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AzTrials

Ulcerative ColitisPhase 2TURANDOTNCT01620255

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

A Phase 2 study testing PF-00547659 SC Injection in people with Ulcerative Colitis, run by Shire at 190 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
PF-00547659 SC Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
357 participants
Where
190 sitesin 21 countries
Study dates
2 Nov 2012to 4 Feb 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

190 sites in 21 countries.

190 sites in 21 countries

United States99 sites

  • Albany Medical College

    Albany, New York, 12208

  • Georgia Endoscopy Center

    Alpharetta, Georgia, 30005

  • Florida Surgery Center

    Altamonte Springs, Florida, 32701

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-5000

  • GI Consultants

    Atlanta, Georgia, 30342

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • Signature Healthcare Brockton

    Brockton, Massachusetts, 02302

  • UNC Hospitals Endoscopy Center At Meadowmont

    Chapel Hill, North Carolina, 27517

  • Department of Pharmacy Investigational Drug Services

    Chapel Hill, North Carolina, 27599

  • UNC Memorial Hospital

    Chapel Hill, North Carolina, 27599

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Surgery Center of Columbia

    Columbia, Missouri, 65265

  • Gastroenterology Associates

    Crystal River, Florida, 34429

  • Rocky Mountain Clinical Research, LLC.

    Denver, Colorado, 80222

  • Gastro One

    Germantown, Tennessee, 38138

  • East Valley Endoscopy

    Grand Rapids, Michigan, 49546

  • Endoscopy Center of Connecticut, LLC

    Guilford, Connecticut, 06437

  • Endoscopy Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Gastroenterology Center of Connecticut, PC

    Hamden, Connecticut, 06518

  • Medical REsearch Center of CT Drug

    Hamden, Connecticut, 06518

  • Medical Research Network of Connecticut

    Hamden, Connecticut, 06518

  • Research Consultant Group

    Hialeah, Florida, 33013

  • Th Palmetto Surgery Center

    Hialeah, Florida, 33016

  • Houston Hospital for Specialized Surgery

    Houston, Texas, 77004

  • Baylor Clinic (Drug Storage)

    Houston, Texas, 77030

  • Baylor College Of Medicine - Baylor Medical Center

    Houston, Texas, 77030

  • Spring Gastroenterology and Associates

    Humble, Texas, 77338

  • Spring Gastroenterology Drug

    Humble, Texas, 77338

  • Covance Central Laboratory Services Inc

    Indianapolis, Indiana, 46214

  • Covance Central Laboratory Services, Inc

    Indianapolis, Indiana, 46214

  • Covance Laboratory Services, Inc

    Indianapolis, Indiana, 46214

  • Citrus Memorial Hospital

    Inverness, Florida, 34452

  • Inverness Medical Imaging

    Inverness, Florida, 34452

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center

    Inverness, Florida, 34453

  • UCSD Health System-Pharmacy only

    La Jolla, California, 92037

  • Clinical and Translational Research Institute

    La Jolla, California, 92093

  • Perlman Medical Offices

    La Jolla, California, 92093

  • Thornton Hospital

    La Jolla, California, 92093

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • University of Nevada School of Medicine (UNSOM)

    Las Vegas, Nevada, 89102

  • Las Vegas Surgery Center

    Las Vegas, Nevada, 89106

  • Steinberg Diagnostic Medical Imaging Centers

    Las Vegas, Nevada, 89109

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 3756

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Sand Lake Imaging

    Maitland, Florida, 32751

  • Diagnostic Imaging

    Memphis, Tennessee, 38119

  • Center for Digestive and Liver Diseases

    Mexico, Missouri, 65265

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinic - Local Lab

    Miami, Florida, 33136

  • University of Miami Hospital and Clinic

    Miami, Florida, 33136

  • University of Miami Hospital

    Miami, Florida, 33136

  • Coral View Surgery Center

    Miami, Florida, 33144

  • Center for Diagnostic Imaging

    Miami Beach, Florida, 33179

  • PI Radiology

    Milwaukee, Wisconsin, 53222

  • Minneapolis Medical Eye Clinic

    Minneapolis, Minnesota, 55404

  • Noran Neurology Clinic

    Minneapolis, Minnesota, 55407

  • First Quality Laboratory

    Miramar, Florida, 33025

  • FQL Research, LLC

    Miramar, Florida, 33025

  • Vanderbilt University Medical Center: GI Clinical Research

    Nashville, Tennessee, 37212-1610

  • Vanderbilt University Medical Center: IBD Clinic

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center: Drug Shipment

    Nashville, Tennessee, 37232-7610

  • Vanderbilt University Medical Center: Endoscopy Lab

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center: Outpatient Radiology

