A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: tofacitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 614
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health Box Hill Hospital
• Austria
  • Wien, Austria, 1090
    • AKH Wien, Universitaetsklinik fuer Innere Medizin III,
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Hertiage Medical Research Clinic- University Of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Center
    • Hamilton, Ontario, Canada, L8S 4K1
      • Hamilton Health Sciences Corporation - McMaster University Medical Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 00000
      • Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
• Croatia
  • Zadar, Croatia, 23 000
    • General Hospital Zadar
• Czech Republic
  • Hradec Kralove, Czech Republic, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Praha 4, Czech Republic, 140 21
    • Institut Klinicke a Experimentalni Mediciny
  • Praha 7, Czech Republic, 170 04
    • Klinicke Centrum ISCARE I.V.F.
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Hospital
  • Aarhus C, Denmark, 8000
    • Aarhus University Hospital
• Estonia
  • Tallinn, Estonia, 10617
    • ECG Unit of West Tallinn Central Hospital
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital Internal Diseases Clinic
  • Tallinn, Estonia, 10617
    • X-Ray Department of West Tallinn Central Hospital
• France
  • Nantes, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Toulouse Cedex 9, France, 31059
    • Hopital Rangueil
• Germany
  • Berlin, Germany, 13353
    • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle (Saale)
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Lüneburg, Germany, 21339
    • Klinikum Lüneburg/Abteilung Gastroenterologie
• Hungary
  • Budapest, Hungary, 1032
    • Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
  • Pecs, Hungary, 7624
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
  • Vac, Hungary, H-2600
    • Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center, Beilinson Campus
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Aviano, Italy, 33081
    • SOC Gastroenterologia Centro di Riferimento Oncologico
  • Milan, Italy, 20089
    • IBD Center - IRCCS Humanitas
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • AOU Mater Domini - U.O. Fisiopatologia Digestiva
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas IRCSS
  • PA
    • Palermo, PA, Italy, 90146
      • A.O.R. Villa Sofia- Cervello
    • Palermo, PA, Italy, 90146
      • Comitato Etico Palermo 2
• Japan
  • Fukuoka, Japan, 818-8502
    • Fukuoka University Chikushi Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Kagoshima, Japan, 892-0846
    • Sameshima Hospital
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 113-8519
    • Tokyo Medical And Dental University Hospital, Faculty of Medicine
  • Aichi
    • Nagakute, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki National Hospital
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8677
      • Chiba University Hospital
    • Sakura, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0033
      • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • The Hospital of Hyogo College of Medicine
  • Ibaraki
    • Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
      • National Hospital Organization Mito Medical Center
  • Kochi
    • Kochi-shi, Kochi, Japan, 780-0901
      • Kuniyoshi Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 983-8520
      • National Hospital Organization Sendai Medical Center
  • Osaka
    • Takatsuki-shi, Osaka, Japan, 569-8686
      • Osaka Medical College Hospital
  • Shiga
    • Otsu-shi, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0032
      • Tokai University Hachioji Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • Jikei University Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Showa University Hospital
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Ntt Medical Center Tokyo
• Latvia
  • Riga, Latvia, LV-1006
    • Digestive Diseases Center GASTRO
  • Riga, Latvia, LV-1006
    • ECG room, Clinic "Linezers"
  • Riga, Latvia, LV-1006
    • X-Ray Department, Clinic "Linezers"
• Netherlands
  • ZH
    • Leiden, ZH, Netherlands, 2333 ZA
      • Leiden University Medical Center
• New Zealand
  • Dunedin, New Zealand, 9016
    • Southern District Health Board
  • Tauranga, New Zealand, 3143
    • Bop Clinical School Clinical Trials Unit
  • Auckland
    • Milford, Auckland, New Zealand, 0620
      • Shakespeare Specialist Group
• Poland
  • Lodz, Poland, 90-153
    • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
  • Wroclaw, Poland, 53-114
    • Lexmedica
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
      • Gabinet Lekarski - Janusz Rudzinski
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-507
      • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
• Romania
  • Jud Timis
    • Timisoara, Jud Timis, Romania, 300002
      • Cabinet Particular Policlinic Algomed SRL
• Russian Federation
  • Nizhniy Novgorod, Russian Federation, 603126
    • State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
  • Novosibirsk, Russian Federation, 630068
    • Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
  • Novosibirsk, Russian Federation, 630084
    • Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
  • Novosibirsk, Russian Federation, 630091
    • State Budget Educational Institution of Higher Professional Education
  • Saint-Petersburg, Russian Federation, 191015
    • GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
  • Saint-Petersburg, Russian Federation, 196247
    • GUZ City Hospital #26
  • Samara, Russian Federation, 443029
    • Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
  • Samara, Russian Federation, 443093
    • Limited Liability Company Medical Company "Hepatolog"
  • Samara, Russian Federation, 443093
    • Samara Diagnostic center, X-ray Department
  • St. Petersburg, Russian Federation, 191015
    • Federal State Budgetary Military Educational Institution of High Professional Education
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357500
      • Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centre Zvezdara
  • Kragujevac, Serbia, 34000
    • Clinical Centre of Kragujevac
  • Serbia, Europe
    • Zrenjanin, Serbia, Europe, Serbia, 23000
      • General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
• Slovakia
  • Bratislava, Slovakia, 85101
    • Medak s.r.o.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Chris Hani Baragwanath Academic hospital
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7646
      • Endocare Research Centre
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Madrid, Spain, 28006
    • Hospital Universitario La Princesa
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28942
    • Hospital Universitario de Fuenlabrada
• Ukraine
  • Kharkov, Ukraine, 61039
    • State Institution "National L.T. Malaya Therapy Institute of National Academy
  • Kyiv, Ukraine, 01030
    • Kyiv Municipal Clinical Hospital #18, Proctology Department
  • Lviv, Ukraine, 79019
    • LTD "St. Paraskeva Medical Center"
  • Lviv, Ukraine, 79059
    • Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
  • Odesa, Ukraine, 65010
    • SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
  • Uzhgorod, Ukraine, 88009
    • SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia National Medical University
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
  • Ar Krym
    • Simferopol, Ar Krym, Ukraine, 95017
      • InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, NW1 2BU
    • University College London Hospital
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Internal Medicine Center, LLC
    • Mobile, Alabama, United States, 36608
      • Springhill Memorial Hospital
  • California
    • La Jolla, California, United States, 92093
      • UCSD Medical Center
    • La Jolla, California, United States, 92093
      • Investigational Drug Service Pharmacy
    • La Jolla, California, United States, 92093
      • UCSD Medical Centre
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center - Thalians Bldg
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Surgery Center
    • Los Angeles, California, United States, 90048
      • CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
    • Palm Springs, California, United States, 92262
      • Desert Advanced Imaging
    • Palm Springs, California, United States, 92262
      • Erik Palmer, DO
    • Palm Springs, California, United States, 92262
      • Homan A Zadeh, MD, MPH
    • Rancho Mirage, California, United States, 92270
      • Hope Square Surgical Center
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Sharp Rees-Stealy Medical Group,Inc
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Endoscopy Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut, PC
    • Hamden, Connecticut, United States, 06518
      • Endoscopy Center of Connecticut, LLC
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Surgery Center
    • Maitland, Florida, United States, 32751
      • Center for Advanced Gastroenterology
    • Maitland, Florida, United States, 32751
      • MNH Surgical Center
    • Maitland, Florida, United States, 32751
      • Sand Lake Imaging
    • Orange Park, Florida, United States, 32073
      • North Florida Gastroenterology Research, LLC
    • Orange Park, Florida, United States, 32073
      • Orange Park Surgery Center
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Orlando, Florida, United States, 32806
      • Citrus Ambulatory Surgery Center
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, P.A.
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Georgia Endoscopy Center (Colonoscopy only)
    • Atlanta, Georgia, United States, 30342
      • GI Consultants (Colonoscopy only)
    • Johns Creek, Georgia, United States, 30097
      • Emory Healthcare Heart Center (EKG)
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Marietta, Georgia, United States, 30067
      • Icahn School of Medicine at Mount Sinai
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
    • Suwanee, Georgia, United States, 30024
      • Johns Creek Diagnostic Center (X-Ray only)
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan Health Systems
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
    • Ann Arbor, Michigan, United States, 48109-2701
      • East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
    • Ann Arbor, Michigan, United States, 48109-5872
      • Michigan Clinical Research Unit - Univeristy of Michigan Health System
    • Ann Arbor, Michigan, United States, 48109
      • Medical Science Research Building 1 - University of Michigan Health Systems
    • Ypsilanti, Michigan, United States, 48106
      • Michigan Heart SJMH (Blood draws and ECGs only)
    • Ypsilanti, Michigan, United States, 48197
      • Huron Gastroenterology Associates / Center for Digestive Care
    • Ypsilanti, Michigan, United States, 48197
      • Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Center for Advanced Medicine
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Division of Gastroenterology
  • New York
    • Great Neck, New York, United States, 11021
      • NYU Langone Long Island Clinical Research Associates
    • Great Neck, New York, United States, 11021
      • NYU Langone Nassau Gastroenterology Associates
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10028
      • The Private Practice of Simon Lichtiger, MD
    • New York, New York, United States, 10029
      • Mount Sinai Doctos Faculty Practice
    • New York, New York, United States, 10032
      • CUMC Research Pharmacy
    • New York, New York, United States, 10128
      • Kornbluth, Legnani, George MD, PC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
    • Mentor, Ohio, United States, 44060
      • The Endoscopy Center of Lake County
    • Mentor, Ohio, United States, 44060
      • Mentor Medical Campus
  • Texas
    • Houston, Texas, United States, 77004
      • Houston Hospital for Specialized Surgery
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine (Baylor Medical Center)
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Baylor Medical Center (Drug Storage)
    • Houston, Texas, United States, 77034
      • Gastroenterology Consultants, P.A.
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Alpine Medical Group
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • Salt Lake City, Utah, United States, 84124
      • Wasatch Endoscopy Center
    • West Jordan, Utah, United States, 84084
      • RGL Medical Services (x-ray only)
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research - GI Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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-alpha therapy.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Plabebo oral BID
Experimental: tofacitinib 10 mg BID	Drug: tofacitinib; 10 mg oral BID; Other Names: CP-690,550

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (UC). 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 scores indicating more severe disease.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Mucosal Healing at Week 8	Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.	Week 8
Percentage of Participants Achieving Clinical Response at Week 8	Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and 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 scores indicating more severe disease.	Week 8
Percentage of Participants With Endoscopic Remission at Week 8	Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.	Week 8
Percentage of Participants With Clinical Remission at Week 8	Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and 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 scores indicating more severe disease.	Week 8
Percentage of Participants With Symptomatic Remission at Week 8	Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and 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 scores indicating more severe disease.	Week 8
Percentage of Participants With Deep Remission at Week 8	Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and 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 scores indicating more severe disease.	Week 8
Partial Mayo Scores	A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.	Baseline, Weeks 2, 4, 8
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8	Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.	Baseline, Weeks 2, 4, 8
Change From Baseline in Total Mayo Scores at Week 8	Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and 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 scores indicating more severe disease.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• 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. 2022 Jun 1:izac063. doi: 10.1093/ibd/izac063. Online ahead of print.
• 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. 2022 Nov 7:izac084. doi: 10.1093/ibd/izac084. Online ahead of print.
• 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. 2022 Nov 7. doi: 10.1007/s40271-022-00603-w. Online ahead of print.
• 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. 2022 Apr 5. pii: izac061. doi: 10.1093/ibd/izac061. [Epub ahead of print]
• 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.
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Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: tofacitinib; CP-690; 550; Moderate to severe ulcerative colitis; phase 3 clinical trial; Mayo score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921094; 2011-004578-27 (EudraCT Number); OCTAVEINDUCTION1 (Other Identifier: Alias Study Number)