AzTrials
AzTrials

Ulcerative ColitisPhase 3OCTAVENCT01458574

A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

A Phase 3 study testing CP690,550 and CP-690,550 in people with Ulcerative Colitis, run by Pfizer at 275 sites in 31 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

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of… 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?
CP690,550 and CP-690,550
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
593 participants
Where
275 sitesin 31 countries
Study dates
20 Jul 2012to 27 May 2016
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

  • Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
  • Subjects who achieved clinical response in Study A3921094 or A3921095
  • Women of childbearing potential must test negative for pregnancy prior to study enrollment
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Who cannot join

  • Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
  • Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Trial locations and contacts

275 sites in 31 countries.

275 sites in 31 countries

United States94 sites

  • Georgia Endoscopy Center

    Alpharetta, Georgia, 30005

  • Saint Joseph Mercy Hospital - Inpatient Pharmacy

    Ann Arbor, Michigan, 48106

  • East Ann Arbor Health and Geriatrics Center - UMHS

    Ann Arbor, Michigan, 48109-2701

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-5000

  • Michigan Clinical Research Unit - UMHS

    Ann Arbor, Michigan, 48109-5872

  • Medical Science Research Building 1 - UMHS

    Ann Arbor, Michigan, 48109

  • GI Consultants

    Atlanta, Georgia, 30342

  • Professional Quality Research, Inc.- Austin Gastroenterology PA

    Austin, Texas, 78705

  • Austin Endoscopy Center II

    Austin, Texas, 78745

  • Austin Gastroenterology PA

    Austin, Texas, 78745

  • Digestive Disease Associates, PA

    Baltimore, Maryland, 21229

  • Gastrointestinal Diagnostic Center

    Baltimore, Maryland, 21229

  • Bristol Hospital

    Bristol, Connecticut, 06010

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001

  • Howard County GIDC

    Columbia, Maryland, 21044

  • Citrus Surgery & Endoscopy Center (colonoscopy)

    Crystal River, Florida, 34429

  • AGA Clinical Research Associates, LLC

    Egg Harbour Township, New Jersey, 08234

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • NYU Langone Nassau Gastroenterology Associates

    Great Neck, New York, 11021

  • Carolina Research, Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • 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 (Endoscopy only)

    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

  • McGovern Medical School -The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center (colonoscopy)

    Inverness, Florida, 34453

  • Emory Healthcare Heart Center

    Johns Creek, Georgia, 30097

  • UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

    La Jolla, California, 92037-0845

  • UCSD Medical Center

    La Jolla, California, 92093

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • South Jersey Gastroenterology

    Marlton, New Jersey, 08053

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Mentor Medical Campus

    Mentor, Ohio, 44060

  • The Endoscopy Center of Lake County

    Mentor, Ohio, 44060

  • The Center for Digestive Health

    Milwaukee, Wisconsin, 53215

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Internal Medicine Center, LLC

    Mobile, Alabama, 36608

  • Springhill Memorial Hospital (Endoscopy Only)

    Mobile, Alabama, 36608

  • The Private Practice of Simon Lichtiger, MD

    New York, New York, 10028

  • IBD Center - The Mount Sinai Hospital

    New York, New York, 10029

  • Icahn School of Medicine at Mount Sinai

    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

  • Alliance Clinical Research

    Oceanside, California, 92056

  • North Florida Gastroenterology Research, LLC

    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

  • 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

  • Hope Square Surgical Center

    Rancho Mirage, California, 92270

  • VCU Health System Digestive Health Center

    Richmond, Virginia, 23298

  • VCU Health System Endoscopy Suite

    Richmond, Virginia, 23298

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • 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

  • Clinical Applications Laboratories, Inc

    San Diego, California, 92103

  • San Diego Endoscopy Center

    San Diego, California, 92103

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92123

  • UCSF Endoscopy Unit at Mount Zion

    San Francisco, California, 94115

  • University of California San Francisco

    San Francisco, California, 94115

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Johns Creek Diagnostic Center

    Suwanee, Georgia, 30024

  • Cotton-O'Neal Clinical Research Center Digestive Health

    Topeka, Kansas, 66606

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Surgical Centers of Michigan

    Troy, Michigan, 48098

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Utica Surgery Center (Endoscopy Only)

    Utica, Michigan, 48317

  • The Endo Center at Voorhees

    Vorhees, New Jersey, 08043

  • Michigan Heart SJMH

    Ypsilanti, Michigan, 48106

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

  • Saint Joseph Mercy Hospital Outpatient Laboratory

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A.

    Zephyhills, Florida, 33542

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Japan20 sites

  • Tokyo Medical And Dental University Hospital, Faculty of Medicine

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital

    Chiba, 260-8677

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Tokai University Hachioji Hospital

    Hachiōji, Tokyo, 192-0032

  • National Hospital Organization Mito Medical Center

    Higashi-ibaraki-gun, Ibaraki, 311-3193

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 892-0846

  • Kuniyoshi Hospital

    Kochi, Kochi, 780-0901

  • 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

  • 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

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Osaka Medical College Hospital

    Takatsuki-shi, Osaka, 569-8686

Other trials in Japan

Ukraine16 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 of

    Dniepropetrovsk, 49074

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

    Kharkiv, Ukraine, 61037

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

    Kharkiv, 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, Ukraine, 65010

  • Municipal Institution "Odesa Regional Clinical Hospital"

    Odesa, 65025

  • Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"

    Simferopol, Ar Krym, 95017

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

    Uzhhorod, 88009

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

    Vinnytsia, 21005

  • Motor-Sich clinic, LLC

    Zaporizhzhya, 69068

  • Minicipal Institution City Hospital 7, Therapevtic Department,

    Zaporizhzhya, 69118

  • Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University

    Zaporizhzhya, 69118

Other trials in Ukraine

Hungary12 sites

  • Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat

    Békéscsaba, Hungary, 5600

  • Szent Margit Korhaz - III Belgyogyaszat

    Budapest, 1032

  • Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

    Budapest, 1076

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1125

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, H-1135

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

    Debrecen, 4032

  • Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

    Gyula, 5700

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

    Miskolc, 3526

  • Karolina Korhaz

    Mosonmagyaróvár, 9200

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

    Szeged, 6720

  • Javorszky Odon Korhaz

    Vác, 2600

Other trials in Hungary

Russia12 sites

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

    Moscow, 123423

  • State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

    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 No 12"

    Novosibirsk, 630084

  • State Budget Educational Institution of Higher Professional Education

    Novosibirsk, 630091

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

    Novosibirsk, 630117

  • Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

    Samara, 443029

  • Limited Liability Company Medical Company "Hepatolog"

    Samara, 443063

  • Limited Liability Company Medical Company "Hepatolog"

    Samara, 443093

  • Samara Diagnostic center, X-ray Department

    Samara, 443093

  • Municipal Institution of Healthcare City Clinical Hospital 12,

    Saratov, Russia, 410039

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

    Yaroslavl, 150062

Other trials in Russia

Estonia10 sites

  • ECG Unit of West Tallinn Central Hospital

    Tallinn, Estonia, 10617

  • West Tallinn Central Hospital

    Tallinn, Estonia, 10617

  • X- Ray Department of West Tallinn Central Hospital

    Tallinn, Estonia, 10617

  • X-Ray Unit, East Tallinn Central Hospital

    Tallinn, 101 38

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

    Tallinn, 10117

  • Innomedica OU

    Tallinn, 10117

  • East Tallinn Central Hospital Internal Medical Clinic

    Tallinn, 10138

  • ECG Unit, East Tallinn Central Hospital

    Tallinn, 10138

  • X-Ray Department of West Tallinn Central Hospital

    Tallinn, 10617

  • Mammograaf OU (Endoscopy Only)

    Tallinn, 13419

Other trials in Estonia

Poland10 sites

  • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Gabinet Lekarski - Janusz Rudzinski

    Bydgoszcz, 85-681

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

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

    Lodz, Iodzkie, 90-302

  • Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

    Lodz, 90-153

  • Endoskopia Sp. Z O.O.

    Sopot, 81-756

  • H-T. Centrum Medyczne - ENDOTERAPIA

    Tychy, Silesian Voivodeship, 43-100

  • Klinika Chorob Wewnetrznych i Gastroenterologii z

    Warsaw, Masovian Voivodeship, 02-507

  • Nzoz Vivamed

    Warsaw, 03-580

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

France9 sites

  • CHU Amiens PICARDIE - Hopital SUD

    Amiens, 80054

  • Hopital Saint Andre

    Bordeaux, 33075

  • Hopital Beaujon

    Clichy, 92110

  • Hotel-Dieu CHU Nantes

    Nantes, 44093

  • Hopital Saint Louis - Service d'hepato-gastoenterologie

    Paris, 75010

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine - Service de Gastroenterologie

    Paris, 75571

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

    Reims, 51092

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

Other trials in France

New Zealand9 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

  • Southern District Health Board

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3240

  • Shakespeare Specialist Group

    Milford, Auckland, 0620

  • Tauranga Hospital

    Tauranga, Bay of Plenty, 3143

  • P3 Research Limited

    Wellington, 6021

  • Pacific Radiology (X-rays only)

    Wellington, 6021

  • Bowen Hospital

    Wellington, 6035

Other trials in New Zealand

Canada7 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

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • 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

Germany7 sites

  • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

    Berlin, 13353

  • Universitätsklinikum Halle

    Halle, 06120

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schlewig Holstein, 24105

  • Klinikum Lüneburg/Abteilung Gastroenterologie

    Lüneburg, 21339

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Serbia7 sites

  • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

    Belgrade, Serbia, Europe, 11000

  • Clinical Hospital Centre Zvezdara

    Belgrade, 11000

  • Military Medical Academy Belgrade

    Belgrade, 11000

  • Clinical Centre of Kragujevac

    Kragujevac, 34000

  • 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 ""Djordje Joanovic""

    Zrenjanin, 23000

Other trials in Serbia

United Kingdom7 sites

  • Department of Gastroenterology, Old Building

    Bristol, England, BS2 8HW

  • Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB20QQ

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • NWLH NHS trust

    Harrow, Middlesex, HA1 3UJ

  • The North West London Hospitals NHS Trust

    Harrow, Middlesex, HA1 3UJ

  • University College Hospital

    London, Greater London, NW1 2BU

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY

Other trials in United Kingdom

South Korea6 sites

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 471-701

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • KyungHee University Hospital

    Seoul, Republic of Korea, 130-872

  • Kyung Hee University Hospital

    Seoul, 02447

  • Samsung Medical Center

    Seoul, 06351

  • Seoul National University Hospital,

    Seoul, 110-744

Other trials in South Korea

Denmark5 sites

  • Aalborg Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus C, 8000

  • Bispebjerg Hospital

    Copenhagen NV, 2400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Odense University Hospital

    Odense C, 5000

Other trials in Denmark

South Africa5 sites

  • Panorama MediClinic

    Cape Town, Western Cape, 7500

  • Louis Leipoldt Medical Centre

    Cape Town, Western Cape, 7530

  • Dr John Philip Wright

    Claremont, Cape Town, 7708

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng, 2013

  • Endocare Research Centre

    Western Cape, 7646

Other trials in South Africa

Australia4 sites

  • Eastern Health-Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

Other trials in Australia

Belgium4 sites

  • GZA St. Vincentius

    Antwerp, 2018

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

    Leuven, 3000

  • H-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Netherlands4 sites

  • VU University Medical Center (VUMC)

    Amsterdam, 1081 HV

  • Academic Medical Centre

    Amsterdam, 1105 AZ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

  • Leiden University Medical Center (LUMC)

    Leiden, 2333 ZA

Other trials in Netherlands

Slovakia4 sites

  • Medak s.r.o.

    Bratislava, 851 01

  • 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, 080 01

Other trials in Slovakia

Spain4 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge, Servicio de Digestivo

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

Other trials in Spain

Czechia3 sites

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

    Hradec Králové, 500 12

  • Nemocnice Strakonice, a.s., Interni oddeleni

    Strakonice, 386 29

  • Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem

    Ústí nad Labem, 40113

Other trials in Czechia

Israel3 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Rabin Medical Center, Beilinson campus

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Italy3 sites

  • AOU Mater Domini - U.O. Fisiopatologia Digestiva

    Catanzaro, 88100

  • AOR Villa Sofia-Cervello

    Palermo, PA, 90146

  • Istituto Clinico Humanitas IRCSS

    Rozzano, Milano, 20089

Other trials in Italy

Latvia3 sites

  • ECG room Clinic Linezers (ECG only) Riga East University Hospital

    Riga, LV-1006

  • X-Ray Department, Clinic Linezers (radiology only)

    Riga, LV-1006

  • Digestive Diseases Center GASTRO

    Riga, LV1006

Other trials in Latvia

Romania2 sites

  • Spitalul Universitar de Urgenta Bucharest

    Bucharest, 050098

  • Cabinet Particular Policlinic Algomed Srl

    Timișoara, Timiș County, 300002

Other trials in Romania

Austria1 site

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III

    Vienna, State of Vienna, 1090

Other trials in Austria

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 Coloproctología ICO S.A.S.

    Medellín, Antioquia, 00000

Other trials in Colombia

Croatia1 site

  • University Hospital Center Zagreb

    Zagreb, 10 000

Other trials in Croatia

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Being tested
Placebo, CP690,550, CP-690,550
Keywords
Janus kinase inhibitor, JAK 3 inhibitor, inflammatory bowel disease, ulcerative colitis, OCTAVE, CP-690, 550, tofacitinib, Xeljanz
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

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

  • PlaceboDrug

    Placebo 10 mg orally (PO) twice a day (BID)

  • CP690,550Drug

    CP-690,550 5 mg orally (PO) twice a day (BID)

  • CP-690,550Drug

    CP-690,550 10 mg orally (PO) twice a day (BID)

Study groups in NCT01458574
Study groupRoleWhat they receive
Placebo ComparatorPlacebo comparatorNot described
Receives: Drug: Placebo
CP-690,550 5 mg ArmExperimentalNot described
Receives: Drug: CP690,550
CP-690,550 10 mg ArmExperimentalNot described
Receives: Drug: CP-690,550

What is being measured

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

  1. Percentage of Participants In Remission at Week 52

    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 was 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 sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.

    Measured: Week 52

Secondary outcomes (25)

  1. Percentage of Participants With Mucosal Healing at Week 52

    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 sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.

    Measured: Week 52

  2. Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline

    Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.

    Measured: Week 24, 52

  3. Percentage of Participants in Remission at Week 24

    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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24

  4. Percentage of Participants in Sustained Remission

    Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.

    Measured: Week 24, 52

  5. Percentage of Participants With Mucosal Healing at Week 24

    Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.

    Measured: Week 24

  6. Percentage of Participants With Sustained Mucosal Healing

    Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.

    Measured: Week 24, 52

  7. Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline

    Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.

    Measured: Week 24, 52

  8. Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline

    Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.

    Measured: Week 24, 52

  9. Percentage of Participants With Clinical Response at Week 24 and 52

    Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.

    Measured: Week 24, 52

  10. Percentage of Participants With Sustained Clinical Response

    Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.

    Measured: Week 24, 52

  11. Percentage of Participants in Clinical Remission at Week 24 and 52

    Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  12. Percentage of Participants in Sustained Clinical Remission

    Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  13. Percentage of Participants in Deep Remission at Week 24 and 52

    Deep remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  14. Percentage of Participants in Sustained Deep Remission

    Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  15. Percentage of Participants in Symptomatic Remission at Week 24 and 52

    Symptomatic remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  16. Percentage of Participants in Sustained Symptomatic Remission

    Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Week 24, 52

  17. Percentage of Participants in Endoscopic Remission at Week 24 and 52

    Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.

    Measured: Week 24, 52

  18. Percentage of Participants in Sustained Endoscopic Remission

    Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.

    Measured: Week 24, 52

  19. Total Mayo Score at Baseline, Week 24 and 52

    Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.

    Measured: Baseline, Week 24, 52

  20. Change From Baseline in Total Mayo Score at Week 24 and 52

    Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.

    Measured: Baseline, Week 24, 52

  21. Percentage of Participants in Remission, Among Participants With Remission at Baseline

    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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.

    Measured: Week 24, 52

  22. Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline

    Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.

    Measured: Week 24, 52

  23. Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline

    Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.

    Measured: Week 24, 52

  24. Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline

    Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.

    Measured: Week 24, 52

  25. Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline

    Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.

    Measured: Week 24, 52

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 start20 Jul 2012
  3. Primary completion27 May 2016
  4. Study completion27 May 2016

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
Double blind
Who is masked
Participant, Investigator
Enrolment
593 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458574
Sponsor's protocol ID
A3921096
Other IDs
2011-004580-79, OCTAVESUSTAIN
Acronym
OCTAVE
Status last verified
Apr 2017
First submitted
21 Oct 2011
Last updated
18 May 2017
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

  • Lee SD, Allegretti JR, Steinwurz F, Connelly SB, Lawendy N, Paulissen J, Gecse KB. Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by OCTAVE Sustain baseline Mayo endoscopic subscore. BMC Gastroenterol. 2023 Feb 8;23(1):34. doi: 10.1186/s12876-022-02508-2.

    PubMed 36755231

  • 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

  • Vavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Ther Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.

    PubMed 35574426

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP690,550 and CP-690,550 in people with Ulcerative Colitis, run by Pfizer at 275 sites in 31 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 5 inclusion and 3 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 275 sites in United States, Japan, Ukraine, Hungary, Russia and 26 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 18 May 2017). 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 In Remission at Week 52 (time frame: Week 52). 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 NCT01458574, which also lists 34 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 18 May 2017.

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