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NCT02247310

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

Completed Last updated 7 November 2017
What this trial tests

trial testing Interferon beta-1b (Betaferon®, BAY 86-5046) in Multiple Sclerosis, Relapsing Remitting in 498 participants. Completed in 8 November 2016.

Timeline
20 October 2014
Primary endpoint
19 July 2016
8 November 2016

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment498
Start date20 October 2014
Primary completion19 July 2016
Estimated completion8 November 2016
Sites11 locations across Bosnia and Herzegovina, France, Italy, Greece, Belgium, Austria, Hungary, Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, any sex, with Multiple Sclerosis, Relapsing Remitting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Real-World Assessment of Interferon-β-1b and Interferon-β-1a Adherence Before and After the Introduction of the BETACONNECT<sup>®</sup> Autoinjector: A Retrospective Cohort Study.
    Butler O, Heeg S, Holl K, Frenz AK, et al · · 2021 · cited 2× · PMID 33928518 · DOI 10.1007/s40801-021-00248-5

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