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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RPC1063
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 to 75 years (at screening for Cohort 1 and 2)
  • UC confirmed on endoscopy
  • Moderately to severely active UC (May score 6-12)
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide
  • Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria:

  • Have severe extensive colitis as evidence by:
  • Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
  • Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
  • Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
  • History of uveitis or unknown macular edema
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Sites / Locations

  • Arizona Digestive Health
  • Adobe Clinical Research LLC
  • Arkansas Gastroenterology, P.A.
  • Anaheim Clinical Trials
  • Aurora Care Clinic
  • Valley View Internal Medicine
  • Davita Clinical Trials, LLC
  • University of California San Diego Medical Center
  • OM Research
  • University of Southern California - Keck School of Medicine
  • Southern California Research Institute Medical Group, Inc.
  • Gastrointestinal Biosciences
  • UCLA Medical Center
  • Facey Medical Foundation (Parent)
  • Alliance Clinical Research, LLC
  • Medical Associates Research Group, Inc.
  • University of California at San Francisco (PARENT)
  • Medical Research Center of Connecticut, LLC
  • Gastro Florida
  • Clinical Research of West Florida Inc - Clearwater
  • Advanced Pharma Research, Inc
  • Universal Axon Clinical Research
  • Dolphin Medical Research
  • South Florida Clinical Trials
  • Florida Center for Gastroenterology
  • City Medical Group
  • Advanced Clincial Research
  • Advanced Clinical Research of Miami
  • Regenerate Clinical Trials
  • Advanced Research for Health Improvement
  • Advanced Research Institute, Inc.
  • NSB Research
  • Harmony Clinical Research
  • Med-Care Research
  • Center For Digestive Health
  • IMIC, Inc.
  • DBC Research, Corp
  • Theia Clinical Research, LLC
  • Florida Medical Clinic, P.A.
  • Atlanta Gastroenterology Associates LLC
  • Gastrointestinal Specialists of Georgia, PC
  • Grand Teton Research Group, PLLC
  • Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
  • University of Chicago Medical Center
  • DM Clinical Research
  • Carle Foundation Hospital
  • Indiana University Hospital
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • University of Kentucky Medical Center
  • University of Louisville
  • Gastroenterology Associates, LLC
  • University of Maryland Medical Group
  • Woodholme Gastroenterology
  • Johns Hopkins Clinical Research Network
  • Chevy Chase Clinical Research
  • Gastro Center of Maryland
  • Charm City Research Group
  • Boston Medical Center
  • Commonwealth Clinical Studies, PLLC.
  • Community Clinical Research Network
  • University of Michigan Health System
  • Center For Digestive Health
  • Mayo Clinic
  • Ehrhardt Clinical Research, LLC
  • Clinical Research Professionals, LLC - De Paul Medical Dr
  • Washington University
  • Clinical Research Professionals LLC - The Pines Court
  • Clinical Research Professionals, LLC - Olde Cabin Rd
  • Mercy Research
  • Mary Hitchcock Memorial Hospital
  • Montefiore Medical Center
  • NY Scientific
  • Long Island Clinical Research Associates
  • Icahn School of Medicine Mount Sinai Beth Isreal
  • Concord Medical Group PRIME
  • New York University School of Medicine
  • Weill Cornell Medical College
  • Mount Sinai - PRIME
  • Asheville Gastroenterology Associates, P.A.
  • University of North Carolina at Chapel Hill
  • Carolinas HealthCare System Digestive Health
  • East Carolina Gastroenterology, PA
  • Kinston Medical Specialists, PA
  • PMG Research of Rocky Mount, LLC
  • UC Health Clinical Trials Office
  • The Cleveland Clinic Foundation
  • Ohio State University Clinical Trials Management Office
  • Clinical Inquest Center Ltd
  • University of Oklahoma
  • Digestive Disease Specialists
  • Oregon Health & Science University
  • Hospital of the University of Pennsylvania
  • Consultants in Gastroenterology, PA
  • Gastroenterology Associates of Orangeburg
  • Gastro One
  • Vanderbilt University Medical Center
  • Baylor Research Institute
  • Brooke-Army Medical Center
  • Ventavia Research Group, LLC
  • Gulf Coast Research Group LLC
  • The Methodist Hospital Research Institute
  • Houston Endoscopy and Research Center
  • Gastroenterology Research of San Antonio, LLC
  • San Antonio Gastroenterology
  • Texas Digestive Disease Consultants - Southlake
  • Spring Gastroenterology
  • Digestive Health Specialists of Tyler
  • University of Utah
  • University of Virginia
  • Gastroenterology Associates of Tidewater
  • Gastroenterology, LTD
  • Benaroya Research Institute at Virginia Mason
  • University of Washington Medical Center
  • Hospital Italiano
  • Instituto DAMIC Fundacion Rusculleda
  • Hospital Italiano de La Plata
  • Instituto Medico CER
  • Instituto Medico de la Fundacion Estudios Clinicos
  • Centre For Digestive Diseases
  • Nepean Hospital
  • Mater Hospital Brisbane
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Cabrini Hospital Malvern
  • The Alfred Hospital
  • Monash Medical Centre Clayton
  • Royal Prince Alfred Hospital
  • Medical University Vienna
  • Gomel Regional Clinical Hospital
  • City Clinical Hospital No 10
  • Vitebsk Regional Clinical Hospital
  • Imeldaziekenhuis
  • AZ Maria Middelares
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • CHC - Clinique St-Jospeh
  • Medical Centre "Asklepii", OOD
  • UMHAT 'Dr. Georgi Stranski', EAD
  • UMHAT "Kaspela", EOOD
  • MC Rusemed ltd.
  • NMTH "Tsar Boris III"
  • MHAT "Lyulin", EAD
  • City Clinic UMHAC EOOD
  • MHAT 'Tokuda Hospital Sofia', EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Fourth MHAT - Sofia EAD
  • UMHAT 'Sveta Anna' AD
  • UMHAT "SofiaMed", OOD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • MHAT 'Sv. Marina', EAD
  • MC Medica Plus
  • Vancouver General Hospital
  • Brandon Medical Arts Clinic
  • Viable Clinical Research - Lindsay
  • LHSC - University Hospital
  • LHSC - Victoria Hospital
  • Humber River Hospital
  • Mount Sinai Hospital
  • Toronto Liver Centre
  • Toronto Digestive Disease Associates, Inc.
  • Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
  • The Ottawa Hospital - General Campus
  • CHUS - Hôpital Fleurimont
  • Clinical Hospital Center Osijek
  • Clinical Hospital Centre Rijeka
  • Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
  • Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
  • Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
  • Vojenska nemocnice Brno
  • Hepato-Gastroenterologie HK, s.r.o.
  • GASTRO JeKa s.r.o.
  • Gregar s.r.o.
  • PreventaMed
  • ISCARE, a.s.
  • Institut klinicke a experimentalni mediciny
  • Thomayerova nemocnice
  • Nemocnice Slany
  • LTD Research Institute of Clinical Medicine
  • LLC Vivamedi
  • LTD Academician N.Kipshidze Central University Clinic
  • LTD Aversi Clinic
  • LTD Coloproctological Center
  • Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
  • Charite - Campus Virchow-Klinikum
  • DRK Kliniken Berlin Westend
  • Medical Care Unit Dachau
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Crohn Colitis Centrum Rhein Main
  • Universitaetsklinikum Freiburg
  • Universitaetsklinikum Hamburg-Eppendorf
  • Asklepios Klinik Hamburg
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Koeln
  • EUGASTRO GmbH
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitatsklinikum Ulm
  • Laiko General Hospital of Athens
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • General Hospital of Thessaloniki Hippokration
  • 424th Army General Hospital
  • DRC Gyogyszervizsgalo Kozpont Kft
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
  • Obudai Egeszsegugyi Centrum Kft.
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Semmelweis Egyetem
  • Pannonia Maganorvosi Centrum
  • Szent Margit Korhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  • Mohacsi Korhaz
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Meir Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliero Universitaria San Martino
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
  • A.O.U. Policlinico di Modena
  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  • Azienda Ospedaliera Universitaria "Federico II"
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda Ospedaliero Universitaria Pisana
  • Complesso Integrato Columbus
  • Istituto Clinico Humanitas
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Inje University Haeundae Paik Hospital
  • Yeungnam University Hospital
  • Konyang University Hospital
  • Hanyang Univerisy Guri Hospital
  • CHA Bundang Medical Center CHA University
  • Seoul National University Bundang Hospital
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Korea University Anam Hospital
  • Asan Medical Center
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University
  • Ewha Womans University Mokdong Hospital
  • The Catholic University of Korea, St.Vicent's Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Pauls Stradins Clinical University Hospital
  • "Sfanta Treime" Clinical Municipal Hospital
  • Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
  • "Sf. Arhanghel Mihail" Municipal Clinical Hospital
  • Republican Clinical Hospital
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Academisch Medisch Centrum
  • Universitair Medisch Centrum Groningen (UMCG)
  • Maastricht University Medical Center
  • Zuyderland Medisch Centrum - Sittard-Geleen
  • ETZ Elisabeth
  • Christchurch Hospital NZ
  • Dunedin Public Hospital
  • Clinsante S.C. Osrodek Badan Klinicznych
  • Specjalistyczna Przychodnia Lekarska Medicus
  • GLOBE Clinical Research Sp. z o.o. LLC
  • PLEJADY Sp. z o.o. (LLC) Medical Centre
  • Centrum Medyczne A-Z Clinic
  • Healthcare Center Orkan Med Stec Michalska Spolka Jawna
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • KO-MED Centra Kliniczne Lublin II
  • Trialmed Llc
  • SOLUMED Centrum Medyczne
  • Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
  • KO-MED Centra Kliniczne Staszow
  • GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
  • MDM Healthcare Centre
  • Nzoz Vivamed
  • Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
  • LexMedica Osrodek Badan Klinicznych
  • Bacau County Emergency Hospital, Department of Gastroenterology
  • Hyperclinica MedLife Grivita
  • Bucharest University Emergency Hospital, Department of Internal Medicine II
  • TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
  • Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
  • Craiova County Emergency Clinical Hospital
  • "Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
  • Multidisciplinary Medical Clinic "Anthurium"
  • Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
  • SBEI HPE "Kazan State Medical University" of the MoH of the RF
  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  • SBEIHPE Novosibirsk State Medical University
  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • SBEI HPE Rostov State Medical University of the MoH of the RF
  • SBIH City Clinical Hospital #31
  • Union Clinic
  • FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
  • SPb SBIH City Hospital # 26
  • Pavlov First Saint Petersburg State Medical University
  • Private Educational Institution of Higher Education "Medical University "REAVIZ"
  • LLC Medical Company Hepatologist
  • FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
  • SPb SBIH Alexandrovskaya City Hospital
  • SBEI HPE "Stavropol State Medical Academy" MoH of RF
  • Regional Clinical Hospital
  • Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
  • Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
  • Clinical Hospital Center Zvezdara Clinic of Internal Diseases
  • Military Medical Academy, Clinic of Gastroenterology and Hepatology
  • Clinical Hospital Center Zemun Department of Gastroenterology
  • Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
  • Clinical Center Nis, Clinic of Gastroenterology and Hepatology
  • General Hospital Djordje Jovanovic Zrenjanin
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Alian s.r.o.
  • PRO SANUS, a.s., Poliklinika ProCare Central
  • IBDcentrum s.r.o.
  • Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
  • Gastroped s.r.o.
  • Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
  • PIGEAS s.r.o.
  • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
  • Gastromedic s.r.o.
  • EndoCorp s.r.o.
  • Dr MJ Prins Practice
  • Tiervlei Trial Centre
  • Endocare Research
  • Dr JP Wright Practice
  • Dr YS Nanabhay Practice
  • Emmed Research
  • University Hospital Germans Trias i Pujol
  • University Hospital of the Canary Islands (HUC) La Laguna
  • Hospital Universitario de Gran Canaria Dr. Negrin
  • University Hospital Virgen del Rocio
  • RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
  • Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
  • Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
  • Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
  • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
  • CI of PH Kharkiv CCH #2
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • Kyiv City Clinical Hospital #1
  • SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
  • CI of Kyiv RC Regional Clinical Hospital #2
  • Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
  • Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
  • Lviv Regional Clinical Hospital
  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
  • Sumy Regional Clinical Hospital
  • CI of TRC Ternopil University Hospital
  • A. Novak Transcarpathian Regional Clinical Hospital
  • MCIC MC LLC Health Clinic
  • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital
  • Vinnytsia M.I. Pyrohov National Medical University
  • City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
  • Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
  • CI City Hospital #1
  • CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
  • Zaporizhia Regional Clinical Hospital
  • Central District Hospital under Zhytomyr District Council
  • University Hospital Coventry
  • Royal Devon and Exeter Hospital (Wonford)
  • Gloucestershire Royal Hospital
  • Whipps Cross University Hospital
  • St Thomas' Hospital
  • Royal Shrewsbury Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RPC1063 (Ozanimod)

Placebo

Arm Description

1mg, daily oral administration during Induction and Maintenance periods.

Daily oral administration during Induction and Maintenance periods.

Outcomes

Primary Outcome Measures

Percentage of Participants in Clinical Remission at 10 Weeks
Percentage of participants that are in Clinical remission at 10 weeks
Percentage of Participants in Clinical Remission at 52 Weeks
Percentage of participants that are in Clinical remission at 52 weeks

Secondary Outcome Measures

Percentage of Participants With Clinical Response at 10 Weeks
Percentage of participants that are in Clinical response at 10 weeks
Percentage of Participants With Endoscopic Improvement at 10 Weeks
Percentage of participants with endoscopic improvement at 10 weeks
Percentage of Participants With Mucosal Healing at 10 Weeks
Percentage of participants with mucosal healing at 10 weeks
Percentage of Participants in Clinical Response at 52 Weeks
Percentage of participants that are in Clinical response at 52 weeks
Percentage of Participants With Endoscopic Improvement at 52 Weeks
Percentage of participants with endoscopic improvement at 52 weeks
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Percentage of participants with corticosteroid free remission at 52 weeks
Percentage of Participants With Mucosal Healing at 52 Weeks
Percentage of participants with Mucosal Healing at 52 weeks
Percentage of Participants With Durable Clinical Remission at 52 Weeks
Percentage of participants with durable clinical remission at 52 weeks

Full Information

First Posted
April 24, 2015
Last Updated
August 6, 2021
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02435992
Brief Title
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2015 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Detailed Description
The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RPC1063 (Ozanimod)
Arm Type
Experimental
Arm Description
1mg, daily oral administration during Induction and Maintenance periods.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral administration during Induction and Maintenance periods.
Intervention Type
Drug
Intervention Name(s)
RPC1063
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission at 10 Weeks
Description
Percentage of participants that are in Clinical remission at 10 weeks
Time Frame
At 10 Weeks
Title
Percentage of Participants in Clinical Remission at 52 Weeks
Description
Percentage of participants that are in Clinical remission at 52 weeks
Time Frame
At 52 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response at 10 Weeks
Description
Percentage of participants that are in Clinical response at 10 weeks
Time Frame
At 10 Weeks
Title
Percentage of Participants With Endoscopic Improvement at 10 Weeks
Description
Percentage of participants with endoscopic improvement at 10 weeks
Time Frame
At 10 Weeks
Title
Percentage of Participants With Mucosal Healing at 10 Weeks
Description
Percentage of participants with mucosal healing at 10 weeks
Time Frame
At 10 Weeks
Title
Percentage of Participants in Clinical Response at 52 Weeks
Description
Percentage of participants that are in Clinical response at 52 weeks
Time Frame
At 52 Weeks
Title
Percentage of Participants With Endoscopic Improvement at 52 Weeks
Description
Percentage of participants with endoscopic improvement at 52 weeks
Time Frame
At 52 Weeks
Title
Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
Description
Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
Time Frame
At 52 Weeks
Title
Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
Description
Percentage of participants with corticosteroid free remission at 52 weeks
Time Frame
At 52 Weeks
Title
Percentage of Participants With Mucosal Healing at 52 Weeks
Description
Percentage of participants with Mucosal Healing at 52 weeks
Time Frame
At 52 Weeks
Title
Percentage of Participants With Durable Clinical Remission at 52 Weeks
Description
Percentage of participants with durable clinical remission at 52 weeks
Time Frame
At 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 75 years (at screening for Cohort 1 and 2) UC confirmed on endoscopy Moderately to severely active UC (May score 6-12) Currently receiving treatment with aminosalisylate, prednisone, or budesonide Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization Exclusion Criteria: Have severe extensive colitis as evidence by: Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline. Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation. Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk History of uveitis or unknown macular edema Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnnKatrin Petersen, M.D., MSc.
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Digestive Health
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Adobe Clinical Research LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arkansas Gastroenterology, P.A.
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Aurora Care Clinic
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Valley View Internal Medicine
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Davita Clinical Trials, LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
OM Research
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
University of Southern California - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Southern California Research Institute Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Gastrointestinal Biosciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Facey Medical Foundation (Parent)
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Alliance Clinical Research, LLC
City
Oceanside
State/Province
California
ZIP/Postal Code
92056-4497
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California at San Francisco (PARENT)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
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
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756-3839
Country
United States
Facility Name
Clinical Research of West Florida Inc - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Advanced Pharma Research, Inc
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Dolphin Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
South Florida Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
City Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Advanced Clincial Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Advanced Clinical Research of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Regenerate Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advanced Research for Health Improvement
City
Naples
State/Province
Florida
ZIP/Postal Code
34109
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
NSB Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Harmony Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Med-Care Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Center For Digestive Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
IMIC, Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
DBC Research, Corp
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Theia Clinical Research, LLC
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Atlanta Gastroenterology Associates LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Grand Teton Research Group, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Facility Name
DM Clinical Research
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-3767
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
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
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University of Maryland Medical Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Woodholme Gastroenterology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Johns Hopkins Clinical Research Network
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Charm City Research Group
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Commonwealth Clinical Studies, PLLC.
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Community Clinical Research Network
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Center For Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Clinical Research Professionals, LLC - De Paul Medical Dr
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Research Professionals LLC - The Pines Court
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Professionals, LLC - Olde Cabin Rd
