Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients
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
3 other identifiers
observational
67
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 9, 2015
October 1, 2015
2.8 years
June 23, 2009
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of the Daily Life score: Analysis of variance for repeated measurements.
After 1, 3, 6, 9 and 12 months
Secondary Outcomes (4)
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
Study Arms (1)
Group 1
Interventions
The cohort included is described in section 8.5 (inclusion criteria)
Eligibility 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.
You may qualify if:
- The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 26, 2009
Study Start
May 1, 2007
Primary Completion
March 1, 2010
Study Completion
November 1, 2010
Last Updated
October 9, 2015
Record last verified: 2015-10