Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
1 other identifier
interventional
701
32 countries
519
Brief Summary
The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 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. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
519 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedStudy Start
First participant enrolled
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2018
CompletedResults Posted
Study results publicly available
January 23, 2019
CompletedAugust 28, 2019
August 1, 2019
2.1 years
November 3, 2015
January 2, 2019
August 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Who Achieved a Clinical Remission at Week 12
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined \>450.
Week 12
Secondary Outcomes (11)
Percentage of Participants Who Achieved Clinical Remission at Week 52
Week 52
Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52
Week 52
The Percentage of Participants Who Achieved a Clinical Response at Week 12
Week 12
The Percentage of Participants Who Achieved a Clinical Response at Week 4
Week 4
The Percentage of Participants Who Achieved a Clinical Remission at Week 4
Week 4
- +6 more secondary outcomes
Study Arms (4)
GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301
EXPERIMENTALGED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit
GED0301 160mg x 12 weeks followed by periodic GED0301 40mg
EXPERIMENTALGED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit
GED0301 160mg x 12 weeks followed by continuous GED0301 40mg
EXPERIMENTALGED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit
Placebo
PLACEBO COMPARATORPlacebo once daily (QD) until the Week 52 Visit
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female ≥ 18 years
- 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 7 day 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.
You may not qualify if:
- 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
- Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (538)
ADDC Research LLC
Huntsville, Alabama, 35802, United States
Arizona Digestive Health
Mesa, Arizona, 85024, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Colon & Digestive Health Specialists
Scottsdale, Arizona, 85260-1315, United States
Arizona Digestive Health
Sun City, Arizona, 85351, United States
Gastroenterology Associates PA
Little Rock, Arkansas, 72205, United States
HCP Clinical Research LLC
Anaheim, California, 92801, United States
T. Joseph Raoof MD Inc
Encino, California, 91436, United States
Valley View Internal Medicine
Garden Grove, California, 92843, United States
OM Research
Lancaster, California, 93534, United States
University of Southern California Medical Center
Los Angeles, California, 90032, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Medical Associates Research Group Inc.
San Diego, California, 902123, United States
Clinical Applications Laboratories Inc
San Diego, California, 92103, United States
University of California at San Francisco
San Francisco, California, 94158, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Innovative Clinical Research
Lafayette, Colorado, 80026, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010, United States
Medical Research Center of Connecticut LLC
Hamden, Connecticut, 06518, United States
Connecticut GI PC Research Division
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06520, United States
Florida Medical Research - Southeastern Integrated Medical
Gainesville, Florida, 32607, United States
Sarkis Clinical Trials - Parent
Gainesville, Florida, 32607, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
Advance Medical Research Center
Miami, Florida, 33155, United States
Cordova Research Institute
Miami, Florida, 33155, United States
My Community Research Center inc
Miami, Florida, 33155, United States
Sanitas Research
Miami, Florida, 33155, United States
Galiz Research LLC
Miami Springs, Florida, 33166, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
GCRM
Orlando, Florida, 32801, United States
Center For Digestive Health
Orlando, Florida, 32803, United States
BRCR Medical Center Inc.
