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CompletedNCT01620255TURANDOTUpdated Jun 11, 2021Results posted

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

A Phase 2 interventional study of Placebo and PF-00547659 SC Injection in Ulcerative Colitis, sponsored by Shire. Completed at 190 sites in 21 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Shire · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 357 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
357 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Drug Dose Level 1

    Drug: PF-00547659 SC Injection

  • Experimental
    Drug Dose Level 2

    Drug: PF-00547659 SC Injection

  • Experimental
    Drug Dose Level 3

    Drug: PF-00547659 SC Injection

  • Experimental
    Drug Dose Level 4

    Drug: PF-00547659 SC Injection

Interventions

  • DrugPlacebo

    Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

  • DrugPF-00547659 SC Injection

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

  • DrugPF-00547659 SC Injection

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

  • DrugPF-00547659 SC Injection

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

  • DrugPF-00547659 SC Injection

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Week 12

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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".

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

  13. Maximum Serum PF-00547659 Concentration Achieved

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

07

Results

Posted Mar 27, 2017

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Started7371707370
Treated7371707370
Completed6965687064
Not completed46236
Withdrew: Withdrawal by subject41124
Withdrew: Participant underwent fecal transplant00100
Withdrew: Non-compliance01000
Withdrew: Adverse event04011
Withdrew: Withdrawn at discretion of investigator00001

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants in Clinical Remission at Week 12
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Centrally read2.7 (0.7 to 7.6)11.3 (5.7 to 18.8)16.7 (9.9 to 25.4)15.5 (9.5 to 23.6)5.7 (2.5 to 12.5)
Locally read5.5 (2.4 to 12.0)14.1 (7.8 to 22.0)23.6 (15.6 to 33.1)18.3 (11.9 to 27.1)12.9 (7.3 to 21.1)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.0213 (1-sided p-value) · Risk difference (rd): 0.080 · 90% CI 0.019 to 0.140Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0025 (1-sided p-value) · Risk difference (rd): 0.128 · 90% CI 0.056 to 0.199Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0040 (1-sided p-value) · Risk difference (rd): 0.118 · 90% CI 0.048 to 0.188Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.1803 (1-sided p-value) · Risk difference (rd): 0.026 · 90% CI -0.012 to 0.064Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.0582 (1-sided p-value) · Risk difference (rd): 0.080 · 90% CI 0.002 to 0.159Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0014 (1-sided p-value) · Risk difference (rd): 0.178 · 90% CI 0.083 to 0.272Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0125 (1-sided p-value) · Risk difference (rd): 0.122 · 90% CI 0.036 to 0.208Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.0927 (1-sided p-value) · Risk difference (rd): 0.066 · 90% CI -0.009 to 0.142Statistics of risk difference are calculated using the Minimum Risk Weights test.
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Response at Week 12
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Centrally read (n=73,71,72,71,70)28.8 (20.2 to 37.8)38.0 (28.4 to 47.6)54.2 (44.2 to 64.2)45.1 (35.0 to 55.3)50.0 (39.6 to 60.4)
Locally read (n=73,70,72,70,70)32.9 (24.2 to 42.3)38.6 (28.8 to 48.1)54.2 (44.2 to 64.2)48.6 (38.2 to 59.0)51.4 (41.0 to 61.8)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.1379 (1-sided p-value) · Risk difference (rd): 0.089 · 90% CI -0.037 to 0.214Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0011 (1-sided p-value) · Risk difference (rd): 0.254 · 90% CI 0.121 to 0.388Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0239 (1-sided p-value) · Risk difference (rd): 0.163 · 90% CI 0.032 to 0.293Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.0052 (1-sided p-value) · Risk difference (rd): 0.213 · 90% CI 0.080 to 0.347Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.2617 (1-sided p-value) · Risk difference (rd): 0.056 · 90% CI -0.075 to 0.186Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0058 (1-sided p-value) · Risk difference (rd): 0.212 · 90% CI 0.077 to 0.347Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0326 (1-sided p-value) · Risk difference (rd): 0.156 · 90% CI 0.022 to 0.290Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.0145 (1-sided p-value) · Risk difference (rd): 0.185 · 90% CI 0.050 to 0.320Statistics of risk difference are calculated using the Minimum Risk Weights test.
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Mucosal Healing at Week 12
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Centrally read8.2 (3.6 to 15.4)15.5 (9.5 to 23.6)27.8 (19.5 to 37.1)25.4 (17.1 to 35.0)14.3 (8.0 to 22.3)
Locally read21.9 (14.9 to 31.4)22.5 (15.4 to 31.6)37.5 (28.0 to 47.2)35.2 (25.8 to 44.7)28.6 (20.2 to 38.2)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.0618 (1-sided p-value) · Risk difference (rd): 0.081 · 90% CI 0.000 to 0.162Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0009 (1-sided p-value) · Risk difference (rd): 0.187 · 90% CI 0.091 to 0.284Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0027 (1-sided p-value) · Risk difference (rd): 0.159 · 90% CI 0.068 to 0.250Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.0999 (1-sided p-value) · Risk difference (rd): 0.069 · 90% CI -0.013 to 0.151Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.5225 (1-sided p-value) · Risk difference (rd): 0.001 · 90% CI -0.111 to 0.114Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0246 (1-sided p-value) · Risk difference (rd): 0.154 · 90% CI 0.030 to 0.278Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.0464 (1-sided p-value) · Risk difference (rd): 0.130 · 90% CI 0.008 to 0.253Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.2000 (1-sided p-value) · Risk difference (rd): 0.066 · 90% CI -0.053 to 0.186Statistics of risk difference are calculated using the Minimum Risk Weights test.
SecondaryPercentage 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".

Time frame:
Weeks 4, 8, and 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Total Mayo Score at Week 12
units on a scalePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Centrally read baseline (n=73,71,72,71,70)8.4 ± 1.718.7 ± 1.658.1 ± 1.638.4 ± 1.948.7 ± 1.60
Centrally read change (n=67,63,69,67,63)-1.5 ± 2.42-2.4 ± 2.78-2.9 ± 2.49-2.5 ± 2.74-2.9 ± 2.78
Locally read baseline (n=73,70,72,70,70)8.4 ± 1.728.8 ± 1.598.1 ± 1.728.3 ± 1.998.6 ± 1.62
Locally read change (n=67,62,70,66,64)-1.7 ± 2.55-2.7 ± 3.05-3.1 ± 2.70-2.7 ± 2.92-3.1 ± 3.07
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · ANCOVA · p = 0.0494 · Least squares mean (lsm) difference: -0.88 · 90% CI -1.623 to -0.145Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 22.5 mg · ANCOVA · p = 0.0005 · Lsm difference: -1.53 · 90% CI -2.254 to -0.809Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 75 mg · ANCOVA · p = 0.0117 · Lsm difference: -1.12 · 90% CI -1.845 to -0.390Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 225 mg · ANCOVA · p = 0.0049 · Lsm difference: -1.27 · 90% CI -2.016 to -0.533Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 7.5 mg · ANCOVA · p = 0.0543 · Lsm difference: -0.94 · 90% CI -1.737 to -0.137Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 22.5 mg · ANCOVA · p = 0.0008 · Lsm difference: -1.60 · 90% CI -2.372 to -0.819Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 75 mg · ANCOVA · p = 0.0255 · Lsm difference: -1.07 · 90% CI -1.858 to -0.284Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
  • Placebo vs PF-00547659 225 mg · ANCOVA · p = 0.0079 · Lsm difference: -1.29 · 90% CI -2.082 to -0.493Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
SecondaryPercentage 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.

