OPERA: Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01276509
• Collaborator: (none)
• Enrollment: 265
• Locations: 137
• Arms: 4
• Actual Duration (Months): 54.1
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection; Drug: PF-00547659 SC injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
• Actual Study Start Date: Apr 6, 2011
• Actual Primary Completion Date: Feb 7, 2014
• Actual Study Completion Date: Oct 9, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo-SC Injection Placebo delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Placebo delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 1- SC injection Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 2-SC injection Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 3- SC injection Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.	Drug: PF-00547659 SC injection; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate [Week 8 and week 12]

   Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.

Secondary Outcome Measures

1. Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo [Week 0-12]

   Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.

2. Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo [Week 0-12]

   Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.

3. Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission [Weeks 8 and week 12]

   Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).

4. Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time [Week 2, 4, 6, 8, 10 and 12]

   Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.

5. Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer [Week 2, 4, 6, 8, 10 and 12]

   Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.

6. Immunogenicity Assessment of Anti-drug Antibodies (ADAs) [Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36]

   Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659

7. The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) [Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252]

   The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.

8. The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) [Day 1, 14, and 28]

   The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)

9. The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) [Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252]

   The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.

10. The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) [Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252]

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.

11. The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) [Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252]

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.

12. The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) [Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252]

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).

• hsCRP greater than 3mg/L

• Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

• Pregnant or breast feeding

• Short bowel syndrome due to multiple small bowel resections

• Presence of a stoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clopton Clinic	Jonesboro	Arkansas	United States	72401
2	Gastroenterology Specialists of Arkansas	Jonesboro	Arkansas	United States	72401
3	Little Rock Diagnostic Clinic, P.A.	Little Rock	Arkansas	United States	72205
4	UCSD Medical Center-Thornton Hospital	La Jolla	California	United States	92037
5	Community Clinical Trials	Orange	California	United States	92868
6	Gastro Diagnostics	Orange	California	United States	92868
7	Inland Gastroenterology Medical Associates, Inc.	Redlands	California	United States	92374
8	BioMark Research Inc.	Whittier	California	United States	90603
9	Clinical Research of the Rockies	Lafayette	Colorado	United States	80026
10	Rocky Mountain Gastroenterology Associates	Thornton	Colorado	United States	80229
11	Connecticut Clinical Research Foundation	Bristol	Connecticut	United States	06010
12	Shands Endoscopy Center	Gainesville	Florida	United States	32608
13	Shands Hospital at the University of Florida	Gainesville	Florida	United States	32610
14	Shands Medical Plaza	Gainesville	Florida	United States	32610
