BAY86-5046 (Betaseron), Non Interventional Studies (BETAEVAL)
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ClinicalTrials.gov Identifier: NCT02121444 |
Recruitment Status :
Completed
First Posted : April 23, 2014
Last Update Posted : October 18, 2017
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Condition or disease | Intervention/treatment |
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Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY 86-5046) Device: BETACONNECT auto-injector. |
Study Type : | Observational |
Actual Enrollment : | 151 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon® |
Actual Study Start Date : | June 23, 2014 |
Actual Primary Completion Date : | March 9, 2016 |
Actual Study Completion Date : | June 1, 2016 |

Group/Cohort | Intervention/treatment |
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Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
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Drug: Interferon beta-1b (Betaferon, BAY 86-5046) Device: BETACONNECT auto-injector. |
- Adherence measure to Betaferon therapy based on the real BETACONNECT injections [ Time Frame: up to 24 weeks ]Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.
- Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire [ Time Frame: up to 24 weeks ]
- Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire [ Time Frame: up to 24 weeks ]
- Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) [ Time Frame: up to 24 weeks ]
- Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: up to 24 weeks ]
- Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) [ Time Frame: up to 24 weeks ]
- Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) [ Time Frame: up to 24 weeks ]
- Local skin reactions recorded by Health Care Provider (HCP) evaluation [ Time Frame: up to 24 weeks ]
- Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device [ Time Frame: up to 24 weeks ]
- Number of Treatment-emergent Adverse Events (TEAE) [ Time Frame: up to 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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): NCT02121444
Germany | |
Many Locations, Germany |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02121444 |
Other Study ID Numbers: |
17101 BF1414DE ( Other Identifier: Company internal ) |
First Posted: | April 23, 2014 Key Record Dates |
Last Update Posted: | October 18, 2017 |
Last Verified: | October 2017 |
RRMS CIS |
Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons |
Interferon-beta Interferon beta-1b Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |