A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
NCT ID: NCT00615199
Last Updated: 2013-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2008-01-31
2009-10-31
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
TRIPLE
Study Groups
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1mg BD
CP-690,550
administration via oral route twice daily
5mg BD
CP-690,550
administration via oral route twice daily
15mg BD
CP-690,550
administration via oral route twice daily
Placebo BID
Placebo
administration via oral route twice daily
Interventions
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CP-690,550
administration via oral route twice daily
CP-690,550
administration via oral route twice daily
CP-690,550
administration via oral route twice daily
Placebo
administration via oral route twice daily
Eligibility Criteria
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Inclusion Criteria
* Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
* Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
Exclusion Criteria
* Subjects with evidence of hematopoietic disorders
* Subjects with evidence of active or latent TB
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
Birmingham, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Lakewood, Colorado, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, United States
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Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Boca Raton, Florida, United States
Pfizer Investigational Site
Boca Raton, Florida, United States
Pfizer Investigational Site
Boca Raton, Florida, United States
Pfizer Investigational Site
Boca Raton, Florida, United States
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Gainesville, Florida, United States
Pfizer Investigational Site
Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
Pfizer Investigational Site
St. Petersburg, Florida, United States
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Chicago, Illinois, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Chevy Chase, Maryland, United States
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Towson, Maryland, United States
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Troy, Michigan, United States
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Rochester, Minnesota, United States
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Mexico, Missouri, United States
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Great Neck, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
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Salisbury, North Carolina, United States
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Dayton, Ohio, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, United States
Pfizer Investigational Site
Bristol, Tennessee, United States
Pfizer Investigational Site
Kingsport, Tennessee, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
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Seattle, Washington, United States
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Charleston, West Virginia, United States
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Brussels, , Belgium
Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
Hradec Králové, , Czechia
Pfizer Investigational Site
Ústí nad Labem, , Czechia
Pfizer Investigational Site
Vandœuvre-lès-Nancy, France, France
Pfizer Investigational Site
Lille, , France
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Pessac, , France
Pfizer Investigational Site
Békéscsaba, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Szekszárd, , Hungary
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Bologna, , Italy
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Roma, , Italy
Pfizer Investigational Site
Amsterdam, , Netherlands
Pfizer Investigational Site
Lublin, , Poland
Pfizer Investigational Site
Olsztyn, , Poland
Pfizer Investigational Site
Wroclaw, , Poland
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Bratislava, Slovakia, Slovakia
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Nitra, , Slovakia
Pfizer Investigational Site
Durbanvilee, Cape Town, South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa
Pfizer Investigational Site
Durban, KwaZulu-Natal, South Africa
Pfizer Investigational Site
Durban, South Africa, South Africa
Pfizer Investigational Site
Cape Town, Western Cape, South Africa
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Majadahonda, Madrid, Spain
Pfizer Investigational Site
Bristol, , United Kingdom
Pfizer Investigational Site
Salford, , United Kingdom
Countries
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References
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Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.
Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921043
Identifier Type: -
Identifier Source: org_study_id
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