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

• ClinicalTrials.gov Identifier: NCT01470599
• Recruitment Status: Completed
• First Posted: November 11, 2011
• Results First Posted: October 16, 2017
• Last Update Posted: October 16, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Crohn's Disease	Drug: CP-690,550	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• 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
• Actual Study Start Date: April 2012
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 5mg BID	Drug: CP-690,550; ORAL TABLET, TWICE DAILY
Experimental: 10mg BID	Drug: CP-690,550; ORAL TABLETS, TWICE DAILY

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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).
4. 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).
5. 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.
6. 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 :

1. 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.
2. 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.
3. 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.
4. 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.

5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 76 Years (Adult, Older Adult)
• 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

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:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01470599
• Other Study ID Numbers: A3921086; 2011-003622-27 ( EudraCT Number )
• First Posted: November 11, 2011
• 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; Janus Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action