Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— OCTAVE  

Official title:

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470612
• Other study ID #: A3921139
• Secondary ID: 2011-004581-14OC
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2012
• Est. completion date: August 6, 2020

Study information

• Verified date: September 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 944
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR

• Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

• Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.

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

• Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• CP-690,550
5 mg tablets, BID, for at least 12 months
• CP-690,550
10 mg tablets, BID, for at least 12 months

Locations

Country	Name	City	State
Australia	Eastern Health, Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Gastroenterology and Hepatology Unit	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Liverpool Hospital eastern Campus	Liverpool	New South Wales
Austria	Landeskrankenhaus Innsbruck	Innsbruck
Austria	Krankenhaus Barmherzige Brueder St. Veit/Glan	St. Veit an der Glan
Austria	AKH Wien, Universitaetsklinik fuer Innere Medizin III	Wien
Belgium	GZA St Vincentius	Antwerpen
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven (University Hospital Leuven), Campus Gasthuisberg	Leuven
Belgium	H-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Brazil	Hospital de Clinicas de Porto Alegre - HCPA	Porto Alegre	RIO Grande DO SUL
Canada	University of Calgary, Heritage Medical Research Clinic, TRW Building	Calgary	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre	Edmonton	Alberta
Canada	University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Care Centre	Montreal	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan
Colombia	Instituto de Coloproctologia ICO S.A.S.	Medellin	Antioquia
Croatia	University Hospital Center Zagreb	Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Klinicke Centrum ISCARE I.V.F., Gastroenterologie	Praha 7
Czechia	Nemocnice Strakonice, a.s., Interni oddeleni	Strakonice
Czechia	Krajska Zdravotni, A.S.,	Usti Nad Labem
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus C
Denmark	Bispebjerg Hospital	Copenhagen	NV
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense University Hospital	Odense C
Estonia	Innomedica OU	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn	Harjumaa
France	CHU Amiens-Picardie - Hopital Sud	Amiens Cedex 01
France	Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive	Clichy
France	CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie	Nantes
France	Hôpital Saint Louis	Paris
France	Hôpital Saint Louis - Service d'hepato-gastroenterologie	Paris
France	Hopital Saint Antoine - Service de Gastroenterologie	Paris cedex 12
France	Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique	Pessac
France	CHU de Reims - Hopital Robert Debre	Reims cedex
France	Hopital Nord	St Priest En Jarez
France	Hopital Rangueil	Toulouse Cedex 9
Germany	Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit	Berlin
Germany	Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitatsklinikum Schleswig-Holstein, Campus Kiel	Kiel	Schlewig Holstein
Germany	Klinikum Lüneburg	Lüneburg
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	University Hospital Munich-Grosshadern	Munich
Germany	Universitaetsklinikum Ulm	Ulm
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.	Bekescsaba
Hungary	Pannonia Maganorvosi Centrum Kft.	Budapest
Hungary	Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly	Budapest
Hungary	Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia	Gyula
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Karolina Korhaz	Mosonmagyarovar
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika	Szeged
Hungary	Javorszky Odon Korhaz	Vac
Israel	Rambam Health Care Campus	Haifa
Israel	The Edith Wolfson Medical Center/Gastroenterology Department	Holon
Israel	Rabin Medical Center, Beilinson campus	Petah Tikva
Italy	AOU Mater Domini - U.O. Fisiopatologia Digestiva	Catanzaro
Italy	AOR Villa Sofia-Cervello	Palermo	PA
Italy	Istituto Clinico Humanitas IRCCS-IBD Center	Rozzano	Milano
Japan	Tokyo Medical And Dental University Hospital, Faculty of Medicine	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital	Fukuoka
Japan	Tokai University Hachioji Hospital	Hachioji	Tokyo
Japan	National Hospital Organization Mito Medical Center	Higashi-ibaraki-gun	Ibaraki
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori
Japan	Hiroshima University Hospital	Hiroshima
Japan	The Hospital of Hyogo College of Medicine	Hyogo
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima
Japan	Kuniyoshi Hospital	Kochi-shi	Kochi
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Jikei University Hospital	Minato-ku	Tokyo
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	Osaka City University Hospital	Osaka-City	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization Sendai Medical Center	Sendai	Miyagi
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka Medical College Hospital	Takatsuki-shi	Osaka
Japan	Showa University Hospital	Tokyo
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital,	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Latvia	Digestive Diseases Center GASTRO	Riga
Netherlands	Academic Medical Center (AMC)	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Netherlands	University Medical Center Groningen (UMCG)	Groningen
Netherlands	Leiden University Medical Center	Leiden
New Zealand	Auckland City Hospital	Auckland
New Zealand	North Shore Hospital (Waitemata District Health Board)	Auckland
New Zealand	Christchurch Hospital	Christchurch	Canterbury
New Zealand	Southern District Health Board	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School	Tauranga	BAY OF Plenty
New Zealand	P3 Research Limited	Wellington
Poland	Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital	Bialystok	Podlaskie
Poland	Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych	Bydgoszcz	Kujawsko-pomorskie
Poland	Gabinet Lekarski - Janusz Rudzinski	Bydgoszcz	Kujawsko-pomorskie
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow
Poland	Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.	Lodz	Iodzkie
Poland	Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr	Lodz
Poland	Endoskopia SP. Z O.O.	Sopot
Poland	H-T. Centrum Medyczne - ENDOTERAPIA	Tychy	Slaskie
Poland	Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob	Warszawa	Mazowieckie
Poland	NZOZ Vivamed	Warszawa
Poland	Lexmedica	Wroclaw
Romania	Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie	Bucuresti
Romania	Cabinet Particular Policlinic Algomed SRL	Timisoara	Timis
Russian Federation	Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"	Moscow
Russian Federation	State budget Healthcare Institution Moscow regional scientific research clinical institute	Moscow
Russian Federation	State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.	Nizhniy Novgorod
Russian Federation	Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental	Novosibirsk
Russian Federation	FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"	Novosibirsk
Russian Federation	Municipal Budget Institution of Healthcare of Novosibirsk	Novosibirsk
Russian Federation	Limited Liability Company Medical Company "Hepatolog"	Samara
Russian Federation	Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"	Samara
Russian Federation	Samara Diagnostic center, X-ray Department	Samara
Russian Federation	State budget institution of healthcare of Yaroslavl region Regional clinical hospital	Yaroslavl
Serbia	Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology	Belgrade
Serbia	Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology	Belgrade
Serbia	Military Medical Academy	Belgrade	Central Serbia
Serbia	Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology	Kragujevac
Serbia	Clinical Centre of Vojvodina Emergency Internal Medicine Division	Novi Sad
Serbia	Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology	Novi Sad
Serbia	General Hospital Djordje Joanovic	Zrenjanin
Slovakia	Medak s.r.o.	Bratislava
Slovakia	"KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra	Nitra
Slovakia	Poliklinika Libris, Synergy group, a.s.,	Nove Mesto nad Vahom
Slovakia	Gastro I., s.r.o.	Presov
South Africa	Dr JP Wright	Cape Town	Western CAPE
South Africa	Louis Leipoldt Medical Centre	Cape Town	Western CAPE
South Africa	Panorama Medi-Clinic	Cape Town	Western CAPE
South Africa	Chris Hani Baragwanath Academic Hospital	Johannesburg	Gauteng
South Africa	Endocare Research Centre	Paarl	Western CAPE
Spain	Corporacio Sanitaria Parc Tauli	Barcelona
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid,
Spain	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Taiwan	National Taiwan University Hospital	Taipei City
Ukraine	Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"	Chernivtsi
Ukraine	Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'	Chernivtsi
Ukraine	SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases	Dnipropetrovsk
Ukraine	Municipal Healthcare Institution Kharkiv City Clinical Hospital #2	Kharkiv
Ukraine	State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"	Kharkiv
Ukraine	Kyiv Municipal Clinical Hospital #18, Proctology Department	Kyiv
Ukraine	LTD "St. Paraskeva Medical Center"	Lviv
Ukraine	Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,	Lviv
Ukraine	"Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian	Odesa
Ukraine	Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department	Odesa
Ukraine	CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod	Uzhgorod
Ukraine	Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2	Vinnytsia
Ukraine	Minicipal Institution City Hospital #7, Therapeutic Department,	Zaporizhzhia
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	The North West London Hospitals NHS Trust	Harrow	Middlesex
United Kingdom	UCLH NIHR Clinical Research Facility	London	W1t 7ha
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk
United States	East Ann Arbor Health and Geriatrics Center -UMHS	Ann Arbor	Michigan
United States	Medical Science Research Building 1 - UMHS	Ann Arbor	Michigan
United States	Michigan Clinical Research Unit - UMHS	Ann Arbor	Michigan
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	Digestive Disease Associates, PA	Catonsville	Maryland
United States	Gastrointestinal Diagnostic Center	Catonsville	Maryland
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Howard County GIDC	Columbia	Maryland
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Carolina Research, Carolina Digestive Diseases	Greenville	North Carolina
United States	Endoscopy Center of Connecticut, LLC	Guilford	Connecticut
United States	Endoscopy Center of Connecticut, LLC	Hamden	Connecticut
United States	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor College of Medicine- Baylor Medical Center	Houston	Texas
United States	McGovern Medical School -The University of Texas Health Science Center at Houston	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Altman Clinical and Translational Research Institute	La Jolla	California
United States	Perlman Medical Offices - UC San Diego Health System	La Jolla	California
United States	UCSD Medical Center	La Jolla	California
United States	NYU Langone Long Island Clinical Research Associates	Lake Success	New York
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Cedars Sinai Surgery Center	Los Angeles	California
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	South Jersey Gastroenterology, P.A.	Marlton	New Jersey
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Center for Digestive Health	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research - a division of GI Associates, LLC	Milwaukee	Wisconsin
United States	Alabama Medical Group, P.C.	Mobile	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Irving Medical Center	New York	New York
United States	IBD Center - The Mount Sinai Hospital	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Kornbluth, Legnani, George MD, PC	New York	New York
United States	Alliance Clinical Research	Oceanside	California
United States	Center for Endoscopy- Covenant Surgical Partners	Oceanside	California
United States	North Florida Gastroenterology Research, LLC	Orange Park	Florida
United States	Citrus Ambulatory Surgery Center	Orlando	Florida
United States	Internal Medicine Specialists	Orlando	Florida
United States	Advanced Gastroenterology Center	Port Orange	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Endoscopy Center	Port Orange	Florida
United States	Port Orange Urgent Care	Port Orange	Florida
United States	VCU Health System Digestive Health Center	Richmond	Virginia
United States	VCU Health System Endoscopy Suite	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Alpine Medical Group	Salt Lake City	Utah
United States	Salt Lake Regional Hospital	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Clinical Applications Laboratories, Inc	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Sharp Rees-Stealy Medical Group, Inc.	San Diego	California
United States	UCSF Center for Colitis and Crohn's Disease	San Francisco	California
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	Cotton O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Center for Digestive Health	Troy	Michigan
United States	Surgical Centers of Michigan	Troy	Michigan
United States	Desert Sun Clinical Research, LLC	Tucson	Arizona
United States	Desert Sun Gastroenterology	Tucson	Arizona
United States	Desert Sun Surgery Center	Tucson	Arizona
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	The Gastroenterology Group of South Jersey	Vineland	New Jersey
United States	Huron Gastroenterology Associates - Center for Digestive Care	Ypsilanti	Michigan
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)	Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Number of Participants With Laboratory Test Abnormalities	Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Number of Participants With Vital Sign Abnormalities	Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline	Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Number of Participants With Electrocardiogram (ECG) Abnormalities	ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary	Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events	Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Secondary	Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases	Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Secondary	Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Secondary	Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases	Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Secondary	Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Secondary	Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases	PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.	Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Secondary	Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.	Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Secondary	Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases	Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.	Months 2, 12, 24 and 36
Secondary	Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.	Months 2, 12, 24 and 36
Secondary	Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.	Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84

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