15	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
16	Florida Center for Gastroenterology	Largo	Florida	United States	33777
17	Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
18	University of Miami Hospital and Clinic	Miami	Florida	United States	33136
19	University of Miami Hospital	Miami	Florida	United States	33136
20	University of Miami	Miami	Florida	United States	FL 33136
21	Cirtus Ambulartory Surgery Center	Orlando	Florida	United States	32806
22	Internal Medicine Specialists	Orlando	Florida	United States	32806
23	Heartland Medical Research (Administrative Only)	Clive	Iowa	United States	50325
24	Iowa Digestive Disease Center	Clive	Iowa	United States	50325
25	Iowa Endoscopy Center (Colonoscopy Only)	Clive	Iowa	United States	50325
26	Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
27	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01655
28	University of Massachusetts Worcester	Worcester	Massachusetts	United States	01655
29	Center for Digestive Health	Troy	Michigan	United States	48098
30	Surgical Centers of Michigan	Troy	Michigan	United States	48098
31	Minneapolis Heart Institute, West Health Campus	Minneapolis	Minnesota	United States	55404
32	Noran Neurology Clinic	Minneapolis	Minnesota	United States	55407
33	Consulting Radiology (Xray testing only)	Plymouth	Minnesota	United States	55446
34	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota	United States	55446
35	Mayo Clinic	Rochester	Minnesota	United States	55905
36	Surgery Center of Columbia	Columbia	Missouri	United States	65201
37	Audrain Medical Center	Mexico	Missouri	United States	65265
38	Center for Digestive and Liver Diseases, Inc.	Mexico	Missouri	United States	65265
39	Barnes-Jewish Hospital - Investigational Drug Services	Saint Louis	Missouri	United States	63110
40	Center for Advanced Medicine	Saint Louis	Missouri	United States	63110
41	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
42	Albany Medical College	Albany	New York	United States	12208
43	Life Medi-Research And Management	Brooklyn	New York	United States	11206
44	New York Hospital Queens	Flushing	New York	United States	11355
45	Long Island Clinical Research Associates, LLP	Great Neck	New York	United States	11021
46	Nassau Gastroenterology Associates Office Based Surgery	Great Neck	New York	United States	11021
47	Nassau Gastroenterology Associates, P.C.	Great Neck	New York	United States	11021
48	North Shore Primary Care, P.C.	Great Neck	New York	United States	11021
49	Beth Israel Medical Center - Phillip Ambulatory Care Center	New York	New York	United States	10003
50	East side Endoscopy, LLC (for colonscopy testing only)	New York	New York	United States	10010
51	Lenox Hill Endoscopy Center	New York	New York	United States	10075
52	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
53	CTRC Hospital - UNC Memorial Hospital	Chapel Hill	North Carolina	United States	27514
54	North Carolina Memorial Hospital Endoscopy Center	Chapel Hill	North Carolina	United States	27514
55	UNC Hospitals Department of Pharmacy	Chapel Hill	North Carolina	United States	27514
56	UNC Hospitals Endoscopy	Chapel Hill	North Carolina	United States	27517
57	Hillsborough Campus	Hillsborough	North Carolina	United States	27278
58	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
59	The Offices of Dr. Vincent Armenio, M.D.	East Providence	Rhode Island	United States	02914
60	Pharma Resource	East Providence	Rhode Island	United States	02915
61	Bayside Endoscopy Center	Providence	Rhode Island	United States	02905
62	Nashville Medical Research Institute	Nashville	Tennessee	United States	37205
63	Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center	Pasadena	Texas	United States	77505
64	University of Utah HSC	Salt Lake City	Utah	United States	84132
65	Charlottesville Gastroenterology Associates	Charlottesville	Virginia	United States	22902
66	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
67	University of Washington Medical Center	Seattle	Washington	United States	98195
68	Allegiance Research Specialists	Wauwatosa	Wisconsin	United States	53226
69	GI Associates	Wauwatosa	Wisconsin	United States	53226
70	AKH Wien Universitaetsklinik fuer Innere Medizin III	Wien		Austria	1090
71	UZ Gasthuisberg	Leuven		Belgium	B-3000
72	Centre Hospitalier Universitaire de Liege	Liege		Belgium	4000
