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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tofacitinib
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Tofacitinib, CP-690, 550, Moderate to severe ulcerative colitis, phase 3 clinical trial, Mayo score

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
  • Subjects with moderately to severely active UC based on Mayo score criteria.

  • Subjects must have failed or be intolerant of at least one of the following treatments for UC:

    • Corticosteroids (oral or intravenous).
    • Azathioprine or 6 mercaptopurine (6 MP).
    • Anti TNF therapy.

Exclusion Criteria:

  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects with disease limited to distal 15 cm.
  • Subjects without previous treatment for UC (ie, treatment naïve).
  • Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Sites / Locations

  • Desert Sun Clinical Research, LLC
  • Desert Sun Gastroenterology
  • Desert Sun Surgery Center
  • Alliance Clinical Research
  • Clinical Application Laboratories
  • San Diego Endoscopy Center
  • UCSF Endoscopy Unit at Mount Zion
  • University of California San Francisco
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Bristol Hospital
  • Connecticut Clinical Research Foundation
  • Yale New Haven Hospital
  • Yale University School of Medicine
  • Central Connecticut Endoscopy Center
  • Citrus Surgery & Endoscopy Center (Colonoscopy)
  • Nature Coast Clinical Research
  • Suncoast Endoscopy Center (colonoscopy)
  • Gastroenterology Group of Naples
  • Advanced Gastroenterology Center
  • Advanced Medical Research Center
  • Endoscopy Center
  • Port Orange Urgent Care
  • Atlanta Center for Gastroenterology, P.C.
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Gastrointestinal Specialists, A.M.C.
  • Shreveport Endoscopy Center, A.M.C.
  • Louisiana Research Center, LLC
  • Chevy Chase Endoscopy Center (Endoscopies Only)
  • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health
  • Surgical Centers of Michigan
  • Mayo Clinic
  • Surgery Center of Columbia
  • Hannibal Regional Hospital
  • Audrain Medical Center
  • Center for Digestive & Liver Disease, Inc.
  • Dartmouth-Hitchcock Medical Center
  • AGA Clinical Research Associates, LLC
  • South Jersey Gastroenterology
  • The Gastroenterology Group of South Jersey
  • The Endo Center at Voorhees
  • University of Rochester
  • Carolina Research - Carolina Digestive Diseases
  • Regional Gastroenterology Associates of Lancaster, Ltd.
  • Vanderbilt University Medical Center - IBD Clinic
  • Vanderbilt University Medical Center - GI Research Office
  • Vanderbilt University Medical Center - Drug Shipment
  • Vanderbilt University Medical Center - GCRC
  • Vanderbilt University Medical Center - Heart Station
  • Vanderbilt University Medical Center - Radiology
  • Texas Clinical Research Institiute
  • Austin Gastroenterology PA/Professional Quality Research, Inc.
  • Austin Gastroenterology PA
  • Austin Endoscopy Center II
  • Memorial Hermann Hospital
  • The University of Texas Health Science Center at Houston
  • Digestive Health Specialists of Tyler
  • VCU Health System Digestive Health Center
  • VCU Health System Endoscopy Suite
  • VCU Medical Center Investigational Drug Service (IDS)
  • Virginia Commonwealth University, Clinical Research Services (CRSU)
  • The Canberra Hospital
  • Concord Hospital -Concord Repatriation Hospital
  • Concord Repatriation General Hospital
  • Liverpool Hospital Eastern Campus
  • Monash Medical Centre
  • Medizinische Universitat Innsbruck
  • Krankenhaus Barmherzige Brueder St. Veit/Glan
  • GZA St Vincentius
  • AZ Groeninge, Campus Kennedylaan
  • 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
  • Montreal General Hospital - McGill University Health Centre
  • Saskatoon City Hospital
  • Royal University Hospital
  • Instituto de Coloproctologia ICO S.A.S.
  • University Hospital Center Osijek, Clinic of Internal Medicine,
  • University Hospital Center Rijeka
  • University Hospital Center Zagreb,Department of Gastroenterology
  • Nemocnice Strakonice, a.s., Interni oddeleni
  • Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
  • Bispebjerg Hospital
  • Hvidovre University Hospital
  • Odense University Hospital
  • ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
  • Innomedica OU
  • X-Ray Unit, Qualitas AS (X-Ray Only)
  • East Tallinn Central Hospital Internal Medicine Clinic
  • ECG Unit, East Tallinn Central Hospital
  • X-Ray Unit, East Tallinn Central Hospital
  • Quattromed HTI Laboratorid OU
  • Mammograaf OU (Endoscopy Only)
  • CHU Amiens PICARDIE - Hopital SUD
  • Hopital Saint Andre
  • Hopital Beaujon
  • Hopital Saint Antoine
  • C.H.U. de Reims - Hôpital Robert Debré
  • Hopital Nord
  • Universitäetsklinik Schleswig-Holstein, Campus Kiel
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Gastroenterologische Gemeinschaftspraxis Minden
  • University Hospital Munich-Grosshadern
  • Universitaetsklinikum Ulm
  • Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
  • Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
  • Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
  • MH Honvedkorhaz
  • Pannonia Maganorvosi Centrum Kft.
  • Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
  • Bekes Megyei Pandy Kalman Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • "Karolina Korhaz Rendelointezet,Belgyogyaszat
  • Rambam Health Care Campus
  • The Edith Wolfson Medical Center/Gastroenterology Institute
  • Kaplan Medical Center
  • Hanyang University Guri Hospital, Clinical Laboratory
  • CHA Bundang Medical Center, CHA University
  • Pusan National University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Kyung Hee University Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Daugavpils Regional Hospital
  • VU University Medical Center (VUMC)
  • Academic Medical Centre (AMC),
  • University Medical Center Groningen (UMCG)
  • Christchurch Hospital
  • Auckland City Hospital
  • 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,
  • Oddzial Chorob Wewnetrznych i Gastroenterologii,
  • H-T Centrum Medyczne sp. z o.o. sp. komandytowa
  • Gabinet Endoskopii Przewodu Pokarmowego
  • Endoskopia Sp. z.o.o.
  • Nzoz Vivamed
  • Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
  • Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
  • State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
  • Municipal institution of healthcare "Clinical Hospital # 2"
  • OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
  • Federal state budget institution "State scientific centre of coloproctology"
  • State budget Healthcare Institution Moscow regional scientific research clinical institute
  • Federal State Budgetary Institution "Scientific Research Institute of Physiology and
  • Municipal institution of healthcare "City clinical hospital 12"
  • State budget institution of healthcare of Yaroslavl region Regional clinical hospital
  • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
  • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
  • Clinical Centre of Vojvodina, Emergency Internal Medicine Division
  • General Hospital Subotica
  • Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
  • KM Management spol. s r.o.
  • Aura SA, s.r.o.
  • Gastro I., s.r.o.
  • Panorama Medi-Clinic
  • The Louis Leipoldt Medical Centre
  • Dr JP Wright
  • Corporacio Sanitaria Parc Tauli
  • Hospital Universitario de Bellvitge
  • Chung Shan Medical University Hospital
  • National Taiwan University Hospital
  • 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
  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
  • Kyiv City Clinical Hospital #8,
  • Municipal Institution "Odesa Regional Clinical Hospital"
  • Medical Clinical Research Center "Health Clinic" on the base of
  • Motor-Sich clinic, LLC
  • Minicipal Institution "City Hospital #7" Therapeutic Department,
  • Department of Gastroenterology, Old Building
  • St Mark's Hospital
  • Norfolk and Norwich University Hospital
  • Norfolk and Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tofacitinib 10 mg BID

Placebo BID

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Remission at Week 8
Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.

Secondary Outcome Measures

Percentage of Participants Achieving Mucosal Healing at Week 8
Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Response at Week 8
Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Percentage of Participants With Endoscopic Remission at Week 8
Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Percentage of Participants With Clinical Remission at Week 8
Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Percentage of Participants With Symptomatic Remission at Week 8
Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Percentage of Participants With Deep Remission at Week 8
Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Partial Mayo Scores
A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Total Mayo Score at Week 8
Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.

Full Information

First Posted
October 21, 2011
Last Updated
April 26, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01458951
Brief Title
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Acronym
OCTAVE
Official Title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (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
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Tofacitinib, CP-690, 550, Moderate to severe ulcerative colitis, phase 3 clinical trial, Mayo score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tofacitinib 10 mg BID
Arm Type
Experimental
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tofacitinib
Other Intervention Name(s)
CP-690,550
Intervention Description
10 mg oral BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral BID
Primary Outcome Measure Information:
Title
Percentage of Participants With Remission at Week 8
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 is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Mucosal Healing at Week 8
Description
Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants Achieving Clinical Response at Week 8
Description
Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants With Endoscopic Remission at Week 8
Description
Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants With Clinical Remission at Week 8
Description
Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants With Symptomatic Remission at Week 8
Description
Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants With Deep Remission at Week 8
Description
Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Week 8
Title
Partial Mayo Scores
Description
A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.
Time Frame
Baseline, Weeks 2, 4, 8
Title
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8
Description
Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.
Time Frame
Baseline, Weeks 2, 4, 8
Title
Change From Baseline in Total Mayo Score at Week 8
Description
Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Time Frame
Baseline, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be at least 18 years of age. Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study. Subjects with moderately to severely active UC based on Mayo score criteria. Subjects must have failed or be intolerant of at least one of the following treatments for UC: Corticosteroids (oral or intravenous). Azathioprine or 6 mercaptopurine (6 MP). Anti TNF therapy. Exclusion Criteria: Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. Subjects with disease limited to distal 15 cm. Subjects without previous treatment for UC (ie, treatment naïve). Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
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
Desert Sun Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Desert Sun Gastroenterology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Desert Sun Surgery Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Application Laboratories
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
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
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
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
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Gastrointestinal Specialists, A.M.C.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Shreveport Endoscopy Center, A.M.C.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Chevy Chase Endoscopy Center (Endoscopies Only)
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
MGG Group Co., Inc., Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
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
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Surgery Center of Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Hannibal Regional Hospital
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Facility Name
Audrain Medical Center
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Center for Digestive & Liver Disease, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
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 Harbor 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 Gastroenterology Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
The Endo Center at Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
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
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Vanderbilt University Medical Center - IBD Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1375
Country
United States
Facility Name
Vanderbilt University Medical Center - GI Research Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Facility Name
Vanderbilt University Medical Center - Drug Shipment
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7610
Country
United States
Facility Name
Vanderbilt University Medical Center - GCRC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center - Heart Station
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Medical Center - Radiology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Clinical Research Institiute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Austin Gastroenterology PA/Professional Quality Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Gastroenterology PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Austin Endoscopy Center II
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
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
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
VCU Medical Center Investigational Drug Service (IDS)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University, Clinical Research Services (CRSU)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Concord Hospital -Concord Repatriation Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital Eastern Campus
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Krankenhaus Barmherzige Brueder St. Veit/Glan
City
St. Veit an der Glan
ZIP/Postal Code
9300
Country
Austria
Facility Name
GZA St Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
AZ Groeninge, Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
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
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 Coloproctologia ICO S.A.S.
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
00000
Country
Colombia
Facility Name
University Hospital Center Osijek, Clinic of Internal Medicine,
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
University Hospital Center Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
University Hospital Center Zagreb,Department of Gastroenterology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
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 Usti nad Labem, o.z.
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Hvidovre University 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
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
X-Ray Unit, Qualitas AS (X-Ray Only)
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
East Tallinn Central Hospital Internal Medicine Clinic
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
ECG Unit, East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
X-Ray Unit, East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Quattromed HTI Laboratorid OU
City
Tallinn
ZIP/Postal Code
12618
Country
Estonia
Facility Name
Mammograaf OU (Endoscopy Only)
City
Tallinn
ZIP/Postal Code
13419
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
Hopital Saint Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
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
St Priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Universitäetsklinik Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schlewig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
University Hospital Munich-Grosshadern
City
Munich
ZIP/Postal Code
81377
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
State/Province
Europe
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
City
Budapest
ZIP/Postal Code
H-1076
Country
Hungary
Facility Name
MH Honvedkorhaz
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
H-1135
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
H-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 Rendelointezet,Belgyogyaszat
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
The Edith Wolfson Medical Center/Gastroenterology Institute
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Hanyang University Guri Hospital, Clinical Laboratory
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
VU University Medical Center (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academic Medical Centre (AMC),
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
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,
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych i Gastroenterologii,
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-950
Country
Poland
Facility Name
H-T Centrum Medyczne sp. z o.o. sp. komandytowa
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43100
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
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
Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
City
Bucuresti
State/Province
Sector 5
ZIP/Postal Code
cod 050098
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
City
jud. Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
City
Moscow
State/Province
Russia
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Municipal institution of healthcare "Clinical Hospital # 2"
City
Yaroslavl
State/Province
Russia
ZIP/Postal Code
150010
Country
Russian Federation
Facility Name
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
City
Yaroslavl
State/Province
Russia
ZIP/Postal Code
150040
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 Healthcare Institution Moscow regional scientific research clinical institute
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Scientific Research Institute of Physiology and
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Municipal institution of healthcare "City clinical hospital 12"
City
Saratov
ZIP/Postal Code
410039
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
ZIP/Postal Code
11000
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 Subotica
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
Facility Name
Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
City
Bratislava
ZIP/Postal Code
831 04
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
08001
Country
Slovakia
Facility Name
Panorama Medi-Clinic
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
The Louis Leipoldt Medical Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Dr JP Wright
City
Claremont, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
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
City
Dnipropetrovsk
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
Kyiv City Clinical Hospital #8,
City
Kiev
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Clinical Hospital"
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Medical Clinical Research Center "Health Clinic" on the base of
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Motor-Sich clinic, LLC
City
Zaporizhzhia
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
Minicipal Institution "City Hospital #7" Therapeutic Department,
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine
Facility Name
Department of Gastroenterology, Old Building
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
St Mark's Hospital
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
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
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
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
35380664
Citation
Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
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
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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921095&StudyName=A%20Study%20To%20Evaluate%20Both%20The%20Efficacy%20and%20Safety%20Profile%20of%20CP-690%2C550%20In%20Patients%20With%20Moderately%20to%20Severely%20Active%20Ulcerative%20Col
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A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

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