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A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis (TURANDOT)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
PF-00547659 SC Injection
PF-00547659 SC Injection
PF-00547659 SC Injection
PF-00547659 SC Injection
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
  • Ulcerative colitis must be active beyond the rectum.
  • Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Diagnosis of indeterminate colitis or Crohn's Disease
  • Subjects with history of colonic or small bowel obstruction or resection.

Sites / Locations

  • Mayo Clinic Arizona
  • UCSD Health System-Pharmacy only
  • Clinical and Translational Research Institute
  • Perlman Medical Offices
  • Thornton Hospital
  • Community Clinical Trials
  • GastroDiagnostics - Community Clinical Trials Drug
  • Rocky Mountain Clinical Research, LLC.
  • Clinical Research of the Rockies
  • Rocky Mountain Gastroenterology Associates
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical REsearch Center of CT Drug
  • Medical Research Network of Connecticut
  • Florida Surgery Center
  • Gastroenterology Associates
  • Research Consultant Group
  • Th Palmetto Surgery Center
  • Citrus Memorial Hospital
  • Inverness Medical Imaging
  • Nature Coast Clinical Research
  • Suncoast Endoscopy Center
  • Sand Lake Imaging
  • Center for Diagnostic Imaging
  • Sylvester Comprehensive Cancer Center
  • University of Miami Hospital and Clinic - Local Lab
  • University of Miami Hospital and Clinic
  • University of Miami Hospital
  • Coral View Surgery Center
  • First Quality Laboratory
  • FQL Research, LLC
  • Venutre Ambulatory Sugery Center
  • Boston Diagnostic Imaging
  • Citrus Ambulatory Surgery Center
  • Internal Medicine Specialists
  • Shafran Gastroenterology Center
  • Georgia Endoscopy Center
  • GI Consultants
  • Atlanta Gastroenterology Specialist
  • Covance Central Laboratory Services Inc
  • Covance Central Laboratory Services, Inc
  • Covance Laboratory Services, Inc
  • University of Kentucky Chandler Medical Center
  • University of Kentucky Medical Center
  • Endoscopic Microsurgery Associates
  • Commonwealth Clinical Studies
  • Signature Healthcare Brockton
  • University of Michigan Health Systems
  • East Valley Endoscopy
  • Gastroenterology Associates of Western Michigan
  • Metro Health Endoscopy Unit
  • Minneapolis Medical Eye Clinic
  • Noran Neurology Clinic
  • Minneapolis Heart Institute
  • Consulting Radiology
  • Minnesota Gastroenterology, P.A.
  • Surgery Center of Columbia
  • Center for Digestive and Liver Diseases
  • Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
  • Barnes-Jewish Hospital Radiology (X-Ray Only)
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • University of Nevada School of Medicine (UNSOM)
  • Las Vegas Surgery Center
  • Steinberg Diagnostic Medical Imaging Centers
  • Dartmouth-Hitchcock Medical Center
  • Albany Medical College
  • New York Presbyterian Hospital - Weill Cornell Medical College
  • New York Presbyterian Hospital
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Weill Cornell Medical College of Cornell University
  • Premier Medical Group of the Hudson Valley, PC
  • Premier Medical Group Research Department - Drug
  • UNC Hospitals Endoscopy Center At Meadowmont
  • Department of Pharmacy Investigational Drug Services
  • UNC Memorial Hospital
  • University of North Carolina at Chapel Hill
  • The Oregon Clinic, PC - Gastroenterology West
  • Gastro One
  • Diagnostic Imaging
  • Vanderbilt University Medical Center: GI Clinical Research
  • Vanderbilt University Medical Center: IBD Clinic
  • Vanderbilt University Medical Center: Drug Shipment
  • Vanderbilt University Medical Center: Endoscopy Lab
  • Vanderbilt University Medical Center: Outpatient Radiology
  • Houston Hospital for Specialized Surgery
  • Baylor Clinic (Drug Storage)
  • Baylor College Of Medicine - Baylor Medical Center
  • Spring Gastroenterology and Associates
