check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
14168
ClinicalTrials.gov Identifier:
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
BothAge
18 YearsTrial summary
Enrollment Goal
67Trial Dates
May 2007 - November 2010Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurementsdate_rangeTime Frame:Over 12 monthsenhanced_encryptionNoSafety Issue:
- Correlation coefficient with quality of life scalesdate_rangeTime Frame:Over 12 monthsenhanced_encryptionNoSafety Issue:
- Kinetics of treatment discontinuation: Kaplan Meierdate_rangeTime Frame:Over 12 monthsenhanced_encryptionNoSafety Issue:
- Rate of treatment continuationdate_rangeTime Frame:After 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A