures

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