Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:4/17/2018
Start Date:January 2010
End Date:March 2013

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Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to
methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
study will also compare the safety of CP-690,550 with methotrexate.


Inclusion Criteria:

- Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated
with methotrexate.

- Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

- Active disease as defined by both >=6 tender or painful joints on motion and >= 6
joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a
C-reactive protein (CRP) concentration > 7 mg/dL

Exclusion Criteria:

- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
<100 x 109/L

- History of any other rheumatic autoimmune disease other than Sjogren's syndrome

- No malignancy or history of malignancy

- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug

- No chronic liver disease, recent or active hepatitis or other contraindication to
methotrexate therapy
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Los Angeles, California 90033
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Albany, New York 12206
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Austin, Texas 78705
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725 Uruguay
Buenos Aires, C1015
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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171 Ashley Avenue
Charleston, South Carolina 29425
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Clarksburg, West Virginia 26301
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Clarksburg, West Virginia 26301
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Dubuque, Iowa 52001
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Duncansville, Pennsylvania 16635
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Gainesville, Florida 32607
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Hickory, North Carolina 28602
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Indianapolis, Indiana 46227
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Jackson, Tennessee 38305
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Jackson, Tennessee 38305
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Little Rock, Arkansas 72205
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Los Angeles, California 90033
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Los Angeles, California 90033
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New Orleans, Louisiana 70112
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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Seattle, Washington 98122
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Seattle, Washington 98101
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13801 Bruce B Downs Boulevard
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Worcester, Massachusetts 01610
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Wyomissing, Pennsylvania 19610
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