Clinical trial NCT00206648: An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* RRMS patients that are receiving treatment with Avonex 30 µg once weekly

Exclusion Criteria:

* Primary Progressive or Secondary Progressive MS

Primary outcomes:
measure: Time to onset of first relapse
timeFrame: Time to onset of first relapse
Secondary outcomes:
measure: Number of patients relapse free at week 104
timeFrame: At week 104
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Irvine
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Flossmoor
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Golden Valley
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Nepean
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: