Trial Condition(s):

Multiple Sclerosis, Relapsing Remitting

BETAEVAL Global - The new BETACONNECT auto-injector : Adherence and EVALuation of Multiple Sclerosis patients treated with Betaferon

Bayer Identifier:

17591

ClinicalTrials.gov Identifier:

NCT02247310

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
498
Trial Dates
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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
Status
LocationsStatus
Locations

Investigative Site

Many locations, France

Status
Completed
 
Locations

Investigative Site

Many locations, Italy

Status
Completed
 
Locations

Investigative Site

Many locations, Spain

Status
Completed
 
Locations

Investigative Site

Many locations, Belgium

Status
Completed
 
Locations

Investigative Site

Many locations, Austria

Status
Completed
 
Locations

Investigative Site

Many locations, Hungary

Status
Completed
 
Locations

Investigative Site

Many locations, Greece

Status
Completed
 
Locations

Investigative Site

Many locations, Switzerland

Status
Completed
 
Locations

Investigative Site

Many locations, Croatia

Status
Completed
 
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many Locations, Bosnia and Herzegovina

Status
Completed
 

Trial Design