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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
March 31, 2009
April 1, 2009
June 26, 2014
October 2007
January 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00873340 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Physical Disability in Patients Treated With Betaferon
Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
n.a
Non-Probability Sample
MS community sample
Multiple Sclerosis
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.
Group 1
Intervention: Drug: Interferon-1beta (Betaseron, BAY86-5046)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
 
NCT00873340
14173
BF0712CO ( Other Identifier: company internal )
2007- 001 Col ( Other Identifier: company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014