A Study Of PF-00547659 In Patients With Moderate To Sever... | NCT01620255

ID	Type	Description	Link
2012-002030-37	EudraCT Number
TURANDOT	Other Identifier	Alias Study Number

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
Drug Dose Level 1	Experimental	Drug: PF-00547659 SC Injection
Drug Dose Level 2	Experimental	Drug: PF-00547659 SC Injection
Drug Dose Level 3	Experimental	Drug: PF-00547659 SC Injection
Drug Dose Level 4	Experimental	Drug: PF-00547659 SC Injection

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks	Placebo

Measure	Description	Time Frame
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.	Week 12

Measure	Description	Time Frame
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.

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Scottsdale	Arizona	85259	United States
UCSD Health System-Pharmacy only

PubMed Identifier	Type	Citation	Retractions
30901380	Derived	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.
28527704

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.

Posted

Number

90% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG002	PF-00547659 22.5 mg	Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG003	PF-00547659 75 mg	Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG004	PF-00547659 225 mg	Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Units	Counts
Participants	OG00073 OG00171 OG00272 OG003

Title

Denominators

Categories

Centrally read

Title	Measurements
	OG0002.7(0.7 to 7.6) OG00111.3(5.7 to 18.8) OG00216.7(9.9 to 25.4) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	PF-00547659 7.5 mg versus (vs) placebo, centrally read	Cochran-Mantel-Haenszel	Statistics of risk difference are calculated using the Minimum Risk Weights test.	0.0213	1-sided p-value	Risk Difference (RD)	0.080			2-Sided	90	0.019	0.140			Statistics of risk difference are calculated using the Minimum Risk Weights test.		Superiority or Other (legacy)

Secondary

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.

The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.

Posted

Number

90% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg

Secondary

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.

The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.

Posted

Number

90% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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".

As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.

Posted

Weeks 4, 8, and 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Number

percentage of participants

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg

Secondary

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.

Posted

Geometric Mean

90% Confidence Interval

percent change

Baseline, Weeks 4, 8, and 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Geometric Mean

90% Confidence Interval

percent change

Baseline; Weeks 4, 8, and 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline (BL), Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001

Secondary

Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12

The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.

Posted

Number

90% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

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.

All randomized participants who received at least 1 dose of study treatment.

Posted

Number

participants

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

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Secondary

Maximum Serum PF-00547659 Concentration Achieved

Participants who received active treatment (PF-00547659) were included in this analysis.

Posted

Mean

Standard Deviation

nanograms (ng)/milliliter (mL)

