A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
NCT ID: NCT01470599
Last Updated: 2017-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2012-04-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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5mg BID
CP-690,550
ORAL TABLET, TWICE DAILY
10mg BID
CP-690,550
ORAL TABLETS, TWICE DAILY
Interventions
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CP-690,550
ORAL TABLET, TWICE DAILY
CP-690,550
ORAL TABLETS, TWICE DAILY
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.
* Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.
Exclusion Criteria
* Subjects who were discontinued from the A3921084 study due to an adverse event.
* Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
18 Years
76 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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Alliance Clinical Research
Oceanside, California, United States
Clinical Research Of The Rockies
Lafayette, Colorado, United States
Gastroenterology Consultants of Clearwater
Clearwater, Florida, United States
West Coast Endoscopy Center
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Shands Endoscopy Center
Gainesville, Florida, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
Investigational Drug Service
Gainesville, Florida, United States
Shands Medical Plaza and Cancer Center
Gainesville, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, United States
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Surgical Centers of Michigan
Troy, Michigan, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
The Endoscopy Center of Lake County
Mentor, Ohio, United States
Great Lakes Gastroenterology
Willoughby, Ohio, United States
Christus Trinity Mother Frances Endoscopy Center
Tyler, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
Endoscopy Center of Tyler
Tyler, Texas, United States
University of Utah HSC
Salt Lake City, Utah, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
GI Associates
Wauwatosa, Wisconsin, United States
Nepean Public Hospital
Kingswood, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, , Austria
4-MBAL, Parvo vatreshno otdelenie
Sofia, , Bulgaria
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, , Bulgaria
Office of Dr. David C Pearson
Victoria, British Columbia, Canada
Office of Drs. Ranjith Andrew Singh, Jamie D. Papp
Victoria, British Columbia, Canada
PerCuro Clinical Research Limited
Victoria, British Columbia, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Montreal General Hospital-Mcgill University Health Centre
Montreal, Quebec, Canada
Medial Pharma spol.s.r.o.
Hradec Králové, , Czechia
RDG centrum s.r.o.
Hradec Králové, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Hopital Huriez - CHRU de Lille
Lille, , France
Hôpital Haut-Lévêque
Pessac, , France
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, , Greece
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, , Hungary
Pannonia Magánorvosi Centrum Kft
Budapest, , Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, , Hungary
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
Gyöngyös, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Department of medicine Shaare Zedek Medical Center
Jerusalem, , Israel
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Toho University Sakura Medical Center
Chiba, , Japan
Osaka City University Hospital
Osaka, , Japan
VU University Medical Center
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Parklands Medical Centre
Durban, , South Africa
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Soeul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2
Madrid, , Spain
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
Odesa, , Ukraine
Medical Clinical Research Center of Medical Center "Health Clinic" LLC
Vinnitsa, , Ukraine
Countries
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References
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Panes J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-003622-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921086
Identifier Type: -
Identifier Source: org_study_id