Time frame:
Baseline; Weeks (W) 4, 8, and 12
Reported as:
Number · percentage of participants
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
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Imp in Stool frequency, W4 (n=67,64,71,69,65)26.87 (-2.043 to -1.014)46.88 (-2.944 to -1.881)36.62 (-3.570 to -2.550)30.43 (-3.162 to -2.131)43.08 (-3.337 to -2.270)
NC in Stool frequency, W4 (n=67,64,71,69,65)59.70 (-2.280 to -1.171)42.19 (-3.241 to -2.084)60.56 (-3.866 to -2.775)63.77 (-3.357 to -2.236)52.31 (-3.583 to -2.442)
Wors in Stool frequency, W4 (n=67,64,71,69,65)13.4310.942.825.804.62
Imp in Stool frequency, W8 (n=71,63,71,69,68)28.1749.2143.6649.2851.47
NC in Stool frequency, W8 (n=71,63,71,69,68)60.5642.8653.5246.3848.53
Wors in Stool frequency, W8 (n=71,63,71,69,68)11.277.942.824.350
Imp in Stool frequency, W12 (n=67,63,71,68,64)35.8249.2156.3445.5956.25
NC in Stool frequency, W12 (n=67,63,71,68,64)52.2441.2738.0348.5337.50
Wors in Stool frequency, W12 (n=67,63,71,68,64)11.949.525.635.886.25
Imp in Rectal Bleeding, W4 (n=67,64,71,69,65)22.3948.4442.2542.0349.23
NC in Rectal Bleeding, W4 (n=67,64,71,69,65)62.6942.1957.7553.6244.62
Wors in Rectal Bleeding, W4 (n=67,64,71,69,65)14.939.3804.356.15
Imp in Rectal Bleeding, W8 (n=71,63,71,69,68)33.8050.7940.8546.3864.71
NC in Rectal Bleeding, W8 (n=71,63,71,69,68)54.9336.5150.7044.9333.82
Wors in Rectal Bleeding, W8 (n=71,63,71,69,68)11.2712.708.458.701.47
Imp in Rectal Bleeding, W12 (n=67,63,71,68,64)37.3153.9750.7047.0660.94
NC in Rectal Bleeding, W12 (n=67,63,71,68,64)50.7534.9242.2545.5935.94
Wors in Rectal Bleeding, W12 (n=67,63,71,68,64)11.9411.117.047.353.13
Imp in PGA, W4 (n=67,64,71,69,65)47.7657.8156.3456.5260.00
NC in PGA, W4 (n=67,64,71,69,65)49.2534.3839.4442.0335.38
Wors in PGA, W4 (n=67,64,71,69,65)2.997.814.231.454.62
Imp in PGA, W8 (n=71,63,71,69,68)59.1561.9066.2062.3267.65
NC in PGA, W8 (n=71,63,71,69,68)33.8030.1630.9937.6830.88
Wors in PGA, W8 (n=71,63,71,69,68)7.047.942.8201.47
Imp in PGA, W12 (n=67,63,71,68,64)50.7561.9064.7955.8857.81
NC in PGA, W12 (n=67,63,71,68,64)43.2831.7532.3939.7132.81
Wors in PGA, W12 (n=67,63,71,68,64)5.976.352.824.419.38
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.1016 · Lsm difference: -0.25 · 90% CI -0.511 to 0.001Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0654 · Lsm difference: -0.28 · 90% CI -0.529 to -0.030LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1500 · Lsm difference: -0.22 · 90% CI -0.472 to 0.031LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0132 · Lsm difference: -0.38 · 90% CI -0.637 to -0.129LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.0526 · Lsm difference: -0.30 · 90% CI -0.555 to -0.046LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0422 · Lsm difference: -0.31 · 90% CI -0.554 to -0.058LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0110 · Lsm difference: -0.39 · 90% CI -0.637 to -0.137LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0010 · Lsm difference: -0.50 · 90% CI -0.755 to -0.254LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.1611 · Lsm difference: -0.22 · 90% CI -0.475 to 0.038LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0186 · Lsm difference: -0.36 · 90% CI -0.608 to -0.108LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1647 · Lsm difference: -0.21 · 90% CI -0.465 to 0.039LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0231 · Lsm difference: -0.35 · 90% CI -0.607 to -0.097LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.0002 · Lsm difference: -0.46 · 90% CI -0.658 to -0.260LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = <0.0001 · Lsm difference: -0.52 · 90% CI -0.710 to -0.322LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = <0.0001 · Lsm difference: -0.49 · 90% CI -0.686 to -0.295LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0012 · Lsm difference: -0.39 · 90% CI -0.587 to -0.192LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.0207 · Lsm difference: -0.28 · 90% CI -0.475 to -0.081LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0402 · Lsm difference: -0.24 · 90% CI -0.432 to -0.048LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0071 · Lsm difference: -0.32 · 90% CI -0.511 to -0.124LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = <0.0001 · Lsm difference: -0.47 · 90% CI -0.664 to -0.275LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.0395 · Lsm difference: -0.25 · 90% CI -0.449 to -0.050LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0073 · Lsm difference: -0.32 · 90% CI -0.511 to -0.123LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0413 · Lsm difference: -0.24 · 90% CI -0.439 to -0.047LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0008 · Lsm difference: -0.40 · 90% CI -0.602 to -0.206LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.1862 · Lsm difference: -0.19 · 90% CI -0.421 to 0.046LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0998 · Lsm difference: -0.23 · 90% CI -0.455 to -0.000LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1085 · Lsm difference: -0.22 · 90% CI -0.453 to 0.006LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.3161 · Lsm difference: -0.14 · 90% CI -0.372 to 0.090LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.4962 · Lsm difference: -0.10 · 90% CI -0.328 to 0.136LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0371 · Lsm difference: -0.29 · 90% CI -0.512 to -0.060LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1212 · Lsm difference: -0.21 · 90% CI -0.441 to 0.013LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.1870 · Lsm difference: -0.18 · 90% CI -0.410 to 0.045LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.1133 · Lsm difference: -0.23 · 90% CI -0.459 to 0.009LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0022 · Lsm difference: -0.43 · 90% CI -0.653 to -0.198LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0788 · Lsm difference: -0.25 · 90% CI -0.475 to -0.016LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0717 · Lsm difference: -0.25 · 90% CI -0.485 to -0.022LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
SecondaryPercentage 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.

Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Imp (n=67,63,69,67,63)25.37 (-2.043 to -1.014)28.57 (-2.944 to -1.881)47.83 (-3.570 to -2.550)47.76 (-3.162 to -2.131)39.68 (-3.337 to -2.270)
NC (n=67,63,69,67,63)61.19 (-2.280 to -1.171)60.32 (-3.241 to -2.084)49.28 (-3.866 to -2.775)46.27 (-3.357 to -2.236)57.14 (-3.583 to -2.442)
Wors (n=67,63,69,67,63)13.4311.112.905.973.17
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · ANCOVA · p = 0.5406 · Lsm difference: -0.08 · 90% CI -0.286 to 0.131ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · ANCOVA · p = 0.0007 · Lsm difference: -0.42 · 90% CI -0.628 to -0.221ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · ANCOVA · p = 0.0063 · Lsm difference: -0.34 · 90% CI -0.549 to -0.137ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · ANCOVA · p = 0.0748 · Lsm difference: -0.23 · 90% CI -0.436 to -0.018ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
SecondaryPercent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12

Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.

Time frame:
Baseline, Weeks 4, 8, and 12
Reported as:
Geometric mean · percent change
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
percent changePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Week 4 (n=62,57,68,67,60)-25.62 (-43.49 to -2.09)-40.21 (-55.56 to -19.54)-23.50 (-44.27 to 5.00)-46.22 (-61.46 to -24.95)-39.27 (-56.74 to -14.75)
Week 8 (n=67,57,67,63,65)-21.68 (-39.62 to 1.60)-44.49 (-60.05 to -22.88)-44.77 (-60.49 to -22.80)-57.20 (-69.74 to -39.45)-49.54 (-65.08 to -27.07)
Week 12 (n=61,55,64,64,59)-22.59 (-42.68 to 4.54)-56.34 (-69.39 to -37.72)-58.41 (-72.26 to -37.65)-56.72 (-71.67 to -33.88)-64.52 (-76.92 to -45.43)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.9744 · Lsm difference: -1.9 · 90% CI -101.00 to 97.14LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.2023 · Lsm difference: 74.9 · 90% CI -21.77 to 171.66LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.5808 · Lsm difference: 32.9 · 90% CI -65.09 to 130.79LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.5388 · Lsm difference: 37.6 · 90% CI -63.12 to 138.34LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.8902 · Lsm difference: -8.2 · 90% CI -106.24 to 89.81LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.8616 · Lsm difference: 10.2 · 90% CI -86.14 to 106.54LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.5684 · Lsm difference: -34.3 · 90% CI -133.49 to 64.79LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.5700 · Lsm difference: 33.8 · 90% CI -64.20 to 131.86LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.6234 · Lsm difference: -30.0 · 90% CI -130.56 to 70.57LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.5474 · Lsm difference: 36.0 · 90% CI -62.44 to 134.38LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1918 · Lsm difference: 78.5 · 90% CI -20.48 to 177.56LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.9615 · Lsm difference: -3.0 · 90% CI -104.88 to 98.91LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
SecondaryPercent 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.

Time frame:
Baseline; Weeks 4, 8, and 12
Reported as:
Geometric mean · percent change
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
percent changePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Week 4 (n=67,64,69,71,65)-11.60 (-25.69 to 5.17)-19.17 (-34.22 to -0.67)-26.90 (-39.41 to -11.82)-35.21 (-49.10 to -17.55)-17.70 (-30.08 to -3.13)
Week 8 (n=71,63,69,71,68)-2.42 (-22.75 to 23.25)-6.00 (-23.09 to 14.89)-31.43 (-44.11 to -15.88)-43.15 (-54.57 to -28.86)-22.70 (-36.72 to -5.59)
Week 12 (n=67,62,68,71,64)14.85 (-11.16 to 48.48)4.51 (-18.02 to 33.25)-20.40 (-38.61 to 3.22)-15.96 (-33.12 to 5.60)2.31 (-18.48 to 28.42)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.9328 · Lsm difference: 6.4 · 90% CI -118.60 to 131.41LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.8962 · Lsm difference: -9.8 · 90% CI -132.91 to 113.39LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.8775 · Lsm difference: 11.5 · 90% CI -110.83 to 133.74LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.8224 · Lsm difference: -17.0 · 90% CI -142.02 to 107.94LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.4831 · Lsm difference: -52.7 · 90% CI -176.48 to 71.02LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.1183 · Lsm difference: -115.2 · 90% CI -236.63 to 6.13LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.1139 · Lsm difference: -115.8 · 90% CI -236.29 to 4.69LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.1931 · Lsm difference: -96.4 · 90% CI -218.17 to 25.46LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.1182 · Lsm difference: -119.7 · 90% CI -245.66 to 6.32LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.5784 · Lsm difference: -41.7 · 90% CI -165.34 to 81.87LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0279 · Lsm difference: -163.6 · 90% CI -285.84 to -41.29LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.1053 · Lsm difference: -123.5 · 90% CI -249.00 to 1.93LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
SecondaryChange 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.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
units on a scalePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Baseline (BL)(n=69,68,65,71,66)128.0 ± 30.69122.1 ± 38.82133.4 ± 34.79128.0 ± 32.42132.3 ± 36.84
Change at W12 (n=62,55,61,64,54)19.8 ± 34.0820.1 ± 35.2432.7 ± 34.1032.1 ± 31.7036.2 ± 29.45
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.8302 · Lsm difference: -1.10 · 90% CI -9.507 to 7.317LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0141 · Lsm difference: 12.33 · 90% CI 4.084 to 20.567LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0182 · Lsm difference: 11.70 · 90% CI 3.564 to 19.840LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0026 · Lsm difference: 15.48 · 90% CI 7.056 to 23.907LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
SecondaryChange 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.

Time frame:
Baseline (BL), Week 12
Reported as:
Mean · units on a scale
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
units on a scalePlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
BL, bowel fx (n=69,68,65,71,66)38.9 ± 9.9637.0 ± 12.2341.7 ± 10.6038.5 ± 9.9541.0 ± 11.37
Change at W12, bowel fx (n=62,55,61,64,54)7.4 ± 11.936.9 ± 12.5111.3 ± 11.0511.8 ± 12.0712.8 ± 11.45
BL, emotional fx (n=69,68,65,71,66)50.4 ± 12.6048.4 ± 15.3951.2 ± 14.7050.4 ± 13.7351.3 ± 15.92
Change at W12, emotional fx (n=62,55,61,64,54)5.9 ± 11.916.6 ± 12.2210.8 ± 13.8510.0 ± 12.0412.0 ± 11.40
BL, systemic symptoms (SS)(n=69,68,65,71,66)18.1 ± 5.6218.2 ± 6.8119.6 ± 5.9818.4 ± 6.4219.0 ± 5.97
Change at W12, SS (n=62,55,61,64,54)3.3 ± 6.673.1 ± 5.954.7 ± 5.914.9 ± 5.494.8 ± 5.05
BL, social fx (n=69,68,65,71,66)20.6 ± 7.8718.5 ± 8.0720.9 ± 7.3720.7 ± 6.9920.9 ± 7.73
Change at W12, social fx (n=62,55,61,64,54)3.3 ± 6.273.6 ± 7.335.9 ± 6.515.4 ± 6.906.6 ± 6.58
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.6862 · Lsm difference: -0.73 · 90% CI -3.689 to 2.235LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0135 · Lsm difference: 4.37 · 90% CI 1.467 to 7.280LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0171 · Lsm difference: 4.16 · 90% CI 1.293 to 7.023LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0041 · Lsm difference: 5.20 · 90% CI 2.232 to 8.172LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.9072 · Lsm difference: 0.22 · 90% CI -2.897 to 3.339LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0161 · Lsm difference: 4.47 · 90% CI 1.420 to 7.522LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0271 · Lsm difference: 4.06 · 90% CI 1.042 to 7.071LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0020 · Lsm difference: 5.90 · 90% CI 2.778 to 9.026LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.7711 · Lsm difference: -0.26 · 90% CI -1.756 to 1.229LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0582 · Lsm difference: 1.69 · 90% CI 0.223 to 3.147LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0558 · Lsm difference: 1.68 · 90% CI 0.235 to 3.120LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0686 · Lsm difference: 1.66 · 90% CI 0.161 to 3.153LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 7.5 mg · Mixed Models Analysis · p = 0.7561 · Lsm difference: -0.33 · 90% CI -2.094 to 1.429LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 22.5 mg · Mixed Models Analysis · p = 0.0384 · Lsm difference: 2.17 · 90% CI 0.447 to 3.891LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 75 mg · Mixed Models Analysis · p = 0.0729 · Lsm difference: 1.86 · 90% CI 0.154 to 3.557LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
  • Placebo vs PF-00547659 225 mg · Mixed Models Analysis · p = 0.0060 · Lsm difference: 2.95 · 90% CI 1.190 to 4.715LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
SecondaryPercentage 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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
percentage of participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 1236.9 (27.4 to 47.5)36.8 (26.9 to 47.9)55.6 (45.0 to 66.3)46.9 (36.1 to 57.5)48.1 (36.3 to 59.4)
Statistical analysis
  • Placebo vs PF-00547659 7.5 mg · Cochran-Mantel-Haenszel · p = 0.5201 (1-sided p-value) · Risk difference (rd): -0.002 · 90% CI -0.145 to 0.142Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 22.5 mg · Cochran-Mantel-Haenszel · p = 0.0217 (1-sided p-value) · Risk difference (rd): 0.183 · 90% CI 0.039 to 0.328Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 75 mg · Cochran-Mantel-Haenszel · p = 0.1473 (1-sided p-value) · Risk difference (rd): 0.096 · 90% CI -0.045 to 0.237Statistics of risk difference are calculated using the Minimum Risk Weights test.
  • Placebo vs PF-00547659 225 mg · Cochran-Mantel-Haenszel · p = 0.1231 (1-sided p-value) · Risk difference (rd): 0.112 · 90% CI -0.038 to 0.261Statistics of risk difference are calculated using the Minimum Risk Weights test.
SecondaryNumber 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.

Time frame:
Screening through to end of treatment period, up to 12 weeks
Reported as:
Number · participants
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)
participantsPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
With TEAEs3941364343
With SAEs411133
Withdrawals due to TEAEs25031
SecondaryMaximum Serum PF-00547659 Concentration Achieved
Time frame:
Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal
Reported as:
Mean · nanograms (ng)/milliliter (mL)
Maximum Serum PF-00547659 Concentration Achieved
nanograms (ng)/milliliter (mL)PlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Maximum Serum PF-00547659 Concentration Achieved—929.4 ± 1977.82062 ± 1395.56576 ± 2146.021470 ± 4788.4

Adverse events

Collected over Screening till Week 36 or Early Withdrawal, whichever was later.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—4/73 (5.5%)17/73 (23.3%)
PF-00547659 7.5 mg—11/71 (15.5%)16/71 (22.5%)
PF-00547659 22.5 mg—2/70 (2.9%)15/70 (21.4%)
PF-00547659 75 mg—4/73 (5.5%)14/73 (19.2%)
PF-00547659 225 mg—3/70 (4.3%)18/70 (25.7%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
Colitis ulcerativeGastrointestinal disorders1/736/710/702/730/70
DiarrhoeaGastrointestinal disorders2/730/710/700/730/70
Retinal artery embolismEye disorders0/730/711/700/730/70
Abdominal painGastrointestinal disorders0/730/710/700/731/70
Pain in extremityMusculoskeletal and connective tissue disorders0/730/710/700/731/70
MigraineNervous system disorders0/730/710/701/731/70
Tension headacheNervous system disorders0/730/710/700/731/70
Colectomy totalSurgical and medical procedures0/730/711/700/730/70
Anal fistulaGastrointestinal disorders0/731/710/700/730/70
ConstipationGastrointestinal disorders0/731/710/700/730/70
Most frequent other events
Most frequent other events
EventPlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mg
HeadacheNervous system disorders6/735/717/704/738/70
Abdominal painGastrointestinal disorders2/736/713/702/731/70
NauseaGastrointestinal disorders3/736/711/701/734/70
NasopharyngitisInfections and infestations3/730/713/705/734/70
VomitingGastrointestinal disorders3/731/714/700/732/70
AnaemiaBlood and lymphatic system disorders0/730/712/704/732/70
CoughRespiratory, thoracic and mediastinal disorders4/731/710/701/730/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mgTotal
Mean38.6 ± 12.741.3 ± 12.542.1 ± 14.737.7 ± 12.441.3 ± 13.240.2 ± 13.2
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-00547659 7.5 mgPF-00547659 22.5 mgPF-00547659 75 mgPF-00547659 225 mgTotal
Female2932253528149
Male4439453842208
08

Study locations

190 sites
  • Mayo Clinic Arizona
    Scottsdale, Arizona 85259, United States
  • UCSD Health System-Pharmacy only
    La Jolla, California 92037, United States
  • Clinical and Translational Research Institute
    La Jolla, California 92093, United States
  • Perlman Medical Offices
    La Jolla, California 92093, United States
  • Thornton Hospital
    La Jolla, California 92093, United States
  • Community Clinical Trials
    Orange, California 92868, United States
  • GastroDiagnostics - Community Clinical Trials Drug
    Orange, California 92868, United States
  • Rocky Mountain Clinical Research, LLC.
    Denver, Colorado 80222, United States
  • Clinical Research of the Rockies
    Lafayette, Colorado 80026, United States
  • Rocky Mountain Gastroenterology Associates
    Thornton, Colorado 80229, United States
  • Endoscopy Center of Connecticut, LLC
    Guilford, Connecticut 06437, United States
  • Endoscopy Center of Connecticut, LLC
    Hamden, Connecticut 06518, United States
  • Gastroenterology Center of Connecticut, PC
    Hamden, Connecticut 06518, United States
  • Medical REsearch Center of CT Drug
    Hamden, Connecticut 06518, United States
  • Medical Research Network of Connecticut
    Hamden, Connecticut 06518, United States
  • Florida Surgery Center
    Altamonte Springs, Florida 32701, United States
  • Gastroenterology Associates
    Crystal River, Florida 34429, United States
  • Research Consultant Group
    Hialeah, Florida 33013, United States
  • Th Palmetto Surgery Center
    Hialeah, Florida 33016, United States
  • Citrus Memorial Hospital
    Inverness, Florida 34452, United States
  • Inverness Medical Imaging
    Inverness, Florida 34452, United States
  • Nature Coast Clinical Research
    Inverness, Florida 34452, United States
  • Suncoast Endoscopy Center
    Inverness, Florida 34453, United States
  • Sand Lake Imaging
    Maitland, Florida 32751, United States
  • Center for Diagnostic Imaging
    Miami Beach, Florida 33179, United States
  • Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • University of Miami Hospital and Clinic - Local Lab
    Miami, Florida 33136, United States
  • University of Miami Hospital and Clinic
    Miami, Florida 33136, United States
  • University of Miami Hospital
    Miami, Florida 33136, United States
  • Coral View Surgery Center
    Miami, Florida 33144, United States
  • First Quality Laboratory
    Miramar, Florida 33025, United States
  • FQL Research, LLC
    Miramar, Florida 33025, United States
  • Venutre Ambulatory Sugery Center
    North Miami Beach, Florida 33162, United States
  • Boston Diagnostic Imaging
    Orlando, Florida 32806, United States
  • Citrus Ambulatory Surgery Center
    Orlando, Florida 32806, United States
  • Internal Medicine Specialists
    Orlando, Florida 32806, United States
  • Shafran Gastroenterology Center
    Winter Park, Florida 32789, United States
  • Georgia Endoscopy Center
    Alpharetta, Georgia 30005, United States
  • GI Consultants
    Atlanta, Georgia 30342, United States
  • Atlanta Gastroenterology Specialist
    Suwanee, Georgia 30024, United States
  • Covance Central Laboratory Services Inc
    Indianapolis, Indiana 46214, United States
  • Covance Central Laboratory Services, Inc
    Indianapolis, Indiana 46214, United States
  • Covance Laboratory Services, Inc
    Indianapolis, Indiana 46214, United States
  • University of Kentucky Chandler Medical Center
    Lexington, Kentucky 40536, United States
  • University of Kentucky Medical Center
    Lexington, Kentucky 40536, United States
  • Endoscopic Microsurgery Associates
    Towson, Maryland 21204, United States
  • Commonwealth Clinical Studies
    Brockton, Massachusetts 02302, United States
  • Signature Healthcare Brockton
    Brockton, Massachusetts 02302, United States
  • University of Michigan Health Systems
    Ann Arbor, Michigan 48109-5000, United States
  • East Valley Endoscopy
    Grand Rapids, Michigan 49546, United States
  • Gastroenterology Associates of Western Michigan
    Wyoming, Michigan 49519, United States
  • Metro Health Endoscopy Unit
    Wyoming, Michigan 49519, United States
  • Minneapolis Medical Eye Clinic
    Minneapolis, Minnesota 55404, United States
  • Noran Neurology Clinic
    Minneapolis, Minnesota 55407, United States
  • Minneapolis Heart Institute
    Plymouth, Minnesota 55441, United States
  • Consulting Radiology
    Plymouth, Minnesota 55446, United States
  • Minnesota Gastroenterology, P.A.
    Plymouth, Minnesota 55446, United States
  • Surgery Center of Columbia
    Columbia, Missouri 65265, United States
  • Center for Digestive and Liver Diseases
    Mexico, Missouri 65265, United States
  • Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
    Saint Louis, Missouri 63108, United States
  • Barnes-Jewish Hospital Radiology (X-Ray Only)
    Saint Louis, Missouri 63110, United States
  • Center for Advanced Medicine
    Saint Louis, Missouri 63110, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • University of Nevada School of Medicine (UNSOM)
    Las Vegas, Nevada 89102, United States
  • Las Vegas Surgery Center
    Las Vegas, Nevada 89106, United States
  • Steinberg Diagnostic Medical Imaging Centers
    Las Vegas, Nevada 89109, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 3756, United States
  • Albany Medical College
    Albany, New York 12208, United States
  • New York Presbyterian Hospital - Weill Cornell Medical College
    New York, New York 10021, United States
  • New York Presbyterian Hospital
    New York, New York 10065, United States
  • Weill Cornell Medical College - New York Presbyterian Hospital
    New York, New York 10065, United States
  • Weill Cornell Medical College of Cornell University
    New York, New York 10065, United States
  • Premier Medical Group of the Hudson Valley, PC
    Poughkeepsie, New York 12601, United States
  • Premier Medical Group Research Department - Drug
    Poughkeepsie, New York 12601, United States
  • UNC Hospitals Endoscopy Center At Meadowmont
    Chapel Hill, North Carolina 27517, United States
  • Department of Pharmacy Investigational Drug Services
    Chapel Hill, North Carolina 27599, United States
  • UNC Memorial Hospital
    Chapel Hill, North Carolina 27599, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • The Oregon Clinic, PC - Gastroenterology West
    Portland, Oregon 97225, United States
  • Gastro One
    Germantown, Tennessee 38138, United States
  • Diagnostic Imaging
    Memphis, Tennessee 38119, United States
  • Vanderbilt University Medical Center: GI Clinical Research
    Nashville, Tennessee 37212-1610, United States
  • Vanderbilt University Medical Center: IBD Clinic
    Nashville, Tennessee 37212, United States
  • Vanderbilt University Medical Center: Drug Shipment
    Nashville, Tennessee 37232-7610, United States
  • Vanderbilt University Medical Center: Endoscopy Lab
    Nashville, Tennessee 37232, United States
  • Vanderbilt University Medical Center: Outpatient Radiology
    Nashville, Tennessee 37232, United States
  • Houston Hospital for Specialized Surgery
    Houston, Texas 77004, United States
  • Baylor Clinic (Drug Storage)
    Houston, Texas 77030, United States
  • Baylor College Of Medicine - Baylor Medical Center
    Houston, Texas 77030, United States
  • Spring Gastroenterology and Associates
    Humble, Texas 77338, United States
  • Spring Gastroenterology Drug
    Humble, Texas 77338, United States
  • Texas Digestive Disease Consultants
    Southlake, Texas 76092, United States
  • Pioneer Research Solutions, Inc
    Sugar Land, Texas 77479, United States
  • McGuire DVAMC
    Richmond, Virginia 23249, United States
  • University of Washington
    Seattle, Washington 98195, United States
  • PI Radiology
    Milwaukee, Wisconsin 53222, United States
  • Allegiance Research Specialists
    Wauwatosa, Wisconsin 53226, United States
  • Dynacare Laboratories
    Wauwatosa, Wisconsin 53226, United States
  • GI associates drug
    Wauwatosa, Wisconsin 53226, United States
  • Concord Repatriation General Hospital
    Concord, New South Wales 2139, Australia

Showing the first 100 of 190 sites across 21 countries.

09

References and documents

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. Erratum In: Lancet. 2019 Dec 22;392(10165):2696. doi: 10.1016/S0140-6736(18)33014-9. PubMed 28527704 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01620255
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Jun 15, 2012
Start date
Nov 2, 2012
Primary completion
Sep 22, 2014
Completion
Feb 4, 2016
Results posted
Mar 27, 2017
Last update
Jun 11, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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