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A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470599
First Posted: November 11, 2011
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

Condition Intervention Phase
Crohn's Disease Drug: CP-690,550 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adjudicated Potential Cardiovascular Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.

  • Adjudicated Malignancy Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.

  • Adjudicated Hepatic Injury Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery & liver failure (all yes, no or undetermined).

  • Adjudicated Opportunistic Infection Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).

  • Adjudicated Gastrointestinal (GI) Perforation Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.

  • Adjudicated Interstitial Lung Disease (ILD) Events [ Time Frame: From baseline to Week 52 ]
    Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).


Secondary Outcome Measures:
  • Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48 [ Time Frame: Week 48 ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.

  • Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.

  • Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.

  • Time to Relapse Among Participants in Clinical Remission at Baseline [ Time Frame: From baseline to Week 52 ]

    Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves.

    n = number of participants remaining at risk.


  • Observed CDAI Score by Week [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.

  • Change From Baseline Observed CDAI Score by Week [ Time Frame: Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.

  • Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline [ Time Frame: Week 48 ]
    Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

  • Corticosteroid Use Over Time [ Time Frame: Weeks 8, 16, 24, 36 and 48 ]
    Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.

  • Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit [ Time Frame: From baseline to Week 48 ]
    There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.

  • Observed Change From Baseline in Fecal Calprotectin by Week [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.

  • Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.

  • Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit [ Time Frame: Baseline and Week 48/early termination (ET) ]
    The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.

  • Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit [ Time Frame: Baseline and Week 48/ET ]
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.

  • Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit [ Time Frame: Week 48/ET ]
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.

  • Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category [ Time Frame: Week 48/ET visit ]
    The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.

  • Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.

  • Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.

  • EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data.

  • Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state.

  • EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.

  • Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit [ Time Frame: Baseline and Week 48/ET visit ]
    EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  • Percentage of Participants Hospitalized Due to Crohn's Disease [ Time Frame: From baseline to Week 52/follow-up ]
    The number of participants hospitalized due to Crohn's disease were recorded at every study visit.

  • Length of Hospitalizations Due to Crohn's Disease [ Time Frame: From baseline to Week 52/follow-up ]
    The length of hospitalizations due to Crohn's disease were recorded at every study visit.


Enrollment: 150
Actual Study Start Date: April 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5mg BID Drug: CP-690,550
ORAL TABLET, TWICE DAILY
Experimental: 10mg BID Drug: CP-690,550
ORAL TABLETS, TWICE DAILY

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
  • 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 have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470599


  Hide Study Locations
Locations
United States, California
Alliance Clinical Research
Oceanside, California, United States, 92056
United States, Colorado
Clinical Research Of The Rockies
Lafayette, Colorado, United States, 80026
United States, Florida
Gastroenterology Consultants of Clearwater
Clearwater, Florida, United States, 33756
West Coast Endoscopy Center
Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Shands Endoscopy Center
Gainesville, Florida, United States, 32608
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610-0214
Investigational Drug Service
Gainesville, Florida, United States, 32610
Shands Medical Plaza and Cancer Center
Gainesville, Florida, United States, 32610
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, United States, 34102
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States, 32073
Internal Medicine Specialists
Orlando, Florida, United States, 32806
United States, Georgia
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
United States, Michigan
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5000
Center for Digestive Health
Troy, Michigan, United States, 48098
Surgical Centers of Michigan
Troy, Michigan, United States, 48098
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County
Mentor, Ohio, United States, 44060
Great Lakes Gastroenterology
Willoughby, Ohio, United States, 44094
United States, Texas
Christus Trinity Mother Frances Endoscopy Center
Tyler, Texas, United States, 75701
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
Endoscopy Center of Tyler
Tyler, Texas, United States, 75701
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States, 53226
GI Associates
Wauwatosa, Wisconsin, United States, 53226
Australia, New South Wales
Nepean Public Hospital
Kingswood, New South Wales, Australia, 2747
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III
Wien, Austria, 1090
Bulgaria
4-MBAL, Parvo vatreshno otdelenie
Sofia, Bulgaria, 1000
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, Bulgaria, 1797
Canada, British Columbia
Office of Dr. David C Pearson
Victoria, British Columbia, Canada, V8R 6R3
Office of Drs. Ranjith Andrew Singh, Jamie D. Papp
Victoria, British Columbia, Canada, V8V 3P9
PerCuro Clinical Research Limited
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal General Hospital-Mcgill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Czechia
RDG centrum s.r.o.
Hradec Kralove, Czechia, 500 12
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 50012
Medial Pharma spol.s.r.o.
Hradec Králové, Czechia, 500 12
France
Hopital Huriez - CHRU de Lille
Lille Cedex, France, 59037
Hôpital Haut-Lévêque
Pessac Cedex, France, 33604
Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Universitaetsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, Greece, 106 76
Hungary
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, Hungary, 1076
Pannonia Magánorvosi Centrum Kft
Budapest, Hungary, 1136
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, H-1125
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
Gyongyos, Hungary, 3200
Clinfan Kft.
Szekszard, Hungary, 7100
Israel
Department of medicine Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, Israel, 44281
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
Toho University Sakura Medical Center
Chiba, Japan, 285-8741
Osaka City University Hospital
Osaka, Japan, 545-8586
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Soeul, Korea, Republic of, 138-736
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
South Africa
Parklands Medical Centre
Durban, South Africa, 4091
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2
Madrid, Spain, 28222
Ukraine
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
Odesa, Ukraine, 65117
Medical Clinical Research Center of Medical Center "Health Clinic" LLC
Vinnitsa, Ukraine, 21029
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470599     History of Changes
Other Study ID Numbers: A3921086
2011-003622-27 ( EudraCT Number )
First Submitted: October 27, 2011
First Posted: November 11, 2011
Results First Submitted: June 20, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action