check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

14173

ClinicalTrials.gov Identifier:

NCT00873340

EudraCT Number:

Not Available

EU CT Number:

Not Available
Physical Disability in Patients Treated With Betaferon

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.

  • - 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
83
Trial Dates
October 2007 - January 2011
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Colombia

Primary Outcome

  • To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon
    date_rangeTime Frame:
    Every 6 months for 2 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • To evaluate Betaferon safety on the daily routine basis
    date_rangeTime Frame:
    Every 6 months
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    Safety Issue:
    Yes
  • To evaluate patient adherence to Betaferon treatment
    date_rangeTime Frame:
    Every 6 months
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    Safety Issue:
    No

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
N/A

Additional Information

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