Back to results

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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

CP690,550

CP-690,550

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Janus kinase inhibitor, JAK 3 inhibitor, inflammatory bowel disease, ulcerative colitis, OCTAVE, CP-690, 550, tofacitinib, Xeljanz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Internal Medicine Center, LLC
Springhill Memorial Hospital (Endoscopy Only)
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
UCSD Medical Center
Alliance Clinical Research
Desert Advanced Imaging
Erik Palmer, DO
Homan A Zadeh, MD, MPH
Hope Square Surgical Center
Sharp Rees-Stealy Medical Group, Inc.
Clinical Applications Laboratories, Inc
San Diego Endoscopy Center
Sharp Rees-Stealy Medical Group
UCSF Endoscopy Unit at Mount Zion
University of California San Francisco
Bristol Hospital
Connecticut Clinical Research Foundation
Endoscopy Center of Connecticut, LLC
Endoscopy Center of Connecticut, LLC
Gastroenterology Center of Connecticut, PC
Medical Research Center of Connecticut, LLC
Central Connecticut Endoscopy Center
Citrus Surgery & Endoscopy Center (colonoscopy)
Nature Coast Clinical Research
Suncoast Endoscopy Center (colonoscopy)
North Florida Gastroenterology Research, LLC
Citrus Ambulatory Surgery Center
Internal Medicine Specialists
Advanced Gastroenterology Center
Advanced Medical Research Center
Endoscopy Center
Port Orange Urgent Care
Florida Medical Clinic, P.A.
Florida Medical Clinic, P.A.
Georgia Endoscopy Center
GI Consultants
Emory Healthcare Heart Center
Gastroenterology Associates of Central Georgia, LLC
Atlanta Gastroenterology Specialists, PC
Johns Creek Diagnostic Center
Cotton-O'Neal Clinical Research Center Digestive Health
Digestive Disease Associates, PA
Gastrointestinal Diagnostic Center
Digestive Disease Associates, PA
Howard County GIDC
Saint Joseph Mercy Hospital - Inpatient Pharmacy
East Ann Arbor Health and Geriatrics Center - UMHS
University of Michigan Health Systems
Michigan Clinical Research Unit - UMHS
Medical Science Research Building 1 - UMHS
Clinical Research Institute of Michigan, LLC
Center for Digestive Health
Surgical Centers of Michigan
Utica Surgery Center (Endoscopy Only)
Michigan Heart SJMH
Huron Gastroenterology Associates
Saint Joseph Mercy Hospital Outpatient Laboratory
Mayo Clinic
Dartmouth Hitchcock Medical Center
AGA Clinical Research Associates, LLC
South Jersey Gastroenterology
The Endo Center at Voorhees
NYU Langone Long Island Clinical Research Associates
NYU Langone Nassau Gastroenterology Associates
The Private Practice of Simon Lichtiger, MD
IBD Center - The Mount Sinai Hospital
Icahn School of Medicine at Mount Sinai
Columbia University Medical Center
CUMC Research Pharmacy
Kornbluth, Legnani, George MD, PC
University of Rochester
Carolina Research, Carolina Digestive Diseases
Cleveland Clinic
Great Lakes Gastroenterology
Mentor Medical Campus
The Endoscopy Center of Lake County
Regional Gastroenterology Associates of Lancaster, Ltd.
Professional Quality Research, Inc.- Austin Gastroenterology PA
Austin Endoscopy Center II
Austin Gastroenterology PA
Houston Hospital for Specialized Surgery (Endoscopy only)
Baylor College of Medicine (Baylor Medical Center)
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
McGovern Medical School -The University of Texas Health Science Center at Houston
Memorial Hermann Hospital
Digestive Health Specialists of Tyler
Alpine Medical Group
Wasatch Clinical Research
Wasatch Endoscopy Center
VCU Health System Digestive Health Center
VCU Health System Endoscopy Suite
Virginia Commonwealth University
The Center for Digestive Health
Wisconsin Center for Advanced Research
Concord Repatriation General Hospital
Liverpool Hospital
Eastern Health-Box Hill Hospital
Monash Medical Centre
AKH Wien, Universitaetsklinik fuer Innere Medizin III
GZA St. Vincentius
AZ Groeninge
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
H-Hartziekenhuis Roeselare-Menen vzw
Hospital de Clinicas de Porto Alegre - HCPA
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
University of Alberta - Zeidler Ledcor Centre
McMaster University Medical Center
London Health Sciences Centre - University Hospital
Montreal General Hospital - McGill University Health Centre
Saskatoon City Hospital
Royal University Hospital
Instituto de Coloproctología ICO S.A.S.
University Hospital Center Zagreb
Hepato-Gastroenterologie HK, s.r.o.
Nemocnice Strakonice, a.s., Interni oddeleni
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem
Aalborg Hospital
Aarhus University Hospital
Bispebjerg Hospital
Hvidovre Hospital
Odense University Hospital
X-Ray Unit, East Tallinn Central Hospital
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Innomedica OU
East Tallinn Central Hospital Internal Medical Clinic
ECG Unit of West Tallinn Central Hospital
West Tallinn Central Hospital
X- Ray Department of West Tallinn Central Hospital
X-Ray Department of West Tallinn Central Hospital
Mammograaf OU (Endoscopy Only)
ECG Unit, East Tallinn Central Hospital
CHU Amiens PICARDIE - Hopital SUD
Hopital Saint Andre
Hopital Beaujon
Hotel-Dieu CHU Nantes
Hopital Saint Antoine - Service de Gastroenterologie
Hopital Saint Louis - Service d'hepato-gastoenterologie
Hopital Saint Louis
C.H.U. de Reims - Hôpital Robert Debré
Hopital Nord
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
Universitätsklinikum Halle
Medizinische Hochschule Hannover
Klinikum Lüneburg/Abteilung Gastroenterologie
Gastroenterologische Gemeinschaftspraxis Minden
Universitaetsklinikum Ulm
Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat
Szent Margit Korhaz - III Belgyogyaszat
Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Pannonia Maganorvosi Centrum Kft.
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek
Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Karolina Korhaz
Pecsi Tudomanyegyetem Klinikai Kozpont
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
Javorszky Odon Korhaz
Rambam Health Care Campus
Rabin Medical Center, Beilinson campus
Kaplan Medical Center
Istituto Clinico Humanitas IRCSS
AOR Villa Sofia-Cervello
AOU Mater Domini - U.O. Fisiopatologia Digestiva
Aichi Medical University Hospital
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
The Hospital of Hyogo College of Medicine
National Hospital Organization Mito Medical Center
Sameshima Hospital
Kuniyoshi Hospital
National Hospital Organization Sendai Medical Center
Osaka Medical College Hospital
Shiga University of Medical Science Hospital
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Tokai University Hachioji Hospital
Kitasato University Kitasato Institute Hospital
NTT Medical Center Tokyo
Showa University Hospital
Keio University Hospital
Chiba University Hospital
Toho University Sakura Medical Center
Kurume University Hospital
Hiroshima University Hospital
Osaka City University Hospital
Hanyang University Guri Hospital
KyungHee University Hospital
Gachon University Gil Medical Center
Kyung Hee University Hospital
Samsung Medical Center
Seoul National University Hospital,
ECG room Clinic Linezers (ECG only) Riga East University Hospital
X-Ray Department, Clinic Linezers (radiology only)
Digestive Diseases Center GASTRO
VU University Medical Center (VUMC)
Academic Medical Centre
University Medical Center Groningen (UMCG)
Leiden University Medical Center (LUMC)
Shakespeare Specialist Group
Tauranga Hospital
Christchurch Hospital
Auckland City Hospital
Southern District Health Board
Waikato Hospital
P3 Research Limited
Pacific Radiology (X-rays only)
Bowen Hospital
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im
Klinika Chorob Wewnetrznych i Gastroenterologii z
H-T. Centrum Medyczne - ENDOTERAPIA
Gabinet Lekarski - Janusz Rudzinski
Gabinet Endoskopii Przewodu Pokarmowego
Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital
Endoskopia Sp. Z O.O.
Nzoz Vivamed
Lexmedica
Cabinet Particular Policlinic Algomed Srl
Spitalul Universitar de Urgenta Bucharest
Municipal Institution of Healthcare City Clinical Hospital 12,
Federal state budget institution "State scientific centre of coloproctology"
State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",
Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"
State Budget Educational Institution of Higher Professional Education
Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
Limited Liability Company Medical Company "Hepatolog"
Limited Liability Company Medical Company "Hepatolog"
Samara Diagnostic center, X-ray Department
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Clinical Hospital Centre Zvezdara
Military Medical Academy Belgrade
Clinical Centre of Kragujevac
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
"General Hospital ""Djordje Joanovic""
Medak s.r.o.
KM Management spol. s.r.o.
Aura SA, s.r.o.
Gastro I., s.r.o.
Dr John Philip Wright
Chris Hani Baragwanath Academic Hospital
Panorama MediClinic
Louis Leipoldt Medical Centre
Endocare Research Centre
Hospital Universitari de Bellvitge, Servicio de Digestivo
Hospital Clinic i Provincial de Barcelona
Hospital Clinico San Carlos
Hospital Universitario de Fuenlabrada
National Taiwan University Hospital
Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Regional Municipal Institution Chernivtsi Regional Clinical Hospital,
State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
State Institution "National L.T. Malaya Therapy Institute of National Academy of
Kyiv Municipal Clinical Hospital #18, Proctology Department
LTD "St. Paraskeva Medical Center"
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
Municipal Institution "Odesa Regional Clinical Hospital"
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,
Motor-Sich clinic, LLC
Minicipal Institution City Hospital 7, Therapevtic Department,
Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University
Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust
Department of Gastroenterology, Old Building
University College Hospital
NWLH NHS trust
The North West London Hospitals NHS Trust
Norfolk and Norwich University Hospital
Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator

CP-690,550 5 mg Arm

CP-690,550 10 mg Arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

Full Information

NCT ID

NCT01458574

First Posted

October 21, 2011

Last Updated

April 7, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01458574

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 20, 2012 (Actual)

Primary Completion Date

May 27, 2016 (Actual)

Study Completion Date

May 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Janus kinase inhibitor, JAK 3 inhibitor, inflammatory bowel disease, ulcerative colitis, OCTAVE, CP-690, 550, tofacitinib, Xeljanz

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

593 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Title

CP-690,550 5 mg Arm

Arm Type

Experimental

Arm Title

CP-690,550 10 mg Arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CP690,550

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants In Remission at Week 52

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Percentage of Participants With Mucosal Healing at Week 52

Description

Time Frame

Week 52

Title

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

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Remission at Week 24

Description

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.

Time Frame

Week 24

Title

Percentage of Participants in Sustained Remission

Description

Time Frame

Week 24, 52

Title

Percentage of Participants With Mucosal Healing at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants With Sustained Mucosal Healing

Description

Time Frame

Week 24, 52

Title

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

Description

Time Frame

Week 24, 52

Title

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

Description

Time Frame

Week 24, 52

Title

Percentage of Participants With Clinical Response at Week 24 and 52

Description

Time Frame

Week 24, 52

Title

Percentage of Participants With Sustained Clinical Response

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Clinical Remission at Week 24 and 52

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Sustained Clinical Remission

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Deep Remission at Week 24 and 52

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Sustained Deep Remission

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Symptomatic Remission at Week 24 and 52

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Sustained Symptomatic Remission

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Endoscopic Remission at Week 24 and 52

Description

Time Frame

Week 24, 52

Title

Percentage of Participants in Sustained Endoscopic Remission

Description

Time Frame

Week 24, 52

Title

Total Mayo Score at Baseline, Week 24 and 52

Description

Time Frame

Baseline, Week 24, 52

Title

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

Description

Time Frame

Baseline, Week 24, 52

Title

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

Description

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.

Time Frame

Week 24, 52

Title

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

Description

Time Frame

Week 24, 52

Title

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

Description

Time Frame

Week 24, 52

Title

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

Description

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.

Time Frame

Week 24, 52

Title

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

Description

Time Frame

Week 24, 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Internal Medicine Center, LLC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Springhill Memorial Hospital (Endoscopy Only)

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92037-0845

Country

United States

Facility Name

UCSD Medical Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Alliance Clinical Research

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Desert Advanced Imaging

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Erik Palmer, DO

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Homan A Zadeh, MD, MPH

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Hope Square Surgical Center

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Sharp Rees-Stealy Medical Group, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92101

Country

United States

Facility Name

Clinical Applications Laboratories, Inc

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

San Diego Endoscopy Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Sharp Rees-Stealy Medical Group

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

UCSF Endoscopy Unit at Mount Zion

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Bristol Hospital

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Connecticut Clinical Research Foundation

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Endoscopy Center of Connecticut, LLC

City

Guilford

State/Province

Connecticut

ZIP/Postal Code

06437

Country

United States

Facility Name

Endoscopy Center of Connecticut, LLC

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Gastroenterology Center of Connecticut, PC

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Medical Research Center of Connecticut, LLC

City

Hamden

State/Province

Connecticut

ZIP/Postal Code

06518

Country

United States

Facility Name

Central Connecticut Endoscopy Center

City

Plainville

State/Province

Connecticut

ZIP/Postal Code

06062

Country

United States

Facility Name

Citrus Surgery & Endoscopy Center (colonoscopy)

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Nature Coast Clinical Research

City

Inverness

State/Province

Florida

ZIP/Postal Code

34452

Country

United States

Facility Name

Suncoast Endoscopy Center (colonoscopy)

City

Inverness

State/Province

Florida

ZIP/Postal Code

34453

Country

United States

Facility Name

North Florida Gastroenterology Research, LLC

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Citrus Ambulatory Surgery Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Internal Medicine Specialists

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Advanced Gastroenterology Center

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Advanced Medical Research Center

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Endoscopy Center

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Port Orange Urgent Care

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Florida Medical Clinic, P.A.

City

Zephyhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Florida Medical Clinic, P.A.

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Georgia Endoscopy Center

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30005

Country

United States

Facility Name

GI Consultants

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Emory Healthcare Heart Center

City

Johns Creek

State/Province

Georgia

ZIP/Postal Code

30097

Country

United States

Facility Name

Gastroenterology Associates of Central Georgia, LLC

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Atlanta Gastroenterology Specialists, PC

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Johns Creek Diagnostic Center

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Cotton-O'Neal Clinical Research Center Digestive Health

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Digestive Disease Associates, PA

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Gastrointestinal Diagnostic Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Digestive Disease Associates, PA

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

Facility Name

Howard County GIDC

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Saint Joseph Mercy Hospital - Inpatient Pharmacy

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

East Ann Arbor Health and Geriatrics Center - UMHS

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-2701

Country

United States

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5000

Country

United States

Facility Name

Michigan Clinical Research Unit - UMHS

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5872

Country

United States

Facility Name

Medical Science Research Building 1 - UMHS

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Clinical Research Institute of Michigan, LLC

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Center for Digestive Health

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Surgical Centers of Michigan

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Utica Surgery Center (Endoscopy Only)

City

Utica

State/Province

Michigan

ZIP/Postal Code

48317

Country

United States

Facility Name

Michigan Heart SJMH

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Huron Gastroenterology Associates

