Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients
Completed
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: Interferon beta-1b, (Betaseron BAY86-5046)
- Registration Number
- NCT00928967
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
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.
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon beta-1b, (Betaseron BAY86-5046) -
- Primary Outcome Measures
Name Time Method Evolution of the Daily Life score: Analysis of variance for repeated measurements. After 1, 3, 6, 9 and 12 months
- Secondary Outcome Measures
Name Time Method 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