AzTrials
AzTrials

Ulcerative ColitisPhase 3OCTAVENCT01458951

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing tofacitinib in people with Ulcerative Colitis, run by Pfizer at 182 sites in 29 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
547 participants
Where
182 sitesin 29 countries
Study dates
Jun 2012to Jun 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 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

182 sites in 29 countries.

182 sites in 29 countries

United States62 sites

  • Texas Clinical Research Institiute

    Arlington, Texas, 76012

  • Austin Gastroenterology PA/Professional Quality Research, Inc.

    Austin, Texas, 78705

  • Austin Gastroenterology PA

    Austin, Texas, 78745

  • Austin Endoscopy Center II

    Austin, Texas, 78746

  • Bristol Hospital

    Bristol, Connecticut, 06010

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Chevy Chase Endoscopy Center (Endoscopies Only)

    Chevy Chase, Maryland, 20815

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Surgery Center of Columbia

    Columbia, Missouri, 65201

  • Citrus Surgery & Endoscopy Center (Colonoscopy)

    Crystal River, Florida, 34429

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • Carolina Research - Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Hannibal Regional Hospital

    Hannibal, Missouri, 63401

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center (colonoscopy)

    Inverness, Florida, 34453

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • South Jersey Gastroenterology

    Marlton, New Jersey, 08053

  • Audrain Medical Center

    Mexico, Missouri, 65265

  • Center for Digestive & Liver Disease, Inc.

    Mexico, Missouri, 65265

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center - IBD Clinic

    Nashville, Tennessee, 37212-1375

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212-1610

  • Vanderbilt University Medical Center - Drug Shipment

    Nashville, Tennessee, 37232-7610

  • Vanderbilt University Medical Center - GCRC

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Heart Station

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center - Radiology

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Alliance Clinical Research

    Oceanside, California, 92056

  • Central Connecticut Endoscopy Center

    Plainville, Connecticut, 06062

  • Advanced Gastroenterology Center

    Port Orange, Florida, 32127

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Endoscopy Center

    Port Orange, Florida, 32127

  • Port Orange Urgent Care

    Port Orange, Florida, 32127

  • VCU Health System Digestive Health Center

    Richmond, Virginia, 23298

  • VCU Health System Endoscopy Suite

    Richmond, Virginia, 23298

  • VCU Medical Center Investigational Drug Service (IDS)

    Richmond, Virginia, 23298

  • Virginia Commonwealth University, Clinical Research Services (CRSU)

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Clinical Application Laboratories

    San Diego, California, 92103

  • San Diego Endoscopy Center

    San Diego, California, 92103

  • UCSF Endoscopy Unit at Mount Zion

    San Francisco, California, 94115

  • University of California San Francisco

    San Francisco, California, 94115

  • Gastrointestinal Specialists, A.M.C.

    Shreveport, Louisiana, 71103

  • Shreveport Endoscopy Center, A.M.C.

    Shreveport, Louisiana, 71103

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Surgical Centers of Michigan

    Troy, Michigan, 48098

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Desert Sun Gastroenterology

    Tucson, Arizona, 85710

  • Desert Sun Surgery Center

    Tucson, Arizona, 85710

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • The Endo Center at Voorhees

    Voorhees Township, New Jersey, 08043

Other trials in United States

Hungary9 sites

  • Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat

    Békéscsaba, Europe, 5600

  • Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly

    Budapest, 1125

  • Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat

    Budapest, H-1076

  • MH Honvedkorhaz

    Budapest, H-1134

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, H-1135

  • Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék

    Debrecen, 4032

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, H-5700

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • "Karolina Korhaz Rendelointezet,Belgyogyaszat

    Mosonmagyaróvár, 9200

Other trials in Hungary

South Korea9 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Hanyang University Guri Hospital, Clinical Laboratory

    Guri-si, Gyeonggi-do, 471-701

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 463-712

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Kyung Hee University Hospital

    Seoul, 130-872

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Ukraine9 sites

  • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, 58001

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

  • State Institution Institute of Gastroenterology of the National Academy of Medical Sciences

    Dnipropetrovsk, 49074

  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

    Kharkiv, 61037

  • Kyiv City Clinical Hospital #8,

    Kiev, Ukraine, 04201

  • Municipal Institution "Odesa Regional Clinical Hospital"

    Odesa, 65025

  • Medical Clinical Research Center "Health Clinic" on the base of

    Vinnytsia, 21029

  • Motor-Sich clinic, LLC

    Zaporizhzhya, 69068

  • Minicipal Institution "City Hospital #7" Therapeutic Department,

    Zaporizhzhya, 69118

Other trials in Ukraine

Estonia8 sites

  • ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

    Tallinn, 10117

  • Innomedica OU

    Tallinn, 10117

  • X-Ray Unit, Qualitas AS (X-Ray Only)

    Tallinn, 10117

  • East Tallinn Central Hospital Internal Medicine Clinic

    Tallinn, 10138

  • ECG Unit, East Tallinn Central Hospital

    Tallinn, 10138

  • X-Ray Unit, East Tallinn Central Hospital

    Tallinn, 10138

  • Quattromed HTI Laboratorid OU

    Tallinn, 12618

  • Mammograaf OU (Endoscopy Only)

    Tallinn, 13419

Other trials in Estonia

Russia8 sites

  • State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"

    Moscow, Russia, 121309

  • Federal state budget institution "State scientific centre of coloproctology"

    Moscow, 123423

  • State budget Healthcare Institution Moscow regional scientific research clinical institute

    Moscow, 129110

  • Federal State Budgetary Institution "Scientific Research Institute of Physiology and

    Novosibirsk, 630117

  • Municipal institution of healthcare "City clinical hospital 12"

    Saratov, 410039

  • Municipal institution of healthcare "Clinical Hospital # 2"

    Yaroslavl, Russia, 150010

  • OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"

    Yaroslavl, Russia, 150040

  • State budget institution of healthcare of Yaroslavl region Regional clinical hospital

    Yaroslavl, 150062

Other trials in Russia

Poland7 sites

  • Oddzial Chorob Wewnetrznych i Gastroenterologii,

    Bialystok, Podlaskie Voivodeship, 15-950

  • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

    Lodz, Iodzkie, 90-302

  • Endoskopia Sp. z.o.o.

    Sopot, 81-756

  • H-T Centrum Medyczne sp. z o.o. sp. komandytowa

    Tychy, Silesian Voivodeship, 43100

  • Nzoz Vivamed

    Warsaw, 03-580

Other trials in Poland

France6 sites

  • CHU Amiens PICARDIE - Hopital SUD

    Amiens, 80054

  • Hopital Saint Andre

    Bordeaux, France, 33075

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Saint Antoine

    Paris, 75571

  • C.H.U. de Reims - Hôpital Robert Debré

    Reims, 51092

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

Other trials in France

New Zealand6 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

  • Waikato Hospital

    Hamilton, 3240

  • P3 Research Limited

    Wellington, 6021

  • Pacific Radiology (X-rays only)

    Wellington, 6021

  • Bowen Hospital

    Wellington, 6035

Other trials in New Zealand

Australia5 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Hospital -Concord Repatriation Hospital

    Concord, New South Wales, 2139

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Liverpool Hospital Eastern Campus

    Liverpool, New South Wales, 2170

Other trials in Australia

Canada5 sites

  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

    Edmonton, Alberta, T6G 2B7

  • University of Alberta - Zeidler Ledcor Centre

    Edmonton, Alberta, T6G 2X8

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

Germany5 sites

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, 60590

  • Universitäetsklinik Schleswig-Holstein, Campus Kiel

    Kiel, Schlewig Holstein, 24105

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • University Hospital Munich-Grosshadern

    Munich, 81377

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Serbia4 sites

  • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

    Belgrade, 11000

  • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

    Novi Sad, 21000

  • Clinical Centre of Vojvodina, Emergency Internal Medicine Division

    Novi Sad, 21000

  • General Hospital Subotica

    Subotica, 24000

Other trials in Serbia

Slovakia4 sites

  • Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion

    Bratislava, 831 04

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Aura SA, s.r.o.

    Nové Mesto nad Váhom, 91501

  • Gastro I., s.r.o.

    Prešov, 08001

Other trials in Slovakia

United Kingdom4 sites

  • Department of Gastroenterology, Old Building

    Bristol, England, BS2 8HW

  • St Mark's Hospital

    Harrow, Middlesex, HA1 3UJ

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

Other trials in United Kingdom

Belgium3 sites

  • GZA St Vincentius

    Antwerp, 2018

  • AZ Groeninge, Campus Kennedylaan

    Kortrijk, 8500

  • H-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Croatia3 sites

  • University Hospital Center Osijek, Clinic of Internal Medicine,

    Osijek, 31000

  • University Hospital Center Rijeka

    Rijeka, 51000

  • University Hospital Center Zagreb,Department of Gastroenterology

    Zagreb, 10000

Other trials in Croatia

Denmark3 sites

  • Bispebjerg Hospital

    Copenhagen, NV, 2400

  • Hvidovre University Hospital

    Hvidovre, 2650

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

Israel3 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • The Edith Wolfson Medical Center/Gastroenterology Institute

    Holon, 58100

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Netherlands3 sites

  • VU University Medical Center (VUMC)

    Amsterdam, 1081 HV

  • Academic Medical Centre (AMC),

    Amsterdam, 1105AZ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

Other trials in Netherlands

South Africa3 sites

  • Panorama Medi-Clinic

    Cape Town, Western Cape, 7500

  • The Louis Leipoldt Medical Centre

    Cape Town, Western Cape, 7530

  • Dr JP Wright

    Claremont, Cape Town, Western Cape, 7708

Other trials in South Africa

Austria2 sites

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • Krankenhaus Barmherzige Brueder St. Veit/Glan

    Sankt Veit an der Glan, 9300

Other trials in Austria

Czechia2 sites

  • Nemocnice Strakonice, a.s., Interni oddeleni

    Strakonice, 386 29

  • Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.

    Ústí nad Labem, 40113

Other trials in Czechia

Romania2 sites

  • Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie

    Bucharest, Sector 5, cod 050098

  • Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie

    Jud. Mures, 540103

Other trials in Romania

Spain2 sites

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

Other trials in Spain

Taiwan2 sites

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Brazil1 site

  • Hospital de Clinicas de Porto Alegre - HCPA

    Porto Alegre, Rio Grande do Sul, 90035-003

Other trials in Brazil

Colombia1 site

  • Instituto de Coloproctologia ICO S.A.S.

    Medellín, Antioquia, 00000

Other trials in Colombia

Latvia1 site

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

Other trials in Latvia

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

    Placebo oral BID

Study groups in NCT01458951
Study groupRoleWhat they receive
tofacitinib 10 mg BIDExperimentalNot described
Receives: Drug: tofacitinib
Placebo BIDPlacebo 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 . 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.

    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 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.

    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 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.

    Measured: Week 8

  5. 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.

    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 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.

    Measured: Week 8

  7. 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.

    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) 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.

    Measured: Baseline, Weeks 2, 4, 8

  9. 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.

    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 posted25 Oct 2011 (estimated)
  2. Study startJun 2012
  3. Primary completionMay 2015
  4. Study completionJun 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
547 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458951
Sponsor's protocol ID
A3921095
Other IDs
2011-004579-35, OCTAVEINDUCTION2
Acronym
OCTAVE
Status last verified
Apr 2016
First submitted
21 Oct 2011
Last updated
1 Jun 2016
Data monitoring committee
Yes

Publications

  • Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.

    PubMed 38778549

  • 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

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 182 sites in 29 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 1 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 182 sites in United States, Hungary, South Korea, Ukraine, Estonia and 24 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 1 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 NCT01458951, which also lists 36 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 1 Jun 2016.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in