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.

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): 547
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • The Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Concord, New South Wales, Australia, 2139
      • Concord Hospital -Concord Repatriation Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital eastern Campus
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • St. Veit an der Glan, Austria, 9300
    • Krankenhaus Barmherzige Brueder St. Veit/Glan
• Belgium
  • Antwerpen, Belgium, 2018
    • GZA St Vincentius
  • Kortrijk, Belgium, 8500
    • AZ Groeninge, Campus Kennedylaan
  • Roeselare, Belgium, 8800
    • H-Hartziekenhuis Roeselare-Menen vzw
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre - HCPA
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta - Zeidler Ledcor Centre
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - McGill University Health Centre
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
    • Saskatoon, Saskatchewan, Canada, S7K 0M7
      • Saskatoon City Hospital
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 00000
      • Instituto de Coloproctologia ICO S.A.S.
• Croatia
  • Osijek, Croatia, 31000
    • University Hospital Center Osijek, Clinic of Internal Medicine,
  • Rijeka, Croatia, 51000
    • University Hospital Center Rijeka
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb,Department of Gastroenterology
• Czech Republic
  • Strakonice, Czech Republic, 386 29
    • Nemocnice Strakonice, a.s., Interni oddeleni
  • Usti nad Labem, Czech Republic, 40113
    • Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre University Hospital
  • Odense C, Denmark, 5000
    • Odense University Hospital
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital
• Estonia
  • Tallinn, Estonia, 10117
    • Innomedica OÜ
  • Tallinn, Estonia, 10117
    • ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
  • Tallinn, Estonia, 10117
    • X-Ray Unit, Qualitas AS (X-Ray Only)
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital Internal Medicine Clinic
  • Tallinn, Estonia, 10138
    • ECG Unit, East Tallinn Central Hospital
  • Tallinn, Estonia, 10138
    • X-Ray Unit, East Tallinn Central Hospital
  • Tallinn, Estonia, 12618
    • Quattromed HTI Laboratorid OU
  • Tallinn, Estonia, 13419
    • Mammograaf OU (Endoscopy Only)
• France
  • Amiens Cedex 1, France, 80054
    • Chu Amiens Picardie - Hopital Sud
  • Bordeaux cedex, France, 33075
    • Hopital Saint André
  • Clichy Cedex, France, 92110
    • Hopital Beaujon
  • Paris Cedex 12, France, 75571
    • Hôpital Saint Antoine
  • Reims cedex, France, 51092
    • C.H.U. de Reims - Hôpital Robert Debré
  • St Priest En Jarez, France, 42270
    • Hopital Nord
• Germany
  • Frankfurt, Germany, 60590
    • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Munich, Germany, 81377
    • University Hospital Munich-Grosshadern
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
  • Schlewig Holstein
    • Kiel, Schlewig Holstein, Germany, 24105
      • Universitäetsklinik Schleswig-Holstein, Campus Kiel
• Hungary
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
  • Budapest, Hungary, H-1076
    • Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
  • Budapest, Hungary, H-1134
    • MH Honvedkorhaz
  • Budapest, Hungary, H-1135
    • Pannonia Maganorvosi Centrum Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
  • Gyula, Hungary, H-5700
    • Békés Megyei Pándy Kálmán Kórház
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Mosonmagyarovar, Hungary, 9200
    • "Karolina Korhaz Rendelointezet,Belgyogyaszat
  • Europe
    • Bekescsaba, Europe, Hungary, 5600
      • Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Holon, Israel, 58100
    • The Edith Wolfson Medical Center/Gastroenterology Institute
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 130-872
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
      • Hanyang University Guri Hospital, Clinical Laboratory
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • Cha Bundang Medical Center, Cha University
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Daugavpils Regional Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU University Medical Center (VUMC)
  • Amsterdam, Netherlands, 1105AZ
    • Academic Medical Centre (AMC),
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen (UMCG)
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Wellington, New Zealand, 6021
    • P3 Research Limited
  • Wellington, New Zealand, 6021
    • Pacific Radiology (X-rays only)
  • Wellington, New Zealand, 6035
    • Bowen Hospital
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital
• Poland
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Sopot, Poland, 81-756
    • Endoskopia Sp. z.o.o.
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Iodzkie
    • Lodz, Iodzkie, Poland, 90-302
      • Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-950
      • Oddzial Chorob Wewnetrznych i Gastroenterologii,
  • Slaskie
    • Tychy, Slaskie, Poland, 43100
      • H-T Centrum Medyczne sp. z o.o. sp. komandytowa
• Romania
  • jud. Mures, Romania, 540103
    • Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
  • Sector 5
    • Bucuresti, Sector 5, Romania, cod 050098
      • Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
• Russian Federation
  • Moscow, Russian Federation, 123423
    • Federal state budget institution "State scientific centre of coloproctology"
  • Moscow, Russian Federation, 129110
    • State budget Healthcare Institution Moscow regional scientific research clinical institute
  • Novosibirsk, Russian Federation, 630117
    • Federal State Budgetary Institution "Scientific Research Institute of Physiology and
  • Saratov, Russian Federation, 410039
    • Municipal institution of healthcare "City clinical hospital 12"
  • Yaroslavl, Russian Federation, 150062
    • State budget institution of healthcare of Yaroslavl region Regional clinical hospital
  • Russia
    • Moscow, Russia, Russian Federation, 121309
      • State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
    • Yaroslavl, Russia, Russian Federation, 150010
      • Municipal institution of healthcare "Clinical Hospital # 2"
    • Yaroslavl, Russia, Russian Federation, 150040
      • OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina, Emergency Internal Medicine Division
  • Subotica, Serbia, 24000
    • General Hospital Subotica
• Slovakia
  • Bratislava, Slovakia, 831 04
    • Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
  • Nove Mesto Nad Vahom, Slovakia, 91501
    • Aura SA, s.r.o.
  • Presov, Slovakia, 08001
    • GASTRO I., s.r.o.
• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • Panorama Medi-Clinic
    • Cape Town, Western Cape, South Africa, 7530
      • The Louis Leipoldt Medical Centre
    • Claremont, Cape Town, Western Cape, South Africa, 7708
      • Dr JP Wright
• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitario de Bellvitge
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
• Taiwan
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taipei City, Taiwan, 10002
    • National Taiwan University Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
  • Chernivtsi,, Ukraine, 58001
    • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
  • Dnipropetrovsk, Ukraine, 49074
    • State Institution Institute of Gastroenterology of the National Academy of Medical Sciences
  • Kharkiv, Ukraine, 61037
    • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
  • Kiev, Ukraine, 04201
    • Kyiv City Clinical Hospital #8,
  • Odesa, Ukraine, 65025
    • Municipal Institution "Odesa Regional Clinical Hospital"
  • Vinnytsya, Ukraine, 21029
    • Medical Clinical Research Center "Health Clinic" on the base of
  • Zaporizhzhia, Ukraine, 69068
    • Motor-Sich clinic, LLC
  • Zaporizhzhia, Ukraine, 69118
    • Minicipal Institution "City Hospital #7" Therapeutic Department,
• United Kingdom
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • England
    • Bristol, England, United Kingdom, BS2 8HW
      • Department of Gastroenterology, Old Building
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • St Mark's Hospital
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Desert Sun Clinical Research, LLC
    • Tucson, Arizona, United States, 85710
      • Desert Sun Gastroenterology
    • Tucson, Arizona, United States, 85710
      • Desert Sun Surgery Center
  • California
    • Oceanside, California, United States, 92056
      • Alliance Clinical Research
    • San Diego, California, United States, 92103
      • San Diego Endoscopy Center
    • San Diego, California, United States, 92103
      • Clinical Application Laboratories
    • San Francisco, California, United States, 94115
      • University of California San Francisco
    • San Francisco, California, United States, 94115
      • UCSF Endoscopy Unit at Mount Zion
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
    • Bristol, Connecticut, United States, 06010
      • Bristol Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
    • Plainville, Connecticut, United States, 06062
      • Central Connecticut Endoscopy Center
  • Florida
    • Crystal River, Florida, United States, 34429
      • Citrus Surgery & Endoscopy Center (colonoscopy)
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Inverness, Florida, United States, 34453
      • Suncoast Endoscopy Center (colonoscopy)
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
    • Port Orange, Florida, United States, 32127
      • Advanced Gastroenterology Center
    • Port Orange, Florida, United States, 32127
      • Endoscopy Center
    • Port Orange, Florida, United States, 32127
      • Port Orange Urgent Care
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
    • Shreveport, Louisiana, United States, 71103
      • GastroIntestinal Specialists, A.M.C.
    • Shreveport, Louisiana, United States, 71103
      • Shreveport Endoscopy Center, A.M.C.
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • MGG Group Co., Inc., Chevy Chase Clinical Research
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Endoscopy Center (Endoscopies Only)
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • Troy, Michigan, United States, 48098
      • Surgical Centers of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Surgery Center of Columbia
    • Hannibal, Missouri, United States, 63401
      • Hannibal Regional Hospital
    • Mexico, Missouri, United States, 65265
      • Audrain Medical Center
    • Mexico, Missouri, United States, 65265
      • Center for Digestive & Liver Disease, Inc.
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
    • Marlton, New Jersey, United States, 08053
      • South Jersey Gastroenterology
    • Vineland, New Jersey, United States, 08360
      • The Gastroenterology Group of South Jersey
    • Voorhees, New Jersey, United States, 08043
      • The Endo Center at Voorhees
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Research - Carolina Digestive Diseases
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Regional Gastroenterology Associates of Lancaster, Ltd.
  • Tennessee
    • Nashville, Tennessee, United States, 37212-1610
      • Vanderbilt University Medical Center - GI Research Office
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center - Heart Station
    • Nashville, Tennessee, United States, 37212-1375
      • Vanderbilt University Medical Center - IBD Clinic
    • Nashville, Tennessee, United States, 37232-7610
      • Vanderbilt University Medical Center - Drug Shipment
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center - GCRC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center - Radiology
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institiute
    • Austin, Texas, United States, 78705
      • Austin Gastroenterology PA/Professional Quality Research, Inc.
    • Austin, Texas, United States, 78745
      • Austin Gastroenterology PA
    • Austin, Texas, United States, 78746
      • Austin Endoscopy Center II
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCU Health System Digestive Health Center
    • Richmond, Virginia, United States, 23298
      • VCU Health System Endoscopy Suite
    • Richmond, Virginia, United States, 23298
      • VCU Medical Center Investigational Drug Service (IDS)
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University, Clinical Research Services (CRSU)

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 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
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

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 . 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 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 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 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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.	Week 8
Percentage of Participants With Symptomatic Remission at Week 8	Symptomatic remission 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.	Week 8
Partial Mayo Scores	A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and 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) ranges 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 graded from 0 to 3 with higher scores indicating more severe disease.	Baseline, Weeks 2, 4, 8
Change From Baseline in Total Mayo Score 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 flexible centrally read 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 score indicating more severe disease.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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:izac061. doi: 10.1093/ibd/izac061. Online ahead of print.
• 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.
• 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.
• 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;:
• 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.
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Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (ESTIMATE): October 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 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: A3921095; 2011-004579-35 (EUDRACT_NUMBER); OCTAVEINDUCTION2 (OTHER: Alias Study Number)