Clinical trial NCT02247310: BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
Official title: BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing Remitting
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 498
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) who are treated with Betaferon or will be treated with Betaferon® according to the attending physician's decision and for whom the patient and the physician have agreed to use the BETACONNECT device.

The study will be conducted in neurological centers and neurology departments specialized in the treatment of Multiple Sclerosis patients.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to therapy at the final visit.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Satisfaction with and evaluation of the BETACONNECT auto-injector
timeFrame: At baseline,4 weeks,12 weeks and 24 weeks
measure: Injection site pain and prophylactic analgesic use
timeFrame: At baseline,4 weeks,12 weeks and 24 weeks
measure: Health related quality of life
timeFrame: At baseline,12 weeks and 24 weeks
measure: Anxiety
timeFrame: At baseline,12 weeks and 24 weeks
measure: Depression
timeFrame: At baseline,12 weeks and 24 weeks
measure: Fatigue
timeFrame: At baseline,12 weeks and 24 weeks
measure: Cognition
timeFrame: At baseline,12 weeks and 24 weeks
measure: Local skin reactions
timeFrame: At baseline,4 weeks,12 weeks and 24 weeks
measure: Injection-related specifics
timeFrame: At 4 weeks,12 weeks and 24 weeks
Other outcomes:
Locations:
city: Many locations
country: Austria
city: Many locations
country: Belgium
city: Many Locations
country: Bosnia and Herzegovina
city: Many locations
country: Croatia
city: Many Locations
country: Czechia
city: Many locations
country: France
city: Many locations
country: Greece
city: Many locations
country: Hungary
city: Many locations
country: Italy
city: Many locations
country: Spain
city: Many locations
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: