Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
- Registration Number
- NCT02403323
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 790
Part 1 Open-Label Extension:
- Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
- Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
- Patients who transfer from Part 1
- Completion of the 12-week safety follow-up period prior to entering
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Etrolizumab Open-Label Extension Etrolizumab Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled).
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Crohn's Disease Activity Index (CDAI) Remission at 12-week Intervals Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE CDAI is a score obtained from composite of eight assessments: number of liquid or soft stools, abdominal pain, general well-being, presence of complications, taking lomotil (diphenoxylate/atropine) or other opiates for diarrhea, presence of an abdominal mass, hematocrit, and percentage deviation from standard weight. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores range from 0 to 600. A higher score indicates worse outcome. A total score of less than 150 corresponds to remission.
Part 1: Number of Participants With Clinical Remission at 12-week Intervals Day 1 and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240 and 252 of OLE Clinical remission was defined as a liquid/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain (AP) mean daily score ≤1 with no worsening in either subscore compared to baseline, where the average was taken over 7 days prior to visit. Abdominal pain severity was assessed using the abdominal pain questionnaire which is an 11-point numeric rating scale with score ranging from 0 (no pain) to 10 (worse pain). Liquid/soft stool frequency was reported using the bristol stool form scale which classifies stools into seven groups based on its consistency i.e., type 1- separate hard lumps, type 2- sausage-shaped but lumpy, type 3- like a sausage but with cracks on the surface, type 4- like a sausage or snake, smooth and soft, type 5- soft blobs with clear-cut edges, type 6- fluffy pieces with ragged edges and type 7- entirely liquid with no solid pieces.
Part 1: Number of Participants With Improvement in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 At OLE Week 108 SES-CD is an endoscopic score composite of 4 variables (ulcers size, percentage of ulcerated surface, inflamed surface, and presence of narrowing) in up to 5 ileocolonic segments (ileum right, colon, transverse colon, left colon, rectum) and scored on a scale of 0-3, with total score from 0-60. Higher score indicates higher ulcer surface/size in the 4 variables. Endoscopic improvement was defined as ≥50% reduction in SES-CD score compared to baseline.
Part 1: Number of Participants With Adverse Event (AE) and Severity of AEs as Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) From Day 1 up to end of 12-week safety follow-up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4=Life threatening consequences, urgent intervention indicated; Grade 5=Death related to AE. Multiple occurrences of AEs in the same category at the worst (highest) NCIC-CTCAE grade for an individual are counted only once.
Part 1: Number of Participants With Serious Adverse Events (SAEs) From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AEs were graded per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event. If a participant experienced multiple occurrences of AEs at different grades, they were counted in each grade where they had at least one AE of that grade.
Part 1: Incidence Rate of Infection-related Adverse Event From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AE rate (per 100 participant years) = \[Total number of AEs (in OLE only) / Total number of participant years at risk (in OLE only)\]\*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).
Part 1: Number of Participants With Serious Infection Related AES From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 From Day 1 up to end of safety 12-week follow-up in OLE (approximately 6.3 years) AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions were graded per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.
Part 1: Number of Participants With Adverse Events Leading to Etrolizumab Discontinuation From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.
Part 1: Number of Participants With Malignancies From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.
Part 1: Incidence Rate of Malignancies From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) Malignancy rate (per 100 participant years) = \[Total number of malignancies (in OLE only) / Total number of participant years at risk (in OLE only)\]\*100. Total participant-years at risk is the sum over all participants of the time intervals (in years) from the first dose of study treatment in Part 1 (OLE) until the participant completes/withdraws from the study (including the 12-week safety follow-up, if applicable).
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 From Day 1 up to end of 12-week safety follow up in OLE (approximately 6.3 years) Hypersensitivity was reported using the MedDRA anaphylactic reaction standard MedDRA query (SMQ) and Sampson's criteria. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2 = Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3 = Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.
Part 2: Number of Participants With Confirmed or Suspected Progressive Multifocal Leukoencephalopathy (PML) From end of safety follow-up in Part 1 or study GA29144 up to maximum of 92 weeks PML was assessed by the PML Subjective Checklist (symptom assessment) and the PML Objective Checklist (neurologic evaluation).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (287)
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
🇭🇺Budapest, Hungary
Valley Gastroenterology Consultants
🇺🇸Arcadia, California, United States
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Digestive Care Associates, A Medical Corporation
🇺🇸San Carlos, California, United States
SDG Clinical Research
🇺🇸San Diego, California, United States
Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
🇺🇸San Francisco, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Innovative Medical Research of South Florida
🇺🇸Aventura, Florida, United States
West Central Gastroenterology d/b/a Gastro Florida
🇺🇸Clearwater, Florida, United States
IMIC, Inc
🇺🇸Miami Beach, Florida, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
FQL Research, LLC
🇺🇸Miramar, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Atlanta Center for Gastroenterology, PC
🇺🇸Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Advanced Clinical Research
🇺🇸Spokane, Idaho, United States
Northwestern Uni-Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
🇺🇸Topeka, Kansas, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Gastroenterology Associates of Western Michigan, P.L.C.
🇺🇸Grand Rapids, Michigan, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Ehrhardt Clinical Research, LLC
🇺🇸Belton, Missouri, United States
Concorde Medical Group
🇺🇸New York, New York, United States
Weill Cornell Medical College-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
🇺🇸Charlotte, North Carolina, United States
Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston
🇺🇸Kinston, North Carolina, United States
Consultants for Clinical Research Inc.
🇺🇸Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Digestive Disease Specialists, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Great Lakes Medical Research, LLC
🇺🇸Harrisburg, Pennsylvania, United States
Innovative Clinical Research
🇺🇸Greenville, South Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center; Internal Medicne
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Wellness Clinical Research Center
🇺🇸San Antonio, Texas, United States
Texas Digestive Disease Consultants - Southlake
🇺🇸Southlake, Texas, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
Ericksen Research and Development
🇺🇸Clinton, Utah, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
McGuire Research Institute; Gastroenterology
🇺🇸Richmond, Virginia, United States
Digestive Disease Institute; Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Hospital Italiano
🇦🇷Caba, Argentina
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Footscray Hospital
🇦🇺Footscray, Victoria, Australia
St Frances Xavier Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
🇦🇺Parkville, Victoria, Australia
The Alfred Hospital
🇦🇺Prahan, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg
🇦🇹Salzburg, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
UZ Brussel
🇧🇪Brussel, Belgium
CHU St Pierre (César de Paepe) X
🇧🇪Bruxelles, Belgium
ULB Hopital Erasme; Service de Néphrologie
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
🇧🇷Goiânia, GO, Brazil
Hospital Felicio Rocho
🇧🇷Belo Horizonte, MG, Brazil
Centro Digestivo de Curitiba
🇧🇷Curitiba, PR, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Sao Vicente de Paulo
🇧🇷Passo Fundo, RS, Brazil
Hospital das Clinicas - UFRGS
🇧🇷Porto Alegre, RS, Brazil
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, RS, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
🇧🇷Botucatu, SP, Brazil
Pesquisare Saúde Sociedade Simples
🇧🇷Santo Andre, SP, Brazil
Praxis Pesquisa Médica
🇧🇷Santo Andre, SP, Brazil
Hospital Estadual Mario Covas
🇧🇷Sao Bernardo Do Campo, SP, Brazil
Hospital de Base de Sao Jose do Rio Preto
🇧🇷Sao Jose do Rio Preto, SP, Brazil
Hospital Sírio-Libanês
🇧🇷Sao Paulo, SP, Brazil
Universidade Federal de Sao Paulo - UNIFES
🇧🇷Sao Paulo, SP, Brazil
Hospital do Servidor Público Estadual/HSPE-SP
🇧🇷São Paulo, SP, Brazil
"City Clinic UMHAC" EOOD
🇧🇬Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
University of Calgary
🇨🇦Calgary, Alberta, Canada
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
🇨🇦Edmonton, Alberta, Canada
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority; Neurosurgery Department
🇨🇦Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
🇨🇦Halifax, Nova Scotia, Canada
University Hospital - London Health Sciences Centre
🇨🇦London, Ontario, Canada
Taunton Health Centre
🇨🇦Oshawa, Ontario, Canada
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit
🇨🇦Ottawa, Ontario, Canada
Toronto Digestive Disease Associates
🇨🇦Vaughan, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve - Rosemont
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
🇨🇦Montreal, Quebec, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Clinical Hospital Centre Osijek
🇭🇷Osijek, Croatia
General Hospital Pula
🇭🇷Pula, Croatia
Clinical Hospital Center Sestre Milosrdnice
🇭🇷Zagreb, Croatia
Vojenska nemocnice Brno
🇨🇿Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika
🇨🇿Brno, Czechia
Nemocnice Ceske Budejovice a.s.
🇨🇿Ceske Budejovice, Czechia
Gastroenterologie s.r.o.
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
PreventaMed, s.r.o.
🇨🇿Olomouc, Czechia
Fakultni nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
ISCARE a.s.
🇨🇿Praha 7, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha, Czechia
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
North Estonia Medical Centre Foundation
🇪🇪Tallinn, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
CHU Amiens - Hopital Sud
🇫🇷Amiens, France
CHU NANTES - Hôtel Dieu; Pharmacy
🇫🇷Nantes, France
CHU de Caen Hopital Cote de Nacre
🇫🇷Caen, France
Hôpital Beaujon
🇫🇷Clichy cedex, France
Hopital Claude Huriez - CHU Lille
🇫🇷Lille, France
CHU Nice - Hopital de l'Archet 2
🇫🇷Nice, France
Hôpital Saint-Louis
🇫🇷Paris, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
🇫🇷Pessac, France
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie
🇫🇷Pierre-Benite, France
CHU du Reims - Hopital Robert Debré
🇫🇷Reims, France
CHU Saint Etienne - Hôpital Nord
🇫🇷Saint Etienne, France
Höpital Hautepierre; Pediatrie1
🇫🇷Strasbourg, France
Hôpital de Brabois Adultes
🇫🇷Vandoeuvre-les-nancy, France
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie
🇩🇪Berlin, Germany
Krankenhaus Waldfriede e. V.
🇩🇪Berlin, Germany
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
🇩🇪Bochum, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum Mannheim GmbH Universitätsklinikum
🇩🇪Mannheim, Germany
Gemeinschaftspraxis
🇩🇪Schweinfurt, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
🇭🇺Bekescsaba, Hungary
Obudai Egeszsegugyi Centrum Kft.
🇭🇺Budapest, Hungary
Szt Janos Korhaz es EbudaiEgyesitettKorhazak
🇭🇺Budapest, Hungary
Pannonia Maganorvosi Centrum
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
🇭🇺Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
🇭🇺Gyor, Hungary
Pest Megyei Flor Ferenc Korhaz
🇭🇺Kistarcsa, Hungary
Haemek Medical Center
🇮🇱Afula, Israel
Soroka University Medical Centre
🇮🇱Beer Sheva, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Holy Family Hospital
🇮🇱Nazareth, Israel
Rabin Medical Center-Beilinson Campus
🇮🇱Petach Tikva, Israel
Tel Aviv Sourasky Medical Center; Pharmacy
🇮🇱Tel Aviv, Israel
A.O.U. Policlinico di Modena
🇮🇹Modena, Emilia-Romagna, Italy
Policlinico Universitario Agostino Gemelli; Farmacia
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Lazio, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju-si, Korea, Republic of
Asst Fatebenefratelli Sacco (Fatebenefratelli)
🇮🇹Milano, Lombardia, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Lombardia, Italy
I.R.C.C.S Policlinico San Donato
🇮🇹San Donato Milanese (MI), Lombardia, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Florence, Toscana, Italy
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam Univ. Hospital
🇰🇷Daegu, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
CHA Bundang Medical Centre; CHA university
🇰🇷Seongnam, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Pauls Stradins Clinical University Hospital
🇱🇻R?ga, Latvia
Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Clinical Research Institute
🇲🇽Tlalnepantla de Baz, Mexico CITY (federal District), Mexico
Medical Care & Research SA de CV
🇲🇽Mérida, Yucatan, Mexico
Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology
🇱🇹Vilnius, Lithuania
Amsterdam UMC, Locatie VUMC; Gastroenterology
🇳🇱Amsterdam, Netherlands
Amsterdam UMC Location AMC
🇳🇱Amsterdam, Netherlands
Leids Universitair Medisch Centrum; Cardiology
🇳🇱Leiden, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Spitalul Clinic Colentina
🇷🇴Sector 2, Romania
