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A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CP-690,550
CP-690,550
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
  • Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
  • Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
  • Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
  • Subjects receiving the following treatment for Crohn's disease:
  • Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
  • Anti-TNFα therapy within 8 weeks prior to baseline.
  • Interferon therapy within 8 weeks prior to baseline.
  • Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
  • Intravenous corticosteroids within 2 weeks prior to baseline.

Sites / Locations

  • ACRI - Phase 1, LLC
  • Advanced Clinical Research Institute - Phase 1, LLC
  • AGMG Endoscopy Center
  • Alliance Clinical Research
  • Alliance Clinical Research, LLC
  • Sharp Rees-Stealy Medical Group, Inc.
  • Sharp Rees-Stealy Medical Group, Inc.
  • Clinical Research Of The Rockies
  • Endoscopy Center of the Rockies - Longmont
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical Research Center of Connecticut, LLC
  • Metropolitan Gastroenterology Group, PC
  • Gasteroenterology Consultants of Clearwater
  • West Coast Endoscopy Center
  • Clinical Research of West Florida, Inc
  • Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)
  • Shands Endoscopy Center
  • Shands Hospital at the University of Florida
  • Investigational Drug Service
  • Shands Medical Plaza and Cancer Center
  • Nature Coast Clinical Research
  • Suncoast Endoscopy Center (Colonoscopy Only)
  • FQL Research, LLC
  • Gastroenterology Group of Naples
  • Gulfshore Endoscopy Center (Endoscopies Only)
  • North Florida Gastroenterology Research, LLC
  • Internal Medicine Specialists
  • Florida Medical Clinic, P.A.
  • Gastroenterology Associates of Central Georgia, LLC
  • Southwest Gastroenterology
  • Heartland Medical Research, Inc (Administrative Only)
  • Iowa Digestive Disease Center
  • Iowa Endoscopy Center (Colonoscopy Only)
  • Iowa Radiology (MRI, X-Ray Only)
  • Cotton-O'Neil Clinical (X-Ray)
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Stormont-Vail MRI Center of Kansas
  • University of Kentucky Chandler Medical Center
  • Chevy Chase Endoscopy Center
  • Metropolitan Gastroenterology Group, PC
  • East Ann Arbor Health and Geriatrics Center
  • University of Michigan Health Systems
  • Clinical Research Institute of Michigan LLC
  • Center for Digestive Health
  • Dartmouth Hitchcock Medical Center
  • NYU Langone Long Island Clinical Research Associates
  • NYU Langone Nassau Gastroenterology Associates
  • Premier Medical Group of the Hudson Valley, PC
  • Charlotte Gastroenterology and Hepatology, PLLC
  • Charlotte Radiology (Chest X-Ray Only)
  • University Hospitals Chagrin Highlands Health Center
  • University Hospitals Case Medical Center
  • Cleveland Clinic
  • Dayton Gastroenterology, Inc.
  • Great Lakes Gastroenterology
  • The Endoscopy Center of Lake County
  • University Hospitals Westlake Medical Center
  • Great Lakes Gastroenterology
  • Regional Gastroenterology Associates of Lancaster, Ltd.
  • UT Health Science Center
  • Digestive Health Specialists of Tyler
  • University of Utah
  • Cardiology Consultants (ECG Site Only)
  • Digestive and Liver Disease Specialists
  • MRI & CT Diagnostics
  • The Center for Digestive Health
  • Wisconsin Center for Advanced Research - GI Associates, LLC
  • Wisconsin Center for Advanced Research
  • Medical Diagnostic Imaging (MDI) X-ray and MRI only
  • Allegiance Research Specialists
  • GI Associates
  • Nepean Public Hospital
  • Monash Medical Center
  • Royal Melbourne Hospital
  • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • 4-MBAL, Parvo vatreshno otdelenie
  • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
  • MBAL Voennomeditsinska Akademia
  • MBAL Sofiamed OOD, Otdelenie po gastroenterologia
  • University of Calgary
  • Office of Dr. David C. Pearson
  • Office of Drs. Ranjith Andrew Singh and Jamie D. Papp
  • PerCuro Clinical Research Ltd.
  • London Health Sciences Centre - University Hospital
  • Sunnybrook Health Sciences Centre
  • Hopital Maisonneuve-Rosemont
  • Montreal General Hospital - McGill University Health Centre
  • Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre
  • University Hospital Centre Rijeka
  • University Hospital Center Zagreb
  • Hepato-Gastroenterologie HK, s.r.o.
  • RDG centrum s.r.o.
  • Medial Pharma spol.s.r.o.
  • Hopital Huriez, CHRU de Lille
  • Hopital Haut-Leveque
  • Hopital Robert Debre
  • Charite - Campus Berlin Mitte
  • Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Universitaetsklinikum Schleswig-Holstein
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I
  • General Hospital of Athens "Evangelismos",1st Gastroenterology Department
  • Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly
  • Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
  • Pannonia Maganorvosi Centrum Kft
  • Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium
  • Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft
  • Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly
  • Clinfan Kft.
  • Digestive Diseases Institute, Shaare Zedek Medical Center
  • Dept. of Gastroenterology & Hepatology, Meir Medical Center
  • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Fukuoka University Chikushi Hospital
  • Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
  • The Hospital of Hyogo College of Medicine
  • National Hospital Organization Sendai Medical Center
  • Tokyo Medical And Dental University Hospital, Faculty of Medicine
  • Keio University Hospital
  • Toho University Sakura Medical Center
  • Osaka City University Hospital
  • Severance Hospital, Yeonsei University Health System
  • Samsung Medical Center
  • ASAN Medical Center
  • VU University Medical Center
  • Academisch Medisch Centrum
  • Kingsbury Hospital
  • Parklands Medical Centre
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Clinic de Barcelona
  • Hospital Universitario de La Princesa
  • State Institution "Institute of Gastroenterology of AMS of Ukraine"
  • Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,
  • State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"
  • Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course
  • Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
  • Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo BID

5mg BID

10mg BID

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8
Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.

Secondary Outcome Measures

Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4
Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8
Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
CDAI Scores at Weeks 2, 4, and 8
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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.
C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8
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.
Calprotectin Fecal Concentrations at Weeks 2, 4, and 8
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.
Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit
Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit
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.
Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)
IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL. Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors. The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size.
Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit
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. Positive change in total score indicated improvement in QOL.
Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit
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. Positive change in total score indicated improvement in QOL.
Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category
The IBD Patient Reported Treatment Impact Modified (PRTI) 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 re-use 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 8/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 SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.
Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA
The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit
EQ-5D 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, self-care, 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.
Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA
EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
EQ-5D 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.
Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA
EQ-5D 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. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.

Full Information

First Posted
July 11, 2011
Last Updated
March 17, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01393626
Brief Title
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Title
5mg BID
Arm Type
Experimental
Arm Title
10mg BID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablets twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
oral tablets twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
oral tablets twice daily
Primary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8
Description
Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4
Description
Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Weeks 2 and 4
Title
Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8
Description
Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Weeks 2, 4, and 8
Title
Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8
Description
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Weeks 2, 4, and 8
Title
Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8
Description
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Weeks 2, 4, and 8
Title
CDAI Scores at Weeks 2, 4, and 8
Description
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal 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.
Time Frame
Weeks 2, 4, and 8
Title
C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8
Description
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.
Time Frame
Weeks 2, 4, and 8
Title
Calprotectin Fecal Concentrations at Weeks 2, 4, and 8
Description
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.
Time Frame
Weeks 2, 4, and 8
Title
Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit
Description
Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
Time Frame
Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
Title
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit
Description
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.
Time Frame
Baseline, Week 8/ET visit
Title
Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)
Description
IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL. Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors. The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Week 8/ET visit
Title
Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit
Description
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. Positive change in total score indicated improvement in QOL.
Time Frame
Week 8/ET visit
Title
Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit
Description
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. Positive change in total score indicated improvement in QOL.
Time Frame
Week 8/ET visit
Title
Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category
Description
The IBD Patient Reported Treatment Impact Modified (PRTI) 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 re-use 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.
Time Frame
Week 8/ET visit
Title
Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit
Description
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 SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.
Time Frame
Baseline, Week 8/ET visit
Title
Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA
Description
The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Week 8/ET visit
Title
EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit
Description
EQ-5D 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, self-care, 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.
Time Frame
Baseline, Week 8/ET visit
Title
Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA
Description
EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Week 8/ET visit
Title
EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
Description
EQ-5D 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.
Time Frame
Baseline, Week 8/ET visit
Title
Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA
Description
EQ-5D 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. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Time Frame
