BENEFIT Extension Study
Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
2 other identifiers
observational
283
18 countries
18
Brief Summary
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2007
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 15, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 5, 2012
March 1, 2012
3.3 years
October 15, 2007
March 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
End of Study
Study Arms (1)
Group 1
Interventions
Eligibility Criteria
This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.
You may qualify if:
- All patients randomized and treated at least once in study 304747
You may not qualify if:
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (18)
Unknown Facility
Many Locations, Austria
Unknown Facility
Many Locations, Belgium
Unknown Facility
Many Locations, Canada
Unknown Facility
Many Locations, Czechia
Unknown Facility
Many Locations, Denmark
Unknown Facility
Many Locations, Finland
Unknown Facility
Many Locations, France
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Hungary
Unknown Facility
Many Locations, Israel
Unknown Facility
Many Locations, Italy
Unknown Facility
Many Locations, Netherlands
Unknown Facility
Many Locations, Norway
Unknown Facility
Many Locations, Poland
Unknown Facility
Many Locations, Slovenia
Unknown Facility
Many Locations, Spain
Unknown Facility
Many Locations, Sweden
Unknown Facility
Many Locations, Switzerland
Related Publications (1)
Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.
PMID: 23842212DERIVED
Biospecimen
Population of Benefit Studies
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
October 15, 2007
First Posted
October 16, 2007
Study Start
September 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 5, 2012
Record last verified: 2012-03