73	Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique	Liege		Belgium	4000
74	Centre Hospitalier de Mouscron	Mouscron		Belgium	7700
75	4-MHAT	Sofia		Bulgaria	1000
76	MBAL Sofiamed OOD,Otdelenie po gastroenterologia	Sofia		Bulgaria	1979
77	Vancouver Coastal Health - Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
78	Vancouver Coastal Health - Vancouver Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
79	Oshawa Clinic	Oshawa	Ontario	Canada	L1H 1B9
80	Toronto Digestive Disease Associates Inc.	Vaughan	Ontario	Canada	L4L 4Y7
81	CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie	Amiens Cedex 01		France	80054
82	Hopital Saint-Andre	Bordeaux cedex		France	33075
83	Hopital Beaujon- Essais cliniques	Clichy Cedex		France	92110
84	Hopital de l'Archet 2 - CHU de Nice	NICE Cedex 3		France	06202
85	Hopital Cochin-Essais Cliniques	Paris		France	75014
86	Hopital Charles Nicolle	Rouen Cedex 1		France	76031
87	Hopital Nord	St Priest En Jarez		France	42270
88	Hopital Rangueil	Toulouse cedex 09		France	31059
89	Charite - Campus Berlin Mitte Medizinische Klinik	Berlin		Germany	10117
90	Krankenhaus Martha-Maria Halle-Doelau gGmbH	Halle		Germany	06120
91	Universitaetsklinikum Schleswig-Holstein	Kiel		Germany	24105
92	Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie	Luebeck		Germany	23538
93	Gastroenterologische Gemeinschaftspraxis Minden	Minden		Germany	32423
94	Universitaetsklinikum Regensburg	Regensburg		Germany	93042
95	Robert-Bosch-Krankenhaus	Stuttgart		Germany	70376
96	Universitaetklinikum Ulm	Ulm		Germany	89081
97	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori	Japan	036-8545
98	National Hospital Organization Takasaki General Medical Center	Takasaki	Gunma	Japan	370-0829
99	Jikei University Hospital	Minato-ku	Tokyo	Japan	105-8471
100	Keio University Hospital	Shinjuku-ku	Tokyo	Japan	160-8582
101	Aichi Medical University Hospital	Aichi		Japan	480-1195
102	Chiba University Hospital	Chiba		Japan	260-8677
103	Yokohama City University Medical Center	Kanagawa		Japan	232-0024
104	Pusan National University Hospital	Busan		Korea, Republic of	602-739
105	Yeungnam University Hospital	Daegu		Korea, Republic of	705-717
106	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
107	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	110-746
108	Yonsei University College of Medicine, Severance Hospital	Seoul		Korea, Republic of	120-752
109	Samsung Medical Center	Seoul		Korea, Republic of	135-710
110	Asan Medical Center	Seoul		Korea, Republic of	138-736
111	University Medical Center Groningen (UMCG)	Groningen	GR	Netherlands	9713GZ
112	Academic Medical Center	Amsterdam	NH	Netherlands	1105 AZ
113	Maastricht University Medical Center	Maastricht		Netherlands	6229 HX
114	Asker And Baerum Hospital	Gjettum		Norway	1346
115	Oslo Universitetssykehus	Oslo		Norway	0424
116	Lovisenberg Diakonale Sykehus	Oslo		Norway	0440
117	Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej	Bydgoszcz		Poland	85-168
118	Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.	Lodz		Poland	90-302
119	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie	Warszawa		Poland	02-507
120	Lexmedica	Wroclaw		Poland	53-114
121	Military Medical Academy	Belgrade		Serbia	11000
122	Clinical Hospital Centre Bezanijska Kosa	Belgrade		Serbia	11080
123	Clinical Center Nis Clinic for Gastroenterology and Hepatology	Nis		Serbia	18000
124	Clinical Hospital Center Zemun	Zemun		Serbia	11080
125	Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.	Bratislava		Slovakia	831 04
126	Medak s.r.o.	Bratislava		Slovakia	851 01
127	Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.	Nitra		Slovakia	949 01
128	Synergy group, a.s.	Nove Mesto Nad Vahom		Slovakia	915 01
129	Wits Clinical Research	Johannesburg	Gauteng	South Africa	2193
130	Parklands Medical Centre	Durban	Kwa-zulu - Natal	South Africa	4091
131	Kingsbury Hospital	Cape Town	Western CAPE	South Africa	7708
132	Hospital Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
133	Hospital Clinic de Barcelona	Barcelona		Spain	08036
134	Hospital Universitari Bellvitge	Barcelona		Spain	08907
135	Hospital Universitario de La Princesa	Madrid		Spain	28006
136	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28007
137	Corporacio Sanitaria Parc Tauli de Sabadell	Sabadell		Spain	08208

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01276509
• Other Study ID Numbers: A7281006; 2010-023437-30; OPERA
• First Posted: Jan 13, 2011
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
• Additional relevant MeSH terms: Crohn Disease

Study Results

Participant Flow

Pre-assignment Detail	In total, 265 participants were randomized and 262 entered the study and received study treatment.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Period Title: Overall Study
STARTED	66	65	68	63
COMPLETED	53	53	63	58
NOT COMPLETED	13	12	5	5

Baseline Characteristics

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo	Total
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.	Total of all reporting groups
Overall Participants	66	65	68	63	262
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.3 (13.0)	34.4 (10.7)	35.9 (11.0)	34.4 (11.1)	35.5 (11.5)
Sex: Female, Male (Count of Participants)
Female	48 72.7%	35 53.8%	43 63.2%	30 47.6%	156 59.5%
Male	18 27.3%	30 46.2%	25 36.8%	33 52.4%	106 40.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
Description	Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
Time Frame	Week 8 and week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all randomized participants who received at least one dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Week 8 (n =50, 55, 62, 56)	52.7 79.8%	60.1 92.5%	62.7 92.2%	47.7 75.7%
Week 12 (n = 51, 49, 61, 54)	62.0 93.9%	64.7 99.5%	57.5 84.6%	58.6 93%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 22.5 mg, Placebo
	Comments	Difference from placebo at Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3393
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.050
	Confidence Interval	(2-Sided) 90%; -0.149 to 0.249
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.121
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 75 mg, Placebo
	Comments	Difference from placebo at Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1433
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.124
	Confidence Interval	(2-Sided) 90%; -0.068 to 0.316
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 225 mg, Placebo
	Comments	Difference from placebo at Week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0922
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.150
	Confidence Interval	(2-Sided) 90%; -0.036 to 0.335
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.113
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 22.5 mg, Placebo
	Comments	Difference from placebo at Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3864
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.034
	Confidence Interval	(2-Sided) 90%; -0.158 to 0.225
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 75 mg, Placebo
	Comments	Difference from placebo at Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3005
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.061
	Confidence Interval	(2-Sided) 90%; -0.131 to 0.253
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 225 mg, Placebo
	Comments	Difference from placebo at Week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5385
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	-0.011
	Confidence Interval	(2-Sided) 90%; -0.198 to 0.176
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.114
	Estimation Comments

2. Secondary Outcome

Title	Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Description	Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
Time Frame	Week 0-12

Outcome Measure Data

Analysis Population Description

The safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Participants with AEs (all causalities)	57 86.4%	51 78.5%	54 79.4%	54 85.7%
Participants with AEs (treatment related)	20 30.3%	24 36.9%	29 42.6%	22 34.9%
Withdrawal due to AEs (all causalities)	9 13.6%	8 12.3%	4 5.9%	3 4.8%
Withdrawal due to AEs (treatment related)	5 7.6%	2 3.1%	0 0%	1 1.6%
Participants with SAEs (all causalities)	11 16.7%	9 13.8%	11 16.2%	5 7.9%
Participants with SAEs (treatment related)	4 6.1%	4 6.2%	2 2.9%	2 3.2%

3. Secondary Outcome

Title	Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Description	Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Time Frame	Week 0-12

Outcome Measure Data

Analysis Population Description

The safety analysis set included all participants who received at least 1 dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Number of AEs (all causalities)	175	192	192	141
Number of AEs (treatment related)	40	55	64	40

4. Secondary Outcome

Title	Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Description	Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).
Time Frame	Weeks 8 and week 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all randomized participants who received at least one dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Week 8 (n = 50, 56, 62, 57)	29.1 44.1%	23.8 36.6%	26.9 39.6%	16.7 26.5%
Week 12 (n= 51, 49, 61, 55)	26.8 40.6%	28.5 43.8%	29.6 43.5%	23.0 36.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 22.5 mg, Placebo
	Comments	Difference from placebo at week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1234
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.124
	Confidence Interval	(2-Sided) 90%; -0.052 to 0.299
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.107
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 75 mg, Placebo
	Comments	Difference from placebo at week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2378
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.071
	Confidence Interval	(2-Sided) 90%; -0.092 to 0.234
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.099
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 225 mg, Placebo
	Comments	Difference from placebo at week 8
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1529
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.102
	Confidence Interval	(2-Sided) 90%; -0.062 to 0.266
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.100
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 22.5 mg, Placebo
	Comments	Difference from placebo at week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3661
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.038
	Confidence Interval	(2-Sided) 90%; -0.146 to 0.222
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.112
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 75 mg, Placebo
	Comments	Difference from placebo at week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3169
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.055
	Confidence Interval	(2-Sided) 90%; -0.136 to 0.246
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.116
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-00547659 225 mg, Placebo
	Comments	Difference from placebo at week 12
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2755
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	0.066
	Confidence Interval	(2-Sided) 90%; -0.116 to 0.248
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.111
	Estimation Comments

5. Secondary Outcome

Title	Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Description	Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Time Frame	Week 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all randomized participants who received at least one dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Week 2 (n = 64, 60, 63, 60)	35.1 53.2%	22.4 34.5%	33.8 49.7%	35.5 56.3%
Week 4 (n = 58, 60, 65, 58)	38.0 57.6%	39.5 60.8%	36.2 53.2%	38.3 60.8%
Week 6 (n =56, 54, 64, 58)	45.3 68.6%	53.4 82.2%	47.5 69.9%	48.0 76.2%
Week 8 (n =50, 55, 62, 56)	52.7 79.8%	60.1 92.5%	62.7 92.2%	47.7 75.7%
Week 10 (n =50, 48, 60, 52)	67.4 102.1%	58.2 89.5%	61.6 90.6%	53.0 84.1%
Week 12 (n = 51, 49, 61, 54)	62.0 93.9%	64.7 99.5%	57.5 84.6%	58.6 93%

6. Secondary Outcome

Title	Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Description	Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
Time Frame	Week 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

The full analysis set included all randomized participants who received at least one dose of study medication.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg	Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks	Placebo delivered SC, 3 doses separated by 4 weeks.
Measure Participants	66	65	68	63
Week 2 (n = 64, 60, 63, 60)	19.3 29.2%	18.4 28.3%	20.0 29.4%	18.5 29.4%
Week 4 (n = 58, 60 ,65, 58)	29.2 44.2%	32.3 49.7%	28.2 41.5%	29.5 46.8%
Week 6 (n =56, 54, 64, 58)	40.6 61.5%	42.6 65.5%	40.4 59.4%	39.3 62.4%
Week 8 (n = 50, 55, 62, 56)	50.5 76.5%	48.3 74.3%	57.0 83.8%	41.4 65.7%
Week 10 (n = 50, 48, 62, 52)	53.2 80.6%	47.4 72.9%	50.9 74.9%	43.6 69.2%
Week 12 (n = 51, 49, 61, 54)	56.0 84.8%	47.7 73.4%	53.8 79.1%	44.4 70.5%

7. Secondary Outcome

Title	Immunogenicity Assessment of Anti-drug Antibodies (ADAs)
Description	Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
Time Frame	Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36

Outcome Measure Data

Analysis Population Description

The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	66	65	68
Day 1 (n =46, 52, 53)	3	5	1
Week 4 (n = 55, 52, 55)	2	4	2
Week 8 (n = 44, 47, 56)	1	1	1
Week 12 (n = 47, 51, 51)	3	5	1
Week 20 (n = 4, 3, 1)	0	0	0
Week 28 (n = 8, 1, 1)	1	0	0
Week 36 (n = 6, 2, 1)	0	0	0

8. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.
Time Frame	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	6	8	6
Geometric Mean (Geometric Coefficient of Variation) [µg•hr/mL]	615300 (63)	4464000 (28)	13760000 (49)

9. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)
Time Frame	Day 1, 14, and 28

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	7	10	12
Geometric Mean (Geometric Coefficient of Variation) [µg•hr/mL]	549500 (53)	4214000 (31)	10850000 (45)

10. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.
Time Frame	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	7	10	13
Geometric Mean (Geometric Coefficient of Variation) [µg/mL]	1756 (45)	10800 (22)	24100 (47)

11. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.
Time Frame	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	7	10	13
Median (Full Range) [Hours]	140 (45)	143 (22)	165 (47)

12. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.
Time Frame	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	6	8	6
Mean (Standard Deviation) [Day]	4.977 (2.8435)	8.770 (2.3571)	12.22 (3.8306)

13. Secondary Outcome

Title	The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)
Description	The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.
Time Frame	Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.

Arm/Group Title	PF-00547659 22.5 mg	PF-00547659 75 mg	PF-00547659 225 mg
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.	PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks	PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
Measure Participants	6	8	6
Geometric Mean (Geometric Coefficient of Variation) [mL/hr]	36.54 (63)	16.79 (28)	16.38 (49)

Adverse Events

Arm/Group Title	PF-00547659 22.5 mg		PF-00547659 75 mg		PF-00547659 225 mg		Placebo
Arm/Group Description	PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.		PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks		PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks		Placebo delivered SC, 3 doses separated by 4 weeks.
All Cause Mortality
	PF-00547659 22.5 mg		PF-00547659 75 mg		PF-00547659 225 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PF-00547659 22.5 mg		PF-00547659 75 mg		PF-00547659 225 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/66 (18.2%)		11/65 (16.9%)		11/68 (16.2%)		6/63 (9.5%)
Gastrointestinal disorders
Abdominal adhesions	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Colitis ulcerative	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Crohn's disease	5/66 (7.6%)		6/65 (9.2%)		4/68 (5.9%)		4/63 (6.3%)
Fistula of small intestine	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Gastrointestinal inflammation	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Intestinal obstruction	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Rectal stenosis	0/66 (0%)		0/65 (0%)		0/68 (0%)		1/63 (1.6%)
Small intestinal obstruction	0/66 (0%)		1/65 (1.5%)		2/68 (2.9%)		0/63 (0%)
Subileus	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
General disorders
Chest pain	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Pyrexia	0/66 (0%)		1/65 (1.5%)		1/68 (1.5%)		1/63 (1.6%)
Hepatobiliary disorders
Cholecystitis	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Infections and infestations
Anal abscess	0/66 (0%)		1/65 (1.5%)		1/68 (1.5%)		1/63 (1.6%)
Appendicitis	2/66 (3%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Liver abscess	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Postoperative wound infection	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Rectal abscess	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Sepsis	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Staphylococcal infection	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Staphylococcal sepsis	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Urinary tract infection	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Injury, poisoning and procedural complications
Gastrointestinal stoma complication	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Metabolism and nutrition disorders
Dehydration	1/66 (1.5%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/66 (1.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Myalgia	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Nervous system disorders
Cerebellar infarction	0/66 (0%)		1/65 (1.5%)		0/68 (0%)		0/63 (0%)
Headache	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Transient ischaemic attack	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Renal and urinary disorders
Calculus urinary	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Respiratory, thoracic and mediastinal disorders
Lung disorder	0/66 (0%)		0/65 (0%)		1/68 (1.5%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	PF-00547659 22.5 mg		PF-00547659 75 mg		PF-00547659 225 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/66 (54.5%)		32/65 (49.2%)		42/68 (61.8%)		35/63 (55.6%)
Gastrointestinal disorders
Abdominal pain	7/66 (10.6%)		1/65 (1.5%)		4/68 (5.9%)		3/63 (4.8%)
Crohn's disease	5/66 (7.6%)		7/65 (10.8%)		1/68 (1.5%)		5/63 (7.9%)
Diarrhoea	1/66 (1.5%)		4/65 (6.2%)		1/68 (1.5%)		1/63 (1.6%)
Nausea	7/66 (10.6%)		4/65 (6.2%)		5/68 (7.4%)		7/63 (11.1%)
Proctalgia	1/66 (1.5%)		4/65 (6.2%)		1/68 (1.5%)		0/63 (0%)
Vomiting	4/66 (6.1%)		3/65 (4.6%)		3/68 (4.4%)		4/63 (6.3%)
General disorders
Fatigue	5/66 (7.6%)		4/65 (6.2%)		2/68 (2.9%)		3/63 (4.8%)
Injection site erythema	1/66 (1.5%)		4/65 (6.2%)		2/68 (2.9%)		3/63 (4.8%)
Oedema peripheral	0/66 (0%)		1/65 (1.5%)		5/68 (7.4%)		0/63 (0%)
Pyrexia	5/66 (7.6%)		6/65 (9.2%)		8/68 (11.8%)		7/63 (11.1%)
Infections and infestations
Influenza	4/66 (6.1%)		2/65 (3.1%)		1/68 (1.5%)		1/63 (1.6%)
Nasopharyngitis	3/66 (4.5%)		4/65 (6.2%)		5/68 (7.4%)		5/63 (7.9%)
Urinary tract infection	2/66 (3%)		1/65 (1.5%)		3/68 (4.4%)		5/63 (7.9%)
Vulvovaginal mycotic infection	3/66 (4.5%)		0/65 (0%)		0/68 (0%)		0/63 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/66 (7.6%)		6/65 (9.2%)		5/68 (7.4%)		3/63 (4.8%)
Back pain	0/66 (0%)		1/65 (1.5%)		4/68 (5.9%)		2/63 (3.2%)
Nervous system disorders
Headache	6/66 (9.1%)		3/65 (4.6%)		8/68 (11.8%)		6/63 (9.5%)
Skin and subcutaneous tissue disorders
Erythema	3/66 (4.5%)		2/65 (3.1%)		4/68 (5.9%)		2/63 (3.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.