Clinical trial NCT02121444: BAY86-5046 (Betaseron), Non Interventional Studies
Official title: BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: RRMS
CIS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

Brief summary: This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.


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 patients 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 measure to Betaferon therapy based on the real BETACONNECT injections
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire
timeFrame: up to 24 weeks
measure: Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire
timeFrame: up to 24 weeks
measure: Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 24 weeks
measure: Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: up to 24 weeks
measure: Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)
timeFrame: up to 24 weeks
measure: Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)
timeFrame: up to 24 weeks
measure: Local skin reactions recorded by Health Care Provider (HCP) evaluation
timeFrame: up to 24 weeks
measure: Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
timeFrame: up to 24 weeks
measure: Number of Treatment-emergent Adverse Events (TEAE)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kleiter I, Lang M, Jeske J, Norenberg C, Stollfuss B, Schurks M. Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT(R) autoinjector: a prospective observational cohort study. BMC Neurol. 2017 Sep 6;17(1):174. doi: 10.1186/s12883-017-0953-8.