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A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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-alpha 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

  • Internal Medicine Center, LLC
  • Springhill Memorial Hospital
  • Investigational Drug Service Pharmacy
  • UCSD Medical Center
  • UCSD Medical Centre
  • Cedars Sinai Medical Center - Thalians Bldg
  • Cedars Sinai Medical Center
  • Cedars Sinai Surgery Center
  • Cedars-Sinai Medical Center
  • CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
  • Desert Advanced Imaging
  • Erik Palmer, DO
  • Homan A Zadeh, MD, MPH
  • Hope Square Surgical Center
  • Sharp Rees-Stealy Medical Group, Inc.
  • Sharp Rees-Stealy Medical Group
  • Sharp Rees-Stealy Medical Group,Inc
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical Research Center of Connecticut, LLC
  • Florida Surgery Center
  • Center for Advanced Gastroenterology
  • MNH Surgical Center
  • Sand Lake Imaging
  • North Florida Gastroenterology Research, LLC
  • Orange Park Surgery Center
  • Citrus Ambulatory Surgery Center
  • Internal Medicine Specialists
  • Shafran Gastroenterology Center
  • Florida Medical Clinic, P.A.
  • Georgia Endoscopy Center (Colonoscopy only)
  • GI Consultants (Colonoscopy only)
  • Emory Healthcare Heart Center (EKG)
  • Gastroenterology Associates of Central Georgia
  • Icahn School of Medicine at Mount Sinai
  • Atlanta Gastroenterology Specialists, PC
  • Johns Creek Diagnostic Center (X-Ray only)
  • Southwest Gastroenterology
  • Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
  • East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
  • University of Michigan Health Systems
  • Michigan Clinical Research Unit - Univeristy of Michigan Health System
  • Medical Science Research Building 1 - University of Michigan Health Systems
  • Michigan Heart SJMH (Blood draws and ECGs only)
  • Huron Gastroenterology Associates / Center for Digestive Care
  • Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
  • Center for Advanced Medicine
  • Washington University School of Medicine - Division of Gastroenterology
  • NYU Langone Long Island Clinical Research Associates
  • NYU Langone Nassau Gastroenterology Associates
  • The Private Practice of Simon Lichtiger, MD
  • Mount Sinai Doctos Faculty Practice
  • Mount Sinai Medical Center
  • Mount Sinai School of Medicine
  • Columbia University Medical Center
  • CUMC Research Pharmacy
  • Kornbluth, Legnani, George MD, PC
  • Cleveland Clinic
  • Great Lakes Gastroenterology
  • Mentor Medical Campus
  • The Endoscopy Center of Lake County
  • Houston Hospital for Specialized Surgery
  • Baylor College of Medicine (Baylor Medical Center)
  • Baylor College of Medicine - Baylor Medical Center (Drug Storage)
  • Gastroenterology Consultants, P.A.
  • Alpine Medical Group
  • Wasatch Clinical Research
  • Wasatch Endoscopy Center
  • RGL Medical Services (x-ray only)
  • Wisconsin Center for Advanced Research - GI Associates, LLC
  • Royal Prince Alfred Hospital
  • Nepean Hospital
  • Eastern Health Box Hill Hospital
  • AKH Wien, Universitaetsklinik fuer Innere Medizin III,
  • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
  • Hertiage Medical Research Clinic- University Of Calgary
  • McMaster University Medical Center
  • Hamilton Health Sciences Corporation - McMaster University Medical Centre
  • London Health Sciences Centre - University Hospital
  • Hopital Maisonneuve-Rosemont
  • Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
  • General Hospital Zadar
  • Hepato-Gastroenterologie HK, s.r.o.
  • Institut klinicke a experimentalni mediciny
  • Klinicke Centrum ISCARE I.V.F.
  • Aalborg Hospital
  • Aarhus University Hospital
  • ECG Unit of West Tallinn Central Hospital
  • West Tallinn Central Hospital Internal Diseases Clinic
  • X-Ray Department of West Tallinn Central Hospital
  • CHU de Nantes - Hotel Dieu
  • Hopital Saint-Louis
  • Hopital Rangueil
  • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
  • Universitaetsklinikum Halle (Saale)
  • Medizinische Hochschule Hannover
  • Klinikum Luneburg/Abteilung Gastroenterologie
  • Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
  • Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
  • Rabin Medical Center, Beilinson campus
  • Tel Aviv Sourasky Medical Center
  • AOU Mater Domini - U.O. Fisiopatologia Digestiva
  • Istituto Clinico Humanitas IRCSS
  • A.O.R. Villa Sofia- Cervello
  • Comitato Etico Palermo 2
  • SOC Gastroenterologia Centro di Riferimento Oncologico
  • IBD Center - IRCCS Humanitas
  • Aichi Medical University Hospital
  • National Hospital Organization Hirosaki National Hospital
  • Chiba University Hospital
  • Toho University Sakura Medical Center
  • Kurume 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
  • Kuniyoshi Hospital
  • National Hospital Organization Sendai Medical Center
  • Osaka Medical College Hospital
  • Shiga University of Medical Science Hospital
  • Tokai University Hachioji Hospital
  • Jikei University Hospital
  • Kitasato University Kitasato Institute Hospital
  • NTT Medical Center Tokyo
  • Showa University Hospital
  • Fukuoka University Chikushi Hospital
  • Hiroshima University Hospital
  • Sameshima Hospital
  • Osaka City University Hospital
  • Tokyo Medical And Dental University Hospital, Faculty of Medicine
  • Keio University Hospital
  • Digestive Diseases Center GASTRO
  • ECG room, Clinic "Linezers"
  • X-Ray Department, Clinic "Linezers"
  • Leiden University Medical Center
  • Shakespeare Specialist Group
  • Southern District Health Board
  • Bop Clinical School Clinical Trials Unit
  • Gabinet Lekarski - Janusz Rudzinski
  • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
  • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
  • Lexmedica
  • Cabinet Particular Policlinic Algomed SRL
  • Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
  • State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
  • Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
  • Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
  • State Budget Educational Institution of Higher Professional Education
  • GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
  • GUZ City Hospital #26
  • Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
  • Limited Liability Company Medical Company "Hepatolog"
  • Samara Diagnostic center, X-ray Department
  • Federal State Budgetary Military Educational Institution of High Professional Education
  • General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
  • Clinical Hospital Centre Zvezdara
  • Military Medical Academy
  • Clinical Centre of Kragujevac
  • Medak s.r.o.
  • Chris Hani Baragwanath Academic Hospital
  • Endocare Research Centre
  • Hospital Clínic i provincial de Barcelona
  • Hospital Universitario La Princesa
  • Hospital Clinico San Carlos
  • Hospital Universitario de Fuenlabrada
  • InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
  • State Institution "National L.T. Malaya Therapy Institute of National Academy
  • 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,
  • SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
  • Vinnytsia National Medical University
  • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
  • Cambridge University Hospitals Nhs Foundation Trust
  • University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tofacitinib 10 mg BID

Placebo

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 (UC). 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 scores 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 subscore of at least 1 point or an absolute rectal bleeding subscore 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 centrally read flexible 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 scores 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 centrally read flexible 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 scores indicating more severe disease.
Percentage of Participants With Symptomatic Remission at Week 8
Symptomatic 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 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 centrally read flexible 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 scores 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 centrally read flexible 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 scores indicating more severe disease.
Partial Mayo Scores
A Partial Mayo Score (mayo score without endoscopy) graded 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 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) graded 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 grading from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Total Mayo Scores 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 centrally read flexible 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 scores indicating more severe disease.

Full Information

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

Unique Protocol Identification Number
NCT01465763
Brief Title
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe 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
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 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
614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tofacitinib 10 mg BID
Arm Type
Experimental
Arm Title
Placebo
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
Plabebo 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 (UC). 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 scores 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 subscore of at least 1 point or an absolute rectal bleeding subscore 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 centrally read flexible 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 scores 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 centrally read flexible 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 scores indicating more severe disease.
Time Frame
Week 8
Title
Percentage of Participants With Symptomatic Remission at Week 8
Description
Symptomatic 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 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 centrally read flexible 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 scores 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 centrally read flexible 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 scores indicating more severe disease.
Time Frame
Week 8
Title
Partial Mayo Scores
Description
A Partial Mayo Score (mayo score without endoscopy) graded 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 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) graded 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 grading 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 Scores 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 centrally read flexible 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 scores 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-alpha 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
Internal Medicine Center, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Springhill Memorial Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigational Drug Service Pharmacy
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSD Medical Centre
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars Sinai Medical Center - Thalians Bldg
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars Sinai Surgery Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group,Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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
Florida Surgery Center
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Center for Advanced Gastroenterology
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
MNH Surgical Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Sand Lake Imaging
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
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
Orange Park Surgery Center
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
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
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 (Colonoscopy only)
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
GI Consultants (Colonoscopy only)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Emory Healthcare Heart Center (EKG)
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
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 (X-Ray only)
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
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 - Univeristy of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5872
Country
United States
Facility Name
Medical Science Research Building 1 - University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan Heart SJMH (Blood draws and ECGs only)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Huron Gastroenterology Associates / Center for Digestive Care
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine - Division of Gastroenterology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Mount Sinai Doctos Faculty Practice
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai School of Medicine
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
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Houston Hospital for Specialized Surgery
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
Gastroenterology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
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
RGL Medical Services (x-ray only)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84084
Country
United States
Facility Name
Wisconsin Center for Advanced Research - GI Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Eastern Health Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
AKH Wien, Universitaetsklinik fuer Innere Medizin III,
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hertiage Medical Research Clinic- University Of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hamilton Health Sciences Corporation - McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
00000
Country
Colombia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23 000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czech Republic
Facility Name
Institut klinicke a experimentalni mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Klinicke Centrum ISCARE I.V.F.
City
Praha 7
ZIP/Postal Code
170 04
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
ECG Unit of West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
West Tallinn Central Hospital Internal Diseases Clinic
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
CHU de Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum Luneburg/Abteilung Gastroenterologie
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
City
Vac
ZIP/Postal Code
H-2600
Country
Hungary
Facility Name
Rabin Medical Center, Beilinson campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
AOU Mater Domini - U.O. Fisiopatologia Digestiva
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
Istituto Clinico Humanitas IRCSS
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
A.O.R. Villa Sofia- Cervello
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Comitato Etico Palermo 2
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
SOC Gastroenterologia Centro di Riferimento Oncologico
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
IBD Center - IRCCS Humanitas
City
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
National Hospital Organization Hirosaki National Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8545
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
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
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
Tokai University Hachioji Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
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
Fukuoka University Chikushi Hospital
City
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital, Faculty of Medicine
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Digestive Diseases Center GASTRO
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
ECG room, Clinic "Linezers"
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
X-Ray Department, Clinic "Linezers"
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
ZH
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
Southern District Health Board
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Bop Clinical School Clinical Trials Unit
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Gabinet Lekarski - Janusz Rudzinski
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
City
Lodz
ZIP/Postal Code
90-153
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
Jud Timis
ZIP/Postal Code
300002
Country
Romania
Facility Name
Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
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
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
GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
GUZ City Hospital #26
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
City
Samara
ZIP/Postal Code
443029
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
Federal State Budgetary Military Educational Institution of High Professional Education
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
City
Zrenjanin
State/Province
Serbia, Europe
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Clinical Hospital Centre Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre of Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Medak s.r.o.
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Chris Hani Baragwanath Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Endocare Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Hospital Clínic i provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
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
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
City
Simferopol
State/Province
Ar Krym
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
State Institution "National L.T. Malaya Therapy Institute of National Academy
City
Kharkov
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
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Vinnytsia National Medical University
City
Vinnytsia
ZIP/Postal Code
21005
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
Cambridge University Hospitals Nhs Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
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
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
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Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921094&StudyName=A%20Study%20Evaluating%20The%20Efficacy%20And%20Safety%20Of%20CP-690%2C550%20In%20Patients%20With%20Moderate%20To%20Severe%20Ulcerative%20Colitis
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A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

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