An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
ABOVE
A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex
2 other identifiers
interventional
271
2 countries
53
Brief Summary
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2003
Typical duration for phase_4
53 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
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedDecember 31, 2014
December 1, 2014
September 13, 2005
December 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time to onset of first relapse
Time to onset of first relapse
Secondary Outcomes (1)
Number of patients relapse free at week 104
At week 104
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- RRMS patients that are receiving treatment with Avonex 30 µg once weekly
You may not qualify if:
- Primary Progressive or Secondary Progressive MS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (53)
Unknown Facility
Tucson, Arizona, 85741, United States
Unknown Facility
Berkeley, California, 94705, United States
Unknown Facility
Irvine, California, 92697, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angeles, California, 90095-1721, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Jose, California, 95124, United States
Unknown Facility
Walnut Creek, California, 94596, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Wilmington, Delaware, 19806, United States
Unknown Facility
Melbourne, Florida, 32940, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Tampa, Florida, 33609, United States
Unknown Facility
Atlanta, Georgia, 30309-1465, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Columbus, Georgia, 31909, United States
Unknown Facility
Savannah, Georgia, 31405, United States
Unknown Facility
Flossmoor, Illinois, 60422, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Fort Wayne, Indiana, 46805, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Des Moines, Iowa, 50314, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Shreveport, Louisiana, 71130, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Golden Valley, Minnesota, 55422, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Kansas City, Missouri, 64108, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Reno, Nevada, 89509, United States
Unknown Facility
Albuquerque, New Mexico, 87131-5281, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Mineola, New York, 11501, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Dayton, Ohio, 45409, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Providence, Rhode Island, 02905, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Roanoke, Virginia, 24014, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Nepean, Ontario, K2G 6E2, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
March 1, 2003
Study Completion
October 1, 2005
Last Updated
December 31, 2014
Record last verified: 2014-12