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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CP-690,550
CP-690,550
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 Ulcerative colitis, open-label, long term treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
  • Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

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

Sites / Locations

  • Alabama Medical Group, P.C.
  • Desert Sun Clinical Research, LLC
  • Desert Sun Gastroenterology
  • Desert Sun Surgery Center
  • Altman Clinical and Translational Research Institute
  • Perlman Medical Offices - UC San Diego Health System
  • UCSD Medical Center
  • Cedars Sinai Medical Center
  • Cedars Sinai Surgery Center
  • Alliance Clinical Research
  • Center for Endoscopy- Covenant Surgical Partners
  • Sharp Rees-Stealy Medical Group, Inc.
  • Clinical Applications Laboratories, Inc
  • Sharp Rees-Stealy Medical Group
  • UCSF Center for Colitis and Crohn's Disease
  • Connecticut Clinical Research Institute
  • Endoscopy Center of Connecticut, LLC
  • Endoscopy Center of Connecticut, LLC
  • Gastroenterology Center of Connecticut, PC
  • Medical Research Center of Connecticut, LLC
  • Yale New Haven Hospital
  • Yale University School of Medicine
  • Nature Coast Clinical Research
  • North Florida Gastroenterology Research, LLC
  • Citrus Ambulatory Surgery Center
  • Internal Medicine Specialists
  • Advanced Gastroenterology Center
  • Advanced Medical Research Center
  • Endoscopy Center
  • Port Orange Urgent Care
  • Florida Medical Clinic, P.A.
  • Atlanta Center for Gastroenterology, P.C.
  • Gastroenterology Associates of Central Georgia, LLC
  • Atlanta Gastroenterology Specialists, PC
  • Cotton O'Neil Clinical Research Center, Digestive Health
  • Digestive Disease Associates, PA
  • Gastrointestinal Diagnostic Center
  • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Howard County GIDC
  • East Ann Arbor Health and Geriatrics Center -UMHS
  • Michigan Clinical Research Unit - UMHS
  • Medical Science Research Building 1 - UMHS
  • University of Michigan Health Systems
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health
  • Surgical Centers of Michigan
  • Huron Gastroenterology Associates - Center for Digestive Care
  • Mayo Clinic
  • Dartmouth Hitchcock Medical Center
  • AGA Clinical Research Associates, LLC
  • South Jersey Gastroenterology, P.A.
  • The Gastroenterology Group of South Jersey
  • NYU Langone Long Island Clinical Research Associates
  • IBD Center - The Mount Sinai Hospital
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Irving Medical Center
  • Kornbluth, Legnani, George MD, PC
  • University of Rochester
  • Carolina Research, Carolina Digestive Diseases
  • Cleveland Clinic
  • Great Lakes Gastroenterology Research, LLC
  • Vanderbilt University Medical Center
  • Texas Clinical Research Institute
  • Baylor College of Medicine- Baylor Medical Center
  • McGovern Medical School -The University of Texas Health Science Center at Houston
  • Memorial Hermann Hospital
  • Tyler Research Institute, LLC
  • Alpine Medical Group
  • Salt Lake Regional Hospital
  • Wasatch Clinical Research
  • VCU Health System Digestive Health Center
  • VCU Health System Endoscopy Suite
  • Virginia Commonwealth University
  • Center for Digestive Health
  • Wisconsin Center for Advanced Research - a division of GI Associates, LLC
  • The Canberra Hospital
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Nepean Hospital
  • Liverpool Hospital eastern Campus
  • Eastern Health, Box Hill Hospital
  • Gastroenterology and Hepatology Unit
  • Landeskrankenhaus Innsbruck
  • Krankenhaus Barmherzige Brueder St. Veit/Glan
  • AKH Wien, Universitaetsklinik fuer Innere Medizin III
  • GZA St Vincentius
  • AZ Groeninge
  • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
  • H-Hartziekenhuis Roeselare-Menen vzw
  • Hospital de Clinicas de Porto Alegre - HCPA
  • University of Calgary, Heritage Medical Research Clinic, TRW Building
  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
  • University of Alberta - Zeidler Ledcor Centre
  • McMaster University Medical Center
  • London Health Sciences Centre - University Hospital
  • Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
  • Montreal General Hospital - McGill University Health Care Centre
  • Saskatoon City Hospital
  • Royal University Hospital
  • Instituto de Coloproctologia ICO S.A.S.
  • University Hospital Center Zagreb
  • Hepato-Gastroenterologie HK, s.r.o.
  • Klinicke Centrum ISCARE I.V.F., Gastroenterologie
  • Nemocnice Strakonice, a.s., Interni oddeleni
  • Krajska Zdravotni, A.S.,
  • Bispebjerg Hospital
  • Aalborg Hospital
  • Aarhus University Hospital
  • Hvidovre Hospital
  • Odense University Hospital
  • West Tallinn Central Hospital
  • Innomedica OU
  • CHU Amiens-Picardie - Hopital Sud
  • Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive
  • CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
  • Hopital Saint Antoine - Service de Gastroenterologie
  • Hôpital Saint Louis - Service d'hepato-gastroenterologie
  • Hôpital Saint Louis
  • Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
  • CHU de Reims - Hopital Robert Debre
  • Hopital Nord
  • Hopital Rangueil
  • Universitatsklinikum Schleswig-Holstein, Campus Kiel
  • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
  • Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
  • Medizinische Hochschule Hannover
  • Klinikum Lüneburg
  • Gastroenterologische Gemeinschaftspraxis Minden
  • University Hospital Munich-Grosshadern
  • Universitaetsklinikum Ulm
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
  • Pannonia Maganorvosi Centrum Kft.
  • Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
  • Debreceni Egyetem Klinikai Kozpont
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Karolina Korhaz
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
  • Javorszky Odon Korhaz
  • Rambam Health Care Campus
  • The Edith Wolfson Medical Center/Gastroenterology Department
  • Rabin Medical Center, Beilinson campus
  • Istituto Clinico Humanitas IRCCS-IBD Center
  • AOR Villa Sofia-Cervello
  • AOU Mater Domini - U.O. Fisiopatologia Digestiva
  • Aichi Medical University Hospital
  • National Hospital Organization Hirosaki National Hospital
  • Toho University Sakura Medical Center
  • Kurume University Hospital
  • Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
  • National Hospital Organization Mito Medical Center
  • Sameshima Hospital
  • Kuniyoshi Hospital
  • National Hospital Organization Sendai Medical Center
  • Osaka City University Hospital
  • Osaka Medical College Hospital
  • Shiga University of Medical Science Hospital
  • Tokyo Medical And Dental University Hospital, Faculty of Medicine
  • Tokai University Hachioji Hospital
  • Jikei University Hospital
  • Kitasato University Kitasato Institute Hospital
  • Keio University Hospital
  • Fukuoka University Chikushi Hospital
  • Hiroshima University Hospital
  • The Hospital of Hyogo College of Medicine
  • Showa University Hospital
  • Hanyang University Guri Hospital
  • Gachon University Gil Medical Center
  • Kyung Hee University Hospital
  • Seoul National University Hospital,
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Digestive Diseases Center GASTRO
  • VU University Medical Center
  • Academic Medical Center (AMC)
  • University Medical Center Groningen (UMCG)
  • Leiden University Medical Center
  • Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
  • Christchurch Hospital
  • North Shore Hospital (Waitemata District Health Board)
  • Auckland City Hospital
  • Southern District Health Board
  • Waikato Hospital
  • P3 Research Limited
  • Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
  • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
  • Gabinet Lekarski - Janusz Rudzinski
  • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob
  • Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
  • H-T. Centrum Medyczne - ENDOTERAPIA
  • Gabinet Endoskopii Przewodu Pokarmowego
  • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr
  • Endoskopia SP. Z O.O.
  • NZOZ Vivamed
  • Lexmedica
  • Cabinet Particular Policlinic Algomed SRL
  • Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
  • Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"
  • State budget Healthcare Institution Moscow regional scientific research clinical institute
  • State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
  • Municipal Budget Institution of Healthcare of Novosibirsk
  • Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental
  • FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
  • Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
  • Limited Liability Company Medical Company "Hepatolog"
  • Samara Diagnostic center, X-ray Department
  • State budget institution of healthcare of Yaroslavl region Regional clinical hospital
  • Military Medical Academy
  • Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology
  • Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
  • Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology
  • Clinical Centre of Vojvodina Emergency Internal Medicine Division
  • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
  • General Hospital Djordje Joanovic
  • Medak s.r.o.
  • "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
  • Poliklinika Libris, Synergy group, a.s.,
  • Gastro I., s.r.o.
  • Chris Hani Baragwanath Academic Hospital
  • Panorama Medi-Clinic
  • Louis Leipoldt Medical Centre
  • Dr JP Wright
  • Endocare Research Centre
  • Hospital Universitario de Bellvitge
  • Hospital Universitario de Fuenlabrada
  • Hospital Clinic i Provincial de Barcelona
  • Corporacio Sanitaria Parc Tauli
  • Hospital Universitario de La Princesa
  • Hospital Clinico San Carlos
  • National Taiwan University Hospital
  • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
  • Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'
  • SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
  • State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"
  • 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,
  • Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
  • "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian
  • CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod
  • Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
  • Minicipal Institution City Hospital #7, Therapeutic Department,
  • Bristol Royal Infirmary
  • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
  • The North West London Hospitals NHS Trust
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • UCLH NIHR Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CP-690,550 5 mg BID