    Nashville, Tennessee, 37232

  • New York Presbyterian Hospital - Weill Cornell Medical College

    New York, New York, 10021

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Weill Cornell Medical College of Cornell University

    New York, New York, 10065

  • Venutre Ambulatory Sugery Center

    North Miami Beach, Florida, 33162

  • Community Clinical Trials

    Orange, California, 92868

  • GastroDiagnostics - Community Clinical Trials Drug

    Orange, California, 92868

  • Boston Diagnostic Imaging

    Orlando, Florida, 32806

  • Citrus Ambulatory Surgery Center

    Orlando, Florida, 32806

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Minneapolis Heart Institute

    Plymouth, Minnesota, 55441

  • Consulting Radiology

    Plymouth, Minnesota, 55446

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • The Oregon Clinic, PC - Gastroenterology West

    Portland, Oregon, 97225

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Premier Medical Group Research Department - Drug

    Poughkeepsie, New York, 12601

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • University of Washington

    Seattle, Washington, 98195

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital Radiology (X-Ray Only)

    St Louis, Missouri, 63110

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Pioneer Research Solutions, Inc

    Sugar Land, Texas, 77479

  • Atlanta Gastroenterology Specialist

    Suwanee, Georgia, 30024

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado, 80229

  • Endoscopic Microsurgery Associates

    Towson, Maryland, 21204

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • Dynacare Laboratories

    Wauwatosa, Wisconsin, 53226

  • GI associates drug

    Wauwatosa, Wisconsin, 53226

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Metro Health Endoscopy Unit

    Wyoming, Michigan, 49519

Other trials in United States

Canada10 sites

  • Hamilton Health Sciences Corporation, McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Oshawa Clinic

    Oshawa, Ontario, L1H 1B9

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • GI Research Institute (GIRI)

    Vancouver, British Columbia, V6Z 2K5

  • Office of Dr. David C. Pearson

    Victoria, British Columbia, V8R 6R3

  • Office of Drs. Ranjit Andrew Singh and Jamie D. Papp

    Victoria, British Columbia, V8V 3P9

  • PerCuro Clinical Research Limited

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

Italy9 sites

  • Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva

    Catanzaro, 88100

  • IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS

    Milan, 20089

  • IRCCS Policlinico San Donato

    Milan, 20097

  • Azienda Ospedaliera -Università di Padova

    Padova, 35128

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

    Roma, 00133

  • Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"

    Roma, 00168

  • AOS San Camillo Forlanini

    Rome, 00152

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

Poland8 sites

  • Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

    Bydgoszcz, 85-168

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.

    Lodz, 90-302

  • Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa

    Poznan, 61-485

  • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem

    Warsaw, 02-507

  • NZOZ Vivamed

    Warsaw, 03-580

  • Wojskowy Szpital Kliniczny z Poliklinika SPOZ

    Wroclaw, 50-981

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

France7 sites

  • CHU Amiens - Hôpital Nord

    Amiens, 80054

  • Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

    Caen, 14033

  • Hopital Huriez CHRU de Lille

    Lille, 59037 Cedex

  • Hôpital l'Archet 2 CHU de Nice

    Nice, CS23079 06202

  • Hopital Haut Leveque

    Pessac, 33604

  • Hôpital Nord Service de Gastro-entérologie

    Saint-Priest-en-Jarez, 42270

  • CHU Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Hospital

    Daegu, 705717

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Yonsei University College of Medicine, Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia6 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • The Canberra Hospital

    Garran, 2605

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Health Services

    South Brisbane, Queensland, 4101

Other trials in Australia

New Zealand6 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Southern Endoscopy Centre

    Christchurch, 8014

  • Midland Neurology & EMG Ltd.

    Hamilton, 3204

  • The Hamilton Eye Clinic

    Hamilton, 3204

  • Cardiac Services Ltd.

