Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing remitting
Treatments betaferon, (bay 86-5046), betaconnect
Sponsor Bayer
Start date October 2014
End date July 2016
Trial size 480 participants
Trial identifier NCT02247310, 17591, BF1401

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
betaferon, (bay 86-5046)
Patients will be treated with Betaferon
betaconnect
Auto-injector device to support the injection of Betaferon

Primary Outcomes

Measure
Adherence to therapy at the final visit.
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Satisfaction with and evaluation of the BETACONNECT auto-injector
time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection site pain and prophylactic analgesic use
time frame: At baseline,4 weeks,12 weeks and 24 weeks
Health related quality of life
time frame: At baseline,12 weeks and 24 weeks
Anxiety
time frame: At baseline,12 weeks and 24 weeks
Depression
time frame: At baseline,12 weeks and 24 weeks
Fatigue
time frame: At baseline,12 weeks and 24 weeks
Cognition
time frame: At baseline,12 weeks and 24 weeks
Local skin reactions
time frame: At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
time frame: At 4 weeks,12 weeks and 24 weeks

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.