Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BF1012PL | Other Identifier | NIS Trial Alias |
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
This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations.
The study is conducted in routine practice setting hence no interference with standard care takes place.
Pharmacologic treatments of MS-fatigue and depression will also be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon, BAY86-5046) | Biological | Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fatigue score over time | short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of depression score over time | short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline | |
| Treatment adherence | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Poland |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinical course of the disease | 12 months |
| Overall treatment tolerability as measured by rate of adverse events | 12 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |