OCTAVE: A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01465763
• Collaborator: (none)
• Enrollment: 614
• Locations: 178
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: tofacitinib; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 614 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tofacitinib 10 mg BID	Drug: tofacitinib; 10 mg oral BID; Other Names: CP-690,550
Placebo Comparator: Placebo	Drug: Placebo; Plabebo oral BID

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Remission at Week 8 [Week 8]

   Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

Secondary Outcome Measures

1. Percentage of Participants Achieving Mucosal Healing at Week 8 [Week 8]

   Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.

2. Percentage of Participants Achieving Clinical Response at Week 8 [Week 8]

   Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

3. Percentage of Participants With Endoscopic Remission at Week 8 [Week 8]

   Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.

4. Percentage of Participants With Clinical Remission at Week 8 [Week 8]

   Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

5. Percentage of Participants With Symptomatic Remission at Week 8 [Week 8]

   Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

6. Percentage of Participants With Deep Remission at Week 8 [Week 8]

   Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

7. Partial Mayo Scores [Baseline, Weeks 2, 4, 8]

   A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.

8. Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8 [Baseline, Weeks 2, 4, 8]

   Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.

9. Change From Baseline in Total Mayo Scores at Week 8 [Baseline, Week 8]

   Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must be at least 18 years of age.

• Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.

• Subjects with moderately to severely active UC based on Mayo score criteria.

• Subjects must have failed or be intolerant of at least one of the following treatments for UC:

• Corticosteroids (oral or intravenous).

• Azathioprine or 6 mercaptopurine (6 MP).

• Anti TNF-alpha therapy.

Exclusion Criteria:

• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.

• Subjects with disease limited to distal 15 cm.

• Subjects without previous treatment for UC (ie, treatment naïve).

• Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internal Medicine Center, LLC	Mobile	Alabama	United States	36608
2	Springhill Memorial Hospital	Mobile	Alabama	United States	36608
3	Investigational Drug Service Pharmacy	La Jolla	California	United States	92093
4	UCSD Medical Center	La Jolla	California	United States	92093
5	UCSD Medical Centre	La Jolla	California	United States	92093
6	Cedars Sinai Medical Center - Thalians Bldg	Los Angeles	California	United States	90048
7	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
8	Cedars Sinai Surgery Center	Los Angeles	California	United States	90048
9	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
10	CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center	Los Angeles	California	United States	90048
11	Desert Advanced Imaging	Palm Springs	California	United States	92262
12	Erik Palmer, DO	Palm Springs	California	United States	92262
13	Homan A Zadeh, MD, MPH	Palm Springs	California	United States	92262
14	Hope Square Surgical Center	Rancho Mirage	California	United States	92270
15	Sharp Rees-Stealy Medical Group, Inc.	San Diego	California	United States	92101
16	Sharp Rees-Stealy Medical Group	San Diego	California	United States	92101
17	Sharp Rees-Stealy Medical Group,Inc	San Diego	California	United States	92123
18	Endoscopy Center of Connecticut, LLC	Guilford	Connecticut	United States	06437
19	Endoscopy Center of Connecticut, LLC	Hamden	Connecticut	United States	06518
20	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut	United States	06518
21	Medical Research Center of Connecticut, LLC	Hamden	Connecticut	United States	06518
22	Florida Surgery Center	Altamonte Springs	Florida	United States	32701
23	Center for Advanced Gastroenterology	Maitland	Florida	United States	32751
24	MNH Surgical Center	Maitland	Florida	United States	32751
25	Sand Lake Imaging	Maitland	Florida	United States	32751
26	North Florida Gastroenterology Research, LLC	Orange Park	Florida	United States	32073
27	Orange Park Surgery Center	Orange Park	Florida	United States	32073
28	Citrus Ambulatory Surgery Center	Orlando	Florida	United States	32806
29	Internal Medicine Specialists	Orlando	Florida	United States	32806
30	Shafran Gastroenterology Center	Winter Park	Florida	United States	32789
31	Florida Medical Clinic, P.A.	Zephyrhills	Florida	United States	33542
32	Georgia Endoscopy Center (Colonoscopy only)	Alpharetta	Georgia	United States	30005
33	GI Consultants (Colonoscopy only)	Atlanta	Georgia	United States	30342
34	Emory Healthcare Heart Center (EKG)	Johns Creek	Georgia	United States	30097
35	Gastroenterology Associates of Central Georgia	Macon	Georgia	United States	31201
36	Icahn School of Medicine at Mount Sinai	Marietta	Georgia	United States	30067
37	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia	United States	30024
38	Johns Creek Diagnostic Center (X-Ray only)	Suwanee	Georgia	United States	30024
39	Southwest Gastroenterology	Oak Lawn	Illinois	United States	60453
40	Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)	Ann Arbor	Michigan	United States	48106
41	East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109-2701
42	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109-5000
43	Michigan Clinical Research Unit - Univeristy of Michigan Health System	Ann Arbor	Michigan	United States	48109-5872
44	Medical Science Research Building 1 - University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109
45	Michigan Heart SJMH (Blood draws and ECGs only)	Ypsilanti	Michigan	United States	48106
46	Huron Gastroenterology Associates / Center for Digestive Care	Ypsilanti	Michigan	United States	48197
47	Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)	Ypsilanti	Michigan	United States	48197
48	Center for Advanced Medicine	Saint Louis	Missouri	United States	63110
49	Washington University School of Medicine - Division of Gastroenterology	Saint Louis	Missouri	United States	63110
50	NYU Langone Long Island Clinical Research Associates	Great Neck	New York	United States	11021
51	NYU Langone Nassau Gastroenterology Associates	Great Neck	New York	United States	11021
52	The Private Practice of Simon Lichtiger, MD	New York	New York	United States	10028
53	Mount Sinai Doctos Faculty Practice	New York	New York	United States	10029
54	Mount Sinai Medical Center	New York	New York	United States	10029
55	Mount Sinai School of Medicine	New York	New York	United States	10029
56	Columbia University Medical Center	New York	New York	United States	10032
57	CUMC Research Pharmacy	New York	New York	United States	10032
58	Kornbluth, Legnani, George MD, PC	New York	New York	United States	10128
59	Cleveland Clinic	Cleveland	Ohio	United States	44195
60	Great Lakes Gastroenterology	Mentor	Ohio	United States	44060
61	Mentor Medical Campus	Mentor	Ohio	United States	44060
62	The Endoscopy Center of Lake County	Mentor	Ohio	United States	44060
63	Houston Hospital for Specialized Surgery	Houston	Texas	United States	77004
64	Baylor College of Medicine (Baylor Medical Center)	Houston	Texas	United States	77030
65	Baylor College of Medicine - Baylor Medical Center (Drug Storage)	Houston	Texas	United States	77030
66	Gastroenterology Consultants, P.A.	Houston	Texas	United States	77034
67	Alpine Medical Group	Salt Lake City	Utah	United States	84102
68	Wasatch Clinical Research	Salt Lake City	Utah	United States	84107
69	Wasatch Endoscopy Center	Salt Lake City	Utah	United States	84124
70	RGL Medical Services (x-ray only)	West Jordan	Utah	United States	84084
71	Wisconsin Center for Advanced Research - GI Associates, LLC	Milwaukee	Wisconsin	United States	53215
72	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
73	Nepean Hospital	Kingswood	New South Wales	Australia	2747
74	Eastern Health Box Hill Hospital	Box Hill	Victoria	Australia	3128
75	AKH Wien, Universitaetsklinik fuer Innere Medizin III,	Wien		Austria	1090
76	UZ Leuven (University Hospital Leuven), Campus Gasthuisberg	Leuven		Belgium	3000
77	Hertiage Medical Research Clinic- University Of Calgary	Calgary	Alberta	Canada	T2N 4Z6
78	McMaster University Medical Center	Hamilton	Ontario	Canada	L8N 3Z5
79	Hamilton Health Sciences Corporation - McMaster University Medical Centre	Hamilton	Ontario	Canada	L8S 4K1
80	London Health Sciences Centre - University Hospital	London	Ontario	Canada	N6A 5A5
81	Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
82	Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.	Barranquilla	Atlantico	Colombia	00000
83	General Hospital Zadar	Zadar		Croatia	23 000
84	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove		Czech Republic	500 12
85	Institut klinicke a experimentalni mediciny	Praha 4		Czech Republic	140 21
86	Klinicke Centrum ISCARE I.V.F.	Praha 7		Czech Republic	170 04
87	Aalborg Hospital	Aalborg		Denmark	9000
88	Aarhus University Hospital	Aarhus C		Denmark	8000
89	ECG Unit of West Tallinn Central Hospital	Tallinn		Estonia	10617
90	West Tallinn Central Hospital Internal Diseases Clinic	Tallinn		Estonia	10617
91	X-Ray Department of West Tallinn Central Hospital	Tallinn		Estonia	10617
92	CHU de Nantes - Hotel Dieu	Nantes		France	44093
93	Hopital Saint-Louis	Paris		France	75010
94	Hopital Rangueil	Toulouse Cedex 9		France	31059
95	Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,	Berlin		Germany	13353
96	Universitaetsklinikum Halle (Saale)	Halle		Germany	06120
97	Medizinische Hochschule Hannover	Hannover		Germany	30625
98	Klinikum Luneburg/Abteilung Gastroenterologie	Lüneburg		Germany	21339
99	Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly	Budapest		Hungary	1032
100	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs		Hungary	7624
101	Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika	Szeged		Hungary	6720
102	Javorszky Odon Korhaz/Gasztroenterologiai Osztaly	Vac		Hungary	H-2600
103	Rabin Medical Center, Beilinson campus	Petah Tikva		Israel	49100
104	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
105	AOU Mater Domini - U.O. Fisiopatologia Digestiva	Catanzaro	CZ	Italy	88100
106	Istituto Clinico Humanitas IRCSS	Rozzano	Milano	Italy	20089
107	A.O.R. Villa Sofia- Cervello	Palermo	PA	Italy	90146
108	Comitato Etico Palermo 2	Palermo	PA	Italy	90146
109	SOC Gastroenterologia Centro di Riferimento Oncologico	Aviano		Italy	33081
110	IBD Center - IRCCS Humanitas	Milan		Italy	20089
111	Aichi Medical University Hospital	Nagakute	Aichi	Japan	480-1195
112	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori	Japan	036-8545
113	Chiba University Hospital	Chiba-shi	Chiba	Japan	260-8677
114	Toho University Sakura Medical Center	Sakura	Chiba	Japan	285-8741
115	Kurume University Hospital	Kurume	Fukuoka	Japan	830-0011
116	Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital	Sapporo	Hokkaido	Japan	060-0033
117	The Hospital of Hyogo College of Medicine	Nishinomiya	Hyogo	Japan	663-8501
118	National Hospital Organization Mito Medical Center	Higashi-ibaraki-gun	Ibaraki	Japan	311-3193
119	Kuniyoshi Hospital	Kochi-shi	Kochi	Japan	780-0901
120	National Hospital Organization Sendai Medical Center	Sendai	Miyagi	Japan	983-8520
121	Osaka Medical College Hospital	Takatsuki-shi	Osaka	Japan	569-8686
122	Shiga University of Medical Science Hospital	Otsu-shi	Shiga	Japan	520-2192
123	Tokai University Hachioji Hospital	Hachioji	Tokyo	Japan	192-0032
124	Jikei University Hospital	Minato-ku	Tokyo	Japan	105-8471
125	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo	Japan	108-8642
126	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo	Japan	141-8625
127	Showa University Hospital	Shinagawa-ku	Tokyo	Japan	142-8666
128	Fukuoka University Chikushi Hospital	Fukuoka		Japan	818-8502
129	Hiroshima University Hospital	Hiroshima		Japan	734-8551
130	Sameshima Hospital	Kagoshima		Japan	892-0846
131	Osaka City University Hospital	Osaka		Japan	545-8586
132	Tokyo Medical And Dental University Hospital, Faculty of Medicine	Tokyo		Japan	113-8519
133	Keio University Hospital	Tokyo		Japan	160-8582
134	Digestive Diseases Center GASTRO	Riga		Latvia	LV-1006
135	ECG room, Clinic "Linezers"	Riga		Latvia	LV-1006
136	X-Ray Department, Clinic "Linezers"	Riga		Latvia	LV-1006
137	Leiden University Medical Center	Leiden	ZH	Netherlands	2333 ZA
138	Shakespeare Specialist Group	Milford	Auckland	New Zealand	0620
139	Southern District Health Board	Dunedin		New Zealand	9016
140	Bop Clinical School Clinical Trials Unit	Tauranga		New Zealand	3143
141	Gabinet Lekarski - Janusz Rudzinski	Bydgoszcz	Kujawsko-pomorskie	Poland	85-681
142	Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia	Warszawa	Mazowieckie	Poland	02-507
143	Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki	Lodz		Poland	90-153
144	Lexmedica	Wroclaw		Poland	53-114
145	Cabinet Particular Policlinic Algomed SRL	Timisoara	Jud Timis	Romania	300002
146	Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"	Pyatigorsk	Stavropol Region	Russian Federation	357500
147	State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko	Nizhniy Novgorod		Russian Federation	603126
148	Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"	Novosibirsk		Russian Federation	630068
149	Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital	Novosibirsk		Russian Federation	630084
150	State Budget Educational Institution of Higher Professional Education	Novosibirsk		Russian Federation	630091
151	GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"	Saint-Petersburg		Russian Federation	191015
152	GUZ City Hospital #26	Saint-Petersburg		Russian Federation	196247
153	Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock	Samara		Russian Federation	443029
154	Limited Liability Company Medical Company "Hepatolog"	Samara		Russian Federation	443093
155	Samara Diagnostic center, X-ray Department	Samara		Russian Federation	443093
156	Federal State Budgetary Military Educational Institution of High Professional Education	St. Petersburg		Russian Federation	191015
157	General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology	Zrenjanin	Serbia, Europe	Serbia	23000
158	Clinical Hospital Centre Zvezdara	Belgrade		Serbia	11000
159	Military Medical Academy	Belgrade		Serbia	11000
160	Clinical Centre of Kragujevac	Kragujevac		Serbia	34000
161	Medak s.r.o.	Bratislava		Slovakia	85101
162	Chris Hani Baragwanath Academic Hospital	Johannesburg	Gauteng	South Africa	2013
163	Endocare Research Centre	Cape Town	Western Cape	South Africa	7646
164	Hospital Clínic i provincial de Barcelona	Barcelona		Spain	08036
165	Hospital Universitario La Princesa	Madrid		Spain	28006
166	Hospital Clinico San Carlos	Madrid		Spain	28040
167	Hospital Universitario de Fuenlabrada	Madrid		Spain	28942
168	InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University	Simferopol	Ar Krym	Ukraine	95017
169	State Institution "National L.T. Malaya Therapy Institute of National Academy	Kharkov		Ukraine	61039
170	Kyiv Municipal Clinical Hospital #18, Proctology Department	Kyiv		Ukraine	01030
171	LTD "St. Paraskeva Medical Center"	Lviv		Ukraine	79019
172	Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,	Lviv		Ukraine	79059
173	SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,	Odesa		Ukraine	65010
174	SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI	Uzhgorod		Ukraine	88009
175	Vinnytsia National Medical University	Vinnytsia		Ukraine	21005
176	Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2	Vinnytsia		Ukraine	21005
177	Cambridge University Hospitals Nhs Foundation Trust	Cambridge		United Kingdom	CB2 0QQ
178	University College London Hospital	London		United Kingdom	NW1 2BU

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

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: Pfizer
• ClinicalTrials.gov Identifier: NCT01465763
• Other Study ID Numbers: A3921094; 2011-004578-27; OCTAVEINDUCTION1
• First Posted: Nov 6, 2011
• Last Update Posted: Jun 7, 2016
• Last Verified: May 1, 2016

• Keywords provided by Pfizer: tofacitinib; CP-690; 550; Moderate to severe ulcerative colitis; phase 3 clinical trial; Mayo score
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; Tofacitinib

Study Results

Participant Flow

Pre-assignment Detail	Participants were randomized to tofacitinib 10 milligram (mg) or placebo twice a day (BID)(4:1 ratio) after protocol amendment 3, which removed tofacitinib 15 mg BID. Due to low participant numbers, tofacitinib 15 mg BID was excluded from efficacy analyses, but was included in participant flow, baseline characteristics and adverse events analyses.

Arm/Group Title	Tofacitinib 10 mg BID	Tofacitinib 15 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Period Title: Overall Study
STARTED	476	16	122
COMPLETED	445	15	118
NOT COMPLETED	31	1	4

Baseline Characteristics

Arm/Group Title	Tofacitinib 10 mg BID	Tofacitinib 15 mg BID	Placebo BID	Total
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.	Total of all reporting groups
Overall Participants	476	16	122	614
Age, Customized (participants) [Number]
18 to 44 Years	295 62%	11 68.8%	72 59%	378 61.6%
45 to 64 Years	145 30.5%	4 25%	39 32%	188 30.6%
Greater Than or Equal to (>=) 65 Years	36 7.6%	1 6.3%	11 9%	48 7.8%
Sex: Female, Male (Count of Participants)
Female	199 41.8%	7 43.8%	45 36.9%	251 40.9%
Male	277 58.2%	9 56.3%	77 63.1%	363 59.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Remission at Week 8
Description	Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	18.5 3.9%	8.2 51.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0070
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 4.3 to 16.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving Mucosal Healing at Week 8
Description	Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	31.3 6.6%	15.6 97.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	15.7
	Confidence Interval	(2-Sided) 95%; 8.1 to 23.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving Clinical Response at Week 8
Description	Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	59.9 12.6%	32.8 205%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	27.1
	Confidence Interval	(2-Sided) 95%; 17.7 to 36.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With Endoscopic Remission at Week 8
Description	Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	6.7 1.4%	1.6 10%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0345
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	5.1
	Confidence Interval	(2-Sided) 95%; 1.9 to 8.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With Clinical Remission at Week 8
Description	Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	18.5 3.9%	8.2 51.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0070
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 4.3 to 16.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants With Symptomatic Remission at Week 8
Description	Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	11.8 2.5%	5.7 35.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0601
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	6.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 11.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants With Deep Remission at Week 8
Description	Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Number [percentage of participants]	6.5 1.4%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0043
	Comments
	Method	CMH Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; 4.3 to 8.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Partial Mayo Scores
Description	A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Time Frame	Baseline, Weeks 2, 4, 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Baseline: (n= 475, 121)	6.3 (1.2)	6.5 (1.2)
At Week 2: (n= 465, 122)	4.2 (2.2)	5.2 (2.1)
At Week 4: (n= 461, 118)	3.5 (2.3)	4.8 (2.4)
At week 8: (n= 449, 119)	3.2 (2.4)	4.8 (2.5)

9. Secondary Outcome

Title	Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Description	Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Time Frame	Baseline, Weeks 2, 4, 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Change at Week 2: (n= 464, 121)	-2.1 (0.1)	-1.2 (0.2)
Change at week 4: (n= 460, 117)	-2.8 (0.1)	-1.6 (0.2)
Change at week 8: (n= 448, 118)	-3.1 (0.1)	-1.6 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed-Effects Model
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -1.3 to -0.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed-Effects Model
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -1.5 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed-Effects Model
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -1.9 to -1.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Total Mayo Scores at Week 8
Description	Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Arm/Group Title	Tofacitinib 10 mg BID	Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
Measure Participants	476	122
Baseline (n= 472, 121)	9.0 (1.4)	9.1 (1.4)
Change at Week 8 (n= 443, 117)	-3.8 (2.8)	-1.9 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean Difference
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -2.5 to -1.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments

Adverse Events

Time Frame	Baseline up to Day 98
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title	Tofacitinib 10 mg BID		Tofacitinib 15 mg BID		Placebo BID
Arm/Group Description	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.		Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.		Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
All Cause Mortality
	Tofacitinib 10 mg BID		Tofacitinib 15 mg BID		Placebo BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Tofacitinib 10 mg BID		Tofacitinib 15 mg BID		Placebo BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/476 (3.4%)		0/16 (0%)		5/122 (4.1%)
Cardiac disorders
Acute coronary syndrome	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Gastrointestinal disorders
Colitis ulcerative	5/476 (1.1%)		0/16 (0%)		2/122 (1.6%)
Intestinal perforation	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
General disorders
Malaise	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Immune system disorders
Drug hypersensitivity	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Infections and infestations
Anal abscess	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Cellulitis	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Clostridium difficile infection	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Febrile infection	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Otitis externa	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Pneumonia	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Injury, poisoning and procedural complications
Animal bite	0/476 (0%)		0/16 (0%)		1/122 (0.8%)
Joint injury	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Reproductive system and breast disorders
Vulva cyst	0/476 (0%)		0/16 (0%)		1/122 (0.8%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/476 (0%)		0/16 (0%)		1/122 (0.8%)
Skin and subcutaneous tissue disorders
Drug eruption	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Vascular disorders
Aortic dissection	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Temporal arteritis	1/476 (0.2%)		0/16 (0%)		0/122 (0%)
Other (Not Including Serious) Adverse Events
	Tofacitinib 10 mg BID		Tofacitinib 15 mg BID		Placebo BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	148/476 (31.1%)		12/16 (75%)		38/122 (31.1%)
Blood and lymphatic system disorders
Anaemia	11/476 (2.3%)		1/16 (6.3%)		6/122 (4.9%)
Gastrointestinal disorders
Colitis ulcerative	6/476 (1.3%)		1/16 (6.3%)		3/122 (2.5%)
Flatulence	2/476 (0.4%)		1/16 (6.3%)		1/122 (0.8%)
Gastrooesophageal reflux disease	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
Nausea	15/476 (3.2%)		1/16 (6.3%)		5/122 (4.1%)
General disorders
Fatigue	10/476 (2.1%)		1/16 (6.3%)		4/122 (3.3%)
Pyrexia	14/476 (2.9%)		1/16 (6.3%)		3/122 (2.5%)
Infections and infestations
Folliculitis	9/476 (1.9%)		1/16 (6.3%)		0/122 (0%)
Gastroenteritis	7/476 (1.5%)		1/16 (6.3%)		2/122 (1.6%)
Nasopharyngitis	34/476 (7.1%)		3/16 (18.8%)		9/122 (7.4%)
Sinusitis	2/476 (0.4%)		2/16 (12.5%)		1/122 (0.8%)
Upper respiratory tract infection	15/476 (3.2%)		1/16 (6.3%)		1/122 (0.8%)
Investigations
Blood creatine phosphokinase increased	12/476 (2.5%)		1/16 (6.3%)		0/122 (0%)
Liver function test abnormal	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
White blood cell count increased	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	2/476 (0.4%)		1/16 (6.3%)		2/122 (1.6%)
Nervous system disorders
Headache	37/476 (7.8%)		0/16 (0%)		8/122 (6.6%)
Psychiatric disorders
Anxiety	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
Depressed mood	1/476 (0.2%)		1/16 (6.3%)		1/122 (0.8%)
Renal and urinary disorders
Dysuria	1/476 (0.2%)		1/16 (6.3%)		0/122 (0%)
Haematuria	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
Skin and subcutaneous tissue disorders
Acne	10/476 (2.1%)		3/16 (18.8%)		0/122 (0%)
Alopecia	5/476 (1.1%)		1/16 (6.3%)		1/122 (0.8%)
Dermatitis acneiform	0/476 (0%)		1/16 (6.3%)		0/122 (0%)
Night sweats	0/476 (0%)		1/16 (6.3%)		0/122 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.