Multiple Sclerosis
Conditions
Keywords
MS, Multiple Sclerosis, Betaferon, Colombia
Brief summary
To gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods
Interventions
Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be observed.
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
* Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.
Exclusion criteria
* Pregnancy * Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients * Patients with a history of severe depressive disorders and/or suicidal ideation * Patient with decompensated liver disease * Patient with epilepsy not adequately controlled by treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon | Every 6 months for 2 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Betaferon safety on the daily routine basis | Every 6 months |
| To evaluate patient adherence to Betaferon treatment | Every 6 months |
Countries
Colombia
Outcome results
None listed