A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
NCT ID: NCT01465763
Last Updated: 2016-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
614 participants
INTERVENTIONAL
2012-04-30
2015-05-31
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
Placebo
Plabebo oral BID
Interventions
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tofacitinib
10 mg oral BID
Placebo
Plabebo 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-alpha 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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Internal Medicine Center, LLC
Mobile, Alabama, United States
Springhill Memorial Hospital
Mobile, Alabama, United States
Investigational Drug Service Pharmacy
La Jolla, California, United States
UCSD Medical Center
La Jolla, California, United States
UCSD Medical Centre
La Jolla, California, United States
Cedars Sinai Medical Center - Thalians Bldg
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Cedars Sinai Surgery Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
Los Angeles, California, United States
Desert Advanced Imaging
Palm Springs, California, United States
Erik Palmer, DO
Palm Springs, California, United States
Homan A Zadeh, MD, MPH
Palm Springs, California, United States
Hope Square Surgical Center
Rancho Mirage, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Sharp Rees-Stealy Medical Group,Inc
San Diego, California, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Florida Surgery Center
Altamonte Springs, Florida, United States
Center for Advanced Gastroenterology
Maitland, Florida, United States
MNH Surgical Center
Maitland, Florida, United States
Sand Lake Imaging
Maitland, Florida, United States
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States
Orange Park Surgery Center
Orange Park, Florida, United States
Citrus Ambulatory Surgery Center
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Georgia Endoscopy Center (Colonoscopy only)
Alpharetta, Georgia, United States
GI Consultants (Colonoscopy only)
Atlanta, Georgia, United States
Emory Healthcare Heart Center (EKG)
Johns Creek, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Icahn School of Medicine at Mount Sinai
Marietta, Georgia, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
Johns Creek Diagnostic Center (X-Ray only)
Suwanee, Georgia, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
Ann Arbor, Michigan, United States
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
Ann Arbor, Michigan, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Michigan Clinical Research Unit - Univeristy of Michigan Health System
Ann Arbor, Michigan, United States
Medical Science Research Building 1 - University of Michigan Health Systems
Ann Arbor, Michigan, United States
Michigan Heart SJMH (Blood draws and ECGs only)
Ypsilanti, Michigan, United States
Huron Gastroenterology Associates / Center for Digestive Care
Ypsilanti, Michigan, United States
Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
Ypsilanti, Michigan, United States
Center for Advanced Medicine
St Louis, Missouri, United States
Washington University School of Medicine - Division of Gastroenterology
St Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States
The Private Practice of Simon Lichtiger, MD
New York, New York, United States
Mount Sinai Doctos Faculty Practice
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
CUMC Research Pharmacy
New York, New York, United States
Kornbluth, Legnani, George MD, PC
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Mentor Medical Campus
Mentor, Ohio, United States
The Endoscopy Center of Lake County
Mentor, Ohio, United States
Houston Hospital for Specialized Surgery
Houston, Texas, United States
Baylor College of Medicine (Baylor Medical Center)
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
Houston, Texas, United States
Gastroenterology Consultants, P.A.
Houston, Texas, United States
Alpine Medical Group
Salt Lake City, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Wasatch Endoscopy Center
Salt Lake City, Utah, United States
RGL Medical Services (x-ray only)
West Jordan, Utah, United States
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Eastern Health Box Hill Hospital
Box Hill, Victoria, Australia
AKH Wien, Universitaetsklinik fuer Innere Medizin III,
Vienna, , Austria
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, , Belgium
Hertiage Medical Research Clinic- University Of Calgary
Calgary, Alberta, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
Hamilton Health Sciences Corporation - McMaster University Medical Centre
Hamilton, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
Barranquilla, Atlántico, Colombia
General Hospital Zadar
Zadar, , Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Institut klinicke a experimentalni mediciny
Prague, , Czechia
Klinicke Centrum ISCARE I.V.F.
Prague, , Czechia
Aalborg Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus C, , Denmark
ECG Unit of West Tallinn Central Hospital
Tallinn, , Estonia
West Tallinn Central Hospital Internal Diseases Clinic
Tallinn, , Estonia
X-Ray Department of West Tallinn Central Hospital
Tallinn, , Estonia
CHU de Nantes - Hotel Dieu
Nantes, , France
Hopital Saint-Louis
Paris, , France
Hopital Rangueil
Toulouse, , France
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
Berlin, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Luneburg/Abteilung Gastroenterologie
Lüneburg, , Germany
Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
Szeged, , Hungary
Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
Vác, , Hungary
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, Israel
Rabin Medical Center, Beilinson campus
Petah Tikva, , Israel
AOU Mater Domini - U.O. Fisiopatologia Digestiva
Catanzaro, CZ, Italy
Istituto Clinico Humanitas IRCSS
Rozzano, Milano, Italy
IBD Center - IRCCS Humanitas
Milan, Milan, Italy
A.O.R. Villa Sofia- Cervello
Palermo, PA, Italy
Comitato Etico Palermo 2
Palermo, PA, Italy
SOC Gastroenterologia Centro di Riferimento Oncologico
Aviano, , Italy
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, Japan
Chiba University Hospital
Chiba, Chiba, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
National Hospital Organization Mito Medical Center
Higashi-ibaraki-gun, Ibaraki, Japan
Kuniyoshi Hospital
Kochi, Kochi, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Tokai University Hachioji Hospital
Hachiōji, Tokyo, Japan
Jikei University Hospital
Minato-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Keio University Hospital
Tokyo, Tokyo, Japan
Fukuoka University Chikushi Hospital
Fukuoka, , Japan
Sameshima Hospital
Kagoshima, , Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Tokyo, , Japan
Digestive Diseases Center GASTRO
Riga, , Latvia
ECG room, Clinic "Linezers"
Riga, , Latvia
X-Ray Department, Clinic "Linezers"
Riga, , Latvia
Leiden University Medical Center
Leiden, South Holland, Netherlands
Shakespeare Specialist Group
Milford, Auckland, New Zealand
Southern District Health Board
Dunedin, , New Zealand
Bop Clinical School Clinical Trials Unit
Tauranga, , New Zealand
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
Warsaw, Masovian Voivodeship, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
Lodz, , Poland
Lexmedica
Wroclaw, , Poland
Cabinet Particular Policlinic Algomed SRL
Timișoara, Jud Timis, Romania
Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
Pyatigorsk, Stavropol Kray, Russia
State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
Nizhny Novgorod, , Russia
Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
Novosibirsk, , Russia
Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
Novosibirsk, , Russia
State Budget Educational Institution of Higher Professional Education
Novosibirsk, , Russia
Federal State Budgetary Military Educational Institution of High Professional Education
Saint Petersburg, , Russia
GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
Saint Petersburg, , Russia
GUZ City Hospital #26
Saint Petersburg, , Russia
Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
Samara, , Russia
Limited Liability Company Medical Company "Hepatolog"
Samara, , Russia
Samara Diagnostic center, X-ray Department
Samara, , Russia
General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
Zrenjanin, Serbia, Europe, Serbia
Clinical Hospital Centre Zvezdara
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Centre of Kragujevac
Kragujevac, , Serbia
Medak s.r.o.
Bratislava, Slovakia, Slovakia
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
Endocare Research Centre
Cape Town, Western Cape, South Africa
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Clínic i provincial de Barcelona
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
Simferopol, Ar Krym, Ukraine
State Institution "National L.T. Malaya Therapy Institute of National Academy
Kharkiv, Ukraine, Ukraine
Kyiv Municipal Clinical Hospital #18, Proctology Department
Kyiv, , Ukraine
LTD "St. Paraskeva Medical Center"
Lviv, , Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
Lviv, , Ukraine
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
Odesa, , Ukraine
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
Uzhhorod, , Ukraine
Vinnytsia National Medical University
Vinnytsia, , Ukraine
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
Vinnytsia, , Ukraine
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, , United Kingdom
University College London Hospital
London, , United Kingdom
Countries
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References
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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.
Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30.
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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2011-004578-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OCTAVEINDUCTION1
Identifier Type: OTHER
Identifier Source: secondary_id
A3921094
Identifier Type: -
Identifier Source: org_study_id
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