OCTAVE: A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01458951
• Collaborator: (none)
• Enrollment: 547
• Locations: 182
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 3
• 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: 547 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: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jun 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 BID	Drug: Placebo; Placebo 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 . 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 score 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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.

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

   Symptomatic remission 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.

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

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

9. Change From Baseline in Total Mayo Score 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 flexible centrally read 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 score 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 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	Desert Sun Clinical Research, LLC	Tucson	Arizona	United States	85710
2	Desert Sun Gastroenterology	Tucson	Arizona	United States	85710
3	Desert Sun Surgery Center	Tucson	Arizona	United States	85710
4	Alliance Clinical Research	Oceanside	California	United States	92056
5	Clinical Application Laboratories	San Diego	California	United States	92103
6	San Diego Endoscopy Center	San Diego	California	United States	92103
7	UCSF Endoscopy Unit at Mount Zion	San Francisco	California	United States	94115
8	University of California San Francisco	San Francisco	California	United States	94115
9	Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California	United States	90502
10	Bristol Hospital	Bristol	Connecticut	United States	06010
11	Connecticut Clinical Research Foundation	Bristol	Connecticut	United States	06010
12	Yale New Haven Hospital	New Haven	Connecticut	United States	06510
13	Yale University School of Medicine	New Haven	Connecticut	United States	06510
14	Central Connecticut Endoscopy Center	Plainville	Connecticut	United States	06062
15	Citrus Surgery & Endoscopy Center (Colonoscopy)	Crystal River	Florida	United States	34429
16	Nature Coast Clinical Research	Inverness	Florida	United States	34452
17	Suncoast Endoscopy Center (colonoscopy)	Inverness	Florida	United States	34453
18	Gastroenterology Group of Naples	Naples	Florida	United States	34102
19	Advanced Gastroenterology Center	Port Orange	Florida	United States	32127
20	Advanced Medical Research Center	Port Orange	Florida	United States	32127
21	Endoscopy Center	Port Orange	Florida	United States	32127
22	Port Orange Urgent Care	Port Orange	Florida	United States	32127
23	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia	United States	30033
24	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas	United States	66606
25	Gastrointestinal Specialists, A.M.C.	Shreveport	Louisiana	United States	71103
26	Shreveport Endoscopy Center, A.M.C.	Shreveport	Louisiana	United States	71103
27	Louisiana Research Center, LLC	Shreveport	Louisiana	United States	71105
28	Chevy Chase Endoscopy Center (Endoscopies Only)	Chevy Chase	Maryland	United States	20815
29	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
30	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
31	Center for Digestive Health	Troy	Michigan	United States	48098
32	Surgical Centers of Michigan	Troy	Michigan	United States	48098
33	Mayo Clinic	Rochester	Minnesota	United States	55905
34	Surgery Center of Columbia	Columbia	Missouri	United States	65201
35	Hannibal Regional Hospital	Hannibal	Missouri	United States	63401
36	Audrain Medical Center	Mexico	Missouri	United States	65265
37	Center for Digestive & Liver Disease, Inc.	Mexico	Missouri	United States	65265
38	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
39	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey	United States	08234
40	South Jersey Gastroenterology	Marlton	New Jersey	United States	08053
41	The Gastroenterology Group of South Jersey	Vineland	New Jersey	United States	08360
42	The Endo Center at Voorhees	Voorhees	New Jersey	United States	08043
43	University of Rochester	Rochester	New York	United States	14642
44	Carolina Research - Carolina Digestive Diseases	Greenville	North Carolina	United States	27834
45	Regional Gastroenterology Associates of Lancaster, Ltd.	Lancaster	Pennsylvania	United States	17604
46	Vanderbilt University Medical Center - IBD Clinic	Nashville	Tennessee	United States	37212-1375
47	Vanderbilt University Medical Center - GI Research Office	Nashville	Tennessee	United States	37212-1610
48	Vanderbilt University Medical Center - Drug Shipment	Nashville	Tennessee	United States	37232-7610
49	Vanderbilt University Medical Center - GCRC	Nashville	Tennessee	United States	37232
50	Vanderbilt University Medical Center - Heart Station	Nashville	Tennessee	United States	37232
51	Vanderbilt University Medical Center - Radiology	Nashville	Tennessee	United States	37232
52	Texas Clinical Research Institiute	Arlington	Texas	United States	76012
53	Austin Gastroenterology PA/Professional Quality Research, Inc.	Austin	Texas	United States	78705
54	Austin Gastroenterology PA	Austin	Texas	United States	78745
55	Austin Endoscopy Center II	Austin	Texas	United States	78746
56	Memorial Hermann Hospital	Houston	Texas	United States	77030
57	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
58	Digestive Health Specialists of Tyler	Tyler	Texas	United States	75701
59	VCU Health System Digestive Health Center	Richmond	Virginia	United States	23298
60	VCU Health System Endoscopy Suite	Richmond	Virginia	United States	23298
61	VCU Medical Center Investigational Drug Service (IDS)	Richmond	Virginia	United States	23298
62	Virginia Commonwealth University, Clinical Research Services (CRSU)	Richmond	Virginia	United States	23298
63	The Canberra Hospital	Garran	Australian Capital Territory	Australia	2605
64	Concord Hospital -Concord Repatriation Hospital	Concord	New South Wales	Australia	2139
65	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
66	Liverpool Hospital Eastern Campus	Liverpool	New South Wales	Australia	2170
67	Monash Medical Centre	Clayton	Victoria	Australia	3168
68	Medizinische Universitat Innsbruck	Innsbruck		Austria	6020
69	Krankenhaus Barmherzige Brueder St. Veit/Glan	St. Veit an der Glan		Austria	9300
70	GZA St Vincentius	Antwerpen		Belgium	2018
71	AZ Groeninge, Campus Kennedylaan	Kortrijk		Belgium	8500
72	H-Hartziekenhuis Roeselare-Menen vzw	Roeselare		Belgium	8800
73	Hospital de Clinicas de Porto Alegre - HCPA	Porto Alegre	Rio Grande do Sul	Brazil	90035-003
74	University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre	Edmonton	Alberta	Canada	T6G 2B7
75	University of Alberta - Zeidler Ledcor Centre	Edmonton	Alberta	Canada	T6G 2X8
76	Montreal General Hospital - McGill University Health Centre	Montreal	Quebec	Canada	H3G 1A4
77	Saskatoon City Hospital	Saskatoon	Saskatchewan	Canada	S7K 0M7
78	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8
79	Instituto de Coloproctologia ICO S.A.S.	Medellin	Antioquia	Colombia	00000
80	University Hospital Center Osijek, Clinic of Internal Medicine,	Osijek		Croatia	31000
81	University Hospital Center Rijeka	Rijeka		Croatia	51000
82	University Hospital Center Zagreb,Department of Gastroenterology	Zagreb		Croatia	10000
83	Nemocnice Strakonice, a.s., Interni oddeleni	Strakonice		Czech Republic	386 29
84	Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.	Usti nad Labem		Czech Republic	40113
85	Bispebjerg Hospital	Copenhagen	NV	Denmark	2400
86	Hvidovre University Hospital	Hvidovre		Denmark	2650
87	Odense University Hospital	Odense C		Denmark	5000
88	ECG Unit, Innomedica OU and Qualitas AS (ECG Only)	Tallinn		Estonia	10117
89	Innomedica OU	Tallinn		Estonia	10117
90	X-Ray Unit, Qualitas AS (X-Ray Only)	Tallinn		Estonia	10117
91	East Tallinn Central Hospital Internal Medicine Clinic	Tallinn		Estonia	10138
92	ECG Unit, East Tallinn Central Hospital	Tallinn		Estonia	10138
93	X-Ray Unit, East Tallinn Central Hospital	Tallinn		Estonia	10138
94	Quattromed HTI Laboratorid OU	Tallinn		Estonia	12618
95	Mammograaf OU (Endoscopy Only)	Tallinn		Estonia	13419
96	CHU Amiens PICARDIE - Hopital SUD	Amiens Cedex 1		France	80054
97	Hopital Saint Andre	Bordeaux cedex		France	33075
98	Hopital Beaujon	Clichy Cedex		France	92110
99	Hopital Saint Antoine	Paris Cedex 12		France	75571
100	C.H.U. de Reims - Hôpital Robert Debré	Reims cedex		France	51092
101	Hopital Nord	St Priest En Jarez		France	42270
102	Universitäetsklinik Schleswig-Holstein, Campus Kiel	Kiel	Schlewig Holstein	Germany	24105
103	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt		Germany	60590
104	Gastroenterologische Gemeinschaftspraxis Minden	Minden		Germany	32423
105	University Hospital Munich-Grosshadern	Munich		Germany	81377
106	Universitaetsklinikum Ulm	Ulm		Germany	89081
107	Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat	Bekescsaba	Europe	Hungary	5600
108	Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly	Budapest		Hungary	1125
109	Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat	Budapest		Hungary	H-1076
110	MH Honvedkorhaz	Budapest		Hungary	H-1134
111	Pannonia Maganorvosi Centrum Kft.	Budapest		Hungary	H-1135
112	Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék	Debrecen		Hungary	4032
113	Bekes Megyei Pandy Kalman Korhaz	Gyula		Hungary	H-5700
114	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc		Hungary	3526
115	"Karolina Korhaz Rendelointezet,Belgyogyaszat	Mosonmagyarovar		Hungary	9200
116	Rambam Health Care Campus	Haifa		Israel	31096
117	The Edith Wolfson Medical Center/Gastroenterology Institute	Holon		Israel	58100
118	Kaplan Medical Center	Rehovot		Israel	76100
119	Hanyang University Guri Hospital, Clinical Laboratory	Guri-si	Gyeonggi-do	Korea, Republic of	471-701
120	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-712
121	Pusan National University Hospital	Busan		Korea, Republic of	602-739
122	Gachon University Gil Medical Center	Incheon		Korea, Republic of	405-760
123	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
124	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
125	Kyung Hee University Hospital	Seoul		Korea, Republic of	130-872
126	Samsung Medical Center	Seoul		Korea, Republic of	135-710
127	Asan Medical Center	Seoul		Korea, Republic of	138-736
128	Daugavpils Regional Hospital	Daugavpils		Latvia	LV-5417
129	VU University Medical Center (VUMC)	Amsterdam		Netherlands	1081 HV
130	Academic Medical Centre (AMC),	Amsterdam		Netherlands	1105AZ
131	University Medical Center Groningen (UMCG)	Groningen		Netherlands	9713 GZ
132	Christchurch Hospital	Christchurch	Canterbury	New Zealand	8011
133	Auckland City Hospital	Auckland		New Zealand	1023
134	Waikato Hospital	Hamilton		New Zealand	3240
135	P3 Research Limited	Wellington		New Zealand	6021
136	Pacific Radiology (X-rays only)	Wellington		New Zealand	6021
137	Bowen Hospital	Wellington		New Zealand	6035
138	Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.	Lodz	Iodzkie	Poland	90-302
139	Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,	Bydgoszcz	Kujawsko-pomorskie	Poland	85-168
140	Oddzial Chorob Wewnetrznych i Gastroenterologii,	Bialystok	Podlaskie	Poland	15-950
141	H-T Centrum Medyczne sp. z o.o. sp. komandytowa	Tychy	Slaskie	Poland	43100
142	Gabinet Endoskopii Przewodu Pokarmowego	Krakow		Poland	31-009
143	Endoskopia Sp. z.o.o.	Sopot		Poland	81-756
144	Nzoz Vivamed	Warszawa		Poland	03-580
145	Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie	Bucuresti	Sector 5	Romania	cod 050098
146	Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie	jud. Mures		Romania	540103
147	State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"	Moscow	Russia	Russian Federation	121309
148	Municipal institution of healthcare "Clinical Hospital # 2"	Yaroslavl	Russia	Russian Federation	150010
149	OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"	Yaroslavl	Russia	Russian Federation	150040
150	Federal state budget institution "State scientific centre of coloproctology"	Moscow		Russian Federation	123423
151	State budget Healthcare Institution Moscow regional scientific research clinical institute	Moscow		Russian Federation	129110
152	Federal State Budgetary Institution "Scientific Research Institute of Physiology and	Novosibirsk		Russian Federation	630117
153	Municipal institution of healthcare "City clinical hospital 12"	Saratov		Russian Federation	410039
154	State budget institution of healthcare of Yaroslavl region Regional clinical hospital	Yaroslavl		Russian Federation	150062
155	Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology	Belgrade		Serbia	11000
156	Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology	Novi Sad		Serbia	21000
157	Clinical Centre of Vojvodina, Emergency Internal Medicine Division	Novi Sad		Serbia	21000
158	General Hospital Subotica	Subotica		Serbia	24000
159	Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion	Bratislava		Slovakia	831 04
160	KM Management spol. s r.o.	Nitra		Slovakia	949 01
161	Aura SA, s.r.o.	Nove Mesto Nad Vahom		Slovakia	91501
162	Gastro I., s.r.o.	Presov		Slovakia	08001
163	Panorama Medi-Clinic	Cape Town	Western Cape	South Africa	7500
164	The Louis Leipoldt Medical Centre	Cape Town	Western Cape	South Africa	7530
165	Dr JP Wright	Claremont, Cape Town	Western Cape	South Africa	7708
166	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona	Spain	08208
167	Hospital Universitario de Bellvitge	Barcelona		Spain	08907
168	Chung Shan Medical University Hospital	Taichung		Taiwan	40201
169	National Taiwan University Hospital	Taipei City		Taiwan	10002
170	Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"	Chernivtsi,		Ukraine	58001
171	Regional Municipal Institution Chernivtsi Regional Clinical Hospital	Chernivtsi		Ukraine	58001
172	State Institution Institute of Gastroenterology of the National Academy of Medical Sciences	Dnipropetrovsk		Ukraine	49074
173	Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department	Kharkiv		Ukraine	61037
174	Kyiv City Clinical Hospital #8,	Kiev		Ukraine	04201
175	Municipal Institution "Odesa Regional Clinical Hospital"	Odesa		Ukraine	65025
176	Medical Clinical Research Center "Health Clinic" on the base of	Vinnytsya		Ukraine	21029
177	Motor-Sich clinic, LLC	Zaporizhzhia		Ukraine	69068
178	Minicipal Institution "City Hospital #7" Therapeutic Department,	Zaporizhzhia		Ukraine	69118
179	Department of Gastroenterology, Old Building	Bristol	England	United Kingdom	BS2 8HW
180	St Mark's Hospital	Harrow	Middlesex	United Kingdom	HA1 3UJ
181	Norfolk and Norwich University Hospital	Norwich	Norfolk	United Kingdom	NR4 7UY
182	Norfolk and Norwich University Hospital	Norwich		United Kingdom	NR4 7UY

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: NCT01458951
• Other Study ID Numbers: A3921095; 2011-004579-35; OCTAVEINDUCTION2
• First Posted: Oct 25, 2011
• Last Update Posted: Jun 1, 2016
• Last Verified: Apr 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 2, 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	429	6	112
COMPLETED	397	5	97
NOT COMPLETED	32	1	15

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	429	6	112	547
Age, Customized (participants) [Number]
18 to 44 Years	265 61.8%	5 83.3%	72 64.3%	342 62.5%
45 to 64 Years	139 32.4%	1 16.7%	35 31.3%	175 32%
Greater Than or Equal to (>=) 65 Years	25 5.8%	0 0%	5 4.5%	30 5.5%
Sex: Female, Male (Count of Participants)
Female	170 39.6%	3 50%	57 50.9%	230 42%
Male	259 60.4%	3 50%	55 49.1%	317 58%

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 . 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 score indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	16.6 3.9%	3.6 60%

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. Percentage difference and its 95% CI was 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	0.0005
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	13.0
	Confidence Interval	(2-Sided) 95%; 8.1 to 17.9
	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

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	28.4 6.6%	11.6 193.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was 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	0.0002
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	16.8
	Confidence Interval	(2-Sided) 95%; 9.5 to 24.1
	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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 flexible centrally read 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 score indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	55.0 12.8%	28.6 476.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was 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	Percentage difference
	Estimated Value	26.4
	Confidence Interval	(2-Sided) 95%; 16.8 to 36.0
	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

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	7.0 1.6%	1.8 30%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was 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	0.0425
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	5.2
	Confidence Interval	(2-Sided) 95%; 1.8 to 8.6
	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 flexible centrally read 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 score indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	16.8 3.9%	3.6 60%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was 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	0.0004
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95%; 8.3 to 18.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants With Symptomatic Remission at Week 8
Description	Symptomatic remission 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 flexible centrally read 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 score indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	10.7 2.5%	2.7 45%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was 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	0.0090
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	8.0
	Confidence Interval	(2-Sided) 95%; 3.9 to 12.2
	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 flexible centrally read 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 score indicating more severe disease.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Number [percentage of participants]	5.1 1.2%	1.8 30%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib 10 mg BID, Placebo BID
	Comments	P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was 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	0.1408
	Comments
	Method	CMH Chi-square Test
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95%; 0.1 to 6.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Partial Mayo Scores
Description	A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and 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

Full analysis set included all participants who were 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	429	112
Baseline (n= 428, 112 )	6.4 (1.3)	6.4 (1.2)
Week 2 (n= 419, 107 )	4.4 (2.2)	5.4 (1.7)
Week 4 (n= 412, 102 )	3.7 (2.3)	4.8 (2.0)
Week 8 (n= 401, 98 )	3.3 (2.3)	4.5 (2.1)

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) ranges 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 graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame	Baseline, Weeks 2, 4, 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Change at Week 2 (n= 418, 107 )	-2.0 (0.1)	-1.0 (0.2)
Change at Week 4 (n= 411, 102 )	-2.7 (0.1)	-1.5 (0.2)
Change at Week 8 (n= 400, 98 )	-3.0 (0.1)	-1.7 (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 subjects as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -1.4 to -0.6
	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 subjects as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -1.6 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 subjects as a random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least square mean difference
	Estimated Value	-1.3
	Confidence Interval	(2-Sided) 95%; -1.7 to -0.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.2
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Total Mayo Score 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 flexible centrally read 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 score indicating more severe disease.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who were 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	429	112
Baseline (n=428,112)	9.0 (1.5)	8.9 (1.5)
Change at Week 8 (n=396,98)	-3.7 (2.8)	-2.0 (2.4)

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	-1.6
	Confidence Interval	(2-Sided) 95%; -2.2 to -1.0
	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	18/429 (4.2%)		0/6 (0%)		9/112 (8%)
Blood and lymphatic system disorders
Anaemia	0/429 (0%)		0/6 (0%)		1/112 (0.9%)
Cardiac disorders
Cardiac failure congestive	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Gastrointestinal disorders
Abdominal pain	2/429 (0.5%)		0/6 (0%)		0/112 (0%)
Anal fistula	0/429 (0%)		0/6 (0%)		1/112 (0.9%)
Colitis ulcerative	8/429 (1.9%)		0/6 (0%)		4/112 (3.6%)
Constipation	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Crohn's disease	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Intestinal perforation	0/429 (0%)		0/6 (0%)		1/112 (0.9%)
Proctalgia	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
General disorders
Asthenia	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Chills	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Infections and infestations
Furuncle	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Injury, poisoning and procedural complications
Femur fracture	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Hip fracture	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Metabolism and nutrition disorders
Dehydration	0/429 (0%)		0/6 (0%)		1/112 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma	1/429 (0.2%)		0/6 (0%)		0/112 (0%)
Colon neoplasm	0/429 (0%)		0/6 (0%)		1/112 (0.9%)
Vascular disorders
Hypertension	1/429 (0.2%)		0/6 (0%)		0/112 (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	68/429 (15.9%)		4/6 (66.7%)		20/112 (17.9%)
Blood and lymphatic system disorders
Anaemia	11/429 (2.6%)		1/6 (16.7%)		2/112 (1.8%)
Gastrointestinal disorders
Abdominal pain	7/429 (1.6%)		0/6 (0%)		6/112 (5.4%)
Abdominal pain upper	7/429 (1.6%)		1/6 (16.7%)		0/112 (0%)
Infections and infestations
Vulvovaginal candidiasis	0/429 (0%)		1/6 (16.7%)		0/112 (0%)
Injury, poisoning and procedural complications
Contusion	1/429 (0.2%)		1/6 (16.7%)		0/112 (0%)
Investigations
Urine analysis abnormal	0/429 (0%)		1/6 (16.7%)		0/112 (0%)
Metabolism and nutrition disorders
Hypercholesterolaemia	7/429 (1.6%)		1/6 (16.7%)		0/112 (0%)
Hypertriglyceridaemia	0/429 (0%)		1/6 (16.7%)		0/112 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	11/429 (2.6%)		0/6 (0%)		6/112 (5.4%)
Nervous system disorders
Headache	33/429 (7.7%)		0/6 (0%)		9/112 (8%)

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.