Trial Condition(s):
Multiple Sclerosis
Physical Disability in Patients Treated With Betaferon
Bayer Identifier:
14173
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Physical Disability observational study in patients treated with Betaferon in daily practice
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with BetaferonTimeframe: Every 6 months for 2 years
Secondary Outcome
- To evaluate Betaferon safety on the daily routine basisTimeframe: Every 6 months
- To evaluate patient adherence to Betaferon treatmentTimeframe: Every 6 months
Additional Information
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