Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
OCTAVE
A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
3 other identifiers
interventional
944
29 countries
247
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2012
Longer than P75 for phase_3
247 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2020
CompletedResults Posted
Study results publicly available
September 17, 2021
CompletedSeptember 17, 2021
September 1, 2021
7.9 years
October 21, 2011
August 3, 2021
September 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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)
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)
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)
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)
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)
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)
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 Outcomes (9)
Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Months 2, 12, 24 and 36
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Months 2, 12, 24 and 36
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
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
- +4 more secondary outcomes
Study Arms (2)
CP-690,550 5 mg BID
EXPERIMENTAL5 mg BID
CP-690,550 10 mg BID
EXPERIMENTAL10 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (252)
Alabama Medical Group, P.C.
Mobile, Alabama, 36608, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710, United States
Desert Sun Gastroenterology
Tucson, Arizona, 85710, United States
Desert Sun Surgery Center
Tucson, Arizona, 85710, United States
Altman Clinical and Translational Research Institute
La Jolla, California, 92037-0897, United States
Perlman Medical Offices - UC San Diego Health System
La Jolla, California, 92037, United States
UCSD Medical Center
La Jolla, California, 92093, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Cedars Sinai Surgery Center
Los Angeles, California, 90048, United States
Alliance Clinical Research
Oceanside, California, 92056, United States
Center for Endoscopy- Covenant Surgical Partners
Oceanside, California, 92056, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92101, United States
Clinical Applications Laboratories, Inc
San Diego, California, 92103, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
UCSF Center for Colitis and Crohn's Disease
San Francisco, California, 94115, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, 06437, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, 06518, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
North Florida Gastroenterology Research, LLC
Orange Park, Florida, 32073, United States
Citrus Ambulatory Surgery Center
Orlando, Florida, 32806, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Advanced Gastroenterology Center
Port Orange, Florida, 32127, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Endoscopy Center
Port Orange, Florida, 32127, United States
Port Orange Urgent Care
Port Orange, Florida, 32127, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Cotton O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Gastrointestinal Diagnostic Center
Catonsville, Maryland, 21228, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Howard County GIDC
Columbia, Maryland, 21044, United States
East Ann Arbor Health and Geriatrics Center -UMHS
Ann Arbor, Michigan, 48109-2701, United States
Michigan Clinical Research Unit - UMHS
Ann Arbor, Michigan, 48109-5872, United States
Medical Science Research Building 1 - UMHS
Ann Arbor, Michigan, 48109, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Surgical Centers of Michigan
Troy, Michigan, 48098, United States
Huron Gastroenterology Associates - Center for Digestive Care
Ypsilanti, Michigan, 48197, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
South Jersey Gastroenterology, P.A.
Marlton, New Jersey, 08053, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042, United States
IBD Center - The Mount Sinai Hospital
New York, New York, 10029, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Kornbluth, Legnani, George MD, PC
New York, New York, 10128, United States
University of Rochester
Rochester, New York, 14642, United States
Carolina Research, Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, 77030, United States
McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Alpine Medical Group
Salt Lake City, Utah, 84102, United States
Salt Lake Regional Hospital
Salt Lake City, Utah, 84102, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
VCU Health System Digestive Health Center
Richmond, Virginia, 23298, United States
VCU Health System Endoscopy Suite
Richmond, Virginia, 23298, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Center for Digestive Health
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research - a division of GI Associates, LLC
Milwaukee, Wisconsin, 53215, United States
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Liverpool Hospital eastern Campus
Liverpool, New South Wales, 2170, Australia
Eastern Health, Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Gastroenterology and Hepatology Unit
Clayton, Victoria, 3168, Australia
Landeskrankenhaus Innsbruck
Innsbruck, 6020, Austria
Krankenhaus Barmherzige Brueder St. Veit/Glan
Sankt Veit an der Glan, 9300, Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
GZA St Vincentius
Antwerp, 2018, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, 3000, Belgium
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, 8800, Belgium
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
University of Calgary, Heritage Medical Research Clinic, TRW Building
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7, Canada
University of Alberta - Zeidler Ledcor Centre
Edmonton, Alberta, T6G 2X8, Canada
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
Montreal, Quebec, H1T 2M4, Canada
Montreal General Hospital - McGill University Health Care Centre
Montreal, Quebec, H3G 1A4, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, S7K 0M7, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Instituto de Coloproctologia ICO S.A.S.
Medellín, Antioquia, 00000, Colombia
University Hospital Center Zagreb
Zagreb, 10 000, Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
Klinicke Centrum ISCARE I.V.F., Gastroenterologie
Prague, 170 04, Czechia
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, 386 29, Czechia
Krajska Zdravotni, A.S.,
Ústí nad Labem, 401 13, Czechia
Bispebjerg Hospital
Copenhagen, NV, 2400, Denmark
Aalborg Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus C, 8000, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense C, 5000, Denmark
West Tallinn Central Hospital
Tallinn, Harju, 10617, Estonia
Innomedica OU
Tallinn, 10117, Estonia
CHU Amiens-Picardie - Hopital Sud
Amiens, 80054, France
Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive
Clichy, 92110, France
CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
Nantes, 44093, France
Hôpital Saint Louis - Service d'hepato-gastroenterologie
Paris, 75010, France
Hôpital Saint Louis
Paris, 75010, France
Hopital Saint Antoine - Service de Gastroenterologie
Paris, 75571, France
Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
Pessac, 33604, France
CHU de Reims - Hopital Robert Debre
Reims, 51092, France
Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Hopital Rangueil
Toulouse, 31059, France
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, 24105, Germany
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
Berlin, 13353, Germany
Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
Halle, 06120, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum Lüneburg
Lüneburg, 21339, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
University Hospital Munich-Grosshadern
Munich, 81377, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
Békéscsaba, 5600, Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet
Budapest, 1076, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136, Hungary
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
Budapest, H-1032, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
Gyula, 5700, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
Karolina Korhaz
Mosonmagyaróvár, 9200, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
Szeged, 6720, Hungary
Javorszky Odon Korhaz
Vác, 2600, Hungary
Rambam Health Care Campus
Haifa, 31096, Israel
The Edith Wolfson Medical Center/Gastroenterology Department
Holon, 58100, Israel
Rabin Medical Center, Beilinson campus
Petah Tikva, 49100, Israel
Istituto Clinico Humanitas IRCCS-IBD Center
Rozzano, Milano, 20089, Italy
AOR Villa Sofia-Cervello
Palermo, PA, 90146, Italy
AOU Mater Domini - U.O. Fisiopatologia Digestiva
Catanzaro, 88100, Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, 036-8545, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, 060-0033, Japan
National Hospital Organization Mito Medical Center
Higashi-ibaraki-gun, Ibaraki, 311-3193, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Kuniyoshi Hospital
Kochi, Kochi, 780-0901, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokai University Hachioji Hospital
Hachiōji, Tokyo, 192-0032, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Fukuoka University Chikushi Hospital
Fukuoka, 818-8502, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
The Hospital of Hyogo College of Medicine
Hyōgo, 663-8501, Japan
Showa University Hospital
Tokyo, 142-8666, Japan
Digestive Diseases Center GASTRO
Riga, LV-1006, Latvia
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
Academic Medical Center (AMC)
Amsterdam, 1105 AZ, Netherlands
University Medical Center Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
Tauranga, Bay of Plenty, 3112, New Zealand
Christchurch Hospital
Christchurch, Canterbury, 8011, New Zealand
North Shore Hospital (Waitemata District Health Board)
Auckland, 0620, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Southern District Health Board
Dunedin, 9016, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
P3 Research Limited
Wellington, 6021, New Zealand
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, 90-302, Poland
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681, Poland
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob
Warsaw, Masovian Voivodeship, 02-507, Poland
Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
Bialystok, Podlaskie Voivodeship, 15-950, Poland
H-T. Centrum Medyczne - ENDOTERAPIA
Tychy, Silesian Voivodeship, 43-100, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr
Lodz, 90-153, Poland
Endoskopia SP. Z O.O.
Sopot, 81-756, Poland
NZOZ Vivamed
Warsaw, 03-580, Poland
Lexmedica
Wroclaw, 53-114, Poland
Cabinet Particular Policlinic Algomed SRL
Timișoara, Timiș County, 300002, Romania
Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
Bucharest, 050098, Romania
Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"
Moscow, 123423, Russia
State budget Healthcare Institution Moscow regional scientific research clinical institute
Moscow, 129110, Russia
State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
Nizhny Novgorod, 603126, Russia
Municipal Budget Institution of Healthcare of Novosibirsk
Novosibirsk, 630084, Russia
Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental
Novosibirsk, 630117, Russia
FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
Novosibirsk, 630117, Russia
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
Samara, 443029, Russia
Limited Liability Company Medical Company "Hepatolog"
Samara, 443093, Russia
Samara Diagnostic center, X-ray Department
Samara, 443093, Russia
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
Yaroslavl, 150062, Russia
Military Medical Academy
Belgrade, Central Serbia, 11000, Serbia
Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
Belgrade, 11000, Serbia
Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology
Kragujevac, 34000, Serbia
Clinical Centre of Vojvodina Emergency Internal Medicine Division
Novi Sad, 21000, Serbia
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Novi Sad, 21000, Serbia
General Hospital Djordje Joanovic
Zrenjanin, 23000, Serbia
Medak s.r.o.
Bratislava, 85101, Slovakia
"KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
Nitra, 949 01, Slovakia
Poliklinika Libris, Synergy group, a.s.,
Nové Mesto nad Váhom, 915 01, Slovakia
Gastro I., s.r.o.
Prešov, 080 01, Slovakia
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, 2013, South Africa
Panorama Medi-Clinic
Cape Town, Western Cape, 7500, South Africa
Louis Leipoldt Medical Centre
Cape Town, Western Cape, 7530, South Africa
Dr JP Wright
Cape Town, Western Cape, 7708, South Africa
Endocare Research Centre
Paarl, Western Cape, 7646, South Africa
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital,
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Corporacio Sanitaria Parc Tauli
Barcelona, 08208, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
National Taiwan University Hospital
Taipei, 10002, Taiwan
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001, Ukraine
Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'
Chernivtsi, 58001, Ukraine
SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
Dnipropetrovsk, 49074, Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
Kharkiv, 61037, Ukraine
State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"
Kharkiv, 61039, Ukraine
Kyiv Municipal Clinical Hospital #18, Proctology Department
Kyiv, 01030, Ukraine
LTD "St. Paraskeva Medical Center"
Lviv, 79019, Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
Lviv, 79059, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
Odesa, 65025, Ukraine
"Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian
Odesa, 65059, Ukraine
CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod
Uzhhorod, 88009, Ukraine
Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
Vinnytsia, 21005, Ukraine
Minicipal Institution City Hospital #7, Therapeutic Department,
Zaporizhzhia, 69118, Ukraine
Bristol Royal Infirmary
Bristol, England, BS2 8HW, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 0QQ, United Kingdom
The North West London Hospitals NHS Trust
Harrow, Middlesex, HA1 3UJ, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
UCLH NIHR Clinical Research Facility
London, W1T 7HA, United Kingdom
Related Publications (27)
Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.
PMID: 38778549DERIVEDRubin DT, Torres J, Regueiro M, Reinisch W, Prideaux L, Kotze PG, Tan FH, Gardiner S, Mundayat R, Cadatal MJ, Ng SC. Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis. Crohns Colitis 360. 2024 Jan 20;6(1):otae004. doi: 10.1093/crocol/otae004. eCollection 2024 Jan.
PMID: 38425446DERIVEDRubin DT, Salese L, Cohen M, Kotze PG, Woolcott JC, Su C, Mundayat R, Paulissen J, Torres J, Long MD. Presence of risk factors associated with colectomy among patients with ulcerative colitis: a post hoc analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program. Therap Adv Gastroenterol. 2023 Aug 7;16:17562848231189122. doi: 10.1177/17562848231189122. eCollection 2023.
PMID: 37560161DERIVEDSchreiber S, Rubin DT, Ng SC, Peyrin-Biroulet L, Danese S, Modesto I, Guo X, Su C, Kwok KK, Jo H, Chen Y, Yndestad A, Reinisch W, Dubinsky MC. Major Adverse Cardiovascular Events by Baseline Cardiovascular Risk in Patients with Ulcerative Colitis Treated with Tofacitinib: Data from the OCTAVE Clinical Programme. J Crohns Colitis. 2023 Nov 24;17(11):1761-1770. doi: 10.1093/ecco-jcc/jjad104.
PMID: 37402275DERIVEDKristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
PMID: 36931693DERIVEDWinthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
PMID: 36526796DERIVEDLichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
PMID: 36342120DERIVEDHudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.
PMID: 36336750DERIVEDBiedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222.
PMID: 36242764DERIVEDSandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141.
PMID: 36124702DERIVEDLoftus EV, Baumgart DC, Gecse K, Kinnucan JA, Connelly SB, Salese L, Su C, Kwok KK, Woolcott JC, Armuzzi A. Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program. Inflamm Bowel Dis. 2023 May 2;29(5):744-751. doi: 10.1093/ibd/izac139.
PMID: 35792493DERIVEDWinthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
PMID: 35648151DERIVEDDubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
PMID: 35380664DERIVEDFeagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.
PMID: 34614208DERIVEDPanes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.
PMID: 33884415DERIVEDSandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
PMID: 33684552DERIVEDCurtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.
PMID: 33324993DERIVEDSandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.
PMID: 33127596DERIVEDColombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.
PMID: 33039585DERIVEDSands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.
PMID: 32870265DERIVEDPanaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
PMID: 32816215DERIVEDLichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.
PMID: 32766762DERIVEDSands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panes J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29.
PMID: 31660640DERIVEDSandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
PMID: 31599001DERIVEDSands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.
PMID: 31077827DERIVEDSandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.
PMID: 30476584DERIVEDWinthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.
PMID: 29850873DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2011
First Posted
November 11, 2011
Study Start
October 1, 2012
Primary Completion
August 6, 2020
Study Completion
August 6, 2020
Last Updated
September 17, 2021
Results First Posted
September 17, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.