AzTrials
AzTrials

Ulcerative ColitisPhase 3OCTAVENCT01465763

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

A Phase 3 study testing tofacitinib in people with Ulcerative Colitis, run by Pfizer at 178 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
tofacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
614 participants
Where
178 sitesin 28 countries
Study dates
Apr 2012to May 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

178 sites in 28 countries.

178 sites in 28 countries

United States71 sites

  • Georgia Endoscopy Center (Colonoscopy only)

    Alpharetta, Georgia, 30005

  • Florida Surgery Center

    Altamonte Springs, Florida, 32701

  • Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)

    Ann Arbor, Michigan, 48106

  • East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-2701

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-5000

  • Michigan Clinical Research Unit - Univeristy of Michigan Health System

    Ann Arbor, Michigan, 48109-5872

  • Medical Science Research Building 1 - University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • GI Consultants (Colonoscopy only)

    Atlanta, Georgia, 30342

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • NYU Langone Nassau Gastroenterology Associates

    Great Neck, New York, 11021

  • Endoscopy Center of Connecticut, LLC

    Guilford, Connecticut, 06437

  • Endoscopy Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Gastroenterology Center of Connecticut, PC

    Hamden, Connecticut, 06518

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Houston Hospital for Specialized Surgery

    Houston, Texas, 77004

  • Baylor College of Medicine (Baylor Medical Center)

    Houston, Texas, 77030

  • Baylor College of Medicine - Baylor Medical Center (Drug Storage)

    Houston, Texas, 77030

  • Gastroenterology Consultants, P.A.

    Houston, Texas, 77034

  • Emory Healthcare Heart Center (EKG)

    Johns Creek, Georgia, 30097

  • Investigational Drug Service Pharmacy

    La Jolla, California, 92093

  • UCSD Medical Center

    La Jolla, California, 92093

  • UCSD Medical Centre

    La Jolla, California, 92093

  • Cedars Sinai Medical Center - Thalians Bldg

    Los Angeles, California, 90048

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Cedars Sinai Surgery Center

    Los Angeles, California, 90048

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center

    Los Angeles, California, 90048

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • MNH Surgical Center

    Maitland, Florida, 32751

  • Sand Lake Imaging

    Maitland, Florida, 32751

  • Icahn School of Medicine at Mount Sinai

    Marietta, Georgia, 30067

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Mentor Medical Campus

    Mentor, Ohio, 44060

  • The Endoscopy Center of Lake County

    Mentor, Ohio, 44060

  • Wisconsin Center for Advanced Research - GI Associates, LLC

    Milwaukee, Wisconsin, 53215

  • Internal Medicine Center, LLC

    Mobile, Alabama, 36608

  • Springhill Memorial Hospital

    Mobile, Alabama, 36608

  • The Private Practice of Simon Lichtiger, MD

    New York, New York, 10028

  • Mount Sinai Doctos Faculty Practice

    New York, New York, 10029

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • CUMC Research Pharmacy

    New York, New York, 10032

  • Kornbluth, Legnani, George MD, PC

    New York, New York, 10128

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • North Florida Gastroenterology Research, LLC

    Orange Park, Florida, 32073

  • Orange Park Surgery Center

    Orange Park, Florida, 32073

  • Citrus Ambulatory Surgery Center

    Orlando, Florida, 32806

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Desert Advanced Imaging

    Palm Springs, California, 92262

  • Erik Palmer, DO

    Palm Springs, California, 92262

  • Homan A Zadeh, MD, MPH

    Palm Springs, California, 92262

  • Hope Square Surgical Center

    Rancho Mirage, California, 92270

  • Alpine Medical Group

    Salt Lake City, Utah, 84102

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Wasatch Endoscopy Center

    Salt Lake City, Utah, 84124

  • Sharp Rees-Stealy Medical Group, Inc.

    San Diego, California, 92101

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92101

  • Sharp Rees-Stealy Medical Group,Inc

    San Diego, California, 92123

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine - Division of Gastroenterology

    St Louis, Missouri, 63110

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Johns Creek Diagnostic Center (X-Ray only)

    Suwanee, Georgia, 30024

  • RGL Medical Services (x-ray only)

    West Jordan, Utah, 84084

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Michigan Heart SJMH (Blood draws and ECGs only)

    Ypsilanti, Michigan, 48106

  • Huron Gastroenterology Associates / Center for Digestive Care

    Ypsilanti, Michigan, 48197

  • Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Japan23 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • Fukuoka University Chikushi Hospital

    Fukuoka, 818-8502

  • Tokai University Hachioji Hospital

    Hachiōji, Tokyo, 192-0032

  • National Hospital Organization Mito Medical Center

    Higashi-ibaraki-gun, Ibaraki, 311-3193

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori, 036-8545

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Kuniyoshi Hospital

    Kochi, Kochi, 780-0901

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • The Hospital of Hyogo College of Medicine

    Nishinomiya, Hyōgo, 663-8501

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

    Sapporo, Hokkaido, 060-0033

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • Osaka Medical College Hospital

    Takatsuki-shi, Osaka, 569-8686

  • Keio University Hospital

    Tokyo, Tokyo, 160-8582

  • Tokyo Medical And Dental University Hospital, Faculty of Medicine

    Tokyo, 113-8519

Other trials in Japan

Russia11 sites

  • State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko

    Nizhny Novgorod, 603126

  • Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"

    Novosibirsk, 630068

  • Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital

    Novosibirsk, 630084

  • State Budget Educational Institution of Higher Professional Education

    Novosibirsk, 630091

  • Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"

    Pyatigorsk, Stavropol Kray, 357500

  • Federal State Budgetary Military Educational Institution of High Professional Education

    Saint Petersburg, 191015

  • GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"

    Saint Petersburg, 191015

  • GUZ City Hospital #26

    Saint Petersburg, 196247

  • Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock

    Samara, 443029

  • Limited Liability Company Medical Company "Hepatolog"

    Samara, 443093

  • Samara Diagnostic center, X-ray Department

    Samara, 443093

Other trials in Russia

Ukraine9 sites

  • State Institution "National L.T. Malaya Therapy Institute of National Academy

    Kharkiv, Ukraine, 61039

  • Kyiv Municipal Clinical Hospital #18, Proctology Department

    Kyiv, 01030

  • LTD "St. Paraskeva Medical Center"

    Lviv, 79019

  • Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

    Lviv, 79059

  • SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

    Odesa, 65010

  • InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University

    Simferopol, Ar Krym, 95017

  • SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI

    Uzhhorod, 88009

  • Vinnytsia National Medical University

    Vinnytsia, 21005

  • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2

    Vinnytsia, 21005

Other trials in Ukraine

Italy6 sites

  • SOC Gastroenterologia Centro di Riferimento Oncologico

    Aviano, 33081

  • AOU Mater Domini - U.O. Fisiopatologia Digestiva

    Catanzaro, CZ, 88100

  • IBD Center - IRCCS Humanitas

    Milan, Milan, 20089

  • A.O.R. Villa Sofia- Cervello

    Palermo, PA, 90146

  • Comitato Etico Palermo 2

    Palermo, PA, 90146

  • Istituto Clinico Humanitas IRCSS

    Rozzano, Milano, 20089

Other trials in Italy

Canada5 sites

  • Hertiage Medical Research Clinic- University Of Calgary

    Calgary, Alberta, T2N 4Z6

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5

  • Hamilton Health Sciences Corporation - McMaster University Medical Centre

    Hamilton, Ontario, L8S 4K1

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

Other trials in Canada

Germany4 sites

  • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

    Berlin, 13353

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum Luneburg/Abteilung Gastroenterologie

    Lüneburg, 21339

Other trials in Germany

Hungary4 sites

  • Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly

    Budapest, 1032

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika

    Szeged, 6720

  • Javorszky Odon Korhaz/Gasztroenterologiai Osztaly

    Vác, H-2600

Other trials in Hungary

Poland4 sites

  • Gabinet Lekarski - Janusz Rudzinski

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681

  • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki

    Lodz, 90-153

  • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia

    Warsaw, Masovian Voivodeship, 02-507

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

Serbia4 sites

  • Clinical Hospital Centre Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Centre of Kragujevac

    Kragujevac, 34000

  • General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology

    Zrenjanin, Serbia, Europe, 23000

Other trials in Serbia

Spain4 sites

  • Hospital Clínic i provincial de Barcelona

    Barcelona, 08036

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

Other trials in Spain

Australia3 sites

  • Eastern Health Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Nepean Hospital

    Kingswood, New South Wales, 2747

Other trials in Australia

Czechia3 sites

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

  • Klinicke Centrum ISCARE I.V.F.

    Prague, 170 04

Other trials in Czechia

Estonia3 sites

  • ECG Unit of West Tallinn Central Hospital

    Tallinn, 10617

  • West Tallinn Central Hospital Internal Diseases Clinic

    Tallinn, 10617

  • X-Ray Department of West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

France3 sites

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Latvia3 sites

  • Digestive Diseases Center GASTRO

    Riga, LV-1006

  • ECG room, Clinic "Linezers"

    Riga, LV-1006

  • X-Ray Department, Clinic "Linezers"

    Riga, LV-1006

Other trials in Latvia

New Zealand3 sites

  • Southern District Health Board

    Dunedin, 9016

  • Shakespeare Specialist Group

    Milford, Auckland, 0620

  • Bop Clinical School Clinical Trials Unit

    Tauranga, 3143

Other trials in New Zealand

Denmark2 sites

  • Aalborg Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus C, 8000

Other trials in Denmark

Israel2 sites

  • Rabin Medical Center, Beilinson campus

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel, 64239

Other trials in Israel

South Africa2 sites

  • Endocare Research Centre

    Cape Town, Western Cape, 7646

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng, 2013

Other trials in South Africa

United Kingdom2 sites

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ

  • University College London Hospital

    London, NW1 2BU

Other trials in United Kingdom

Austria1 site

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III,

    Vienna, 1090

Other trials in Austria

Belgium1 site

  • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Colombia1 site

  • Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.

    Barranquilla, Atlántico, 00000

Other trials in Colombia

Croatia1 site

  • General Hospital Zadar

    Zadar, 23 000

Other trials in Croatia

Netherlands1 site

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

Other trials in Netherlands

Romania1 site

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, Jud Timis, 300002

Other trials in Romania

Slovakia1 site

  • Medak s.r.o.

    Bratislava, Slovakia, 85101

Other trials in Slovakia

About this study

Official title: 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.

Being tested
tofacitinib, Placebo
Keywords
tofacitinib, CP-690, 550, Moderate to severe ulcerative colitis, phase 3 clinical trial, Mayo score
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tofacitinibDrug

    Also called CP-690,550

    10 mg oral BID

  • PlaceboDrug

    Plabebo oral BID

Study groups in NCT01465763
Study groupRoleWhat they receive
tofacitinib 10 mg BIDExperimentalNot described
Receives: Drug: tofacitinib
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Remission at Week 8

    Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (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.

    Measured: Week 8

Secondary outcomes (9)

  1. 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.

    Measured: Week 8

  2. 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.

    Measured: Week 8

  3. 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.

    Measured: Week 8

  4. 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.

    Measured: Week 8

  5. 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.

    Measured: Week 8

  6. 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.

    Measured: Week 8

  7. 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.

    Measured: Baseline, Weeks 2, 4, 8

  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.

    Measured: Baseline, Weeks 2, 4, 8

  9. 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.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01465763
Sponsor's protocol ID
A3921094
Other IDs
2011-004578-27, OCTAVEINDUCTION1
Acronym
OCTAVE
Status last verified
May 2016
First submitted
21 Oct 2011
Last updated
7 Jun 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38425446

  • 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. Ther Adv Gastroenterol. 2023 Aug 7;16:17562848231189122. doi: 10.1177/17562848231189122. eCollection 2023.

    PubMed 37560161

  • 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.

    PubMed 37402275

  • 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.

    PubMed 36931693

  • 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.

    PubMed 36739367

  • 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.

    PubMed 36603566

  • 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.

    PubMed 36526796

  • 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. Ther Adv Gastroenterol. 2022 Dec 5;15:17562848221136331. doi: 10.1177/17562848221136331. eCollection 2022.

    PubMed 36506749

  • 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.

    PubMed 36342120

  • 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.

    PubMed 36336750

  • 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.

    PubMed 36271912

  • 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.

    PubMed 36124702

  • 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.

    PubMed 35792493

  • 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.

    PubMed 35648151

  • 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.

    PubMed 35380740

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tofacitinib in people with Ulcerative Colitis, run by Pfizer at 178 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Japan, Russia, Ukraine, Italy and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Remission at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01465763, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in