Plantation, Florida, 33322, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
East Coast Institute for Research LLC
Saint Augustine, Florida, 32086, United States
Cleveland Clinic Florida Weston
Weston, Florida, 33331, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Atlanta Gastroenterology Specialists PC
Suwanee, Georgia, 30024, United States
Grand Teton Research Group PLLC
Idaho Falls, Idaho, 83404, United States
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
NorthShore University HealthSystem
Highland Park, Illinois, 60035, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Health Science Research Center, LLC
Pratt, Kansas, 67124, United States
Heartland Research Associates LLC
Wichita, Kansas, 67207, United States
Via Christi Research a division of Via Christi Hospitals Wichita Inc
Wichita, Kansas, 67208, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40504, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Gastroenterology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Clinical Trials of SW Louisiana LLC
Lake Charles, Louisiana, 70601, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71103, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21218, United States
Metropolitan Gastroenterology
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland
Columbia, Maryland, 21045, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Commonwealth Clinical Studies PLLC
Brockton, Massachusetts, 02302, United States
UMass Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Medex Research Institute
Caro, Michigan, 48723, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Henry Ford Medical Center - New Center One
Novi, Michigan, 48377, United States
Gastroenterology Associates of Western Michigan PLC
Wyoming, Michigan, 49519, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Ehrhardt Clinical Research LLC
Belton, Missouri, 64012, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65203, United States
Mercy Research
Springfield, Missouri, 65806, United States
Saint Louis University
St Louis, Missouri, 63110 - 0250, United States
Mercy Clinic East Communities d/b/a Mercy Health Research
Washington, Missouri, 63090, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
AGA Clinical Research Associates LLC
Egg Harbor, New Jersey, 08234, United States
Southwest Gastroenterology Associates PC
Albuquerque, New Mexico, 87109, United States
Sing Chan Private Practice
Flushing, New York, 11355, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, 11021, United States
Montefiore Medical Center PRIME
Lake Success, New York, 11041, United States
The Feinstein Institute for Medical Research PRIME
Manhasset, New York, 11030, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
North Shore Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
Concord Medical Group PRIME
New York, New York, 10016, United States
New York University School of Medicine
New York, New York, 10016, United States
New York - Presbyterian/Weill Cornell Medical Center
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601, United States
University of Rochester
Rochester, New York, 14642, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Carolina Center for Liver Disease
Charlotte, North Carolina, 28203, United States
Gaffney Health Services
Charlotte, North Carolina, 28205, United States
Carolinas Medical Center
Charlotte, North Carolina, 28207, United States
PhysiqueMed Clinical Trials
Greensboro, North Carolina, 27455, United States
Kinston Medical Specialists PA
Kinston, North Carolina, 28501, United States
Clinical Trials of America, LLC
Mount Airy, North Carolina, 27030, United States
Trial Management Associates LLC
Wilmington, North Carolina, 28401, United States
PMG Research of Winston-Salem LLC
Winston-Salem, North Carolina, 27103-3914, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Ohio Clinical Research Partners LLC
Akron, Ohio, 44333, United States
Dr. Deepak Sarwal, MD
Centerville, Ohio, 45429, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, 45206, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44106, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Clinical Inquest Center Ltd
Huber Heights, Ohio, 45424-3239, United States
Springfield Health Care Center
Springfield, Ohio, 45504, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Main Line Gastroenterology
Havertown, Pennsylvania, 19083-2742, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Penn State University Milton S Hershey Medical Center
State College, Pennsylvania, 16803, United States
ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Texas Clinical Research Institute LLC
Arlington, Texas, 76012, United States
Texas Digestive Disease Consultants - Dallas
Arlington, Texas, 76012, United States
Texas Digestive Disease Consultants Dallas
Dallas, Texas, 75231, United States
Texas Digestive Disease Consultants - Southlake
Flower Mound, Texas, 75028, United States
Gulf Coast Research Group LLC
Houston, Texas, 77004, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Houston Endoscopy and Research Center
Houston, Texas, 77079, United States
Sagact Pllc
San Antonio, Texas, 78229, United States
San Antonio Military Medical Center
San Antonio, Texas, 78229, United States
Scott & White Medical Center
Temple, Texas, 76508, United States
Digestive Health Specialist of Tyler
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Vermont
Colchester, Vermont, 05446, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Emeritas Research Group
Leesburg, Virginia, 20176, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Hunter Holmes Mcguire Ctr
Richmond, Virginia, 23249, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
University of Washington School of Medicine
Seattle, Washington, 98104, United States
The Vancouver Clinic
Vancouver, Washington, 98664-4896, United States
Dean Clinic Oregon
Madison, Wisconsin, 53716, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596, United States
Bankstown-Lidcombe Hospital
Bankstown, Australian Capital Territory, 2200, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Centre For Digestive Diseases
Five Dock, New South Wales, 2046, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Ballarat Base Hospital
Ballarat, 3350, Australia
Monash Medical Centre Clayton
Bentleigh East, 3165, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
Austin Hospital
Heidelberg, 3084, Australia
Royal Brisbane and Women's Hospital
Herston, 4006, Australia
Nepean Hospital
Kingswood, NSW, 2751, Australia
LKH Universitaetsklinikum Graz
Graz, 8036, Austria
Medizinische Universitat Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Wörtersee
Klagenfurt, 9020, Austria
KH der Barmherzigen Bruder Linz
Linz, 4021, Austria
a.o.Krankenhaus d.Barmherz.Schwestern Ried
Ried I Innkreis, 4910, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Ordination Dr. Thomas Haas Darmpraxis Salzburg
Salzburg, 5020, Austria
KH der Barmherzigen Brüder St.Veit an der Glan
Sankt Veit an der Glan, 9300, Austria
Krankenanstalt Rudolfstiftung Wien
Wein, 1030, Austria
AKH Medizinische Universitat Wien
Wein, 1090, Austria
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
Centre Hospitalier de Mouscron
Mouscron, 9000, Belgium
MHAT Sv Nikolay Chudotvorets EOOD
Lom, 3600, Bulgaria
MHAT Kaspela EOOD
Plovdiv, 4002, Bulgaria
MHAT Ruse AD
Rousse, 7002, Bulgaria
Second MHAT Sofia AD
Sofia, 1202, Bulgaria
City Clinic UMHAC EOOD
Sofia, 1407, Bulgaria
UMHAT Sv Ivan Rilski EAD
Sofia, 1431, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Fourth MHAT Sofia EAD
Sofia, 1606, Bulgaria
MHAT Doverie AD
Sofia, 1632, Bulgaria
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
GI Research Institute
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
South Edmonton Gastroenterology
Edmonton, Alberta, T6L 6K3, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
PerCuro Clinical Research
Victoria, British Columbia, V8V 3P9, Canada
Brandon Medical Arts Clinic
Brandon, Manitoba, R7A 0N7, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
McMaster University Health Sciences Center
Hamilton, Ontario, L8N 3Z5, Canada
London Health Science Center U. Hospital
London, Ontario, N6A 5A5, Canada
LHSC Victoria Hospital
London, Ontario, N6A 5W9, Canada
Montfort Hospital
Ottawa, Ontario, K1K 0T2, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Toronto Digestive Disease Associates Inc
Vaughan, Ontario, L4L 4Y7, Canada
Medicine Professional Corporation
Waterloo, Ontario, N2J 1C4, Canada
Tarabain Osman MD
Windsor, Ontario, N8W 1E6, Canada
Centre de sante et de services sociaux Champlain Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
Recherche GCP Research
Montreal, Quebec, H1M 1B1, Canada
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal, Quebec, H1T 2M4, Canada
CHUM Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
McGill University Health Centre Glen Site Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Recherche Medicale St Jerome Inc
Saint-Jérôme, Quebec, J7Z 5T3, Canada
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H5N4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Recherche Clinique Sigma Inc
Québec, G1G 4A2, Canada
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Clinical Hospital Merkur
Zagreb, 10000, Croatia
Clinical Hospital Sveti Duh
Zagreb, 10000, Croatia
Fakultni nemocnice u sv Anny v Brne
Brno, 656 91, Czechia
Hepato-Gastroenterologie HK
Hradec Králové, 50012, Czechia
Soukroma Gastroenterologicka ambulance a endoskopie
Most, 43401, Czechia
PreventaMed
Olomouc, 77900, Czechia
CCBR Czech as
Pardubice, 530 02, Czechia
CCBR Prague CZ
Prague, 13000, Czechia
IBD Centrum ISCARE IVF as
