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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01620255
Registration number
NCT01620255
Ethics application status
Date submitted
13/06/2012
Date registered
15/06/2012
Date last updated
11/06/2021
Titles & IDs
Public title
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
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Scientific 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)
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Secondary ID [1]
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2012-002030-37
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Secondary ID [2]
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A7281009
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Universal Trial Number (UTN)
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Trial acronym
TURANDOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection
Placebo comparator: Placebo -
Experimental: Drug Dose Level 1 -
Experimental: Drug Dose Level 2 -
Experimental: Drug Dose Level 3 -
Experimental: Drug Dose Level 4 -
Treatment: Drugs: Placebo
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants in Clinical Remission at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants With Clinical Response at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants With Mucosal Healing at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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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
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Assessment method [3]
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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".
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Timepoint [3]
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Weeks 4, 8, and 12
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Secondary outcome [4]
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Change From Baseline in Total Mayo Score at Week 12
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 12
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline; Weeks (W) 4, 8, and 12
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Secondary outcome [6]
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Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 12
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Secondary outcome [7]
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Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
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Assessment method [7]
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Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.
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Timepoint [7]
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Baseline, Weeks 4, 8, and 12
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Secondary outcome [8]
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Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
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Assessment method [8]
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hsCRP was one of the PD biomarkers of the study.
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Timepoint [8]
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Baseline; Weeks 4, 8, and 12
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Secondary outcome [9]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 12
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Secondary outcome [10]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline (BL), Week 12
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Secondary outcome [11]
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Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
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Assessment method [11]
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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.
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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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)
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Assessment method [12]
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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.
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Timepoint [12]
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Screening through to end of treatment period, up to 12 weeks
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Secondary outcome [13]
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Maximum Serum PF-00547659 Concentration Achieved
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Assessment method [13]
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Timepoint [13]
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Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/02/2016
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Sample size
Target
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Accrual to date
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Final
357
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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Mater Health Services - South Brisbane
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Recruitment hospital [4]
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Alfred Hospital - Melbourne
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Recruitment hospital [5]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [6]
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The Canberra Hospital - Garran
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment postcode(s) [6]
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2605 - Garran
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Vandoeuvre les Nancy
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Italy
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Rome
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Italy
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Hamilton
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Bydgoszcz
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Russian Federation
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Nis
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Bratislava
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Nitra
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Ruzomberok
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South Africa
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Cape Town
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Spain
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Madrid
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Spain
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Shire
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01620255
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Trial related presentations / 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. 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. doi: 10.1016/S0140-6736(18)33014-9.
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Results are available at
https://clinicaltrials.gov/study/NCT01620255
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