    Hamilton, 3216

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

Israel5 sites

  • Digestive Disease Institute

    Jerusalem, 91031

  • Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital

    Jerusalem, 91120

  • Dept. of Gastroenterology & Hepatology, Meir Medical Center

    Kfar Saba, 44281

  • Gastroenterology Division, Rabin Medical Center, Beilinson Campus

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Tel HaShomer, 5262000

Other trials in Israel

Serbia5 sites

  • Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine

    Belgrade, 11000

  • Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology

    Belgrade, 11000

  • Military medical Academy

    Belgrade, 11000

  • Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department

    Belgrade, 11080

  • Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

    Niš, 18000

Other trials in Serbia

Slovakia4 sites

  • Gastroenterological Centre Thalion

    Bratislava, 83104

  • KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra

    Nitra, 949 01

  • Gastro I., s.r.o.

    Prešov, Slovak Republic, 08001

  • Ustredna vojenska nemocnice SNP Ruzomberok

    Ružomberok, 034 26

Other trials in Slovakia

Spain4 sites

  • Parc de Salut Mar-Hospital del Mar

    Barcelona, 08003

  • Centro Medico Teknon

    Barcelona, 08022

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

Belgium3 sites

  • AZ St-Elisabeth Herentals

    Herentals, 2200

  • University Hospital Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier de Mouscron

    Mouscron, 7700

Other trials in Belgium

Bulgaria3 sites

  • 4- MBAL

    Sofia, 1000

  • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

    Sofia, 1431

  • MBAL SofiaMed OOD

    Sofia, 1797

Other trials in Bulgaria

Czechia3 sites

  • Hepato-Gastroenterology HK s.r.o.

    Hradec Králové, 50012

  • Klinické Centrum ISCARE I.V.F

    Prague, 170 04

  • Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.

    Ústí nad Labem, 401 13

Other trials in Czechia

Germany3 sites

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitaetsklinik Regensburg

    Regensburg, 93053

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

Other trials in Germany

Netherlands3 sites

  • Academic Medical Center - University of Amsterdam

    Amsterdam, North Holland, 1105 AZ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Hungary2 sites

  • Pannonia Maganorvosi Centrum Kft

    Budapest, 1136

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, 6600

Other trials in Hungary

Austria1 site

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

Russia1 site

  • SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "

    Saint Petersburg, 196247

Other trials in Russia

South Africa1 site

  • Kingsbury Hospital

    Claremont, CAPE TOWN, 7708

Other trials in South Africa

About this study

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)

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.

Being tested
Placebo, PF-00547659 SC Injection
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

  • PF-00547659 SC InjectionDrug

    Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks

  • PF-00547659 SC InjectionDrug

    Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks

  • PF-00547659 SC InjectionDrug

    Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks

  • PF-00547659 SC InjectionDrug

    Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

Study groups in NCT01620255
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Drug Dose Level 1ExperimentalNot described
Receives: Drug: PF-00547659 SC Injection
Drug Dose Level 2ExperimentalNot described
Receives: Drug: PF-00547659 SC Injection
Drug Dose Level 3ExperimentalNot described
Receives: Drug: PF-00547659 SC Injection
Drug Dose Level 4ExperimentalNot described
Receives: Drug: PF-00547659 SC Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

Secondary outcomes (13)

  1. 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.

    Measured: Week 12

  2. 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.

    Measured: Week 12

  3. 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".

    Measured: Weeks 4, 8, and 12

  4. 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.

    Measured: Baseline, Week 12

  5. 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.

    Measured: Baseline; Weeks (W) 4, 8, and 12

  6. 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.

    Measured: Baseline, Week 12

  7. 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.

    Measured: Baseline, Weeks 4, 8, and 12

  8. 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.

    Measured: Baseline; Weeks 4, 8, and 12

  9. 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.

    Measured: Baseline, Week 12

  10. 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.

    Measured: Baseline (BL), Week 12

  11. 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.

    Measured: Week 12

  12. 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.

    Measured: Screening through to end of treatment period, up to 12 weeks

  13. Maximum Serum PF-00547659 Concentration Achieved

    Measured: Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study start2 Nov 2012
  3. Primary completion22 Sep 2014
  4. Study completion4 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620255
Sponsor's protocol ID
A7281009
Other IDs
2012-002030-37, TURANDOT
Acronym
TURANDOT
Status last verified
Jun 2021
First submitted
13 Jun 2012
Last updated
11 Jun 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30901380

  • 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.

    PubMed 28527704

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00547659 SC Injection in people with Ulcerative Colitis, run by Shire at 190 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in United States, Canada, Italy, Poland, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Clinical Remission at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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