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

Bayer

Status: Completed

Conditions: Multiple Sclerosis, Relapsing Remitting

Treatments: Device: BETACONNECT; Drug: Interferon beta-1b (Betaferon®, BAY 86-5046)

Study type: Observational

Funder types: Industry

Identifiers

NCT02247310

17591

BF1401 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 498 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

498 participants in 1 patient group

Cohort 1

Description:

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.

Treatment:

Device: BETACONNECT

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