Trial Condition(s):
Multiple Sclerosis
Open, multicentric, prospective, quality of life Study in Multiple Sclerosis patients
Bayer Identifier:
14168
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Evolution of the Daily Life score: Analysis of variance for repeated measurements.Timeframe: After 1, 3, 6, 9 and 12 months
Secondary Outcome
- Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurementsTimeframe: Over 12 months
- Correlation coefficient with quality of life scalesTimeframe: Over 12 months
- Kinetics of treatment discontinuation: Kaplan MeierTimeframe: Over 12 months
- Rate of treatment continuationTimeframe: After 12 months
Additional Information
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