Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy



Status:Archived
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2010
End Date:March 2012

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Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy


The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and
immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who
have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.


CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in
the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week,
randomized, double-blind, placebo- and active- controlled study comparing several doses and
dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in
patients with active rheumatoid arthritis who have had an unsuccessful response to
methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more
efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12
weeks while maintaining an adequate safety profile. In order to maintain the study blinding
all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as
well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on
stable weekly doses of methotrexate. Assessments during the study include evaluations of
joint pain and swelling, laboratory blood and urine tests, physical examinations, vital
signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will
be eligible to enroll in a long-term extension study receiving CDP6038.


We found this trial at
25
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West Orange, New Jersey
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Albany, New York
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Atlanta, Georgia
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Atlanta, GA
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Austin, Texas
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Austin, TX
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Bettendorf, Iowa 52722
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Bettendorf, IA
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Celebration, Florida
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Celebration, FL
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Centralia, Illinois
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Centralia, IL
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Charleston, South Carolina
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Charleston, SC
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Charlotte, North Carolina
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Charlotte, NC
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Coeur D'Alene, Idaho
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Coeur D'Alene, ID
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Jeffersonville, Indiana
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Jeffersonville, IN
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Lima, OH
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Little Rock, Arkansas
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Little Rock, AR
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Morgantown, West Virginia
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Morgantown, WV
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Nashville, Tennessee
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Nashville, TN
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Newark, Delaware 19718
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Newark, DE
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Newington, Connecticut
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Newington, CT
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Omaha, Nebraska
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Omaha, NE
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Peoria, Arizona
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Peoria, AZ
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Ponca City, Oklahoma
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Ponca City, OK
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Richmond, Virginia
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Richmond, VA
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Santa Clara, California 95051
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Santa Clara, CA
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St Louis, Missouri
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St Louis, MO
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