Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:July 2008
End Date:March 2011

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab
pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized
period followed by an open-label extension phase. In the double-blind phase, eligible
patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up
to and including Week 10. The randomization will be stratified according to the three
factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor
(anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From
Week 12 all patients remaining in the study receive open-label CZP for a minimum 16
additional weeks until CZP is commercially available.

Inclusion Criteria:

- Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

- All concomitant diseases or pathological conditions that could interfere and impact
the assessment of the study treatment

- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trials
We found this trial at
102
sites
Clinical Trial Facility in Gainesville Florida
Gainesville, Florida 32610
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Clinical Trial Facility in Albany New York
Albany, New York 12205
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Clinical Trial Facility in Amarillo Texas
Amarillo, Texas
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Clinical Trial Facility in Asheville North Carolina
Asheville, North Carolina
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Clinical Trial Facility in Battle Creek Michigan
Battle Creek, Michigan
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Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
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Clinical Trial Facility in Boca Raton Florida
Boca Raton, Florida
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, MA
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Clinical Trial Facility in Bronx New York
Bronx, New York
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Bronx, NY
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Clinical Trial Facility in Chapel Hill North Carolina
Chapel Hill, North Carolina
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Clinical Trial Facility in Charleston South Carolina
Charleston, South Carolina 29412
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Clinical Trial Facility in Charlotte North Carolina
Charlotte, North Carolina 28207
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Clinical Trial Facility in Clarksburg West Virginia
Clarksburg, West Virginia 26301
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Clinical Trial Facility in Coeur D'Alene Idaho
Coeur D'Alene, Idaho 83814
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Clinical Trial Facility in Columbia Maryland
Columbia, Maryland 21044
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Clinical Trial Facility in Columbus Ohio
Columbus, Ohio 43214
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Clinical Trial Facility in Covington Louisiana
Covington, Louisiana 70433
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Danbury Connecticut
Danbury, Connecticut 06810
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Clinical Trial Facility in Dayton Ohio
Dayton, Ohio 45409
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Clinical Trial Facility in Delray Beach Florida
Delray Beach, Florida 33406
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Clinical Trial Facility in Denver Colorado
Denver, Colorado
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Clinical Trial Facility in Duluth Minnesota
Duluth, Minnesota
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Clinical Trial Facility in Edmonton Alberta
Edmonton, Alberta
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Clinical Trial Facility in Erie Pennsylvania
Erie, Pennsylvania 16502
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Erie, PA
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Clinical Trial Facility in Evansville Indiana
Evansville, Indiana 47713
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Evansville, IN
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Clinical Trial Facility in Fairfield Ohio
Fairfield, Ohio 45014
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Fairfield, OH
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Clinical Trial Facility in Fall River Massachusetts
Fall River, Massachusetts 02720
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Fall River, MA
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Clinical Trial Facility in Frederick Maryland
Frederick, Maryland 21702
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Clinical Trial Facility in Fullerton California
Fullerton, California 92835
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Clinical Trial Facility in Glendale Wisconsin
Glendale, Wisconsin
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Clinical Trial Facility in Hot Springs Arkansas
Hot Springs, Arkansas 71901
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Clinical Trial Facility in Idaho Falls Idaho
Idaho Falls, Idaho
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Clinical Trial Facility in Jackson Tennessee
Jackson, Tennessee 38305
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Clinical Trial Facility in Jacksonville Florida
Jacksonville, Florida 32209
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Clinical Trial Facility in Kalamazoo Michigan
Kalamazoo, Michigan 49048
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Clinical Trial Facility in La Jolla California
La Jolla, California 92093
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Clinical Trial Facility in Lake Charles Louisiana
Lake Charles, Louisiana 70601
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Clinical Trial Facility in Lansing Michigan
Lansing, Michigan 48912
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Clinical Trial Facility in Lewes Delaware
Lewes, Delaware
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Clinical Trial Facility in Louisville Kentucky
Louisville, Kentucky 40202
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Clinical Trial Facility in Lubbock Texas
Lubbock, Texas 79410
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Clinical Trial Facility in Mayfield Ohio
Mayfield, Ohio 44143
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Clinical Trial Facility in Maywood Illinois
Maywood, Illinois 60153
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Clinical Trial Facility in Monroe North Carolina
Monroe, North Carolina 28110
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Clinical Trial Facility in Monroe Wisconsin
Monroe, Wisconsin 53566
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Clinical Trial Facility in Montgomery Alabama
Montgomery, Alabama 36106
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Clinical Trial Facility in New Brunswick New Jersey
New Brunswick, New Jersey 08901
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Clinical Trial Facility in New York New York
New York, New York 10032
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Clinical Trial Facility in Newark Delaware
Newark, Delaware
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Clinical Trial Facility in Newport News Virginia
Newport News, Virginia 23601
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Clinical Trial Facility in Oklahoma City Oklahoma
Oklahoma City, Oklahoma
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Clinical Trial Facility in Orchard Park New York
Orchard Park, New York
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Clinical Trial Facility in Orlando Florida
Orlando, Florida 32804
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Clinical Trial Facility in Palm Desert California
Palm Desert, California
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Clinical Trial Facility in Peoria Illinois
Peoria, Illinois 61603
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Clinical Trial Facility in Petoskey Michigan
Petoskey, Michigan 49770
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Clinical Trial Facility in Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
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Clinical Trial Facility in Richmond Virginia
Richmond, Virginia 23227
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Clinical Trial Facility in Rochester Minnesota
Rochester, Minnesota 55905
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Rochester, MN
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Clinical Trial Facility in Rochester New York
Rochester, New York
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Clinical Trial Facility in Rock Island Illinois
Rock Island, Illinois 61201
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Clinical Trial Facility in Roslyn New York
Roslyn, New York
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Clinical Trial Facility in Sacramento California
Sacramento, California 95825
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Clinical Trial Facility in Saint Louis Missouri
Saint Louis, Missouri 63110
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Clinical Trial Facility in Salt Lake City Utah
Salt Lake City, Utah
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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Clinical Trial Facility in Santa Barbara California
Santa Barbara, California 93105
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Clinical Trial Facility in Santa Maria California
Santa Maria, California 93454
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Clinical Trial Facility in Smithtown New York
Smithtown, New York 11787
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Clinical Trial Facility in South Miami Florida
South Miami, Florida 33143
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Clinical Trial Facility in Spokane Washington
Spokane, Washington
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Clinical Trial Facility in Springfield Illinois
Springfield, Illinois 62704
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Clinical Trial Facility in Sugar Land Texas
Sugar Land, Texas
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Clinical Trial Facility in Syracuse New York
Syracuse, New York 13202
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Clinical Trial Facility in Tacoma Washington
Tacoma, Washington
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Clinical Trial Facility in Tampa Florida
Tampa, Florida
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Clinical Trial Facility in Tavares Florida
Tavares, Florida
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Clinical Trial Facility in Trumbull Connecticut
Trumbull, Connecticut 06611
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Clinical Trial Facility in Tucson Arizona
Tucson, Arizona 85724
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Clinical Trial Facility in Tustin California
Tustin, California 92780
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Clinical Trial Facility in Voorhees New Jersey
Voorhees, New Jersey 08043
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Clinical Trial Facility in Washington District of Columbia
Washington, District of Columbia
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Clinical Trial Facility in West Reading Pennsylvania
West Reading, Pennsylvania 19611
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Clinical Trial Facility in Westlake Village California
Westlake Village, California 91361
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Clinical Trial Facility in Wexford Pennsylvania
Wexford, Pennsylvania 15090
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Clinical Trial Facility in Wheaton Maryland
Wheaton, Maryland 20902
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Clinical Trial Facility in Whittier California
Whittier, California 90602
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Clinical Trial Facility in Wichita Kansas
Wichita, Kansas 67214
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Clinical Trial Facility in Wilmington North Carolina
Wilmington, North Carolina 28401
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