Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Interferon beta-1b, Fatigue, Depression
Brief summary
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.
Interventions
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Relapsing-remitting multiple sclerosis * Age 18+ * Patients initiating Betaferon treatment
Exclusion criteria
* Patients previously treated with any immunomodulatory drug
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Clinical course of the disease | 12 months |
| Overall treatment tolerability as measured by rate of adverse events | 12 months |
Countries
Poland
Outcome results
None listed