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

ID	Title	Description
OG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
OG002	PF-00547659 22.5 mg	Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	PF-00547659 7.5 mg vs placebo, Stool Frequency, W4	Mixed Models Analysis	Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1016	LSM Difference	-0.25	2-Sided	90	-0.511	0.001	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Stool Frequency, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0654	LSM Difference	-0.28	2-Sided	90	-0.529	-0.030	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Stool Frequency, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1500	LSM Difference	-0.22	2-Sided	90	-0.472	0.031	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Stool Frequency, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0132	LSM Difference	-0.38	2-Sided	90	-0.637	-0.129	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, Stool Frequency, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0526	LSM Difference	-0.30	2-Sided	90	-0.555	-0.046	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Stool Frequency, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0422	LSM Difference	-0.31	2-Sided	90	-0.554	-0.058	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Stool Frequency, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0110	LSM Difference	-0.39	2-Sided	90	-0.637	-0.137	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Stool Frequency, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0010	LSM Difference	-0.50	2-Sided	90	-0.755	-0.254	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, Stool Frequency, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1611	LSM Difference	-0.22	2-Sided	90	-0.475	0.038	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Stool Frequency, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0186	LSM Difference	-0.36	2-Sided	90	-0.608	-0.108	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Stool Frequency, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1647	LSM Difference	-0.21	2-Sided	90	-0.465	0.039	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Stool Frequency, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0231	LSM Difference	-0.35	2-Sided	90	-0.607	-0.097	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0002	LSM Difference	-0.46	2-Sided	90	-0.658	-0.260	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	<0.0001	LSM Difference	-0.52	2-Sided	90	-0.710	-0.322	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Rectal Bleeding, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	<0.0001	LSM Difference	-0.49	2-Sided	90	-0.686	-0.295	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Rectal Bleeding, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0012	LSM Difference	-0.39	2-Sided	90	-0.587	-0.192	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0207	LSM Difference	-0.28	2-Sided	90	-0.475	-0.081	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0402	LSM Difference	-0.24	2-Sided	90	-0.432	-0.048	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Rectal Bleeding, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0071	LSM Difference	-0.32	2-Sided	90	-0.511	-0.124	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Rectal Bleeding, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	<0.0001	LSM Difference	-0.47	2-Sided	90	-0.664	-0.275	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0395	LSM Difference	-0.25	2-Sided	90	-0.449	-0.050	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0073	LSM Difference	-0.32	2-Sided	90	-0.511	-0.123	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, Rectal Bleeding, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0413	LSM Difference	-0.24	2-Sided	90	-0.439	-0.047	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, Rectal Bleeding, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0008	LSM Difference	-0.40	2-Sided	90	-0.602	-0.206	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, PGA, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1862	LSM Difference	-0.19	2-Sided	90	-0.421	0.046	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, PGA, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0998	LSM Difference	-0.23	2-Sided	90	-0.455	-0.000	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, PGA, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1085	LSM Difference	-0.22	2-Sided	90	-0.453	0.006	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, PGA, W4	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.3161	LSM Difference	-0.14	2-Sided	90	-0.372	0.090	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, PGA, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.4962	LSM Difference	-0.10	2-Sided	90	-0.328	0.136	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, PGA, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0371	LSM Difference	-0.29	2-Sided	90	-0.512	-0.060	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, PGA, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1212	LSM Difference	-0.21	2-Sided	90	-0.441	0.013	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, PGA, W8	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1870	LSM Difference	-0.18	2-Sided	90	-0.410	0.045	Superiority or Other (legacy)
OG000 OG001	PF-00547659 7.5 mg vs placebo, PGA, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.1133	LSM Difference	-0.23	2-Sided	90	-0.459	0.009	Superiority or Other (legacy)
OG000 OG002	PF-00547659 22.5 mg vs placebo, PGA, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0022	LSM Difference	-0.43	2-Sided	90	-0.653	-0.198	Superiority or Other (legacy)
OG000 OG003	PF-00547659 75 mg vs placebo, PGA, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0788	LSM Difference	-0.25	2-Sided	90	-0.475	-0.016	Superiority or Other (legacy)
OG000 OG004	PF-00547659 225 mg vs placebo, PGA, W12	Mixed Models Analysis	LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.	0.0717	LSM Difference	-0.25	2-Sided	90	-0.485	-0.022	Superiority or Other (legacy)

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Retinal artery embolism	Eye disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0021 affected70 at risk EG0030 affected73 at risk EG0040 affected70 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0016 affected71 at risk EG0020 affected70 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0002 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Anal abscess	Infections and infestations	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Appendicitis	Infections and infestations	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Epilepsy	Nervous system disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Migraine	Nervous system disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Syncope	Nervous system disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003
Tension headache	Nervous system disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Delirium	Psychiatric disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected71 at risk EG0020 affected70 at risk EG003
Colectomy total	Surgical and medical procedures	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0021 affected70 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v18.1	Non-systematic Assessment	EG0000 affected73 at risk EG0010 affected71 at risk EG0022 affected70 at risk EG0034 affected73 at risk EG0042 affected70 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0002 affected73 at risk EG0016 affected71 at risk EG0023 affected70 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0003 affected73 at risk EG0016 affected71 at risk EG0021 affected70 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0003 affected73 at risk EG0011 affected71 at risk EG0024 affected70 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v18.1	Non-systematic Assessment	EG0003 affected73 at risk EG0010 affected71 at risk EG0023 affected70 at risk EG003
Headache	Nervous system disorders	MedDRA v18.1	Non-systematic Assessment	EG0006 affected73 at risk EG0015 affected71 at risk EG0027 affected70 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v18.1	Non-systematic Assessment	EG0004 affected73 at risk EG0011 affected71 at risk EG0020 affected70 at risk EG003

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Title	Description
BG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
BG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
BG002	PF-00547659 22.5 mg	Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
BG003	PF-00547659 75 mg	Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
BG004	PF-00547659 225 mg	Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	4	73	17	73
EG001	PF-00547659 7.5 mg	Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	11	71	16	71
EG002	PF-00547659 22.5 mg	Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	2	70	15	70
EG003	PF-00547659 75 mg	Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	4	73	14	73
EG004	PF-00547659 225 mg	Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.	3	70	18	70