Baseline, Week 8/ET visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands). Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening. Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline. Exclusion Criteria: Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC. Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve). Subjects receiving the following treatment for Crohn's disease: Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. Anti-TNFα therapy within 8 weeks prior to baseline. Interferon therapy within 8 weeks prior to baseline. Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline. Intravenous corticosteroids within 2 weeks prior to baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
ACRI - Phase 1, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Clinical Research Institute - Phase 1, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
AGMG Endoscopy Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alliance Clinical Research, LLC
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Clinical Research Of The Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Endoscopy Center of the Rockies - Longmont
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Gasteroenterology Consultants of Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
West Coast Endoscopy Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Shands Endoscopy Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0214
Country
United States
Facility Name
Investigational Drug Service
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Shands Medical Plaza and Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Suncoast Endoscopy Center (Colonoscopy Only)
City
Inverness
State/Province
Florida
ZIP/Postal Code
34453
Country
United States
Facility Name
FQL Research, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Gulfshore Endoscopy Center (Endoscopies Only)
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
North Florida Gastroenterology Research, LLC
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Heartland Medical Research, Inc (Administrative Only)
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Endoscopy Center (Colonoscopy Only)
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Radiology (MRI, X-Ray Only)
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Cotton-O'Neil Clinical (X-Ray)
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Stormont-Vail MRI Center of Kansas
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Chevy Chase Endoscopy Center
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
East Ann Arbor Health and Geriatrics Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2701
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5000
Country
United States
Facility Name
Clinical Research Institute of Michigan LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone Nassau Gastroenterology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Charlotte Radiology (Chest X-Ray Only)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
University Hospitals Chagrin Highlands Health Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Dayton Gastroenterology, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Great Lakes Gastroenterology
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
The Endoscopy Center of Lake County
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University Hospitals Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Great Lakes Gastroenterology
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
UT Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Cardiology Consultants (ECG Site Only)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MRI & CT Diagnostics
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
The Center for Digestive Health
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research - GI Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical Diagnostic Imaging (MDI) X-ray and MRI only
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53222
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI Associates
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Nepean Public Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Monash Medical Center
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
AKH Wien Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
4-MBAL, Parvo vatreshno otdelenie
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MBAL Voennomeditsinska Akademia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Office of Dr. David C. Pearson
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R3
Country
Canada
Facility Name
Office of Drs. Ranjith Andrew Singh and Jamie D. Papp
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Facility Name
University Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
RDG centrum s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
Medial Pharma spol.s.r.o.
City
Hradec Králové
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Hopital Huriez, CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33064
Country
France
Facility Name
Hopital Robert Debre
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Charite - Campus Berlin Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
City
Kolonaki Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium
City
Budapest
ZIP/Postal Code
H-1044
Country
Hungary
Facility Name
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Digestive Diseases Institute, Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Dept. of Gastroenterology & Hepatology, Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital, Faculty of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138519
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Severance Hospital, Yeonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Kingsbury Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
State Institution "Institute of Gastroenterology of AMS of Ukraine"
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,
City
Donetsk
ZIP/Postal Code
83017
Country
Ukraine
Facility Name
State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
28209624
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921083&StudyName=A%20Randomized%2C%20Double-blind%2C%20Placebo-controlled%2C%20Parallel%20Group%2C%20Multi-centre%20Study%20To%20Investigate%20The%20Safety%20And%20Efficacy%20Of%20Cp-690%2C550%20For%20Induction%20Therapy%20In%20Subjects%20With%20Moderate%20To%20Severe%20Crohn%27s%20Disease
Description
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Learn more about this trial

A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

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