BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
- BETACONNECT
What it measured
Main measures
Adherence to therapy at the final visit.
Up to 24 weeks
Quality of life (reported by participants)
Other measures (9)
Satisfaction with and evaluation of the BETACONNECT auto-injector
At baseline,4 weeks,12 weeks and 24 weeks
Quality of life (reported by participants)Injection site pain and prophylactic analgesic use
At baseline,4 weeks,12 weeks and 24 weeks
PainSafetyHealth related quality of life
At baseline,12 weeks and 24 weeks
Quality of life (reported by participants)Anxiety
At baseline,12 weeks and 24 weeks
Mood and sleepDepression
At baseline,12 weeks and 24 weeks
Mood and sleepFatigue
At baseline,12 weeks and 24 weeks
Thinking and memoryFatigueCognition
At baseline,12 weeks and 24 weeks
Thinking and memoryLocal skin reactions
At baseline,4 weeks,12 weeks and 24 weeks
Injection-related specifics
At 4 weeks,12 weeks and 24 weeks
Who could take part
Relapsing MS
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- TWINS
Phase 3 · Not yet recruiting
Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumar…
Recruiting
Still running
- Full Responders
Phase 4 · Stopped early
Stopped early
- A Study to Learn More About The Safety of Diroximel Fumar…
Running, not recruiting
Still running
- Study to Investigate Pregnancy Outcomes in Female Partici…
Completed
Result in a paper, not read yet
- 105MS306
Phase 3 · Running, not recruiting
Still running
History
Started
Oct 2014
Main results due
Jul 2016
Finished
Nov 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error