CP-690,550 10 mg BID

Arm Description

5 mg BID

10 mg BID

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Laboratory Test Abnormalities
Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.
Number of Participants With Vital Sign Abnormalities
Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).
Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.
Number of Participants With Electrocardiogram (ECG) Abnormalities
ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).
Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).

Secondary Outcome Measures

Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.
Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.

Full Information

First Posted
October 21, 2011
Last Updated
September 16, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01470612
Brief Title
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Acronym
OCTAVE
Official Title
A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
August 6, 2020 (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 an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, open-label, long term treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
944 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CP-690,550 5 mg BID
Arm Type
Experimental
Arm Description
5 mg BID
Arm Title
CP-690,550 10 mg BID
Arm Type
Experimental
Arm Description
10 mg BID
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
5 mg tablets, BID, for at least 12 months
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
10 mg tablets, BID, for at least 12 months
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
Description
Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Number of Participants With Laboratory Test Abnormalities
Description
Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Number of Participants With Vital Sign Abnormalities
Description
Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
Description
Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Title
Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Description
Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).
Time Frame
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Secondary Outcome Measure Information:
Title
Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Description
Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Description
Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Description
Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Description
Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
Description
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Time Frame
Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Title
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Description
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.
Time Frame
Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Title
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
Description
Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Description
Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.
Time Frame
Months 2, 12, 24 and 36
Title
Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Description
IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.
Time Frame
Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure. Exclusion Criteria: Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
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
Alabama Medical Group, P.C.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
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
Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0897
Country
United States
Facility Name
Perlman Medical Offices - UC San Diego Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
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
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Center for Endoscopy- Covenant Surgical Partners
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Clinical Applications Laboratories, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Center for Colitis and Crohn's Disease
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Connecticut Clinical Research Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Endoscopy Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
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
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
North Florida Gastroenterology Research, LLC
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Citrus Ambulatory Surgery Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advanced Gastroenterology Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Endoscopy Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Port Orange Urgent Care
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
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
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Gastrointestinal Diagnostic Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
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
Howard County GIDC
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
East Ann Arbor Health and Geriatrics Center -UMHS
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2701
Country
United States
Facility Name
Michigan Clinical Research Unit - UMHS
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5872
Country
United States
Facility Name
Medical Science Research Building 1 - UMHS
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Surgical Centers of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Huron Gastroenterology Associates - Center for Digestive Care
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
AGA Clinical Research Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
South Jersey Gastroenterology, P.A.
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
NYU Langone Long Island Clinical Research Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
IBD Center - The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Kornbluth, Legnani, George MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolina Research, Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1375
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
McGovern Medical School -The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Alpine Medical Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Salt Lake Regional Hospital
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
VCU Health System Digestive Health Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
VCU Health System Endoscopy Suite
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Center for Digestive Health
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research - a division of GI Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Liverpool Hospital eastern Campus
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Eastern Health, Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Gastroenterology and Hepatology Unit
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Landeskrankenhaus 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
AKH Wien, Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
GZA St Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
H-Hartziekenhuis Roeselare-Menen vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospital de Clinicas de Porto Alegre - HCPA
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
University of Calgary, Heritage Medical Research Clinic, TRW Building
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Alberta - Zeidler Ledcor Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Care 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 Zagreb
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Klinicke Centrum ISCARE I.V.F., Gastroenterologie
City
Praha 7
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Nemocnice Strakonice, a.s., Interni oddeleni
City
Strakonice
ZIP/Postal Code
386 29
Country
Czechia
Facility Name
Krajska Zdravotni, A.S.,
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
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
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
West Tallinn Central Hospital
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Innomedica OU
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
CHU Amiens-Picardie - Hopital Sud
City
Amiens Cedex 01
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Antoine - Service de Gastroenterologie
City
Paris cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Hôpital Saint Louis - Service d'hepato-gastroenterologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Reims - Hopital Robert Debre
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
Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitatsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schlewig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum Lüneburg
City
Lüneburg
ZIP/Postal Code
21339
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
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Karolina Korhaz
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Javorszky Odon Korhaz
City
Vac
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
The Edith Wolfson Medical Center/Gastroenterology Department
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Rabin Medical Center, Beilinson campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Istituto Clinico Humanitas IRCCS-IBD Center
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOR Villa Sofia-Cervello
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
AOU Mater Domini - U.O. Fisiopatologia Digestiva
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
National Hospital Organization Hirosaki National Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8545
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
National Hospital Organization Mito Medical Center
City
Higashi-ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Kuniyoshi Hospital
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
780-0901
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
545-8586
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
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital, Faculty of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
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
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
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
The Hospital of Hyogo College of Medicine
City
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital,
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Digestive Diseases Center GASTRO
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
City
Tauranga
State/Province
BAY OF Plenty
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
North Shore Hospital (Waitemata District Health Board)
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Southern District Health Board
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
P3 Research Limited
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
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
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 Nieswoistych Chorob
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-950
Country
Poland
Facility Name
H-T. Centrum Medyczne - ENDOTERAPIA
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Endoskopia SP. Z O.O.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
NZOZ Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Cabinet Particular Policlinic Algomed SRL
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300002
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"
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
State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Municipal Budget Institution of Healthcare of Novosibirsk
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
City
Samara
ZIP/Postal Code
443029
Country
Russian Federation
Facility Name
Limited Liability Company Medical Company "Hepatolog"
City
Samara
ZIP/Postal Code
443093
Country
Russian Federation
Facility Name
Samara Diagnostic center, X-ray Department
City
Samara
ZIP/Postal Code
443093
Country
Russian Federation
Facility Name
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
State/Province
Central Serbia
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina Emergency Internal Medicine Division
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
General Hospital Djordje Joanovic
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Medak s.r.o.
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
"KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Poliklinika Libris, Synergy group, a.s.,
City
Nove Mesto nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
Gastro I., s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Chris Hani Baragwanath Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Panorama Medi-Clinic
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Louis Leipoldt Medical Centre
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Dr JP Wright
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Endocare Research Centre
City
Paarl
State/Province
Western CAPE
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid,
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario de 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
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
SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18, Proctology Department
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
LTD "St. Paraskeva Medical Center"
City
Lviv
ZIP/Postal Code
79019
Country
Ukraine
Facility Name
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
"Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian
City
Odesa
ZIP/Postal Code
65059
Country
Ukraine
Facility Name
CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Minicipal Institution City Hospital #7, Therapeutic Department,
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine
Facility Name
Bristol Royal Infirmary
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
The North West London Hospitals NHS Trust
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
UCLH NIHR Clinical Research Facility
City
London
State/Province
W1t 7ha
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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
36242764
Citation
Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2023 Sep 1;29(9):1370-1379. doi: 10.1093/ibd/izac222.
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
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
33884415
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Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921139&StudyName=Long-Term%20Study%20Of%20CP-690%2C550%20In%20Subjects%20With%20Ulcerative%20Colitis
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Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

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