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Physical Disability in Patients Treated With Betaferon

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873340
First Posted: April 1, 2009
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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:
  • To evaluate Betaferon safety on the daily routine basis [ Time Frame: Every 6 months ]
  • To evaluate patient adherence to Betaferon treatment [ Time Frame: Every 6 months ]

Biospecimen Retention:   None Retained
n.a

Enrollment: 83
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: March 31, 2009
First Posted: April 1, 2009
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