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65806
Country
United States
Facility Name
Mary Hitchcock Memorial Hospital
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
07756
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Icahn School of Medicine Mount Sinai Beth Isreal
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Concord Medical Group PRIME
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai - PRIME
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7305
Country
United States
Facility Name
Carolinas HealthCare System Digestive Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
East Carolina Gastroenterology, PA
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Kinston Medical Specialists, PA
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
UC Health Clinical Trials Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Clinical Trials Management Office
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Clinical Inquest Center Ltd
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Digestive Disease Specialists
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4206
Country
United States
Facility Name
Consultants in Gastroenterology, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Gastroenterology Associates of Orangeburg
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Brooke-Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Gulf Coast Research Group LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Gastroenterology Research of San Antonio, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Gastroenterology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Spring Gastroenterology
City
Spring
State/Province
Texas
ZIP/Postal Code
77379
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Gastroenterology, LTD
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Instituto DAMIC Fundacion Rusculleda
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
ZIP/Postal Code
01900
Country
Argentina
Facility Name
Instituto Medico CER
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Instituto Medico de la Fundacion Estudios Clinicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centre For Digestive Diseases
City
Five Dock
State/Province
New South Wales
ZIP/Postal Code
2046
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Cabrini Hospital Malvern
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Bentleigh East
ZIP/Postal Code
3165
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
City Clinical Hospital No 10
City
Minsk
ZIP/Postal Code
220096
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC - Clinique St-Jospeh
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Medical Centre "Asklepii", OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT "Kaspela", EOOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MC Rusemed ltd.
City
Ruse
ZIP/Postal Code
7013
Country
Bulgaria
Facility Name
NMTH "Tsar Boris III"
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT "Lyulin", EAD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
City Clinic UMHAC EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
MHAT 'Tokuda Hospital Sofia', EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Fourth MHAT - Sofia EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT 'Sveta Anna' AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
UMHAT "SofiaMed", OOD
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
MHAT 'Sv. Marina', EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
MC Medica Plus
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Brandon Medical Arts Clinic
City
Brandon
State/Province
Manitoba
ZIP/Postal Code
R7A 0N7
Country
Canada
Facility Name
Viable Clinical Research - Lindsay
City
Lindsay
State/Province
Ontario
ZIP/Postal Code
K9V 5G6
Country
Canada
Facility Name
LHSC - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Quebec
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
CHUS - Hôpital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Clinical Hospital Center Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
63600
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
GASTRO JeKa s.r.o.
City
Klatovy
ZIP/Postal Code
399 01
Country
Czechia
Facility Name
Gregar s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
PreventaMed
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
ISCARE, a.s.
City
Prague 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Institut klinicke a experimentalni mediciny
City
Praha 4
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
LTD Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LLC Vivamedi
City
Tbilisi
ZIP/Postal Code
0131
Country
Georgia
Facility Name
LTD Academician N.Kipshidze Central University Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Aversi Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Coloproctological Center
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
DRK Kliniken Berlin Westend
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Medical Care Unit Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Crohn Colitis Centrum Rhein Main
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20426
Country
Germany
Facility Name
Asklepios Klinik Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11 527
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
715 00
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa Thessaly
ZIP/Postal Code
41110
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokration
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
424th Army General Hospital
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Szent Margit Korhaz
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
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
City
Letavertes
ZIP/Postal Code
4281
Country
Hungary
Facility Name
Mohacsi Korhaz
City
Mohacs
ZIP/Postal Code
7700
Country
Hungary
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-030
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
ZIP/Postal Code
302-718
Country
Korea, Republic of
Facility Name
Hanyang Univerisy Guri Hospital
City
Guri-si
ZIP/Postal Code
471-701
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center CHA University
City
Seongnam-si,
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
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
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
3181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
7985
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St.Vicent's Hospital
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju-Si
ZIP/Postal Code
220701
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
"Sfanta Treime" Clinical Municipal Hospital
City
Chisinau
ZIP/Postal Code
MD-2068
Country
Moldova, Republic of
Facility Name
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
City
Chisinau
ZIP/Postal Code
MD2005
Country
Moldova, Republic of
Facility Name
