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| ID | Type | Description | Link |
|---|---|---|---|
| BF1212DE | Other Identifier | Company internal |
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The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon, BAY 86-5046) | Drug | Patients will be followed-up for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) | up to 3 years | |
| Fatique assessed by the Modified Fatigue Impact Scale (MFIS) | up to 3 years | |
| Functional health status assessed by Short Form-36 (SF-36) | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS) | up to 3 years | |
| Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS) | up to 3 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables will be summarized using descriptive statistics based on adverse events collection | up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with relapsing remitting multiple sclerosis (RRMS) or patients with a clinically isolated syndrome (CIS) with an Expanded Disability Status Scale (EDSS) score ≤5 who tolerate Betaferon according to the investigator's evaluation, but have not received Betaferon longer than six months. Participants will be recruited from private neurological offices and neurology departments throughout Germany.
In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician.
The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30143019 | Derived | Kotterba S, Neusser T, Norenberg C, Bussfeld P, Glaser T, Dorner M, Schurks M. Sleep quality, daytime sleepiness, fatigue, and quality of life in patients with multiple sclerosis treated with interferon beta-1b: results from a prospective observational cohort study. BMC Neurol. 2018 Aug 24;18(1):123. doi: 10.1186/s12883-018-1113-5. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL) |
| up to 3 years |
| Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale. | up to 3 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |