Clinical trial NCT02974322: A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
GED-0301
Mongersen
Adolescent
Pediatric
Children
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone.

All patients who complete the study will have the option to enter a long term active treatment study.


Eligibility criteria: Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

* Male or female ≥ 12 years
* Subject is able to swallow the IP tablets
* Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7day period
* Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab).

Exclusion Criteria:

• The presence of any of the following will exclude a subject from enrollment: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis, or colitis due to immunodeficiency

* Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
* Subject has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded
* Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
* Ileostomy or a colostomy
* Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study
* Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until the Week 12 visit.

Primary outcomes:
measure: Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and Crohn's Disease Activity Index (CDAI) (Rest of World)
timeFrame: week 12
Secondary outcomes:
measure: Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI
timeFrame: Week 4, week 12
measure: Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: Week 12
measure: Clinical response defined by CDAI
timeFrame: Week 4, week 12
measure: Clinical remission defined by PCDAI
timeFrame: Week 12
measure: Adverse Events (AEs)
timeFrame: Up to 20 weeks
measure: Pharmacokinetics (PK)- plasma concentration of GED-0301
timeFrame: Week 4, week 8
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Dcr-Pi Pc
state: Arizona
city: Mesa
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Phoenix
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Sun City
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Little Rock
country: United States
facility: Gastroenterology Associates PA
state: Arkansas
city: Garden Grove
country: United States
facility: Valley View Internal Medicine
state: California
city: Lancaster
country: United States
facility: High Desert Gastroenterology, Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group Inc.
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco (PARENT)
state: California
city: Torrance
country: United States
facility: HCP Clinical Research LLC
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Lafayette
country: United States
facility: Innovative Clinical Research
state: Colorado
city: Bristol
country: United States
facility: Connecticut Gastroenterology Institute
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut LLC
state: Connecticut
city: Hartford
country: United States
facility: Connecticut GI PC Research Division
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Sanitas Research
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Orlando
country: United States
facility: GCRM
state: Florida
city: Orlando
country: United States
facility: Center For Digestive Health
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida Weston
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Healthsystem Research Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Pratt
country: United States
facility: Health Science Research Center, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Wichita
country: United States
facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SW Louisiana LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Group
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Towson
country: United States
facility: Charm City Research Group
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Inc. - PARENT ACCOUNT
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Caro
country: United States
facility: Medex Research Institute
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan PLC
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Springfield
country: United States
facility: Mercy Research
state: Missouri
city: Washington
country: United States
facility: Mercy Research
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates LLC
state: New Jersey
city: Great Neck
country: United States
facility: North Shore-LIJ Health System-Division of Rheumatology
state: New York
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research PRIME
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Center for Liver Disease
state: North Carolina
city: Charlotte
country: United States
facility: Gaffney Health Services
state: North Carolina
city: Greensboro
country: United States
facility: PhysiqueMed Clinical Trials
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists PA
state: North Carolina
city: Mount Airy
country: United States
facility: Clinical Trials of America, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Akron
country: United States
facility: Ohio Clinical Research Partners LLC
state: Ohio
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Centerville
country: United States
facility: Dr. Deepak Sarwal, MD
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Springfield
country: United States
facility: Springfield Health Care Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Havertown
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: State College
country: United States
facility: Penn State University Milton S Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Carolinas Healthcare System
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute LLC
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group LLC
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: Pasadena
country: United States
facility: Digestive Health Center
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Division of Gastroenterology
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes Mcguire Ctr
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center Cancer Institute Research
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Madison
country: United States
facility: Dean Clinic Oregon
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Five Dock
country: Australia
facility: Centre For Digestive Diseases
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
city: Bentleigh East
country: Australia
facility: Monash Medical Centre Clayton
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörtersee
city: Salzburg
country: Austria
facility: LKH - Universitätsklinikum der PMU Salzburg
city: Wein
country: Austria
facility: Krankenanstalt Rudolfstiftung Wien
city: Brussels
country: Belgium
facility: Hopital Universitaire des Enfants
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Calgary
country: Canada
facility: Alberta Childrens Hospital
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre de sante et de services sociaux Champlain Charles Le Moyne
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK, s. r. o.
city: Olomouc
country: Czechia
facility: PreventaMed
city: Praha 3
country: Czechia
facility: CCBR Prague CZ
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Aahus C
country: Denmark
facility: Aarhus Universitetshospital
city: Alborg
country: Denmark
facility: Alborg Universitets Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Koge
country: Denmark
facility: Koge Sygehus
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Amiens Cedex
country: France
facility: CHU Amiens Hopital Sud
city: Besancon Cedex
country: France
facility: CHU Besancon Hopital Jean Minjoz
city: Lille cedex
country: France
facility: Hopital Claude Huriez CHRU Lille
city: Marseille cedex 20
country: France
facility: Hopital Nord CHU Marseille
city: Nice Cedex 3
country: France
facility: CHU Nice Hopital de lArchet 2
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Pierre Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: CHU Reims Hopital Robert Debre
city: Rouen
country: France
facility: CHU de Rouen Hopital Charles Nicolle
city: Toulouse Cedex 09
country: France
facility: CHU de Toulouse Hopital Rangueil
city: Vandoeuvre les Nancy
country: France
facility: Hopital de Brabois Adultes
city: Berlin
country: Germany
facility: Charite - Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Brandenburg an der Havel
country: Germany
facility: Staedisches Klinikum Brandenburg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Essen
country: Germany
facility: Katholische Kliniken Ruhrhalbinsel GmbH
city: Frankfurt
country: Germany
facility: Crohn Colitis Centrum Rhein Main
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig Holstein Campus Kiel
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Minden
country: Germany
facility: Gastroenterologische Praxis Minden
city: Regensburg
country: Germany
facility: Universitatsklinikum Regensburg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos
city: Athens
country: Greece
facility: Athens Medical Center
city: Rio Patras
country: Greece
facility: University General Hospital of Patras
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Universita Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Complesso Integrato Columbus
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Guri-si
country: Korea, Republic of
facility: Hanyang Univerisy Guri Hospital
city: Seongnam-si,
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Riga
country: Latvia
facility: Digestive Diseases Center Gastro
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital clinic Gailezers
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bialystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
city: Bydgoszcz
country: Poland
facility: Clinsante S.C. Osrodek Badan Klinicznych
city: Kraków
country: Poland
facility: Centrum Medyczne A-Z Clinic
city: Lodz
country: Poland
facility: Centrum Medyczne AMED
city: Warsaw
country: Poland
facility: Nzoz Vivamed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes
city: Lisboa
country: Portugal
facility: Hospital Da Luz
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE
city: Viana do Castelo
country: Portugal
facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
city: Oradea
country: Romania
facility: CMI Dr. Tirnaveanu Amelita
city: Timisoara
country: Romania
facility: Centrul de Gastroenterologie Dr. Goldis
city: Moscow
country: Russian Federation
facility: Medical Center Stolitsa-Medikl
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH City Hospital # 26
city: Samara
country: Russian Federation
facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Presov
country: Slovakia
facility: GASTRO I., s.r.o.
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus AB
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: Bern
country: Switzerland
facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve-HUG
city: Zuerich
country: Switzerland
facility: UniversitatSspital Zurich
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Elazig
country: Turkey
facility: Firat University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Izmir
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Malatya
country: Turkey
facility: Inonu Uni. Med. Fac.
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Kharkiv
country: Ukraine
facility: CI of PH Kharkiv CCH #2
city: Kirovohrad
country: Ukraine
facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1
city: Odessa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital
city: Sumy
country: Ukraine
facility: CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
city: Ternopil
country: Ukraine
facility: Ternopil City Communal Emergency Medical Care Hospital
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
city: Zaporizhia
country: Ukraine
facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
city: Zaporozhje
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: University College London Hospitals
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Queens Medical Centre
city: Roxburghshire
country: United Kingdom
facility: Borders General Hospital
Study officials:
affiliation: Celgene Corporation
name: Denesh Chitkara, MD
role: STUDY_DIRECTOR
References: