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

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

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).

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Placebo; Drug: CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo BID	Drug: Placebo; oral tablets twice daily
Experimental: 5mg BID	Drug: CP-690,550; oral tablets twice daily
Experimental: 10mg BID	Drug: CP-690,550; oral tablets twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 2 and 4
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.	Baseline, Weeks 2, 4, and 8
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.	Baseline, Weeks 2, 4, and 8
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.	Baseline, Weeks 2, 4, and 8
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.	Weeks 2, 4, and 8
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.	Weeks 2, 4, and 8
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.	Weeks 2, 4, and 8
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.	Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Week 8/ET visit
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.	Week 8/ET visit
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.	Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit
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.	Baseline, Week 8/ET visit

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921083; 2011-001733-16 (EudraCT Number)