"Sf. Arhanghel Mihail" Municipal Clinical Hospital
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of
Facility Name
Republican Clinical Hospital
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastrich
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard-Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
ETZ Elisabeth
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Christchurch Hospital NZ
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Public Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Clinsante S.C. Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
Specjalistyczna Przychodnia Lekarska Medicus
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
GLOBE Clinical Research Sp. z o.o. LLC
City
Klodzko
ZIP/Postal Code
57-300
Country
Poland
Facility Name
PLEJADY Sp. z o.o. (LLC) Medical Centre
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Centrum Medyczne A-Z Clinic
City
Kraków
ZIP/Postal Code
31-315
Country
Poland
Facility Name
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Santa Familia Centrum Badan, Profilaktyki i Leczenia
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Trialmed Llc
City
Piotrkow Trybunalski
ZIP/Postal Code
97-300
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
MDM Healthcare Centre
City
Warsaw
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Nzoz Vivamed
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
City
Wierzchoslawice
ZIP/Postal Code
33-122
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Bacau County Emergency Hospital, Department of Gastroenterology
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Hyperclinica MedLife Grivita
City
Bucharest
ZIP/Postal Code
010719
Country
Romania
Facility Name
Bucharest University Emergency Hospital, Department of Internal Medicine II
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
City
Cluj-Napoca
ZIP/Postal Code
400132
Country
Romania
Facility Name
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Craiova County Emergency Clinical Hospital
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Multidisciplinary Medical Clinic "Anthurium"
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
City
Irkutsk
ZIP/Postal Code
664005
Country
Russian Federation
Facility Name
SBEI HPE "Kazan State Medical University" of the MoH of the RF
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBEI HPE Rostov State Medical University of the MoH of the RF
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
SBIH City Clinical Hospital #31
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Union Clinic
City
Saint-Peterburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
City
Saint-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
SPb SBIH City Hospital # 26
City
Saint-Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Private Educational Institution of Higher Education "Medical University "REAVIZ"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
LLC Medical Company Hepatologist
City
Samara
Country
Russian Federation
Facility Name
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
SPb SBIH Alexandrovskaya City Hospital
City
St.Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
SBEI HPE "Stavropol State Medical Academy" MoH of RF
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
City
Belgrade
ZIP/Postal Code
11 080
Country
Serbia
Facility Name
Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy, Clinic of Gastroenterology and Hepatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun Department of Gastroenterology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis, Clinic of Gastroenterology and Hepatology
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
General Hospital Djordje Jovanovic Zrenjanin
City
Zrenjanin
ZIP/Postal Code
23 000
Country
Serbia
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Alian s.r.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
PRO SANUS, a.s., Poliklinika ProCare Central
City
Bratislava
ZIP/Postal Code
82107
Country
Slovakia
Facility Name
IBDcentrum s.r.o.
City
Bratislava
ZIP/Postal Code
83104
Country
Slovakia
Facility Name
Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
City
Ilava
ZIP/Postal Code
01901
Country
Slovakia
Facility Name
Gastroped s.r.o.
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
City
Malacky
ZIP/Postal Code
90122
Country
Slovakia
Facility Name
PIGEAS s.r.o.
City
Martin
ZIP/Postal Code
3601
Country
Slovakia
Facility Name
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
City
Michalovce
ZIP/Postal Code
7101
Country
Slovakia
Facility Name
Gastromedic s.r.o.
City
Nove Zamky
ZIP/Postal Code
94002
Country
Slovakia
Facility Name
EndoCorp s.r.o.
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Dr MJ Prins Practice
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Tiervlei Trial Centre
City
Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Endocare Research
City
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Dr JP Wright Practice
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Dr YS Nanabhay Practice
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
University Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
University Hospital of the Canary Islands (HUC) La Laguna
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35012
Country
Spain
Facility Name
University Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
CI of PH Kharkiv CCH #2
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
CI of Kyiv RC Regional Clinical Hospital #2
City
Kyiv
ZIP/Postal Code
04073
Country
Ukraine
Facility Name
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
City
Kyiv
ZIP/Postal Code
1030
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
City
Sumy
ZIP/Postal Code
40021
Country
Ukraine
Facility Name
Sumy Regional Clinical Hospital
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
CI of TRC Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
02029
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Vinnytsia M.I. Pyrohov National Medical University
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
City
Zaporizhia
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
City
Zaporizhia
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
City
Zaporizhzhia
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Zaporizhia Regional Clinical Hospital
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Central District Hospital under Zhytomyr District Council
City
Zhytomyr
ZIP/Postal Code
12430
Country
Ukraine
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
ZIP/Postal Code
SY38XQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34587385
Citation
Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617.
Results Reference
derived
Links:
URL
https://truenorthstudy.com/
Description
Related Info

Learn more about this trial

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

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