Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BF1401 | Other Identifier | Company Internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon®, BAY 86-5046) | Drug | Patients will be treated with Betaferon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to therapy at the final visit. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with and evaluation of the BETACONNECT auto-injector | Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire | At baseline,4 weeks,12 weeks and 24 weeks |
| Injection site pain and prophylactic analgesic use |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Austria | |||||
Not provided
Not provided
Not provided
| BETACONNECT |
| Device |
Auto-injector device to support the injection of Betaferon |
|
Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire |
| At baseline,4 weeks,12 weeks and 24 weeks |
| Health related quality of life | Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire. | At baseline,12 weeks and 24 weeks |
| Anxiety | Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS). | At baseline,12 weeks and 24 weeks |
| Depression | Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D). | At baseline,12 weeks and 24 weeks |
| Fatigue | Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC). | At baseline,12 weeks and 24 weeks |
| Cognition | Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT). | At baseline,12 weeks and 24 weeks |
| Local skin reactions | Local skin reactions will be recorded by HCP evaluation (local inspection). | At baseline,4 weeks,12 weeks and 24 weeks |
| Injection-related specifics | Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device | At 4 weeks,12 weeks and 24 weeks |
| Many Locations |
| Belgium |
| 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 |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided