Crohn Disease Clinical Trial
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
| Verified date | November 2017 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 24, 2018 |
| Est. primary completion date | November 17, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital Institute of Medical and Veterinary Science | Adelaide | South Australia |
| Australia | Ballarat Base Hospital | Ballarat | |
| Australia | Monash Medical Centre Clayton | Bentleigh East | |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | St Vincents Hospital Melbourne | Fitzroy | |
| Australia | Centre For Digestive Diseases | Five Dock | New South Wales |
| Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Mater Adult Hospital | South Brisbane | Queensland |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Austria | Klinikum Klagenfurt am Wörtersee | Klagenfurt | |
| Austria | LKH - Universitätsklinikum der PMU Salzburg | Salzburg | |
| Austria | Krankenanstalt Rudolfstiftung Wien | Wein | |
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | Hopital Universitaire des Enfants | Brussels | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | CHU Sart Tilman | Liege | |
| Canada | Barrie GI Associates | Barrie | Ontario |
| Canada | Alberta Childrens Hospital | Calgary | Alberta |
| Canada | Centre de sante et de services sociaux Champlain Charles Le Moyne | Greenfield Park | Quebec |
| Canada | LHSC - Victoria Hospital | London | Ontario |
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Canada | GI Research Institute | Vancouver | British Columbia |
| Croatia | Clinical Hospital Centre Osijek | Osijek | |
| Czechia | Hepato-Gastroenterologie HK, s. r. o. | Hradec Králové | |
| Czechia | PreventaMed | Olomouc | |
| Czechia | CCBR Prague CZ | Praha 3 | |
| Czechia | Thomayerova nemocnice | Praha 4 | |
| Denmark | Aarhus Universitetshospital | Aahus C | |
| Denmark | Alborg Universitets Hospital | Alborg | |
| Denmark | Hvidovre Hospital | Hvidovre | |
| Denmark | Koge Sygehus | Koge | |
| Denmark | Odense Universitetshospital | Odense C | |
| Denmark | Regionshospitalet Silkeborg | Silkeborg | |
| Finland | Helsingin yliopistollinen keskussairaala | Helsinki | |
| Finland | Tampereen yliopistollinen sairaala | Tampere | |
| France | CHU Amiens Hopital Sud | Amiens Cedex | |
| France | CHU Besancon Hopital Jean Minjoz | Besancon Cedex | |
| France | Hopital Claude Huriez CHRU Lille | Lille cedex | |
| France | Hopital Nord CHU Marseille | Marseille cedex 20 | |
| France | CHU Nice Hopital de lArchet 2 | Nice Cedex 3 | |
| France | Hopital Saint Louis | Paris Cedex 10 | |
| France | Centre Hospitalier Lyon Sud | Pierre Benite cedex | |
| France | CHU Reims Hopital Robert Debre | Reims | |
| France | CHU de Rouen Hopital Charles Nicolle | Rouen | |
| France | CHU de Toulouse Hopital Rangueil | Toulouse Cedex 09 | |
| France | Hopital de Brabois Adultes | Vandoeuvre les Nancy | |
| Germany | Charite - Campus Virchow-Klinikum | Berlin | |
| Germany | DRK Kliniken Berlin Westend | Berlin | |
| Germany | St. Josef-Hospital | Bochum | |
| Germany | Staedisches Klinikum Brandenburg | Brandenburg an der Havel | |
| Germany | Universitaetsklinikum Carl Gustav Carus | Dresden | |
| Germany | Universitaetsklinikum Erlangen | Erlangen | |
| Germany | Katholische Kliniken Ruhrhalbinsel GmbH | Essen | |
| Germany | Kliniken Essen-Mitte | Essen | |
| Germany | Universitaetsklinikum EssenZentrum fuer Innere Medizin | Essen | |
| Germany | Crohn Colitis Centrum Rhein Main | Frankfurt | |
| Germany | Asklepios Klinik Hamburg | Hamburg | |
| Germany | Universitaetsklinikum Schleswig Holstein Campus Kiel | Kiel | |
| Germany | EUGASTRO GmbH | Leipzig | |
| Germany | Gastroenterologische Praxis Minden | Minden | |
| Germany | Universitatsklinikum Regensburg | Regensburg | |
| Germany | Universitaetsklinikum Ulm | Ulm | |
| Germany | HELIOS Klinikum Wuppertal | Wuppertal | |
| Greece | Athens Medical Center | Athens | |
| Greece | General Hospital of Athens Evangelismos | Athens | |
| Greece | University General Hospital of Patras | Rio Patras | |
| Hungary | Obudai Egeszsegugyi Centrum Kft. | Budapest | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Szent Margit Korhaz | Budapest | |
| Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy | Szeged | |
| Israel | Rabin Medical Center | Petah Tikva | |
| Israel | Kaplan Medical Center | Rechovot | |
| Israel | Assaf Harofeh Medical Center | Zerifin | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi | Bologna | |
| Italy | Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Azienda Ospedaliera Di Padova | Padova | |
| Italy | Azienda Ospedaliera Vincenzo Cervello | Palermo | |
| Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | |
| Italy | Complesso Integrato Columbus | Roma | |
| Italy | Universita Campus Bio-Medico di Roma | Roma | |
| Italy | Azienda Ospedaliera San Camillo Forlanini | Rome | |
| Italy | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Rome | |
| Italy | Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona | Salerno | |
| Italy | IRCCS Policlinico San Donato | San Donato Milanese | |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Hanyang Univerisy Guri Hospital | Guri-si | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | CHA Bundang Medical Center CHA University | Seongnam-si, | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-Si | |
| Latvia | Digestive Diseases Center Gastro | Riga | |
| Latvia | Riga East Clinical University Hospital clinic Gailezers | Riga | |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | |
| Poland | SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Bialystok | |
| Poland | Clinsante S.C. Osrodek Badan Klinicznych | Bydgoszcz | |
| Poland | Centrum Medyczne A-Z Clinic | Kraków | |
| Poland | Centrum Medyczne AMED | Lodz | |
| Poland | Nzoz Vivamed | Warsaw | |
| Poland | LexMedica Osrodek Badan Klinicznych | Wroclaw | |
| Portugal | Hospital de Braga | Braga | |
| Portugal | Hospital da Senhora da Oliveira Guimaraes | Guimaraes | |
| Portugal | Hospital Da Luz | Lisboa | |
| Portugal | Centro Hospitalar de Sao Joao, EPE | Porto | |
| Portugal | Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE | Viana do Castelo | |
| Romania | CMI Dr. Tirnaveanu Amelita | Oradea | |
| Romania | Centrul de Gastroenterologie Dr. Goldis | Timisoara | |
| Russian Federation | Medical Center Stolitsa-Medikl | Moscow | |
| Russian Federation | FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS | Novosibirsk | |
| Russian Federation | SBEIHPE Novosibirsk State Medical University | Novosibirsk | |
| Russian Federation | SPb SBIH City Hospital # 26 | Saint-Petersburg | |
| Russian Federation | NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways | Samara | |
| Serbia | Clinical Center Bezanijska Kosa | Belgrade | |
| Slovakia | GASTRO I., s.r.o. | Presov | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario de la Princessa | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal | Madrid | |
| Spain | Complejo Hospitalario de Pontevedra | Pontevedra | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Sweden | Danderyds Sjukhus AB | Stockholm | |
| Switzerland | Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner | Bern | |
| Switzerland | Inselspital - Universitaetsspital Bern | Bern | |
| Switzerland | Hopitaux Universitaires de Geneve-HUG | Geneva | |
| Switzerland | UniversitatSspital Zurich | Zuerich | |
| Turkey | Ankara University Medical Faculty | Ankara | |
| Turkey | Gazi University Medical Faculty | Ankara | |
| Turkey | Hacettepe University Medical Faculty | Ankara | |
| Turkey | Turkiye Yuksek Ihtisas Hospital | Ankara | |
| Turkey | Firat University Medical Faculty | Elazig | |
| Turkey | Acibadem Fulya Hospital | Istanbul | |
| Turkey | Haydarpasa Numune Training and Research Hospital | Istanbul | |
| Turkey | Istanbul Medeniyet Uni Goztepe Training&Res Hosp | Istanbul | |
| Turkey | Istanbul University Cerrahpasa Medical Faculty | Istanbul | |
| Turkey | Marmara University Pendik Training and Research Hospital | Istanbul | |
| Turkey | Dokuz Eylul University Izmir | Izmir | |
| Turkey | Ege University Medical Faculty | Izmir | |
| Turkey | Kocaeli Derince Training and Research Hospital | Kocaeli | |
| Turkey | Inonu Uni. Med. Fac. | Malatya | |
| Turkey | Mersin University Medical Faculty | Mersin | |
| Ukraine | CI of PH Kharkiv CCH #2 | Kharkiv | |
| Ukraine | Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus | Kirovohrad | |
| Ukraine | Kyiv City Clinical Hospital #1 | Kyiv | |
| Ukraine | CI Odesa Regional Clinical Hospital | Odessa | |
| Ukraine | CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI | Sumy | |
| Ukraine | Ternopil City Communal Emergency Medical Care Hospital | Ternopil | |
| Ukraine | SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | |
| Ukraine | SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU | Zaporizhia | |
| Ukraine | CI Zaporizhzhia Regional Clinical Hospital of ZRC | Zaporozhje | |
| United Kingdom | Basingstoke and North Hampshire Hospital | Basingstoke | |
| United Kingdom | University Hospital Coventry | Coventry | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | Hull Royal Infirmary | Hull | |
| United Kingdom | Royal London Hospital | London | |
| United Kingdom | University College London Hospitals | London | |
| United Kingdom | Manchester Royal Infirmary | Manchester | |
| United Kingdom | Nottingham University Hospitals Queens Medical Centre | Nottingham | |
| United Kingdom | Borders General Hospital | Roxburghshire | |
| United States | Ohio Clinical Research Partners LLC | Akron | Ohio |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | Texas Clinical Research Institute LLC | Arlington | Texas |
| United States | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina |
| United States | Georgia Regents University | Augusta | Georgia |
| United States | University Of Colorado | Aurora | Colorado |
| United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
| United States | University of Maryland Medical Group | Baltimore | Maryland |
| United States | Gastroenterology Associates, LLC | Baton Rouge | Louisiana |
| United States | Clinical Inquest Center Ltd | Beavercreek | Ohio |
| United States | Ehrhardt Clinical Research, LLC | Belton | Missouri |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Graves Gilbert Clinic | Bowling Green | Kentucky |
| United States | Connecticut Gastroenterology Institute | Bristol | Connecticut |
| United States | Lahey Clinic Inc. - PARENT ACCOUNT | Burlington | Massachusetts |
| United States | Medex Research Institute | Caro | Michigan |
| United States | Dr. Deepak Sarwal, MD | Centerville | Ohio |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Carolinas Healthcare System | Charleston | South Carolina |
| United States | Carolina Center for Liver Disease | Charlotte | North Carolina |
| United States | Gaffney Health Services | Charlotte | North Carolina |
| United States | Charlottesville Medical Research Center | Charlottesville | Virginia |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | ClinSearch LLC | Chattanooga | Tennessee |
| United States | Gastroenterology Associates of Tidewater | Chesapeake | Virginia |
| United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
| United States | Northwestern University-Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Consultants for Clinical Research Inc. | Cincinnati | Ohio |
| United States | UC Health Clinical Trials Office | Cincinnati | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Columbus Regional Research Institute | Columbus | Georgia |
| United States | AGA Clinical Research Associates LLC | Egg Harbor Township | New Jersey |
| United States | Northshore University Healthsystem Research Institute | Evanston | Illinois |
| United States | Valley View Internal Medicine | Garden Grove | California |
| United States | Gastro One | Germantown | Tennessee |
| United States | North Shore-LIJ Health System-Division of Rheumatology | Great Neck | New York |
| United States | NYU Langone Long Island Clinical Research Associates | Great Neck | New York |
| United States | PhysiqueMed Clinical Trials | Greensboro | North Carolina |
| United States | Medical Research Center of Connecticut LLC | Hamden | Connecticut |
| United States | Connecticut GI PC Research Division | Hartford | Connecticut |
| United States | Main Line Gastroenterology | Havertown | Pennsylvania |
| United States | Gulf Coast Research Group LLC | Houston | Texas |
| United States | Houston Endoscopy and Research Center | Houston | Texas |
| United States | Methodist Hospital | Houston | Texas |
| United States | University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
| United States | Jefferson City Medical Group | Jefferson City | Missouri |
| United States | Kinston Medical Specialists PA | Kinston | North Carolina |
| United States | Innovative Clinical Research | Lafayette | Colorado |
| United States | Clinical Trials of SW Louisiana LLC | Lake Charles | Louisiana |
| United States | Montefiore Medical Center PRIME | Lake Success | New York |
| United States | High Desert Gastroenterology, Inc. | Lancaster | California |
| United States | Florida Center for Gastroenterology | Largo | Florida |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| United States | Dcr-Pi Pc | Litchfield Park | Arizona |
| United States | Gastroenterology Associates PA | Little Rock | Arkansas |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | University of Southern California Medical Center | Los Angeles | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Dean Clinic Oregon | Madison | Wisconsin |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | The Feinstein Institute for Medical Research PRIME | Manhasset | New York |
| United States | Arizona Digestive Health | Mesa | Arizona |
| United States | Advance Medical Research Center | Miami | Florida |
| United States | Cordova Research Institute | Miami | Florida |
| United States | Sanitas Research | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Galiz Research LLC | Miami Springs | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Facey Medical Foundation | Mission Hills | California |
| United States | Clinical Trials of America, LLC | Mount Airy | North Carolina |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Yale University | New Haven | Connecticut |
| United States | Columbia University Medical Center | New York | New York |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | New York University School of Medicine | New York | New York |
| United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
| United States | Henry Ford Health System | Novi | Michigan |
| United States | Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Center For Digestive Health | Orlando | Florida |
| United States | GCRM | Orlando | Florida |
| United States | Digestive Health Center | Pasadena | Texas |
| United States | Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania |
| United States | Arizona Digestive Health | Phoenix | Arizona |
| United States | Phoenix Childrens Hospital | Phoenix | Arizona |
| United States | Advanced Medical Research Center | Port Orange | Florida |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York |
| United States | Health Science Research Center, LLC | Pratt | Kansas |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Hunter Holmes Mcguire Ctr | Richmond | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | East Coast Institute for Research LLC | Saint Augustine | Florida |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | University of Utah Division of Gastroenterology | Salt Lake City | Utah |
| United States | Medical Associates Research Group Inc. | San Diego | California |
| United States | University of California at San Francisco (PARENT) | San Francisco | California |
| United States | Mayo Clinic Arizona | Scottsdale | Arizona |
| United States | Harborview Medical Center | Seattle | Washington |
| United States | Swedish Medical Center Cancer Institute Research | Seattle | Washington |
| United States | University of Washington School of Medicine | Seattle | Washington |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | Louisiana Research Center LLC | Shreveport | Louisiana |
| United States | Texas Digestive Disease Consultants - Southlake | Southlake | Texas |
| United States | Mercy Research | Springfield | Missouri |
| United States | Springfield Health Care Center | Springfield | Ohio |
| United States | Penn State University Milton S Hershey Medical Center | State College | Pennsylvania |
| United States | Arizona Digestive Health | Sun City | Arizona |
| United States | Atlanta Gastroenterology Specialists PC | Suwanee | Georgia |
| United States | Clinical Research of West Florida, Inc. | Tampa | Florida |
| United States | HCP Clinical Research LLC | Torrance | California |
| United States | Charm City Research Group | Towson | Maryland |
| United States | Digestive Health Specialists of Tyler | Tyler | Texas |
| United States | The Vancouver Clinic | Vancouver | Washington |
| United States | Ventura Clinical Trials | Ventura | California |
| United States | Mercy Research | Washington | Missouri |
| United States | Advanced Clinical Research | West Jordan | Utah |
| United States | Cleveland Clinic Florida Weston | Weston | Florida |
| United States | Heartland Research Associates LLC | Wichita | Kansas |
| United States | Via Christi Research a division of Via Christi Hospitals Wichita Inc | Wichita | Kansas |
| United States | Trial Management Associates LLC | Wilmington | North Carolina |
| United States | PMG Research of Winston-Salem | Winston-Salem | North Carolina |
| United States | Shafran Gastroenterology Center | Winter Park | Florida |
| United States | UMass Medical Center | Worcester | Massachusetts |
| United States | Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Australia, Austria, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | The proportion of subjects achieving clinical remission at Week 12. | week 12 | |
| Secondary | Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (US) and CDAI | The proportion of subjects achieving clinical remission at Week 4, Week 12. | Week 4, week 12 | |
| Secondary | Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES-CD) | Endoscopic improvement of the mucosa at Week 12. | Week 12 | |
| Secondary | Clinical response defined by CDAI | The proportion of subjects achieving clinical response at Week 4, Week 12. | Week 4, week 12 | |
| Secondary | Clinical remission defined by PCDAI | The proportion of subjects achieving clinical remission at Week 12 (adolescent subjects only). | Week 12 | |
| Secondary | Adverse Events (AEs) | Incidence and severity of adverse events | Up to 20 weeks | |
| Secondary | Pharmacokinetics (PK)- plasma concentration of GED-0301 | The plasma concentration of GED-0301 at Week 4, Week 8 | Week 4, week 8 |
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