AzTrials
AzTrials

Ulcerative ColitisPhase 3OCTAVENCT01470612

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

A Phase 3 study testing CP-690,550 in people with Ulcerative Colitis, run by Pfizer at 252 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

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550. 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?
CP-690,550
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
944 participants
Where
252 sitesin 31 countries
Study dates
1 Oct 2012to 6 Aug 2020
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 completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
  • Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Who cannot join

  • Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.

Trial locations and contacts

252 sites in 31 countries.

252 sites in 31 countries

United States75 sites

  • East Ann Arbor Health and Geriatrics Center -UMHS

    Ann Arbor, Michigan, 48109-2701

  • Michigan Clinical Research Unit - UMHS

    Ann Arbor, Michigan, 48109-5872

  • Medical Science Research Building 1 - UMHS

    Ann Arbor, Michigan, 48109

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Gastrointestinal Diagnostic Center

    Catonsville, Maryland, 21228

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

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

    Chevy Chase, Maryland, 20815

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Howard County GIDC

    Columbia, Maryland, 21044

  • 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

  • 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

  • Baylor College of Medicine- Baylor Medical Center

    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

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92037-0897

  • Perlman Medical Offices - UC San Diego Health System

    La Jolla, California, 92037

  • UCSD Medical Center

    La Jolla, California, 92093

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Cedars Sinai Surgery Center

    Los Angeles, California, 90048

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • South Jersey Gastroenterology, P.A.

    Marlton, New Jersey, 08053

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Center for Digestive Health

    Milwaukee, Wisconsin, 53215

  • Wisconsin Center for Advanced Research - a division of GI Associates, LLC

    Milwaukee, Wisconsin, 53215

  • Alabama Medical Group, P.C.

    Mobile, Alabama, 36608

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-1375

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • 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 Irving Medical Center

    New York, New York, 10032

  • Kornbluth, Legnani, George MD, PC

    New York, New York, 10128

  • Alliance Clinical Research

    Oceanside, California, 92056

  • Center for Endoscopy- Covenant Surgical Partners

    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

  • 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

  • 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

  • Salt Lake Regional Hospital

    Salt Lake City, Utah, 84102

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Sharp Rees-Stealy Medical Group, Inc.

    San Diego, California, 92101

  • Clinical Applications Laboratories, Inc

    San Diego, California, 92103

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92123

  • UCSF Center for Colitis and Crohn's Disease

    San Francisco, California, 94115

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Cotton O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • 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

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Huron Gastroenterology Associates - Center for Digestive Care

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Japan21 sites

  • Tokyo Medical And Dental University Hospital, Faculty of Medicine

    Bunkyo-ku, Tokyo, 113-8519

  • 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, 734-8551

  • The Hospital of Hyogo College of Medicine

    Hyōgo, 663-8501

  • Sameshima Hospital

    Kagoshima, Kagoshima-ken, 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

  • 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

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Osaka Medical College Hospital

    Takatsuki-shi, Osaka, 569-8686

  • Showa University Hospital

    Tokyo, 142-8666

Other trials in Japan

Ukraine13 sites

  • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, 58001

  • Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'

    Chernivtsi, 58001

  • SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases

    Dnipropetrovsk, 49074

  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2

    Kharkiv, 61037

  • State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"

    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

  • Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department

    Odesa, 65025

  • "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian

    Odesa, 65059

  • CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod

    Uzhhorod, 88009

  • Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

    Vinnytsia, 21005

  • Minicipal Institution City Hospital #7, Therapeutic Department,

    Zaporizhzhya, 69118

Other trials in Ukraine

Hungary12 sites

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.

    Békéscsaba, 5600

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet

    Budapest, 1076

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly

    Budapest, 1125

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, 1136

  • Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály

    Budapest, H-1032

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia

    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

Poland11 sites

  • Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital

    Bialystok, Podlaskie Voivodeship, 15-950

  • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Gabinet Lekarski - Janusz Rudzinski

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 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 Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr

    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 Pododdzialem Leczenia Nieswoistych Chorob

    Warsaw, Masovian Voivodeship, 02-507

  • NZOZ Vivamed

    Warsaw, 03-580

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

France10 sites

  • CHU Amiens-Picardie - Hopital Sud

    Amiens, 80054

  • Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive

    Clichy, 92110

  • CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

    Nantes, 44093

  • Hôpital Saint Louis - Service d'hepato-gastroenterologie

    Paris, 75010

  • Hôpital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine - Service de Gastroenterologie

    Paris, 75571

  • Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique

    Pessac, 33604

  • CHU de Reims - Hopital Robert Debre

    Reims, 51092

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Russia10 sites

  • Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"

    Moscow, 123423

  • State budget Healthcare Institution Moscow regional scientific research clinical institute

    Moscow, 129110

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

    Nizhny Novgorod, 603126

  • Municipal Budget Institution of Healthcare of Novosibirsk

    Novosibirsk, 630084

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

    Novosibirsk, 630117

  • FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"

    Novosibirsk, 630117

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

    Samara, 443029

  • Limited Liability Company Medical Company "Hepatolog"

    Samara, 443093

  • Samara Diagnostic center, X-ray Department

    Samara, 443093

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

    Yaroslavl, 150062

Other trials in Russia

Canada9 sites

  • University of Calgary, Heritage Medical Research Clinic, TRW Building

    Calgary, Alberta, T2N 4Z6

  • 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

  • Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny

    Montreal, Quebec, H1T 2M4

  • Montreal General Hospital - McGill University Health Care Centre

    Montreal, Quebec, H3G 1A4

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

Germany8 sites

  • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit

    Berlin, 13353

  • Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I

    Halle, 06120

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schlewig Holstein, 24105

  • Klinikum Lüneburg

    Lüneburg, 21339

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • University Hospital Munich-Grosshadern

    Munich, 81377

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Australia7 sites

  • Eastern Health, Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Gastroenterology and Hepatology Unit

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Liverpool Hospital eastern Campus

    Liverpool, New South Wales, 2170

Other trials in Australia

New Zealand7 sites

  • North Shore Hospital (Waitemata District Health Board)

    Auckland, 0620

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

  • Southern District Health Board

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3240

  • Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School

    Tauranga, Bay of Plenty, 3112

  • P3 Research Limited

    Wellington, 6021

Other trials in New Zealand

Serbia7 sites

  • Military Medical Academy

    Belgrade, Central Serbia, 11000

  • Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology

    Belgrade, 11000

  • Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology

    Kragujevac, 34000

  • Clinical Centre of Vojvodina Emergency Internal Medicine Division

    Novi Sad, 21000

  • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

    Novi Sad, 21000

  • General Hospital Djordje Joanovic

    Zrenjanin, 23000

Other trials in Serbia

South Korea7 sites

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital,

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Spain6 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Corporacio Sanitaria Parc Tauli

    Barcelona, 08208

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, 28040

Other trials in Spain

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 Medi-Clinic

    Cape Town, Western Cape, 7500

  • Louis Leipoldt Medical Centre

    Cape Town, Western Cape, 7530

  • Dr JP Wright

    Cape Town, Western Cape, 7708

  • Chris Hani Baragwanath Academic Hospital

    Johannesburg, Gauteng, 2013

  • Endocare Research Centre

    Paarl, Western Cape, 7646

Other trials in South Africa

United Kingdom5 sites

  • Bristol Royal Infirmary

    Bristol, England, BS2 8HW

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

    Cambridge, England, CB2 0QQ

  • The North West London Hospitals NHS Trust

    Harrow, Middlesex, HA1 3UJ

  • UCLH NIHR Clinical Research Facility

    London, W1T 7HA

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, Norfolk, NR4 7UY

Other trials in United Kingdom

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

Czechia4 sites

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

    Hradec Králové, 500 12

  • Klinicke Centrum ISCARE I.V.F., Gastroenterologie

    Prague, 170 04

  • Nemocnice Strakonice, a.s., Interni oddeleni

    Strakonice, 386 29

  • Krajska Zdravotni, A.S.,

    Ústí nad Labem, 401 13

Other trials in Czechia

Netherlands4 sites

  • VU University Medical Center

    Amsterdam, 1081 HV

  • Academic Medical Center (AMC)

    Amsterdam, 1105 AZ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

  • Leiden University Medical Center

    Leiden, 2333 ZA

Other trials in Netherlands

Slovakia4 sites

  • Medak s.r.o.

    Bratislava, 85101

  • "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra

    Nitra, 949 01

  • Poliklinika Libris, Synergy group, a.s.,

    Nové Mesto nad Váhom, 915 01

  • Gastro I., s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Austria3 sites

  • Landeskrankenhaus Innsbruck

    Innsbruck, 6020

  • Krankenhaus Barmherzige Brueder St. Veit/Glan

    Sankt Veit an der Glan, 9300

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

Israel3 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • The Edith Wolfson Medical Center/Gastroenterology Department

    Holon, 58100

  • Rabin Medical Center, Beilinson campus

    Petah Tikva, 49100

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 IRCCS-IBD Center

    Rozzano, Milano, 20089

Other trials in Italy

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, Harju, 10617

  • Innomedica OU

    Tallinn, 10117

Other trials in Estonia

Romania2 sites

  • Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie

    Bucharest, 050098

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, Timiș County, 300002

Other trials in Romania

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

Croatia1 site

  • University Hospital Center Zagreb

    Zagreb, 10 000

Other trials in Croatia

Latvia1 site

  • Digestive Diseases Center GASTRO

    Riga, LV-1006

Other trials in Latvia

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

About this study

Official title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

Being tested
CP-690,550
Keywords
Ulcerative colitis, open-label, long term treatment
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • CP-690,550Drug

    5 mg tablets, BID, for at least 12 months

  • CP-690,550Drug

    10 mg tablets, BID, for at least 12 months

Study groups in NCT01470612
Study groupRoleWhat they receive
CP-690,550 5 mg BIDExperimental5 mg BID
Receives: Drug: CP-690,550
CP-690,550 10 mg BIDExperimental10 mg BID
Receives: Drug: CP-690,550

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  2. Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)

    Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  3. Number of Participants With Laboratory Test Abnormalities

    Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  4. Number of Participants With Vital Sign Abnormalities

    Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  5. Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline

    Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  6. Number of Participants With Electrocardiogram (ECG) Abnormalities

    ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

  7. Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events

    Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).

    Measured: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

Secondary outcomes (9)

  1. Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases

    Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.

    Measured: Months 2, 12, 24 and 36

  2. Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)

    Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.

    Measured: Months 2, 12, 24 and 36

  3. Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases

    Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.

    Measured: Months 2, 12, 24 and 36

  4. Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)

    Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.

    Measured: Months 2, 12, 24 and 36

  5. Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases

    PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.

    Measured: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

  6. Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)

    PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.

    Measured: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

  7. Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases

    Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.

    Measured: Months 2, 12, 24 and 36

  8. Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)

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

    Measured: Months 2, 12, 24 and 36

  9. Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)

    IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.

    Measured: Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84

Timeline

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

  1. First posted11 Nov 2011 (estimated)
  2. Study start1 Oct 2012
  3. Primary completion6 Aug 2020
  4. Study completion6 Aug 2020

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01470612
Sponsor's protocol ID
A3921139
Other IDs
2011-004581-14, OCTAVEOPEN
Acronym
OCTAVE
Status last verified
Sep 2021
First submitted
21 Oct 2011
Last updated
17 Sep 2021
Data monitoring committee
Yes
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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

  • 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

  • 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

  • Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222.

    PubMed 36242764

  • 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

  • Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.

    PubMed 35380664

  • Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

    PubMed 34614208

  • Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

    PubMed 33884415

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP-690,550 in people with Ulcerative Colitis, run by Pfizer at 252 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 2 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 252 sites in United States, Japan, Ukraine, Hungary, Poland 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. 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 17 Sep 2021). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)). The study lists 7 primary outcomes in all. 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 NCT01470612, which also lists 27 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 17 Sep 2021.

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