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Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00928967
First received: June 23, 2009
Last updated: October 7, 2015
Last verified: October 2015

June 23, 2009
October 7, 2015
May 2007
March 2010   (final data collection date for primary outcome measure)
Evolution of the Daily Life score: Analysis of variance for repeated measurements. [ Time Frame: After 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928967 on ClinicalTrials.gov Archive Site
  • Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Rate of treatment continuation [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
  • Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements. [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Rate of treatment continuation [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients
Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS
To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
n.a.
Non-Probability Sample
Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria.The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
Multiple Sclerosis
Drug: Interferon beta-1b, (Betaseron BAY86-5046)
The cohort included is described in section 8.5 (inclusion criteria)
Group 1
Intervention: Drug: Interferon beta-1b, (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
67
November 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
  • The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00928967
14168, Daily Life Study, BF0610FR
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2015

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