Physical Disability in Patients Treated With Betaferon

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00873340
First received: March 31, 2009
Last updated: June 27, 2013
Last verified: June 2013

March 31, 2009
June 27, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • To evaluate patient adherence to Betaferon treatment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00873340
14173, BF0712CO, 2007- 001 Col
No
Medical Director, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP