Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Quality of life
Brief summary
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
Interventions
DRUGInterferon beta-1b, (Betaseron BAY86-5046)
The cohort included is described in section 8.5 (inclusion criteria)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of the Daily Life score: Analysis of variance for repeated measurements. | After 1, 3, 6, 9 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements | Over 12 months |
| Correlation coefficient with quality of life scales | Over 12 months |
| Kinetics of treatment discontinuation: Kaplan Meier | Over 12 months |
| Rate of treatment continuation | After 12 months |
Countries
France
Outcome results
None listed