A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
NCT ID: NCT00856544
Last Updated: 2013-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
795 participants
INTERVENTIONAL
2009-05-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active 5 mg
CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Active 10 mg
CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Placebo Sequence 1
Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Placebo Sequence 2
Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Interventions
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CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Eligibility Criteria
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Inclusion Criteria
* The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL.
* Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
* Patient must remain on at least one background traditional disease modifying antirheumatic drug.
* No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huntsville, Alabama, United States
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Jonesboro, Arkansas, United States
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Palo Alto, California, United States
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Stanford, California, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Danbury, Connecticut, United States
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Hamden, Connecticut, United States
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Trumbull, Connecticut, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Plantation, Florida, United States
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Port Richey, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Maywood, Illinois, United States
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Oakbrook Terrace, Illinois, United States
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Rockford, Illinois, United States
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Springfield, Illinois, United States
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Springfield, Illinois, United States
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Vernon Hills, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Leominster, Massachusetts, United States
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Worcester, Massachusetts, United States
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Edina, Minnesota, United States
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Lincoln, Nebraska, United States
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Albany, New York, United States
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Orchard Park, New York, United States
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Rochester, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Bethlehem, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Greenville, South Carolina, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Tacoma, Washington, United States
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Clarksburg, West Virginia, United States
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Campsie, New South Wales, Australia
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Cairns, Queensland, Australia
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Maroochydore, Queensland, Australia
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Woodville, South Australia, Australia
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Malvern East, Victoria, Australia
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Shenton Park, Western Australia, Australia
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Viña del Mar, Región de ValparaÃso, Chile
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Santiago, RM, Chile
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Santiago, RM, Chile
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Providencia, Santiago, RM, Chile
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Viña del Mar, , Chile
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Hefei, Anhui, China
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Hefei, Anhui, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Jinan, Shandong, China
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Qingdao, Shandong, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bucaramanga, Santander Department, Colombia
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Opatija, , Croatia
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Zagreb, , Croatia
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Frederiksberg, , Denmark
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Helsinki, , Finland
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Hyvinkää, , Finland
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Tampere, , Finland
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Berlin, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Nuremberg, , Germany
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Rheine, , Germany
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Maroussi Athens, , Greece
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Putrajaya, Kuala Lumpur, Malaysia
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Seremban, Negeri Sembilan, Malaysia
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Batu Caves, Selangor, Malaysia
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Subang Jaya, Selangor, Malaysia
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Torreón, Coahuila, Mexico
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Morelia, Michoacán, Mexico
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Cuernavaca, Morelos, Mexico
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México, Querétaro, Mexico
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Mérida, Yucatán, Mexico
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Bialystok, , Poland
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Bialystok, , Poland
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Kościan, , Poland
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Poznan, , Poland
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Torun, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Nové Zámky, , Slovakia
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Poprad, , Slovakia
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Považská Bystrica, , Slovakia
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Rimavská Sobota, , Slovakia
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Senica, , Slovakia
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Žilina, , Slovakia
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A Coruña, A Coruña, Spain
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Santiago de Compostela, A Coruña, Spain
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Madrid, Madrid, Spain
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Málaga, Malaga, Spain
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Seville, Sevilla, Spain
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Falun, , Sweden
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Gothenburg, , Sweden
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Uppsala, , Sweden
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Rajathevee, Bangkok, Thailand
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Amphoe Muang, Chiang Mai, Thailand
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Muang District, Khonkaen, Thailand
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Cannock, Staffs, United Kingdom
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Solihull, West Midlands, United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Caracas, DC/ Municipio Libertados, Venezuela
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Caracas, Distrito Federal, Venezuela
Countries
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References
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Related Links
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Other Identifiers
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A3921046
Identifier Type: -
Identifier Source: org_study_id
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