A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
OCTAVE
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
3 other identifiers
interventional
547
27 countries
169
Brief Summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
Typical duration for phase_3
169 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
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 1, 2016
CompletedJune 1, 2016
April 1, 2016
2.9 years
October 21, 2011
April 26, 2016
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Remission at Week 8
Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Week 8
Secondary Outcomes (9)
Percentage of Participants Achieving Mucosal Healing at Week 8
Week 8
Percentage of Participants Achieving Clinical Response at Week 8
Week 8
Percentage of Participants With Endoscopic Remission at Week 8
Week 8
Percentage of Participants With Clinical Remission at Week 8
Week 8
Percentage of Participants With Symptomatic Remission at Week 8
Week 8
- +4 more secondary outcomes
Study Arms (2)
tofacitinib 10 mg BID
EXPERIMENTALPlacebo BID
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subject must be at least 18 years of age.
- Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
- Subjects with moderately to severely active UC based on Mayo score criteria.
- Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF therapy.
You may not qualify if:
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (182)
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
Alliance Clinical Research
Oceanside, California, 92056, United States
Clinical Application Laboratories
San Diego, California, 92103, United States
San Diego Endoscopy Center
San Diego, California, 92103, 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
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Bristol Hospital
Bristol, Connecticut, 06010, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, 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
Gastroenterology Group of Naples
Naples, Florida, 34102, 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
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Gastrointestinal Specialists, A.M.C.
Shreveport, Louisiana, 71103, United States
Shreveport Endoscopy Center, A.M.C.
Shreveport, Louisiana, 71103, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Chevy Chase Endoscopy Center (Endoscopies Only)
Chevy Chase, Maryland, 20815, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, 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
Mayo Clinic
Rochester, Minnesota, 55905, United States
Surgery Center of Columbia
Columbia, Missouri, 65201, United States
Hannibal Regional Hospital
Hannibal, Missouri, 63401, United States
Audrain Medical Center
Mexico, Missouri, 65265, United States
Center for Digestive & Liver Disease, Inc.
Mexico, Missouri, 65265, 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
Marlton, New Jersey, 08053, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360, United States
The Endo Center at Voorhees
Voorhees Township, New Jersey, 08043, United States
University of Rochester
Rochester, New York, 14642, United States
Carolina Research - Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, 37212-1375, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, 37212-1610, United States
Vanderbilt University Medical Center - Drug Shipment
Nashville, Tennessee, 37232-7610, United States
Vanderbilt University Medical Center - GCRC
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center - Heart Station
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center - Radiology
Nashville, Tennessee, 37232, United States
Texas Clinical Research Institiute
Arlington, Texas, 76012, United States
Austin Gastroenterology PA/Professional Quality Research, Inc.
Austin, Texas, 78705, United States
Austin Gastroenterology PA
Austin, Texas, 78745, United States
Austin Endoscopy Center II
Austin, Texas, 78746, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
VCU Health System Digestive Health Center
Richmond, Virginia, 23298, United States
VCU Health System Endoscopy Suite
Richmond, Virginia, 23298, United States
VCU Medical Center Investigational Drug Service (IDS)
Richmond, Virginia, 23298, United States
Virginia Commonwealth University, Clinical Research Services (CRSU)
Richmond, Virginia, 23298, United States
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Concord Hospital -Concord Repatriation Hospital
Concord, New South Wales, 2139, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital Eastern Campus
Liverpool, New South Wales, 2170, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Medizinische Universitat Innsbruck
Innsbruck, 6020, Austria
Krankenhaus Barmherzige Brueder St. Veit/Glan
Sankt Veit an der Glan, 9300, Austria
GZA St Vincentius
Antwerp, 2018, Belgium
AZ Groeninge, Campus Kennedylaan
Kortrijk, 8500, 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
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 Coloproctologia ICO S.A.S.
Medellín, Antioquia, 00000, Colombia
University Hospital Center Osijek, Clinic of Internal Medicine,
Osijek, 31000, Croatia
University Hospital Center Rijeka
Rijeka, 51000, Croatia
University Hospital Center Zagreb,Department of Gastroenterology
Zagreb, 10000, Croatia
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, 386 29, Czechia
Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
Ústí nad Labem, 40113, Czechia
Bispebjerg Hospital
Copenhagen, NV, 2400, Denmark
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense C, 5000, Denmark
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, 10117, Estonia
Innomedica OU
Tallinn, 10117, Estonia
X-Ray Unit, Qualitas AS (X-Ray Only)
Tallinn, 10117, Estonia
East Tallinn Central Hospital Internal Medicine Clinic
Tallinn, 10138, Estonia
ECG Unit, East Tallinn Central Hospital
Tallinn, 10138, Estonia
X-Ray Unit, East Tallinn Central Hospital
Tallinn, 10138, Estonia
Quattromed HTI Laboratorid OU
Tallinn, 12618, Estonia
Mammograaf OU (Endoscopy Only)
Tallinn, 13419, Estonia
Hopital Saint Andre
Bordeaux, France, 33075, France
CHU Amiens PICARDIE - Hopital SUD
Amiens, 80054, France
Hopital Beaujon
Clichy, 92110, France
Hopital Saint Antoine
Paris, 75571, France
C.H.U. de Reims - Hôpital Robert Debré
Reims, 51092, France
Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Universitäetsklinik Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, 24105, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
University Hospital Munich-Grosshadern
Munich, 81377, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
Békéscsaba, Europe, 5600, Hungary
Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
Budapest, 1125, Hungary
Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
Budapest, H-1076, Hungary
MH Honvedkorhaz
Budapest, H-1134, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, H-1135, Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
Debrecen, 4032, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, H-5700, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526, Hungary
"Karolina Korhaz Rendelointezet,Belgyogyaszat
Mosonmagyaróvár, 9200, Hungary
Rambam Health Care Campus
Haifa, 31096, Israel
The Edith Wolfson Medical Center/Gastroenterology Institute
Holon, 58100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Daugavpils Regional Hospital
Daugavpils, LV-5417, Latvia
VU University Medical Center (VUMC)
Amsterdam, 1081 HV, Netherlands
Academic Medical Centre (AMC),
Amsterdam, 1105AZ, Netherlands
University Medical Center Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Christchurch Hospital
Christchurch, Canterbury, 8011, New Zealand
Auckland City Hospital
Auckland, 1023, 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,
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Oddzial Chorob Wewnetrznych i Gastroenterologii,
Bialystok, Podlaskie Voivodeship, 15-950, Poland
H-T Centrum Medyczne sp. z o.o. sp. komandytowa
Tychy, Silesian Voivodeship, 43100, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
Endoskopia Sp. z.o.o.
Sopot, 81-756, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
Bucharest, Sector 5, cod 050098, Romania
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
Jud. Mures, 540103, Romania
State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
Moscow, Russia, 121309, Russia
Municipal institution of healthcare "Clinical Hospital # 2"
Yaroslavl, Russia, 150010, Russia
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
Yaroslavl, Russia, 150040, Russia
Federal state budget institution "State scientific centre of coloproctology"
Moscow, 123423, Russia
State budget Healthcare Institution Moscow regional scientific research clinical institute
Moscow, 129110, Russia
Federal State Budgetary Institution "Scientific Research Institute of Physiology and
Novosibirsk, 630117, Russia
Municipal institution of healthcare "City clinical hospital 12"
Saratov, 410039, 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, 11000, 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 Subotica
Subotica, 24000, Serbia
Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
Bratislava, 831 04, 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, 08001, Slovakia
Panorama Medi-Clinic
Cape Town, Western Cape, 7500, South Africa
The Louis Leipoldt Medical Centre
Cape Town, Western Cape, 7530, South Africa
Dr JP Wright
Claremont, Cape Town, Western Cape, 7708, South Africa
Hanyang University Guri Hospital, Clinical Laboratory
Guri-si, Gyeonggi-do, 471-701, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Kyung Hee University Hospital
Seoul, 130-872, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Kyiv City Clinical Hospital #8,
Kiev, Ukraine, 04201, 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
Dnipropetrovsk, 49074, Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
Kharkiv, 61037, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, 65025, Ukraine
Medical Clinical Research Center "Health Clinic" on the base of
Vinnytsia, 21029, Ukraine
Motor-Sich clinic, LLC
Zaporizhzhia, 69068, Ukraine
Minicipal Institution "City Hospital #7" Therapeutic Department,
Zaporizhzhia, 69118, Ukraine
Department of Gastroenterology, Old Building
Bristol, England, BS2 8HW, United Kingdom
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Related Publications (36)
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: 36931693DERIVEDLichtenstein GR, Cohen BL, Salese L, Modesto I, Wang W, Chan G, Ahmed HM, Su C, Peyrin-Biroulet L. Impact of Concomitant Corticosteroids on Tofacitinib Induction Efficacy and Infection Rates in Ulcerative Colitis. Dig Dis Sci. 2023 Jun;68(6):2624-2634. doi: 10.1007/s10620-022-07794-0. Epub 2023 Feb 4.
PMID: 36739367DERIVEDDubinsky MC, Armuzzi A, Gecse KB, Ullman T, Bushmakin AG, DiBonaventura M, Cappelleri JC, Connelly SB, Woolcott JC, Salese L. Improvements in Disease Activity Partially Mediate the Effect of Tofacitinib Treatment on Generic and Disease-Specific Health-Related Quality of Life in Patients with Ulcerative Colitis: Data from the OCTAVE Program. Dig Dis. 2023;41(4):604-614. doi: 10.1159/000528788. Epub 2023 Jan 5.
PMID: 36603566DERIVEDWinthrop 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: 36526796DERIVEDSandborn WJ, Sands BE, Vermeire S, Leung Y, Guo X, Modesto I, Su C, Wang W, Panes J. Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program. Therap Adv Gastroenterol. 2022 Dec 5;15:17562848221136331. doi: 10.1177/17562848221136331. eCollection 2022.
PMID: 36506749DERIVEDLichtenstein 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: 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: 35648151DERIVEDMukherjee 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: 35380740DERIVEDDubinsky 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: 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.
PMID: 34165201DERIVEDRubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.
PMID: 34035832DERIVEDSandborn 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.
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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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
June 1, 2012
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
June 1, 2016
Results First Posted
June 1, 2016
Record last verified: 2016-04