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

A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 150
• 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 Centre
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Austria
  • Wien, Austria, 1090
    • AKH Wien Universitaetsklinik fuer Innere Medizin III
• Bulgaria
  • Sofia, Bulgaria, 1000
    • 4-MBAL, Parvo vatreshno otdelenie
  • Sofia, Bulgaria, 1797
    • MBAL Sofiamed OOD, Otdelenie po gastroenterologia
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3P9
      • PerCuro Clinical Research Limited
    • Victoria, British Columbia, Canada, V8R 6R3
      • Office of Dr. David C Pearson
    • Victoria, British Columbia, Canada, V8V 3P9
      • Office of Drs. Ranjith Andrew Singh, Jamie D. Papp
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital-Mcgill University Health Centre
• Czechia
  • Hradec Kralove, Czechia, 50012
    • Hepato-Gastroenterologie HK, s.r.o.
  • Hradec Kralove, Czechia, 500 12
    • RDG centrum s.r.o.
  • Hradec Králové, Czechia, 500 12
    • Medial Pharma spol.s.r.o.
• France
  • Lille Cedex, France, 59037
    • Hopital Huriez - CHRU de Lille
  • Pessac Cedex, France, 33604
    • Hôpital Haut-Lévêque
• Germany
  • Berlin, Germany, 12203
    • Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Greece
  • Kolonaki Athens, Greece, 106 76
    • General Hospital of Athens "Evangelismos",1st Gastroenterology Department
• Hungary
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum Kft
  • Budapest, Hungary, 1076
    • Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
  • Budapest, Hungary, H-1125
    • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
  • Gyongyos, Hungary, 3200
    • Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
  • Szekszard, Hungary, 7100
    • Clinfan Kft.
• Israel
  • Jerusalem, Israel, 91031
    • Department of medicine Shaare Zedek Medical Center
  • Kfar Saba, Israel, 44281
    • Dept. of Gastroenterology & Hepatology, Meir Medical Center
  • 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
  • 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
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Soeul, Korea, Republic of, 138-736
    • Asan Medical Center
• 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
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28222
    • Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2
• Ukraine
  • Odesa, Ukraine, 65117
    • Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
  • Vinnitsa, Ukraine, 21029
    • Medical Clinical Research Center of Medical Center "Health Clinic" LLC
• United States
  • California
    • Oceanside, California, United States, 92056
      • Alliance Clinical Research
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Clinical Research of the Rockies
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Clearwater, Florida, United States, 33756
      • West Coast Endoscopy Center
    • Clearwater, Florida, United States, 33756
      • Gastroenterology Consultants of Clearwater
    • 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
    • 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
  • Georgia
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC
  • 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
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • Troy, Michigan, United States, 48098
      • Surgical Centers of Michigan
  • 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
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
    • Mentor, Ohio, United States, 44060
      • The Endoscopy Center of Lake County
    • Willoughby, Ohio, United States, 44094
      • Great Lakes Gastroenterology
  • Texas
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Endoscopy Center
    • Tyler, Texas, United States, 75701
      • Endoscopy Center of Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah HSC
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research - GI Associates, LLC
    • 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 76 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
• Women of childbearing potential must test negative for pregnancy prior to study enrolment.
• Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

• Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
• Subjects who were discontinued from the A3921084 study due to an adverse event.
• Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5mg BID	Drug: CP-690,550; ORAL TABLET, TWICE DAILY; Drug: CP-690,550; ORAL TABLETS, TWICE DAILY
EXPERIMENTAL: 10mg BID	Drug: CP-690,550; ORAL TABLET, TWICE DAILY; Drug: CP-690,550; ORAL TABLETS, TWICE DAILY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Potential Cardiovascular Events	Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.	From baseline to Week 52
Adjudicated Malignancy Events	Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.	From baseline to Week 52
Adjudicated Hepatic Injury Events	Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery & liver failure (all yes, no or undetermined).	From baseline to Week 52
Adjudicated Opportunistic Infection Events	Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).	From baseline to Week 52
Adjudicated Gastrointestinal (GI) Perforation Events	Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.	From baseline to Week 52
Adjudicated Interstitial Lung Disease (ILD) Events	Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).	From baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.	Week 48
Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Time to Relapse Among Participants in Clinical Remission at Baseline	Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves. n = number of participants remaining at risk.	From baseline to Week 52
Observed CDAI Score by Week	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Change From Baseline Observed CDAI Score by Week	CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.	Weeks 8, 16, 24, 36, 48 and 52/follow-up
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline	Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.	Week 48
Corticosteroid Use Over Time	Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.	Weeks 8, 16, 24, 36 and 48
Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit	There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.	From baseline to Week 48
Observed Change From Baseline in Fecal Calprotectin by Week	Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.	Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit	The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.	Baseline and Week 48/early termination (ET)
Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/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). 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 and Week 48/ET
Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/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. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.	Week 48/ET
Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category	The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.	Week 48/ET visit
Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit	The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.	Baseline and Week 48/ET visit
Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit	The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.	Baseline and Week 48/ET visit
EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data.	Baseline and Week 48/ET visit
Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state.	Baseline and Week 48/ET visit
EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.	Baseline and Week 48/ET visit
Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.	Baseline and Week 48/ET visit
Percentage of Participants Hospitalized Due to Crohn's Disease	The number of participants hospitalized due to Crohn's disease were recorded at every study visit.	From baseline to Week 52/follow-up
Length of Hospitalizations Due to Crohn's Disease	The length of hospitalizations due to Crohn's disease were recorded at every study visit.	From baseline to Week 52/follow-up

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panes J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2012
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (ESTIMATE): November 11, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 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: A3921086; 2011-003622-27 (EUDRACT_NUMBER)