Prague, 170 04, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
Ústí nad Labem, 40113, Czechia
Nemocnice Znojmo
Znojmo, 669 02, Czechia
Aarhus Universitetshospital
Aahus C, 8000, Denmark
Alborg University Hospital
Aalborg, 9000, Denmark
Nordsjaellands Hospital Frederikssund
Frederikssund, 3600, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Koge Sygehus
Køge, 4600, Denmark
Regionshospitalet Silkeborg
Silkeborg, 8600, Denmark
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Tampereen yliopistollinen sairaala
Tampere, 33521, Finland
Turunmaan sairaala
Turku, 20700, Finland
CHU Amiens Hopital Sud
Amiens, 80054, France
CHU Besancon Hopital Jean Minjoz
Besançon, 25030, France
CHU Tours Hopital Trousseau
Chambray-lès-Tours, 37170, France
CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
Hopital Beaujon
Clichy, 92110, France
CHU Dijon - Hopital Bocage Central
Dijon, 21000, France
CHU de Grenoble Hopital Nord
Grenoble, 38043, France
Groupement Hospitalier Sud Hopital Bicetre
Le Kremlin-Bicêtre, 94275, France
Hopital Claude Huriez CHRU Lille
Lille, 59037, France
Hopital Nord
Marseille, 13915, France
CHU Nantes Hotel Dieu
Nantes, 44093, France
CHU Nice Hopital de lArchet 2
Nice, 06200, France
Hopital Saint Antoine
Paris, 75012, France
Hopital Saint Louis
Paris, 75475, France
Groupe Hospitalier Sud Hopital Haut Leveque USN
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Reims Hopital Robert Debre
Reims, 51092, France
CHU Rennes Hopital Pontchaillou
Rennes, 35033, France
CHU de Rouen Hopital Charles Nicolle
Rouen, 76031, France
CHU Saint Etienne Hopital Nord
Saint-Etienne, 42055, France
CHU Strasbourg Hopital Hautepierre
Strasbourg, 67098, France
CHU de Toulouse Hopital Rangueil
Toulouse, 31059, France
Hopital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
Berlin, 12200, Germany
Charite Campus Virchow Klinikum
Berlin, 13353, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Krankenhaus Waldfriede e V
Berlin, 14163, Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
Bochum, 44789, Germany
Staedisches Klinikum Brandenburg
Brandenburg, 14770, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Zentrum fuer HIV und Hepatogastroenterologie GmbH
Düsseldorf, 40237, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Kliniken Essen-Mitte
Essen, 45136, Germany
Katholische Kliniken Ruhrhalbinsel GmbH
Essen, 45257, Germany
Agaplesion Markus Krankenhaus
Frankfurt, 60431, Germany
Crohn Colitis Centrum Rhein Main
Frankfurt, 60594, Germany
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Halle Saale
Halle, 06120, Germany
Asklepios Klinik Hamburg
Hamburg, 22559, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
Heidelberg, 69121, Germany
Universitaetsklinikum Jena
Jena, 07740, Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, 24105, Germany
University Leipzig
Leipzig, 04103, Germany
Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen
Leipzig, 04105, Germany
EUGASTRO GmbH
Leipzig, 4103, Germany
Medizinisches Zentrum Klinikum Lueneburg
Lüneburg, 21339, Germany
Universitaetsklinikum Magdeburg A oeR
Magdeburg, 39120, Germany
Klinikum Mannheim GmbH Universitaetsklinikum
Mannheim, 68167, Germany
Gastroenterologische Praxis Minden
Minden, 32423, Germany
Isar Klinik GmbH
München, 80331, Germany
Klinikum der Universitaet Muenchen
München, 81377, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Gastro Campus Research
Münster, 48159, Germany
Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
Niedersachsen, 38126, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
General Hospital of Athens Evangelismos
Athens, 10676, Greece
Athens Medical Center
Athens, 15125, Greece
General Hospital of Nikaea Piraeus Ag. Panteleimon
Athens, 18454, Greece
University General Hospital of Heraklion
Heraklion, 711 10, Greece
General Hospital of Heraklion Benizeleio Pananeio
Heraklion, 71409, Greece
University General Hospital of Ioannina
Ioannina, 45500, Greece
University General Hospital of Patras
Rio Patras, 26500, Greece
Anticancer Hospital of Thessaloniki THEAGENIO
Thessaloniki, 54007, Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki, 54642, Greece
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, 8230, Hungary
Clinexpert Egeszsegugyi Szolg es Ker Kft
Budapest, 1033, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
Semmelweis Egyetem AOK
Budapest, 1083, Hungary
Semmelweis Egyetem AOK
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Endomedix Diagnosztikai Kozpont
Budapest, 1139, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
Dunaújváros, 2400, Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, 3300, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, 5700, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400, Hungary
Mazso-Pharma Kutatas-fejlesztesi Kft
Szeged, 6722, Hungary
Clinfan Szolgaltato Kft
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
HaEmek Medical Center
Afula, 18341, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah University Hospital
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, 64239, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Policlinico G Martino
Messina, 98125, Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Seconda Universita Degli Studi Di Napoli
Naples, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
Hospital of Di Padova
Padua, 35128, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Universita Campus Bio-Medico di Roma
Roma, 00128, Italy
Ospedale Sandro Pertini
Roma, 00157, Italy
Complesso Integrato Columbus
Roma, 00168, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 133, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
Salerno, 84131, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo FG, 71013, Italy
Digestive Diseases Center Gastro
Riga, LV-1006, Latvia
Riga East Clinical University Hospital clinic Gailezers
Riga, LV-1038, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Hospital Sultanah Bahiyah
Alor Star, Kedah, 5460, Malaysia
Hospital Universiti Sains Malaysia
Kelantan, Kelantan, 16150, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Ampang
Ampang, Selangor, 68000, Malaysia
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105, Netherlands
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Leiden Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Medisch Centrum Haaglanden,Antoniushoeve
Leidschendam, 2262 BA, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen, 6162 BG, Netherlands
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Waikato Hospital
Hamilton, 3204, New Zealand
Sykehuset Ostfold Fredrikstad
Fredrikstad, 1603, Norway
Akershus universitetssykehus HF
Lørenskog, 1478, Norway
Oslo Universitetssykehus HF Ulleval
Oslo, 0424, Norway
Oslo Universitetssykehus Rikshospitalet
Oslo, N-0027, Norway
Stavanger Unviversitetssjukehus Helse Stavanger HF
Stavanger, 4011, Norway
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, 15-275, Poland
Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz, 85-794, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
Kielce, 25-364, Poland
Indywidualna Praktyka Lekarska Maciej Zymla
Knurów, 44-190, Poland
Centrum Medyczne Plejady
Krakow, 30-349, Poland
LUX MED Sp. z o.o.
Krakow, 30-415, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-531, Poland
SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
Lodz, 90-647, Poland
Centrum Medyczne AMED
Lodz, 91-365, Poland
GASTROMED Sp.zo.o.
Lublin, 20-582, Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, 61-113, Poland
Centrum Medyczne Medyk
Rzeszów, 35-055, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar E Universitario de Coimbra EPE
Coimbra, 3000-075, Portugal
Hospital da Senhora da Oliveira Guimaraes
Guimarães, 4835-044, Portugal
Hospital Da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar de Sao Joao, EPE
Porto, 4200-319, Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
Viana do Castelo, 4904-858, Portugal
S.C MedLife S.A
Bucharest, 010719, Romania
Tvm Med Serv Srl
Cluj-Napoca, 400132, Romania
Spitalul Clinic Judetean de Urgente Sf. Spiridon
Iași, 700111, Romania
CMI Dr. Tirnaveanu Amelita
Oradea, 410066, Romania
Centrul de Gastroenterologie Dr. Goldis
Timișoara, 300002, Romania
Irkutsk State Medical Academy of Continuing Education
Irkutsk, 664049, Russia
TSBIH Territorial Clinical Hospital
Krasnoyarsk, 660022, Russia
Medical Center Stolitsa-Medikl
Moscow, 115088, Russia
SBHI of NN region RCH of NN n.a. N.A.Semashko
Nizhny Novgorod, 603126, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630054, Russia
RSHI State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087, Russia
FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
Novosibirsk, 630117, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
Omsk, 644043, Russia
SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral
Perm, 614068, Russia
Evromedservis
Pushkin, 196603, Russia
SEIHPE Rostov State Medical University of MoH of RF
Rostov-on-Don, 344022, Russia
City Mariinskaya Hospital
Saint Petersburg, 194104, Russia
SPb SBIH City Hospital # 26
Saint Petersburg, 196247, Russia
Private Educational Institution of Higher Education Medical university REAVIZ
Samara, 443001, Russia
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
Samara, 443041, Russia
SHI Regional Clinical Hospital
Saratov, 410053, Russia
SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno
Tosno, 187000, Russia
SBHI of Yaroslavl Region Clinical Hospital 8
Yaroslavl, 150030, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Center Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Center Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, 975 17, Slovakia
Alian s.r.o.
Bardejov, 08501, Slovakia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Gastroentero-Hepatologicke centrum THALION
Bratislava, 83104, Slovakia
Nemocnica A.Lena Humenne n o
Humenné, 06601, Slovakia
B & B MED, s.r.o.
Košice, 04022, Slovakia
KARDIO 1 s.r.o.
Lučenec, 984 39, Slovakia
Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
Malacky, 90122, Slovakia
Fakultna nemocnica Nitra
Nitra, 949 01, Slovakia
KM Management, spol. s r.o.
Nitra, 94901, Slovakia
GASTRO I., s.r.o.
Prešov, 080 01, Slovakia
Nemocnica s poliklinikou sv Barbory Roznava a s
Rožňava, 04801, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, 01207, Slovakia
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Hanyang Univerisy Guri Hospital
Guri-si, 11923, South Korea
CHA Bundang Medical Center CHA University
Seongnam-si, 13496, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 158-710, South Korea
The Catholic University of Korea, St.Vicent's Hospital
Suwon, 16247, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, 08208, Spain
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, 28702, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Macarena
Seville, 41017, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Sodersjukhuset
Stockholm, 11883, Sweden
Danderyds Sjukhus AB
Stockholm, 18288, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Universitaetsspital Basel
Basel, 4031, Switzerland
Inselspital - Universitaetsspital Bern
Bern, 3010, Switzerland
Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
Bern, 3012, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, 9000, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Turkiye Yuksek Ihtisas Hospital
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Firat University Medical Faculty
Elâzığ, 23119, Turkey (Türkiye)
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, 27310, Turkey (Türkiye)
Yeditepe University Medical School Hospital
Istanbul, 31755, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul, 34098, Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, 34349, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul, 34854, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Inonu Uni. Med. Fac.
Malatya, 44280, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33020, Turkey (Türkiye)
Kocaeli Derince Training and Research Hospital
Umuttepe Kocaeli, 41380, Turkey (Türkiye)
RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
Chernivtsi, 58001, Ukraine
CI of PH Kharkiv CCH #2
Kharkiv, 61037, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039, Ukraine
Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
Kirovohrad, 25006, Ukraine
Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
Kyiv, 01030, Ukraine
Kyiv City Clinical Hospital #1
Kyiv, 02091, Ukraine
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
Kyiv, 04053, Ukraine
Lviv Regional Clinical Hospital D Halytskyi Lviv NMU
Lviv, 79010, Ukraine
Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
Lviv, 79013, Ukraine
CI Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
Communal Institution City Policlinic #20 Cabinet of Gastroenterology
Odesa, 65114, Ukraine
M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
Poltava, 36011, Ukraine
CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
Sumy, 40022, Ukraine
Ternopil City Communal Emergency Medical Care Hospital
Ternopil, 46000, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018, Ukraine
SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, 21029, Ukraine
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhia, 69104, Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, 69600, Ukraine
Queen Elizabeth Hospital
Birmingham, B152WB, United Kingdom
Bristol Royal Infirmary
Bristol, BS1 3NX, United Kingdom
Royal Devon and Exeter Hospital Wonford
Exeter, EX2 5DW, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, G4 OSF UK, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
St Marys Hospital
London, W2 1NY, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung
Manchester, M23 9LT, United Kingdom
Nottingham University Hospitals Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Borders General Hospital
Roxburghshire, TD6 9BS, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY38XQ, United Kingdom
Southampton General Hospital
Southhampton, SO01 6YD, United Kingdom
Related Publications (2)
Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.
PMID: 30364296BACKGROUNDSands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frederic Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, D'Haens G. Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study. Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493.
PMID: 31850931DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Following a recommendation by the DMC, this study was terminated early by the sponsor on 19 Oct 2017 due to a lack of emerging benefit; no emergent safety findings were noted.
Results Point of Contact
- Title
- Anne Mcclain, Senior Manager
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Guillermo Rossiter, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 4, 2015
Study Start
December 8, 2015
Primary Completion
January 5, 2018
Study Completion
January 5, 2018
Last Updated
August 28, 2019
Results First Posted
January 23, 2019
Record last verified: 2019-08