A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
OCTAVE
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
3 other identifiers
interventional
593
29 countries
264
Brief Summary
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Typical duration for phase_3
264 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
October 25, 2011
CompletedStudy Start
First participant enrolled
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2016
CompletedResults Posted
Study results publicly available
May 18, 2017
CompletedMay 18, 2017
April 1, 2017
3.9 years
October 21, 2011
April 7, 2017
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants In Remission at Week 52
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 was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
Week 52
Secondary Outcomes (25)
Percentage of Participants With Mucosal Healing at Week 52
Week 52
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Week 24, 52
Percentage of Participants in Remission at Week 24
Week 24
Percentage of Participants in Sustained Remission
Week 24, 52
Percentage of Participants With Mucosal Healing at Week 24
Week 24
- +20 more secondary outcomes
Study Arms (3)
Placebo Comparator
PLACEBO COMPARATORCP-690,550 5 mg Arm
EXPERIMENTALCP-690,550 10 mg Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
You may not qualify if:
- Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (275)
Internal Medicine Center, LLC
Mobile, Alabama, 36608, United States
Springhill Memorial Hospital (Endoscopy Only)
Mobile, Alabama, 36608, United States
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
La Jolla, California, 92037-0845, United States
UCSD Medical Center
La Jolla, California, 92093, United States
Alliance Clinical Research
Oceanside, California, 92056, United States
Desert Advanced Imaging
Palm Springs, California, 92262, United States
Erik Palmer, DO
Palm Springs, California, 92262, United States
Homan A Zadeh, MD, MPH
Palm Springs, California, 92262, United States
Hope Square Surgical Center
Rancho Mirage, California, 92270, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92101, United States
Clinical Applications Laboratories, Inc
San Diego, California, 92103, United States
San Diego Endoscopy Center
San Diego, California, 92103, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, 94115, United States
University of California San Francisco
San Francisco, California, 94115, United States
Bristol Hospital
Bristol, Connecticut, 06010, United States
Connecticut Clinical Research Foundation
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
Central Connecticut Endoscopy Center
Plainville, Connecticut, 06062, United States
Citrus Surgery & Endoscopy Center (colonoscopy)
Crystal River, Florida, 34429, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida, 34453, 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.
Zephyhills, Florida, 33542, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Georgia Endoscopy Center
Alpharetta, Georgia, 30005, United States
GI Consultants
Atlanta, Georgia, 30342, United States
Emory Healthcare Heart Center
Johns Creek, Georgia, 30097, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Johns Creek Diagnostic Center
Suwanee, Georgia, 30024, United States
Cotton-O'Neal Clinical Research Center Digestive Health
Topeka, Kansas, 66606, United States
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Gastrointestinal Diagnostic Center
Baltimore, Maryland, 21229, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Howard County GIDC
Columbia, Maryland, 21044, United States
Saint Joseph Mercy Hospital - Inpatient Pharmacy
Ann Arbor, Michigan, 48106, United States
East Ann Arbor Health and Geriatrics Center - UMHS
Ann Arbor, Michigan, 48109-2701, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109-5000, 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
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
Utica Surgery Center (Endoscopy Only)
Utica, Michigan, 48317, United States
Michigan Heart SJMH
Ypsilanti, Michigan, 48106, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197, United States
Saint Joseph Mercy Hospital Outpatient Laboratory
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 Harbour Township, New Jersey, 08234, United States
South Jersey Gastroenterology
Marlton, New Jersey, 08053, United States
The Endo Center at Voorhees
Vorhees, New Jersey, 08043, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, 11021, United States
The Private Practice of Simon Lichtiger, MD
New York, New York, 10028, 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 Medical Center
New York, New York, 10032, United States
CUMC Research Pharmacy
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, 44195-0001, United States
Great Lakes Gastroenterology
Mentor, Ohio, 44060, United States
Mentor Medical Campus
Mentor, Ohio, 44060, United States
The Endoscopy Center of Lake County
Mentor, Ohio, 44060, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
Professional Quality Research, Inc.- Austin Gastroenterology PA
Austin, Texas, 78705, United States
Austin Endoscopy Center II
Austin, Texas, 78745, United States
Austin Gastroenterology PA
Austin, Texas, 78745, United States
Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas, 77004, United States
Baylor College of Medicine (Baylor Medical Center)
Houston, Texas, 77030, United States
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
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
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
Alpine Medical Group
Salt Lake City, Utah, 84102, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Wasatch Endoscopy Center
Salt Lake City, Utah, 84124, 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
The Center for Digestive Health
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Eastern Health-Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, 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 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
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, S7K 0M7, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Instituto de Coloproctología 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
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, 386 29, Czechia
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, 40113, Czechia
Aalborg Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus C, 8000, Denmark
Bispebjerg Hospital
Copenhagen NV, 2400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense C, 5000, Denmark
ECG Unit of West Tallinn Central Hospital
Tallinn, Estonia, 10617, Estonia
West Tallinn Central Hospital
Tallinn, Estonia, 10617, Estonia
X- Ray Department of West Tallinn Central Hospital
Tallinn, Estonia, 10617, Estonia
X-Ray Unit, East Tallinn Central Hospital
Tallinn, 101 38, Estonia
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, 10117, Estonia
Innomedica OU
Tallinn, 10117, Estonia
East Tallinn Central Hospital Internal Medical Clinic
Tallinn, 10138, Estonia
ECG Unit, East Tallinn Central Hospital
Tallinn, 10138, Estonia
X-Ray Department of West Tallinn Central Hospital
Tallinn, 10617, Estonia
Mammograaf OU (Endoscopy Only)
Tallinn, 13419, Estonia
CHU Amiens PICARDIE - Hopital SUD
Amiens, 80054, France
Hopital Saint Andre
Bordeaux, 33075, France
Hopital Beaujon
Clichy, 92110, France
Hotel-Dieu CHU Nantes
Nantes, 44093, France
Hopital Saint Louis - Service d'hepato-gastoenterologie
Paris, 75010, France
Hopital Saint Louis
Paris, 75010, France
Hopital Saint Antoine - Service de Gastroenterologie
Paris, 75571, France
C.H.U. de Reims - Hôpital Robert Debré
Reims, 51092, France
Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, 24105, Germany
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
Berlin, 13353, Germany
Universitätsklinikum Halle
Halle, 06120, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Klinikum Lüneburg/Abteilung Gastroenterologie
Lüneburg, 21339, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat
Békéscsaba, Hungary, 5600, Hungary
Szent Margit Korhaz - III Belgyogyaszat
Budapest, 1032, Hungary
Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont
Budapest, 1076, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, H-1135, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek
Debrecen, 4032, Hungary
Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly
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
Rabin Medical Center, Beilinson campus
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Istituto Clinico Humanitas IRCSS
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
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, 060-0033, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, 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
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
Toho University Sakura Medical Center
Chiba, 285-8741, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
ECG room Clinic Linezers (ECG only) Riga East University Hospital
Riga, LV-1006, Latvia
X-Ray Department, Clinic Linezers (radiology only)
Riga, LV-1006, Latvia
Digestive Diseases Center GASTRO
Riga, LV1006, Latvia
VU University Medical Center (VUMC)
Amsterdam, 1081 HV, Netherlands
Academic Medical Centre
Amsterdam, 1105 AZ, Netherlands
University Medical Center Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Leiden University Medical Center (LUMC)
Leiden, 2333 ZA, Netherlands
Shakespeare Specialist Group
Milford, Auckland, 0620, New Zealand
Tauranga Hospital
Tauranga, Bay of Plenty, 3143, New Zealand
Christchurch Hospital
Christchurch, Canterbury, 8011, 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
Pacific Radiology (X-rays only)
Wellington, 6021, New Zealand
Bowen Hospital
Wellington, 6035, New Zealand
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, 90-302, Poland
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Klinika Chorob Wewnetrznych i Gastroenterologii z
Warsaw, Masovian Voivodeship, 02-507, Poland
H-T. Centrum Medyczne - ENDOTERAPIA
Tychy, Silesian Voivodeship, 43-100, Poland
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, 85-681, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital
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
Bucharest, 050098, Romania
Municipal Institution of Healthcare City Clinical Hospital 12,
Saratov, Russia, 410039, Russia
Federal state budget institution "State scientific centre of coloproctology"
Moscow, 123423, Russia
State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
Nizhny Novgorod, 603126, Russia
Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",
Novosibirsk, 630068, Russia
Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"
Novosibirsk, 630084, Russia
State Budget Educational Institution of Higher Professional Education
Novosibirsk, 630091, Russia
Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental
Novosibirsk, 630117, Russia
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
Samara, 443029, Russia
Limited Liability Company Medical Company "Hepatolog"
Samara, 443063, 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
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, Serbia, Europe, 11000, Serbia
Clinical Hospital Centre Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy Belgrade
Belgrade, 11000, Serbia
Clinical Centre of Kragujevac
Kragujevac, 34000, Serbia
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Novi Sad, 21000, Serbia
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
Novi Sad, 21000, Serbia
"General Hospital ""Djordje Joanovic""
Zrenjanin, 23000, Serbia
Medak s.r.o.
Bratislava, 851 01, Slovakia
KM Management spol. s.r.o.
Nitra, 949 01, Slovakia
Aura SA, s.r.o.
Nové Mesto nad Váhom, 91501, Slovakia
Gastro I., s.r.o.
Prešov, 080 01, Slovakia
Dr John Philip Wright
Claremont, Cape Town, 7708, South Africa
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, 2013, South Africa
Panorama MediClinic
Cape Town, Western Cape, 7500, South Africa
Louis Leipoldt Medical Centre
Cape Town, Western Cape, 7530, South Africa
Endocare Research Centre
Western Cape, 7646, South Africa
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701, South Korea
KyungHee University Hospital
Seoul, Republic of Korea, 130-872, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital,
Seoul, 110-744, South Korea
Hospital Universitari de Bellvitge, Servicio de Digestivo
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario de Fuenlabrada
Madrid, 28942, Spain
National Taiwan University Hospital
Taipei, 10002, Taiwan
Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"
Simferopol, Ar Krym, 95017, Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
Kharkiv, Ukraine, 61037, Ukraine
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
Odesa, Ukraine, 65010, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001, Ukraine
Regional Municipal Institution Chernivtsi Regional Clinical Hospital,
Chernivtsi, 58001, Ukraine
State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of
Dniepropetrovsk, 49074, Ukraine
State Institution "National L.T. Malaya Therapy Institute of National Academy of
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"
Odesa, 65025, Ukraine
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.
Uzhhorod, 88009, Ukraine
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,
Vinnytsia, 21005, Ukraine
Motor-Sich clinic, LLC
Zaporizhzhia, 69068, Ukraine
Minicipal Institution City Hospital 7, Therapevtic Department,
Zaporizhzhia, 69118, Ukraine
Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University
Zaporizhzhia, 69118, Ukraine
Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB20QQ, United Kingdom
Department of Gastroenterology, Old Building
Bristol, England, BS2 8HW, United Kingdom
University College Hospital
London, Greater London, NW1 2BU, United Kingdom
NWLH NHS trust
Harrow, Middlesex, HA1 3UJ, United Kingdom
The North West London Hospitals NHS Trust
Harrow, Middlesex, HA1 3UJ, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
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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: 36931693DERIVEDLee SD, Allegretti JR, Steinwurz F, Connelly SB, Lawendy N, Paulissen J, Gecse KB. Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by OCTAVE Sustain baseline Mayo endoscopic subscore. BMC Gastroenterol. 2023 Feb 8;23(1):34. doi: 10.1186/s12876-022-02508-2.
PMID: 36755231DERIVEDWinthrop 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.
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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: 36336750DERIVEDTargownik L, Dubinsky MC, Steinwurz F, Bushmakin AG, Cappelleri JC, Tai E, Gardiner S, Hur P, Panes J. Disease Activity and Health-related Quality of Life Relationships with Work Productivity in Patients with Ulcerative Colitis in OCTAVE Induction 1 and 2 and OCTAVE Sustain. J Crohns Colitis. 2023 Apr 19;17(4):513-523. doi: 10.1093/ecco-jcc/jjac161.
PMID: 36271912DERIVEDSandborn 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: 35648151DERIVEDVavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.
PMID: 35574426DERIVEDMukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.
PMID: 35380740DERIVEDFeagan 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: 34614208DERIVEDFarraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.
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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: 33684552DERIVEDVong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.
PMID: 33513294DERIVEDCurtis 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.
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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.
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PMID: 29028981DERIVEDSandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.
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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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2011
First Posted
October 25, 2011
Study Start
July 20, 2012
Primary Completion
May 27, 2016
Study Completion
May 27, 2016
Last Updated
May 18, 2017
Results First Posted
May 18, 2017
Record last verified: 2017-04