Physical Activity and Fatigue in Early Multiple Sclerosis (MS)
BEGIN
Betaferon Treatment and Exercise Data Gathering IN Early MS
3 other identifiers
observational
1,739
32 countries
32
Brief Summary
The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2006
Longer than P75 for all trials
32 active sites
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
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 30, 2012
May 1, 2012
4.6 years
April 15, 2009
May 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Activity and Fatigue
At baseline and at Month 24
Secondary Outcomes (2)
Health-related Quality of Life
At baseline and at Month 24
Depression
At baseline and at Month 24
Study Arms (1)
Group 1
Interventions
Intravenous therapy according to product information
Eligibility Criteria
Patients after a first demyelinating event suggestive of MS as well as patients with recently diagnosed RRMS (\< 12 months)
You may qualify if:
- Multiple sclerosis diagnosed within the last 12 months
- Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (33)
Unknown Facility
Many Locations, Australia
Unknown Facility
Many Locations, Austria
Unknown Facility
Many Locations, Bahrain
Unknown Facility
Many Locations, Belgium
Unknown Facility
Many Locations, Canada
Unknown Facility
Many Locations, Colombia
Unknown Facility
Many Locations, Czechia
Unknown Facility
Many Locations, Denmark
Unknown Facility
Many Locations, Egypt
Unknown Facility
Many Locations, France
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Greece
Unknown Facility
Many Locations, Indonesia
Unknown Facility
Many Locations, Israel
Unknown Facility
Many Locations, Italy
Unknown Facility
Many Locations, Jordan
Unknown Facility
Many Locations, Kazakhstan
Unknown Facility
Many Locations, Kuwait
Unknown Facility
Many Locations, Lebanon
Unknown Facility
Many Locations, Mexico
Unknown Facility
Many Locations, Netherlands
Unknown Facility
Many Locations, Norway
Unknown Facility
Many Locations, Oman
Unknown Facility
Many Locations, Portugal
Unknown Facility
Many Locations, Slovenia
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Spain
Unknown Facility
Many Locations, Sweden
Unknown Facility
Many Locations, Switzerland
Unknown Facility
Many Locations, Taiwan
Unknown Facility
Many Locations, Thailand
Unknown Facility
Many Locations, United Arab Emirates
Unknown Facility
Many Locations, United Kingdom
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
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 16, 2009
Study Start
August 1, 2006
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 30, 2012
Record last verified: 2012-05