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Saint Joseph Mercy Hospital Outpatient Laboratory

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

AGA Clinical Research Associates, LLC

City

Egg Harbour Township

State/Province

New Jersey

ZIP/Postal Code

08234

Country

United States

Facility Name

South Jersey Gastroenterology

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

The Endo Center at Voorhees

City

Vorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

NYU Langone Long Island Clinical Research Associates

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

NYU Langone Nassau Gastroenterology Associates

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

The Private Practice of Simon Lichtiger, MD

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

Facility Name

IBD Center - The Mount Sinai Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

CUMC Research Pharmacy

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Kornbluth, Legnani, George MD, PC

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Carolina Research, Carolina Digestive Diseases

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195-0001

Country

United States

Facility Name

Great Lakes Gastroenterology

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Mentor Medical Campus

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

The Endoscopy Center of Lake County

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Regional Gastroenterology Associates of Lancaster, Ltd.

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

Facility Name

Professional Quality Research, Inc.- Austin Gastroenterology PA

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Austin Endoscopy Center II

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Austin Gastroenterology PA

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Houston Hospital for Specialized Surgery (Endoscopy only)

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Baylor College of Medicine (Baylor Medical Center)

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

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

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

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

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Digestive Health Specialists of Tyler

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Alpine Medical Group

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Wasatch Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Wasatch Endoscopy Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

VCU Health System Digestive Health Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

VCU Health System Endoscopy Suite

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

The Center for Digestive Health

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Wisconsin Center for Advanced Research

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Concord Repatriation General Hospital

City

Concord

State/Province

New South Wales

ZIP/Postal Code

2139

Country

Australia

Facility Name

Liverpool Hospital

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Eastern Health-Box Hill Hospital

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Monash Medical Centre

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

AKH Wien, Universitaetsklinik fuer Innere Medizin III

City

Wien

State/Province

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

GZA St. Vincentius

City

Antwerpen

ZIP/Postal Code

2018

Country

Belgium

Facility Name

AZ Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

H-Hartziekenhuis Roeselare-Menen vzw

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Hospital de Clinicas de Porto Alegre - HCPA

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

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

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

University of Alberta - Zeidler Ledcor Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

Facility Name

McMaster University Medical Center

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

London Health Sciences Centre - University Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Montreal General Hospital - McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

Saskatoon City Hospital

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0M7

Country

Canada

Facility Name

Royal University Hospital

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Instituto de Coloproctología ICO S.A.S.

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

00000

Country

Colombia

Facility Name

University Hospital Center Zagreb

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Hepato-Gastroenterologie HK, s.r.o.

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czech Republic

Facility Name

Nemocnice Strakonice, a.s., Interni oddeleni

City

Strakonice

ZIP/Postal Code

386 29

Country

Czech Republic

Facility Name

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

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czech Republic

Facility Name

Aalborg Hospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Aarhus University Hospital

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Bispebjerg Hospital

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Hvidovre Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Odense University Hospital

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

X-Ray Unit, East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

101 38

Country

Estonia

Facility Name

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

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

Innomedica OU

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

East Tallinn Central Hospital Internal Medical Clinic

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

ECG Unit of West Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

West Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

X- Ray Department of West Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

X-Ray Department of West Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Mammograaf OU (Endoscopy Only)

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

ECG Unit, East Tallinn Central Hospital

City

Tallin

ZIP/Postal Code

10138

Country

Estonia

Facility Name

CHU Amiens PICARDIE - Hopital SUD

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Hopital Saint Andre

City

Bordeaux cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Hopital Beaujon

City

Clichy Cedex

ZIP/Postal Code

92110

Country

France

Facility Name

Hotel-Dieu CHU Nantes

City

Nantes cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Hopital Saint Antoine - Service de Gastroenterologie

City

Paris cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Hopital Saint Louis - Service d'hepato-gastoenterologie

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Hopital Saint Louis

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

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

City

Reims cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Hopital Nord

City

Saint Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

State/Province

Schlewig Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Universitätsklinikum Halle

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Klinikum Lüneburg/Abteilung Gastroenterologie

City

Lüneburg

ZIP/Postal Code

21339

Country

Germany

Facility Name

Gastroenterologische Gemeinschaftspraxis Minden

City

Minden

ZIP/Postal Code

32423

Country

Germany

Facility Name

Universitaetsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Szent Margit Korhaz - III Belgyogyaszat

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

City

Budapest

ZIP/Postal Code

1076

Country

Hungary

Facility Name

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Pannonia Maganorvosi Centrum Kft.

City

Budapest

ZIP/Postal Code

H-1135

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Karolina Korhaz

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Klinikai Kozpont

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

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

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Javorszky Odon Korhaz

City

Vac

ZIP/Postal Code

2600

Country

Hungary

Facility Name

Rambam Health Care Campus

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Rabin Medical Center, Beilinson campus

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Kaplan Medical Center

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Istituto Clinico Humanitas IRCSS

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

AOR Villa Sofia-Cervello

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

AOU Mater Domini - U.O. Fisiopatologia Digestiva

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Aichi Medical University Hospital

City

Nagakute

State/Province

Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

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

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

The Hospital of Hyogo College of Medicine

City

Nishinomiya

State/Province

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

National Hospital Organization Mito Medical Center

City

Higashi-ibaraki-gun

State/Province

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Sameshima Hospital

City

Kagoshima-shi

State/Province

Kagoshima

ZIP/Postal Code

892-0846

Country

Japan

Facility Name

Kuniyoshi Hospital

City

Kochi-shi

State/Province

Kochi

ZIP/Postal Code

780-0901

Country

Japan

Facility Name

National Hospital Organization Sendai Medical Center

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

983-8520

Country

Japan

Facility Name

Osaka Medical College Hospital

City

Takatsuki-shi

State/Province

Osaka

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Shiga University of Medical Science Hospital

City

Otsu-shi

State/Province

Shiga

ZIP/Postal Code

520-2192

Country

Japan

Facility Name

Tokyo Medical And Dental University Hospital, Faculty of Medicine

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

Tokai University Hachioji Hospital

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0032

Country

Japan

Facility Name

Kitasato University Kitasato Institute Hospital

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-8642

Country

Japan

Facility Name

NTT Medical Center Tokyo

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

Facility Name

Showa University Hospital

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Keio University Hospital

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Chiba University Hospital

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Toho University Sakura Medical Center

City

Chiba

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

Kurume University Hospital

City

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Hiroshima University Hospital

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Osaka City University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Hanyang University Guri Hospital

City

Guri-si

State/Province

Gyeonggi-do

ZIP/Postal Code

471-701

Country

Korea, Republic of

Facility Name

KyungHee University Hospital

City

Seoul

State/Province

Republic of Korea

ZIP/Postal Code

130-872

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Kyung Hee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Seoul National University Hospital,

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

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

City

Riga

ZIP/Postal Code

LV-1006

Country

Latvia

Facility Name

X-Ray Department, Clinic Linezers (radiology only)

City

Riga

ZIP/Postal Code

LV-1006

Country

Latvia

Facility Name

Digestive Diseases Center GASTRO

City

Riga

ZIP/Postal Code

LV1006

Country

Latvia

Facility Name

VU University Medical Center (VUMC)

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Academic Medical Centre

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

University Medical Center Groningen (UMCG)

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Leiden University Medical Center (LUMC)

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Shakespeare Specialist Group

City

Milford

State/Province

Auckland

ZIP/Postal Code

0620

Country

New Zealand

Facility Name

Tauranga Hospital

City

Tauranga

State/Province

Bay of Plenty

ZIP/Postal Code

3143

Country

New Zealand

Facility Name

Christchurch Hospital

City

Christchurch

State/Province

Canterbury Region

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Auckland City Hospital

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Southern District Health Board

City

Dunedin

ZIP/Postal Code

9016

Country

New Zealand

Facility Name

Waikato Hospital

City

Hamilton

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

P3 Research Limited

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Pacific Radiology (X-rays only)

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Bowen Hospital

City

Wellington

ZIP/Postal Code

6035

Country

New Zealand

Facility Name

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

City

Lodz

State/Province

Iodzkie

ZIP/Postal Code

90-302

Country

Poland

Facility Name

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

City

Bydgoszcz

State/Province

Kujawsko-pomorskie

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Klinika Chorob Wewnetrznych i Gastroenterologii z

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-507

Country

Poland

Facility Name

H-T. Centrum Medyczne - ENDOTERAPIA

City

Tychy

State/Province

Slaskie

ZIP/Postal Code

43-100

Country

Poland

Facility Name

Gabinet Lekarski - Janusz Rudzinski

City

Bydgoszcz

ZIP/Postal Code

85-681

Country

Poland

Facility Name

Gabinet Endoskopii Przewodu Pokarmowego

City

Krakow

ZIP/Postal Code

31-009

Country

Poland

Facility Name

Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Endoskopia Sp. Z O.O.

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

Nzoz Vivamed

City

Warszawa

ZIP/Postal Code

03-580

Country

Poland

Facility Name

Lexmedica

City

Wroclaw

ZIP/Postal Code

53-114

Country

Poland

Facility Name

Cabinet Particular Policlinic Algomed Srl

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300002

Country

Romania

Facility Name

Spitalul Universitar de Urgenta Bucharest

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Facility Name

Municipal Institution of Healthcare City Clinical Hospital 12,

City

Saratov

State/Province

Russia

ZIP/Postal Code

410039

Country

Russian Federation

Facility Name

Federal state budget institution "State scientific centre of coloproctology"

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Facility Name

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

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",

City

Novosibirsk,

ZIP/Postal Code

630068

Country

Russian Federation

Facility Name

Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"

City

Novosibirsk

ZIP/Postal Code

630084

Country

Russian Federation

Facility Name

State Budget Educational Institution of Higher Professional Education

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

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

City

Novosibirsk

ZIP/Postal Code

630117

Country

Russian Federation

Facility Name

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

City

Samara

ZIP/Postal Code

443029

Country

Russian Federation

Facility Name

Limited Liability Company Medical Company "Hepatolog"

City

Samara

ZIP/Postal Code

443063

Country

Russian Federation

Facility Name

Limited Liability Company Medical Company "Hepatolog"

City

Samara

ZIP/Postal Code

443093

Country

Russian Federation

Facility Name

Samara Diagnostic center, X-ray Department

City

Samara

ZIP/Postal Code

443093

Country

Russian Federation

Facility Name

State budget institution of healthcare of Yaroslavl region Regional clinical hospital

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

City

Belgrade

State/Province

Serbia, Europe

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Hospital Centre Zvezdara

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Military Medical Academy Belgrade

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Centre of Kragujevac

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Clinical Centre of Vojvodina, Emergency Internal Medicine Division

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

"General Hospital ""Djordje Joanovic""

City

Zrenjanin

ZIP/Postal Code

23000

Country

Serbia

Facility Name

Medak s.r.o.

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

KM Management spol. s.r.o.

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

Aura SA, s.r.o.

City

Nove Mesto nad Vahom

ZIP/Postal Code

91501

Country

Slovakia

Facility Name

Gastro I., s.r.o.

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Dr John Philip Wright

City

Claremont

State/Province

Cape Town

ZIP/Postal Code

7708

Country

South Africa

Facility Name

Chris Hani Baragwanath Academic Hospital

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Panorama MediClinic

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Louis Leipoldt Medical Centre

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Endocare Research Centre

City

Western Cape

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Hospital Universitari de Bellvitge, Servicio de Digestivo

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Clinic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario de Fuenlabrada

City

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

National Taiwan University Hospital

City

Taipei City

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

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

City

Simferopol

State/Province

Ar Krym

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

Regional Municipal Institution Chernivtsi Regional Clinical Hospital,

City

Chernivtsi

ZIP/Postal Code

58001

Country

Ukraine

Facility Name

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

City

Dniepropetrovsk

ZIP/Postal Code

49074

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61037

Country

Ukraine

Facility Name

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

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Kyiv Municipal Clinical Hospital #18, Proctology Department

City

Kyiv

ZIP/Postal Code

01030

Country

Ukraine

Facility Name

LTD "St. Paraskeva Medical Center"

City

Lviv

ZIP/Postal Code

79019

Country

Ukraine

Facility Name

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

City

Lviv

ZIP/Postal Code

79059

Country

Ukraine

Facility Name

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

City

Odesa

ZIP/Postal Code

65010

Country

Ukraine

Facility Name

Municipal Institution "Odesa Regional Clinical Hospital"

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

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

City

Uzhgorod

ZIP/Postal Code

88009

Country

Ukraine

Facility Name

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

City

Vinnytsia

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Motor-Sich clinic, LLC

City

Zaporizhzhia

ZIP/Postal Code

69068

Country

Ukraine

Facility Name

Minicipal Institution City Hospital 7, Therapevtic Department,

City

Zaporizhzhia

ZIP/Postal Code

69118

Country

Ukraine

Facility Name

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

City

Zaporizhzhia

ZIP/Postal Code

69118

Country

Ukraine

Facility Name

Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB20QQ

Country

United Kingdom

Facility Name

Department of Gastroenterology, Old Building

City

Bristol

State/Province

England

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

University College Hospital

City

London

State/Province

Greater London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

NWLH NHS trust

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

The North West London Hospitals NHS Trust

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Norfolk and Norwich University Hospital

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Addenbrooke's Hospital

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36342120

Citation

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.

Results Reference

derived

PubMed Identifier

36336750

Citation

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.

Results Reference

derived

PubMed Identifier

35648151

Citation

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.

Results Reference

derived

PubMed Identifier

35574426

Citation

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. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.

Results Reference

derived

PubMed Identifier

35380740

Citation

Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

Results Reference

derived

PubMed Identifier

34614208

Citation

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.

Results Reference

derived

PubMed Identifier

34165201

Citation

Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

Results Reference

derived

PubMed Identifier

34035832

Citation

Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

Results Reference

derived

PubMed Identifier

33884415

Citation

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.

Results Reference

derived

PubMed Identifier

33684552

Citation

Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

Results Reference

derived

PubMed Identifier

33513294

Citation

Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

Results Reference

derived

PubMed Identifier

33324993

Citation

Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

Results Reference

derived

PubMed Identifier

33039585

Citation

Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

Results Reference

derived

PubMed Identifier

32870265

Citation

Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

Results Reference

derived

PubMed Identifier

32816215

Citation

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

Results Reference

derived

PubMed Identifier

32766762

Citation

Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

Results Reference

derived

PubMed Identifier

31599001

Citation

Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

Results Reference

derived

PubMed Identifier

31077827

Citation

Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

Results Reference

derived

PubMed Identifier

30476584

Citation

Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

Results Reference

derived

PubMed Identifier

29850873

Citation

Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

Results Reference

derived

PubMed Identifier

29743836

Citation

Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum In: Intest Res. 2018 Jul;16(3):499-501.

Results Reference

derived

PubMed Identifier

29028981

Citation

Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

Results Reference

derived

PubMed Identifier

28467869

Citation

Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921096&StudyName=A%20Study%20Of%20Oral%20CP-690%2C550%20As%20A%20Maintenance%20Therapy%20For%20Ulcerative%20Colitis

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs