The Safety And Efficacy Of Maintenance Therapy With CP-690,550
NCT ID: NCT01393899
Last Updated: 2017-01-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2012-03-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
NCT01393626
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
NCT00615199
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
NCT01470599
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
NCT01458574
Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease
NCT00101946
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo BID
Placebo
oral tablets twice daily
5mg BID
CP-690,550
oral tablets twice daily
10mg BID
CP-690,550
oral tablets twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
oral tablets twice daily
CP-690,550
oral tablets twice daily
CP-690,550
oral tablets twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI\<150) in Study A3921083.
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Exclusion Criteria
* Subjects likely to require any type of surgery during the study period.
* Fecal culture/toxin assay indicating presence of pathogenic infection.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ACMG Endoscopy Center
Anaheim, California, United States
ACRI - Phase I, LLC
Anaheim, California, United States
Advanced Clinical Research Institute-Phase 1, LLC
Anaheim, California, United States
West Coast Clinical Trials
Cypress, California, United States
Alliance Clinical Research
Oceanside, California, United States
Clinical Research Of The Rockies
Lafayette, Colorado, United States
Gasteroenterology 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
Shands Medical Plaza and Cancer Center
Gainesville, Florida, United States
University of Florida - College of Medicine
Gainsville, 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
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, 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 Nassau Gastroenterology Associates
Great Neck, New York, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States
Investigational Drug Services - University Hospitals Case Medical Center
Cleveland, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, 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
Cardiology Consultants
Norfolk, Virginia, United States
Digestive & Liver Desease Specialists
Norfolk, Virginia, United States
Metropolitan Gastroenterology Group, P C
Washington DC, Virginia, United States
The Center for Digestive Health
Milwaukee, Wisconsin, 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
Melbourne, , 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 and Jamie D. Papp,
Victoria, British Columbia, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Medial Pharma spol.s.r.o. (Pharmacy only)
Hradec Králové, , Czechia
RDG centrum s.r.o. (Radiology only)
Hradec Králové, , Czechia
Hopital Huriez CHRU de Lille
Lille, , France
Hôpital Haut-Lévêque/Service d hépato-gastroentérologie
Pessac, , France
Charite - Campus Berlin Mitte
Berlin, , Germany
Charite - Campus Benjamin Franklin
Berlin, , Germany
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
Berlin, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I
Ulm, , Germany
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, , Greece
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
Budapest, , Hungary
Pannonia Magánorvosi Centrum Kft
Budapest, , Hungary
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium
Budapest, , Hungary
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, , Hungary
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
Gyöngyös, , Hungary
Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium
Kaposvár, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Digestive Disease Institute
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Toho University Sakura Medical Center
Chiba, , Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Hokkaido, , Japan
VU University Medical Center
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Kingsbury Hospital
Cape Town, Western Cape, South Africa
Parklands Medical Centre
Durban, , South Africa
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine
Seoul, , South Korea
ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Comite Etico de Investigacion Clinica
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2
Donetsk, , Ukraine
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
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-001754-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921084
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.