  • Spring Gastroenterology Drug
  • Texas Digestive Disease Consultants
  • Pioneer Research Solutions, Inc
  • McGuire DVAMC
  • University of Washington
  • PI Radiology
  • Allegiance Research Specialists
  • Dynacare Laboratories
  • GI associates drug
  • Concord Repatriation General Hospital
  • Royal Brisbane and Women's Hospital
  • Mater Health Services
  • Alfred Hospital
  • The Royal Melbourne Hospital
  • The Canberra Hospital
  • AKH Wien, Universitaetsklinik fuer Innere Medizin III
  • AZ St-Elisabeth Herentals
  • University Hospital Gasthuisberg
  • Centre Hospitalier de Mouscron
  • 4- MBAL
  • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
  • MBAL SofiaMed OOD
  • GI Research Institute (GIRI)
  • Office of Dr. David C. Pearson
  • Office of Drs. Ranjit Andrew Singh and Jamie D. Papp
  • PerCuro Clinical Research Limited
  • Hamilton Health Sciences Corporation, McMaster University Medical Centre
  • McMaster University Medical Center
  • London Health Sciences Centre - University Hospital
  • Oshawa Clinic
  • Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont
  • Royal University Hospital
  • Hepato-Gastroenterology HK s.r.o.
  • Klinické Centrum ISCARE I.V.F
  • Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.
  • CHU Amiens - Hôpital Nord
  • Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
  • Hopital Huriez CHRU de Lille
  • Hôpital l'Archet 2 CHU de Nice
  • Hopital Haut Leveque
  • Hôpital Nord Service de Gastro-entérologie
  • CHU Nancy - Hopital Brabois
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Universitaetsklinik Regensburg
  • Robert-Bosch-Krankenhaus GmbH
  • Pannonia Maganorvosi Centrum Kft
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
  • Digestive Disease Institute
  • Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital
  • Dept. of Gastroenterology & Hepatology, Meir Medical Center
  • Gastroenterology Division, Rabin Medical Center, Beilinson Campus
  • The Chaim Sheba Medical Center
  • Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva
  • IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS
  • IRCCS Policlinico San Donato
  • Azienda Ospedaliera -Università di Padova
  • Policlinico Universitario Campus Bio-Medico
  • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
  • Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"
  • AOS San Camillo Forlanini
  • Ospedale Casa Sollievo della Sofferenza
  • Pusan National University Hospital
  • Yeungnam University Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Yonsei University College of Medicine, Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Academic Medical Center - University of Amsterdam
  • University Medical Center Groningen (UMCG)
  • Maastricht University Medical Center
  • Christchurch Hospital
  • Southern Endoscopy Centre
  • Midland Neurology & EMG Ltd.
  • The Hamilton Eye Clinic
  • Cardiac Services Ltd.
  • Waikato Hospital
  • Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
  • Gabinet Endoskopii Przewodu Pokarmowego
  • Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.
  • Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa
  • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem
  • NZOZ Vivamed
  • Wojskowy Szpital Kliniczny z Poliklinika SPOZ
  • Lexmedica
  • SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "
  • Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine
  • Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology
  • Military medical Academy
  • Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department
  • Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
  • Gastro I., s.r.o.
  • Gastroenterological Centre Thalion
  • KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra
  • Ustredna vojenska nemocnice SNP Ruzomberok
  • Kingsbury Hospital
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Parc de Salut Mar-Hospital del Mar
  • Centro Medico Teknon
  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Drug Dose Level 1

Drug Dose Level 2

Drug Dose Level 3

Drug Dose Level 4

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants in Clinical Remission at Week 12
Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.

Secondary Outcome Measures

Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Percentage of Participants With Mucosal Healing at Week 12
Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12
An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of "absolute Partial Mayo Score <=2", it was stated as "change from baseline in Partial Mayo Score <=2".
Change From Baseline in Total Mayo Score at Week 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
hsCRP was one of the PD biomarkers of the study.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. 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, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. 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, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Maximum Serum PF-00547659 Concentration Achieved

Full Information

First Posted
June 13, 2012
Last Updated
June 2, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01620255
Brief Title
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Acronym
TURANDOT
Official Title
A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2012 (Actual)
Primary Completion Date
September 22, 2014 (Actual)
Study Completion Date
February 4, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Drug Dose Level 1
Arm Type
Experimental
Arm Title
Drug Dose Level 2
Arm Type
Experimental
Arm Title
Drug Dose Level 3
Arm Type
Experimental
Arm Title
Drug Dose Level 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC Injection
Intervention Description
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC Injection
Intervention Description
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC Injection
Intervention Description
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-00547659 SC Injection
Intervention Description
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission at Week 12
Description
Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response at Week 12
Description
Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time Frame
Week 12
Title
Percentage of Participants With Mucosal Healing at Week 12
Description
Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time Frame
Week 12
Title
Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12
Description
An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of "absolute Partial Mayo Score <=2", it was stated as "change from baseline in Partial Mayo Score <=2".
Time Frame
Weeks 4, 8, and 12
Title
Change From Baseline in Total Mayo Score at Week 12
Description
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12
Description
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Time Frame
Baseline; Weeks (W) 4, 8, and 12
Title
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
Description
The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
Description
Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.
Time Frame
Baseline, Weeks 4, 8, and 12
Title
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
Description
hsCRP was one of the PD biomarkers of the study.
Time Frame
Baseline; Weeks 4, 8, and 12
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Description
IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. 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, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
Description
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. 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, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.
Time Frame
Baseline (BL), Week 12
Title
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
Description
IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.
Time Frame
Week 12
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)
Description
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Screening through to end of treatment period, up to 12 weeks
Title
Maximum Serum PF-00547659 Concentration Achieved
Time Frame
Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with diagnosis of Ulcerative Colitis for 3 or more months. Ulcerative colitis must be active beyond the rectum. Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points Exclusion Criteria: Pregnant or breast feeding. Diagnosis of indeterminate colitis or Crohn's Disease Subjects with history of colonic or small bowel obstruction or resection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
UCSD Health System-Pharmacy only
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Perlman Medical Offices
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Thornton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GastroDiagnostics - Community Clinical Trials Drug
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rocky Mountain Clinical Research, LLC.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Clinical Research of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
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 CT Drug
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Network of Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Florida Surgery Center
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Gastroenterology Associates
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Research Consultant Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Th Palmetto Surgery Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Citrus Memorial Hospital
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Inverness Medical Imaging
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
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
City
Inverness
State/Province
Florida
ZIP/Postal Code
34453
Country
United States
Facility Name
Sand Lake Imaging
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Center for Diagnostic Imaging
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital and Clinic - Local Lab
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital and Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Coral View Surgery Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
First Quality Laboratory
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
FQL Research, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Venutre Ambulatory Sugery Center
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Boston Diagnostic Imaging
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Citrus Ambulatory Surgery Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Georgia Endoscopy Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
GI Consultants
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Gastroenterology Specialist
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Covance Central Laboratory Services Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46214
Country
United States
Facility Name
Covance Central Laboratory Services, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46214
Country
United States
Facility Name
Covance Laboratory Services, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46214
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
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Endoscopic Microsurgery Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Signature Healthcare Brockton
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
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
East Valley Endoscopy
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Metro Health Endoscopy Unit
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Minneapolis Medical Eye Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Noran Neurology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis Heart Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Consulting Radiology
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Surgery Center of Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Center for Digestive and Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Barnes-Jewish Hospital Radiology (X-Ray Only)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nevada School of Medicine (UNSOM)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Las Vegas Surgery Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Steinberg Diagnostic Medical Imaging Centers
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
3756
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Presbyterian Hospital - Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
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
Premier Medical Group Research Department - Drug
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
UNC Hospitals Endoscopy Center At Meadowmont
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Department of Pharmacy Investigational Drug Services
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
UNC Memorial Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Oregon Clinic, PC - Gastroenterology West
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Diagnostic Imaging
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical Center: GI Clinical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Facility Name
Vanderbilt University Medical Center: IBD Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt University Medical Center: Drug Shipment
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7610
Country
United States
Facility Name
Vanderbilt University Medical Center: Endoscopy Lab
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center: Outpatient Radiology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Houston Hospital for Specialized Surgery
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Baylor Clinic (Drug Storage)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor College Of Medicine - Baylor Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Spring Gastroenterology and Associates
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Spring Gastroenterology Drug
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Pioneer Research Solutions, Inc
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
PI Radiology
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
Dynacare Laboratories
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI associates drug
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Health Services
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
The Canberra Hospital
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
AKH Wien, Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ St-Elisabeth Herentals
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
Facility Name
4- MBAL
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 SofiaMed OOD
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
GI Research Institute (GIRI)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
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. Ranjit Andrew Singh and Jamie D. Papp
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
PerCuro Clinical Research Limited
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Hamilton Health Sciences Corporation, McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Oshawa Clinic
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Hepato-Gastroenterology HK s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Klinické Centrum ISCARE I.V.F
City
Praha 7
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
CHU Amiens - Hôpital Nord
City
Amiens Cedex 01
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Huriez CHRU de Lille
City
Lille
ZIP/Postal Code
59037 Cedex
Country
France
Facility Name
Hôpital l'Archet 2 CHU de Nice
City
Nice Cedex 03
ZIP/Postal Code
CS23079 06202
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Nord Service de Gastro-entérologie
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHU Nancy - Hopital Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinik Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Pannonia Maganorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Digestive Disease Institute
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Dept. of Gastroenterology & Hepatology, Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Gastroenterology Division, Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Ospedaliera -Università di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
AOS San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705717
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Academic Medical Center - University of Amsterdam
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Southern Endoscopy Centre
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
Midland Neurology & EMG Ltd.
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
The Hamilton Eye Clinic
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Cardiac Services Ltd.
City
Hamilton
ZIP/Postal Code
3216
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
NZOZ Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Wojskowy Szpital Kliniczny z Poliklinika SPOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Gastro I., s.r.o.
City
Presov
State/Province
Slovak Republic
ZIP/Postal Code
08001
Country
Slovakia
Facility Name
Gastroenterological Centre Thalion
City
Bratislava
ZIP/Postal Code
83104
Country
Slovakia
Facility Name
KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Ustredna vojenska nemocnice SNP Ruzomberok
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
Facility Name
Kingsbury Hospital
City
Claremont
State/Province
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Parc de Salut Mar-Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Centro Medico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30901380
Citation
Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.
Results Reference
derived
PubMed Identifier
28527704
Citation
Vermeire S, Sandborn WJ, Danese S, Hebuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Gregus M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17. Erratum In: Lancet. 2019 Dec 22;392(10165):2696.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7281009&StudyName=A%20study%20Of%20PF-00547659%20In%20Patients%20With%20Moderate%20To%20Severe%20Ulcerative%20Colitis
Description
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Learn more about this trial

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

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