BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon
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|ClinicalTrials.gov Identifier: NCT02247310|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : November 7, 2017
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.
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis, Relapsing Remitting||Drug: Interferon beta-1b (Betaferon®, BAY 86-5046) Device: BETACONNECT|
|Study Type :||Observational|
|Actual Enrollment :||498 participants|
|Official Title:||BETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®|
|Actual Study Start Date :||October 20, 2014|
|Actual Primary Completion Date :||July 19, 2016|
|Actual Study Completion Date :||November 8, 2016|
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.
Drug: Interferon beta-1b (Betaferon®, BAY 86-5046)
Patients will be treated with Betaferon
Auto-injector device to support the injection of Betaferon
- Adherence to therapy at the final visit. [ Time Frame: Up to 24 weeks ]
- Satisfaction with and evaluation of the BETACONNECT auto-injector [ Time Frame: At baseline,4 weeks,12 weeks and 24 weeks ]Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire
- Injection site pain and prophylactic analgesic use [ Time Frame: At baseline,4 weeks,12 weeks and 24 weeks ]Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire
- Health related quality of life [ Time Frame: At baseline,12 weeks and 24 weeks ]Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire.
- Anxiety [ Time Frame: At baseline,12 weeks and 24 weeks ]Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS).
- Depression [ Time Frame: At baseline,12 weeks and 24 weeks ]Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D).
- Fatigue [ Time Frame: At baseline,12 weeks and 24 weeks ]Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC).
- Cognition [ Time Frame: At baseline,12 weeks and 24 weeks ]Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT).
- Local skin reactions [ Time Frame: At baseline,4 weeks,12 weeks and 24 weeks ]Local skin reactions will be recorded by HCP evaluation (local inspection).
- Injection-related specifics [ Time Frame: At 4 weeks,12 weeks and 24 weeks ]Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247310
|Many locations, Austria|
|Many locations, Belgium|
|Bosnia and Herzegovina|
|Many Locations, Bosnia and Herzegovina|
|Many locations, Croatia|
|Many Locations, Czechia|
|Many locations, France|
|Many locations, Greece|
|Many locations, Hungary|
|Many locations, Italy|
|Many locations, Spain|
|Many locations, Switzerland|
|Study Director:||Bayer Study Director||Bayer|