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Physical Disability in Patients Treated With Betaferon

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ClinicalTrials.gov Identifier: NCT00873340
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon-1beta (Betaseron, BAY86-5046)

Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice
Study Start Date : October 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Interferon-1beta (Betaseron, BAY86-5046)
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.



Primary Outcome Measures :
  1. To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon [ Time Frame: Every 6 months for 2 years ]

Secondary Outcome Measures :
  1. To evaluate Betaferon safety on the daily routine basis [ Time Frame: Every 6 months ]
  2. To evaluate patient adherence to Betaferon treatment [ Time Frame: Every 6 months ]

Biospecimen Retention:   None Retained
n.a


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS community sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873340


Locations
Colombia
Many Locations, Colombia
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00873340     History of Changes
Other Study ID Numbers: 14173
BF0712CO ( Other Identifier: company internal )
2007- 001 Col ( Other Identifier: company internal )
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Bayer:
MS
Multiple Sclerosis
Betaferon
Colombia

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs