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

Ulcerative Colitis Clinical Trial

— OCTAVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458574
• Other study ID #: A3921096
• Secondary ID: 2011-004580-79OC
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2011
• Last updated: August 16, 2016
• Start date: July 2012
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Placebo
Placebo 10 mg orally (PO) twice a day (BID)
• CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
• CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)

Locations

Country	Name	City	State
Australia	Eastern Health Box Hill Hospital	Box Hill	Victoria
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Liverpool Hospital Eastern Campus	Liverpool	New South Wales
Australia	Liverpool Hospital	NSW
Austria	AKH Wien Universitatsklinik fur Innere Medizin III	Wien
Austria	AKH Wien, Universitaetsklinik fuer Innere Medizin III	Wien	Vienna
Belgium	GZA St. Vincentius	Antwerpen
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven (University Hospital Leuven), Campus Gasthuisberg	Leuven
Belgium	H-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre - HCPA	Porto Alegre	Rio Grande Do Sul
Canada	University of Alberta - Zeidler Ledcor Centre	Edmonton	Alberta
Canada	University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre	Edmonton	Alberta
Canada	McMaster University Medical Center	Hamilton	Ontario
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	Montreal General Hospital - McGill University Health Centre	Montreal	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan
Colombia	Biomedical Systems	Brussels, Belgium
Colombia	Robarts Clinical Trials	London, Canada
Colombia	Quintiles, Ltd.	Marietta	GA
Colombia	Instituto de Coloproctología ICO S.A.S.	Medellin	Antioquia
Colombia	Laboratorio Clinico y Reumatologico Reumalab	Medellin	Antioquia
Croatia	University Hospital Center Zagreb	Zagreb
Czech Republic	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czech Republic	Nemocnice Strakonice, a.s., Interni oddeleni	Strakonice
Czech Republic	Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem	Usti nad Labem
Denmark	Aalborg Hospital	Aalborg
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital Department of Hepato Gastroenterrology V Aarhus	Aarhus C
Denmark	Bispebjerg Hospital	Copenhagen	NV
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense University Hospital	Odense C
Estonia	ECG Unit, East Tallinn Central Hospital	Tallin
Estonia	East Tallinn Central Hospital Internal Medical Clinic	Tallinn
Estonia	ECG Unit of West Tallinn Central Hospital	Tallinn
Estonia	ECG Unit, Innomedica OU and Qualitas AS (ECG Only)	Tallinn
Estonia	Innomedica OU	Tallinn
Estonia	Internal Medicine Clinic	Tallinn
Estonia	Mammograaf OU (Endoscopy Only)	Tallinn
Estonia	X-Ray Department of West Tallinn Central Hospital	Tallinn
Estonia	X-Ray Unit, East Tallinn Central Hospital	Tallinn
France	CHU Amiens PICARDIE - Hopital SUD	Amiens Cedex 1
France	Hôpital Haut-Lévêque - Service pharmacie essais cliniques	Bordeaux
France	Hopital Beaujon	Clichy Cedex
France	Hotel-Dieu CHU Nantes	Nantes cedex 01
France	Hopital Saint Louis	Paris
France	Hopital Saint Louis - Service d'hepato-gastoenterologie	Paris
France	Hopital Saint Antoine - Service de Gastroenterologie	Paris cedex 12
France	C.H.U. de Reims - Hôpital Robert Debré	Reims cedex
France	Hopital Nord	Saint Priest en Jarez
Germany	Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,	Berlin
Germany	Universitasklinikum Halle	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel	Schlewig Holstein
Germany	Klinikum Lüneburg/Abteilung Gastroenterologie	Lüneburg
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Universitaetsklinikum Ulm	Ulm	Baden-wurttemberg
Hungary	Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat	Bekescsaba
Hungary	Pannonia Maganorvosi Centrum Kft.	Budapest
Hungary	Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Hungary	Szent Margit Korhaz - III Belgyogyaszat	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek	Debrecen
Hungary	Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly	Gyula
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Karolina Korhaz	Mosonmagyarovar
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika	Szeged
Hungary	Javorszky Odon Korhaz	Vac
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin Medical Center, Beilinson campus	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Italy	AOU Mater Domini	Catanzaro	Milan
Italy	AOU Mater Domini - U.O. Fisiopatologia Digestiva	Catanzaro
Italy	AOR Villa Sofia-Cervello	Palermo	PA
Italy	Istituto Clinico Humanitas IRCSS	Rozzano	Milano
Japan	Tokyo Medical And Dental University Hospital, Faculty of Medicine	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital	Chiba
Japan	Toho University Sakura Medical Center	Chiba
Japan	Kurume University Hospital	Fukuoka
Japan	Tokai University Hachioji Hospital	Hachioji	Tokyo
Japan	National Hospital Organization Mito Medical Center	Higashi-ibaraki-gun	Ibaraki
Japan	Hiroshima University Hospital	Hiroshima
Japan	Sameshima Hospital	Kagoshima-shi	Kagoshima
Japan	Kuniyoshi Hospital	Kochi-shi	Kochi
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	The Hospital of Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Osaka City University Hospital	Osaka
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga
Japan	Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital	Sapporo	Hokkaido
Japan	National Hospital Organization Sendai Medical Center	Sendai	Miyagi
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka Medical College Hospital	Takatsuki-shi	Osaka
Korea, Republic of	Kyung Hee University Hospital, Clinical Laboratory	Dongdaemun-gu	Seoul
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Kyung Hee University Hospital / Department of Gastroenterology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital,	Seoul
Latvia	Digestive Diseases Center GASTRO	Riga
Latvia	ECG room Clinic Linezers (ECG only) Riga East University Hospital	Riga
Latvia	X-Ray Department, Clinic Linezers (radiology only)	Riga
Netherlands	Academic Medical Centre	Amsterdam
Netherlands	VU University Medical Center (VUMC)	Amsterdam
Netherlands	University Medical Center Groningen (UMCG)	Groningen
Netherlands	Leiden University Medical Center (LUMC)	Leiden	ZH
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch	Canterbury Region
New Zealand	Southern District Health Board	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Shakespeare Specialist Group	Milford	Auckland
New Zealand	Tauranga Hospital	Tauranga	Bay of Plenty
New Zealand	Bowen Hospital	Wellington
New Zealand	P3 Research Limited	Wellington
New Zealand	Pacific Radiology (X-rays only)	Wellington
Poland	Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im	Bydgoszcz	Kujawsko-pomorskie
Poland	Gabinet Lekarski - Janusz Rudzinski	Bydgoszcz	Kujawsko-pomorskie
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow
Poland	Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.	Lodz	Iodzkie
Poland	Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital	Lodz
Poland	Endoskopia Sp. Z O.O.	Sopot
Poland	H-T. Centrum Medyczne - ENDOTERAPIA	Tychy	Slaskie
Poland	Klinika Chorob Wewnetrznych i Gastroenterologii z	Warszawa	Mazowieckie
Poland	Nzoz Vivamed	Warszawa
Poland	Lexmedica	Wroclaw
Romania	Spitalul Universitar de Urgenta Bucuresti, Sectia De Medicina Intema II si Gastroenterologie	Bucuresti	Sector 5
Romania	Cabinet Particular Policlinic Algomed Srl	Timisoara	Timis
Russian Federation	Federal state budget institution "State scientific centre of coloproctology"	Moscow
Russian Federation	State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.	Nizhniy Novgorod
Russian Federation	Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental	Novosibirsk
Russian Federation	Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"	Novosibirsk
Russian Federation	State Budget Educational Institution of Higher Professional Education	Novosibirsk
Russian Federation	Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",	Novosibirsk,
Russian Federation	Limited Liability Company Medical Company "Hepatolog"	Samara
Russian Federation	Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"	Samara
Russian Federation	Samara Diagnostic center, X-ray Department	Samara
Russian Federation	Municipal Institution of Healthcare City Clinical Hospital 12,	Saratov	Russia
Russian Federation	State budget institution of healthcare of Yaroslavl region Regional clinical hospital	Yaroslavl
Serbia	Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology	Belgrade	Serbia, Europe
Serbia	Clinical Hospital Centre Zvezdara	Belgrade
Serbia	Military Medical Academy Belgrade	Belgrade
Serbia	Clinical Centre of Kragujevac	Kragujevac
Serbia	Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology	Novi Sad
Serbia	Clinical Centre of Vojvodina, Emergency Internal Medicine Division	Novi Sad
Slovakia	Medak s.r.o.	Bratislava
Slovakia	KM Management spol. s.r.o.	Nitra
Slovakia	Aura SA, s.r.o.	Nove Mesto nad Vahom
Slovakia	Gastro I., s.r.o.	Presov
South Africa	Panorama MediClinic	Cape Town	Western Cape
South Africa	The Loius Leipoldt Medical Centre Alida Thorpe	Cape Town	Western Cape
South Africa	Dr John Philip Wright	Claremon	Cape Town Western Cape
South Africa	Chris Hani Baragwanath Academic Hospital	Johannesburg	Gauteng
South Africa	Endocare Research Centre	Western Cape
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario de Fuenlabrada	Madrid
Taiwan	National Taiwan University Hospital	Taipei City
Ukraine	Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"	Chernivtsi
Ukraine	Regional Municipal Institution ¿Chernivtsi Regional Clinical Hospital¿,	Chernivtsi
Ukraine	State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of	Dniepropetrovsk
Ukraine	Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department	Kharkiv
Ukraine	State Institution "National L.T. Malaya Therapy Institute of National Academy of	Kharkov
Ukraine	Kyiv Municipal Clinical Hospital #18, Proctology Department	Kyiv
Ukraine	LTD "St. Paraskeva Medical Center"	Lviv
Ukraine	Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,	Lviv
Ukraine	Municipal Institution "Odesa Regional Clinical Hospital"	Odesa
Ukraine	SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,	Odesa
Ukraine	SI "Railway Hospital of the State Institution "Odesa Railway" Odesa National Medical University,	Odessa
Ukraine	Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"	Simferopol	Ar Krym
Ukraine	SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.	Uzhgorod
Ukraine	Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,	Vinnytsia
Ukraine	Minicipal Institution City Hospital 7, Therapevtic Department,	Zaporizhzhia
Ukraine	Motor-Sich clinic, LLC	Zaporizhzhia
United Kingdom	Department of Gastroenterology, Old Building	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	NWLH NHS trust	Harrow	Middlesex
United Kingdom	The North West London Hospitals NHS Trust	Harrow	Middlesex
United Kingdom	University College Hospital	London	Greater London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United States	Georgia Endoscopy Center (COLONOSCOPY)	Alpharetta	Georgia
United States	East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems	Ann Arbor	Michigan
United States	Medical Science Research Building 1 - University of Michigan Health Systems	Ann Arbor	Michigan
United States	Michigan Clinical Research Unit - Univeristy of Michigan Health Systems	Ann Arbor	Michigan
United States	Saint Joseph Mercy Hospital - Inpatient Pharmacy	Ann Arbor	Michigan
United States	University of Michigan Health Systems	Ann Arbor	Michigan
United States	GI Consultants (COLONOSCOPY)	Atlanta	Georgia
United States	Austin Endoscopy Center II	Austin	Texas
United States	Professional Quality Research, Inc./Austin Gastroenterology PA	Austin	Texas
United States	Digestive Disease Associates, PA	Baltimore	Maryland
United States	Gastrointestinal Diagnostic Center	Baltimore	Maryland
United States	Bristol Hospital	Bristol	Connecticut
United States	Connecticut Clinical Research Foundation	Bristol	Connecticut
United States	Digestive Disease Associates, PA	Catonsville	Maryland
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Cleveland Clinic	Cleveland	Ohio
United States	Howard County GIDC	Columbia	Maryland
United States	Citrus Surgery & Endoscopy Center (colonoscopy)	Crystal River	Florida
United States	AGA Clinical Research Associates, LLC	Egg Harbour Township	New Jersey
United States	NYU Langone Long Island Clinical Research Associates	Great Neck	New York
United States	NYU Langone Nassau Gastroenterology Associates	Great Neck	New York
United States	Carolina Research, Carolina Digestive Diseases	Greenville	North Carolina
United States	Endoscopy Center of Connecticut, LLC	Guilford	Connecticut
United States	Endoscopy Center of Connecticut, LLC	Hamden	Connecticut
United States	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor College of Medicine (Baylor Medical Center)	Houston	Texas
United States	Baylor College of Medicine - Baylor Medical Center (Drug Storage)	Houston	Texas
United States	Houston Hospital for Specialized Surgery (Endoscopy only)	Houston	Texas
United States	Memorial Hermann Hospital - Ertan Digestive Disease Center	Houston	Texas
United States	The University of Texas at Houston Health Science Center	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Suncoast Endoscopy Center (colonoscopy)	Inverness	Florida
United States	Emory Healthcare Heart Center (EKG)	Johns Creek	Georgia
United States	UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center	La Jolla	California
United States	UCSD Medical Center	La Jolla	California
United States	Regional Gastroenterology Associates of Lancaster, Ltd.	Lancaster	Pennsylvania
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	South Jersey Gastroenterology	Marlton	New Jersey
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Internal Medicine Center, LLC	Mobile	Alabama
United States	Springhill Memorial Hospital (Endoscopy Only)	Mobile	Alabama
United States	Columbia University Medical Center	New York	New York
United States	CUMC Research Pharmacy	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Kornbluth, Legnani, George MD, PC	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Mount Sinai School of Medicine Faculty Practice Associates	New York	New York
United States	Present, Chapman, Marion, Steinlauf, Lichtiger MD, PC	New York	New York
United States	The Private Practice of Simon Lichtiger, MD	New York	New York
United States	Alliance Clinical Research	Oceanside	California
United States	North Florida Gastroenterology Research, LLC	Orange Park	Florida
United States	Orange Park Surgery Center	Orange Park	Florida
United States	Citrus Ambulatory Surgery Center	Orlando	Florida
United States	Internal Medicine Specialists	Orlando	Florida
United States	Desert Advanced Imaging	Palm Springs	California
United States	Erik Palmer, DO	Palm Springs	California
United States	Homan A Zadeh, MD, MPH	Palm Springs	California
United States	Central Connecticut Endoscopy Center	Plainville	Connecticut
United States	Advanced Gastroenterology Center	Port Orange	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Endoscopy Center	Port Orange	Florida
United States	Port Orange Urgent Care	Port Orange	Florida
United States	VCU Health System Digestive Health Center	Richmond	Virginia
United States	VCU Health System Endoscopy Suite	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Alpine Medical Group	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Wasatch Endoscopy Center	Salt Lake City	Utah
United States	Clinical Applications Laboratories, Inc	San Diego	California
United States	San Diego Endoscopy Center	San Diego	California
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Sharp Rees-Stealy Medical Group, Inc.	San Diego	California
United States	Medical Center at Mount Zion	San Francisco	California
United States	UCSF Endoscopy Unit at Mount Zion	San Francisco	California
United States	University of California San Francisco	San Francisco	California
United States	Atlanta Gastroenterology Specialists	Suwanee	Georgia
United States	Johns Creek Diagnostic Center (XRAY)	Suwanee	Georgia
United States	Cotton-O'Neil Clinical Research - Digestive Health	Topeka	Kansas
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Center for Digestive Health	Troy	Michigan
United States	Surgical Centers of Michigan	Troy	Michigan
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	The Endo Center at Voorhees	Vorhees	New Jersey
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan
United States	Michigan Heart SJMH	Ypsilanti	Michigan
United States	Saint Joseph Mercy Hospital Outpatient Laboratory	Ypsilanti	Michigan
United States	Florida Medical Clinic, P.A.	Zephyhills	Florida
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Croatia,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects in remission at Week 52		week 52	No
Secondary	The proportion of subjects with mucosal healing at Week 52		week 52	No
Secondary	The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096		week 24 & 52	No

External Links

•   To obtain contact information for a study center near you, click here.