A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT01458951
Last Updated: 2016-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
547 participants
INTERVENTIONAL
2012-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tofacitinib 10 mg BID
tofacitinib
10 mg oral BID
Placebo BID
Placebo
Placebo oral BID
Interventions
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tofacitinib
10 mg oral BID
Placebo
Placebo oral BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
* Subjects with moderately to severely active UC based on Mayo score criteria.
* Subjects must have failed or be intolerant of at least one of the following treatments for UC:
* Corticosteroids (oral or intravenous).
* Azathioprine or 6 mercaptopurine (6 MP).
* Anti TNF therapy.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Desert Sun Gastroenterology
Tucson, Arizona, United States
Desert Sun Surgery Center
Tucson, Arizona, United States
Alliance Clinical Research
Oceanside, California, United States
Clinical Application Laboratories
San Diego, California, United States
San Diego Endoscopy Center
San Diego, California, United States
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Bristol Hospital
Bristol, Connecticut, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Central Connecticut Endoscopy Center
Plainville, Connecticut, United States
Citrus Surgery & Endoscopy Center (Colonoscopy)
Crystal River, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Advanced Gastroenterology Center
Port Orange, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Endoscopy Center
Port Orange, Florida, United States
Port Orange Urgent Care
Port Orange, Florida, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Gastrointestinal Specialists, A.M.C.
Shreveport, Louisiana, United States
Shreveport Endoscopy Center, A.M.C.
Shreveport, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Chevy Chase Endoscopy Center (Endoscopies Only)
Chevy Chase, Maryland, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Surgical Centers of Michigan
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Surgery Center of Columbia
Columbia, Missouri, United States
Hannibal Regional Hospital
Hannibal, Missouri, United States
Audrain Medical Center
Mexico, Missouri, United States
Center for Digestive & Liver Disease, Inc.
Mexico, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
South Jersey Gastroenterology
Marlton, New Jersey, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States
The Endo Center at Voorhees
Voorhees Township, New Jersey, United States
University of Rochester
Rochester, New York, United States
Carolina Research - Carolina Digestive Diseases
Greenville, North Carolina, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, United States
Vanderbilt University Medical Center - Drug Shipment
Nashville, Tennessee, United States
Vanderbilt University Medical Center - GCRC
Nashville, Tennessee, United States
Vanderbilt University Medical Center - Heart Station
Nashville, Tennessee, United States
Vanderbilt University Medical Center - Radiology
Nashville, Tennessee, United States
Texas Clinical Research Institiute
Arlington, Texas, United States
Austin Gastroenterology PA/Professional Quality Research, Inc.
Austin, Texas, United States
Austin Gastroenterology PA
Austin, Texas, United States
Austin Endoscopy Center II
Austin, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
VCU Health System Digestive Health Center
Richmond, Virginia, United States
VCU Health System Endoscopy Suite
Richmond, Virginia, United States
VCU Medical Center Investigational Drug Service (IDS)
Richmond, Virginia, United States
Virginia Commonwealth University, Clinical Research Services (CRSU)
Richmond, Virginia, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Concord Hospital -Concord Repatriation Hospital
Concord, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Liverpool Hospital Eastern Campus
Liverpool, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Medizinische Universitat Innsbruck
Innsbruck, , Austria
Krankenhaus Barmherzige Brueder St. Veit/Glan
Sankt Veit an der Glan, , Austria
GZA St Vincentius
Antwerp, , Belgium
AZ Groeninge, Campus Kennedylaan
Kortrijk, , Belgium
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, , Belgium
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande do Sul, Brazil
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
University of Alberta - Zeidler Ledcor Centre
Edmonton, Alberta, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Instituto de Coloproctologia ICO S.A.S.
Medellín, Antioquia, Colombia
University Hospital Center Osijek, Clinic of Internal Medicine,
Osijek, , Croatia
University Hospital Center Rijeka
Rijeka, , Croatia
University Hospital Center Zagreb,Department of Gastroenterology
Zagreb, , Croatia
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, , Czechia
Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
Ústí nad Labem, , Czechia
Bispebjerg Hospital
Copenhagen, NV, Denmark
Hvidovre University Hospital
Hvidovre, , Denmark
Odense University Hospital
Odense C, , Denmark
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, , Estonia
Innomedica OU
Tallinn, , Estonia
X-Ray Unit, Qualitas AS (X-Ray Only)
Tallinn, , Estonia
East Tallinn Central Hospital Internal Medicine Clinic
Tallinn, , Estonia
ECG Unit, East Tallinn Central Hospital
Tallinn, , Estonia
X-Ray Unit, East Tallinn Central Hospital
Tallinn, , Estonia
Quattromed HTI Laboratorid OU
Tallinn, , Estonia
Mammograaf OU (Endoscopy Only)
Tallinn, , Estonia
Hopital Saint Andre
Bordeaux, France, France
CHU Amiens PICARDIE - Hopital SUD
Amiens, , France
Hopital Beaujon
Clichy, , France
Hopital Saint Antoine
Paris, , France
C.H.U. de Reims - Hôpital Robert Debré
Reims, , France
Hopital Nord
Saint-Priest-en-Jarez, , France
Universitäetsklinik Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
University Hospital Munich-Grosshadern
Munich, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
Békéscsaba, Europe, Hungary
Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
Budapest, , Hungary
Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
Budapest, , Hungary
MH Honvedkorhaz
Budapest, , Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
Debrecen, , Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, , Hungary
"Karolina Korhaz Rendelointezet,Belgyogyaszat
Mosonmagyaróvár, , Hungary
Rambam Health Care Campus
Haifa, , Israel
The Edith Wolfson Medical Center/Gastroenterology Institute
Holon, , Israel
Kaplan Medical Center
Rehovot, , Israel
Daugavpils Regional Hospital
Daugavpils, , Latvia
VU University Medical Center (VUMC)
Amsterdam, , Netherlands
Academic Medical Centre (AMC),
Amsterdam, , Netherlands
University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
P3 Research Limited
Wellington, , New Zealand
Pacific Radiology (X-rays only)
Wellington, , New Zealand
Bowen Hospital
Wellington, , New Zealand
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, Poland
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Oddzial Chorob Wewnetrznych i Gastroenterologii,
Bialystok, Podlaskie Voivodeship, Poland
H-T Centrum Medyczne sp. z o.o. sp. komandytowa
Tychy, Silesian Voivodeship, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , Poland
Endoskopia Sp. z.o.o.
Sopot, , Poland
Nzoz Vivamed
Warsaw, , Poland
Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
Bucharest, Sector 5, Romania
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
Jud. Mures, , Romania
State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
Moscow, Russia, Russia
Municipal institution of healthcare "Clinical Hospital # 2"
Yaroslavl, Russia, Russia
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
Yaroslavl, Russia, Russia
Federal state budget institution "State scientific centre of coloproctology"
Moscow, , Russia
State budget Healthcare Institution Moscow regional scientific research clinical institute
Moscow, , Russia
Federal State Budgetary Institution "Scientific Research Institute of Physiology and
Novosibirsk, , Russia
Municipal institution of healthcare "City clinical hospital 12"
Saratov, , Russia
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
Yaroslavl, , Russia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, , Serbia
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Novi Sad, , Serbia
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
Novi Sad, , Serbia
General Hospital Subotica
Subotica, , Serbia
Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
Bratislava, , Slovakia
KM Management spol. s r.o.
Nitra, , Slovakia
Aura SA, s.r.o.
Nové Mesto nad Váhom, , Slovakia
Gastro I., s.r.o.
Prešov, , Slovakia
Panorama Medi-Clinic
Cape Town, Western Cape, South Africa
The Louis Leipoldt Medical Centre
Cape Town, Western Cape, South Africa
Dr JP Wright
Claremont, Cape Town, Western Cape, South Africa
Hanyang University Guri Hospital, Clinical Laboratory
Guri-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Kyiv City Clinical Hospital #8,
Kiev, Ukraine, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, , Ukraine
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
State Institution Institute of Gastroenterology of the National Academy of Medical Sciences
Dnipropetrovsk, , Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
Kharkiv, , Ukraine
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, , Ukraine
Medical Clinical Research Center "Health Clinic" on the base of
Vinnytsia, , Ukraine
Motor-Sich clinic, LLC
Zaporizhzhia, , Ukraine
Minicipal Institution "City Hospital #7" Therapeutic Department,
Zaporizhzhia, , Ukraine
Department of Gastroenterology, Old Building
Bristol, England, United Kingdom
St Mark's Hospital
Harrow, Middlesex, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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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.
Rubin 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.
Rubin 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.
Schreiber 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.
Kristensen 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.
Lichtenstein 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.
Dubinsky 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.
Winthrop 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.
Sandborn 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.
Lichtenstein 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.
Hudesman 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.
Targownik 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.
Sandborn 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.
Loftus 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.
Winthrop 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.
Mukherjee 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.
Dubinsky 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.
Feagan 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.
Farraye 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.
Rubin 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.
Sandborn 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.
Vong 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.
Curtis 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.
Sandborn 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.
Sands 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.
Panaccione 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.
Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panes J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.
Lichtenstein 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.
Sandborn 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.
Sands 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.
Sandborn 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.
Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.
Winthrop 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.
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Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133.
Sandborn 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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Other Identifiers
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2011-004579-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OCTAVEINDUCTION2
Identifier Type: OTHER
Identifier Source: secondary_id
A3921095
Identifier Type: -
Identifier Source: org_study_id
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