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An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS (ABOVE)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Betaferon/Betaseron
Betaferon/Betaseron
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: RRMS patients that are receiving treatment with Avonex 30 µg once weekly Exclusion Criteria: Primary Progressive or Secondary Progressive MS

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Time to onset of first relapse

Secondary Outcome Measures

Number of patients relapse free at week 104

Full Information

First Posted
September 13, 2005
Last Updated
December 30, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00206648
Brief Title
An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS
Acronym
ABOVE
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Betaferon/Betaseron
Intervention Description
Betaseron 250 µg SC every other day
Intervention Type
Drug
Intervention Name(s)
Betaferon/Betaseron
Intervention Description
Avonex 30 µg IM once per week
Primary Outcome Measure Information:
Title
Time to onset of first relapse
Time Frame
Time to onset of first relapse
Secondary Outcome Measure Information:
Title
Number of patients relapse free at week 104
Time Frame
At week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: RRMS patients that are receiving treatment with Avonex 30 µg once weekly Exclusion Criteria: Primary Progressive or Secondary Progressive MS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1721
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19806
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-1465
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5281
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Nepean
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS

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