check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

14168

ClinicalTrials.gov Identifier:

NCT00928967

EudraCT Number:

Not Available

EU CT Number:

Not Available
Open, multicentric, prospective, quality of life Study in Multiple Sclerosis patients

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.

Trial summary

Enrollment Goal
67
Trial Dates
May 2007 - November 2010
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France

Primary Outcome

  • Evolution of the Daily Life score: Analysis of variance for repeated measurements.
    date_rangeTime Frame:
    After 1, 3, 6, 9 and 12 months
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    Safety Issue:
    No

Secondary Outcome

  • Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements
    date_rangeTime Frame:
    Over 12 months
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    Safety Issue:
    No
  • Correlation coefficient with quality of life scales
    date_rangeTime Frame:
    Over 12 months
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    Safety Issue:
    No
  • Kinetics of treatment discontinuation: Kaplan Meier
    date_rangeTime Frame:
    Over 12 months
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    Safety Issue:
    No
  • Rate of treatment continuation
    date_rangeTime Frame:
    After 12 months
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    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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