Centrul de Gastroenterologie Dr. Goldis
🇷🇴Timisoara, Romania
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
🇳🇱Sittard-Geleen, Netherlands
ETZ TweeSteden
🇳🇱Tilburg, Netherlands
North Shore Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital NZ
🇳🇿Christchurch, New Zealand
Dunedin Public Hospital
🇳🇿Dunedin, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Hutt Hospital
🇳🇿Lower Hutt, New Zealand
Shakespeare Specialist Group
🇳🇿Takapuna, New Zealand
Tauranga Hospital
🇳🇿Tauranga, New Zealand
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
🇵🇱Bia?ystok, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Bydgoszcz, Poland
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
🇵🇱Elblag, Poland
ETG Kielce
🇵🇱Kielce, Poland
Centrum Opieki Zdrowotnej Orkan-Med
🇵🇱Ksawerow, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Lublin, Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
🇵🇱Nowy Targ, Poland
Centrum Medyczne "MEDYK"
🇵🇱Rzeszow, Poland
Gabinet Lekarski, Bartosz Korczowski
🇵🇱Rzeszów, Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
🇵🇱Szczecin, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
🇵🇱Toru?, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Zespó Przychodni Specjalistycznych PRIMA
🇵🇱Warszawa, Poland
Przychodnia EuroMediCare
🇵🇱Wroc?aw, Poland
PlanetMed sp. z o.o.
🇵🇱Wroc?aw, Poland
LexMedica Osrodek Badan Klinicznych
🇵🇱Wroclaw, Poland
S.C MedLife S.A
🇷🇴Bucuresti, Romania
SBEI HPE Altai StateMedicalUniversityofMoH andSD
🇷🇺Barnaul, Altaj, Russian Federation
LLC "Novosibirsk GastroCenter"
🇷🇺Novosibirsk, Altaj, Russian Federation
LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
SEIHPE "Rostov SMU of MoH of RF"
🇷🇺Rostov-on-Don, Rostov, Russian Federation
Baltic Medicine
🇷🇺St.Petersburg, Leningrad, Russian Federation
Evromedservis LCC
🇷🇺Pushkin, Sankt Petersburg, Russian Federation
Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department
🇷🇺Saint-Petersburg, Sankt Petersburg, Russian Federation
SBIH City Clinical Hospital #31
🇷🇺Sankt-peterburg, Sankt Petersburg, Russian Federation
Irkutsk State Medical Academy of Continuing Education
🇷🇺Irkutsk, Russian Federation
North-Western Medical University n.a. I.I. Mechnikov; Rheumatology
🇷🇺Sankt-peterburg, Sankt Petersburg, Russian Federation
SBEIHPE Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
BHI of Omsk region Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
Clinical Center Zvezdara
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Endomed, s.r.o.
🇸🇰Košice, Slovakia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
General Hospital Djordje Joanovic
🇷🇸Zrenjanin, Serbia
Accout Center s.r.o.
🇸🇰Šahy, Slovakia
Dr D Epstein Practice
🇿🇦Cape Town, South Africa
Emmed Research
🇿🇦Pretoria, South Africa
Hospital Universitario de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Clínic i Provincial; Servicio de Farmacia
🇪🇸Barcelona, Spain
Hospital Reina Sofia; Medical Oncology
🇪🇸Cordoba, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Inselspital-Universitaetsspital Bern
🇨🇭Bern, Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
🇨🇭Bern, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Hacettepe University Medical Faculty; Gastroenterology
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Acibadem Fulya Hospital; Neurology
🇹🇷Istanbul, Turkey
Haydarpasa Numune Training and Research Hospital; Gastroenterology
🇹🇷Istanbul, Turkey
Medeniyet University Goztepe Training and Research Hospital.
🇹🇷Kadiköy, Turkey
Kocaeli Universitesi Tip Fakultesi; Infectious Diseases
🇹🇷Kocaeli, Turkey
Acibadem Kozyatagi Hospital; Gastroenterology
🇹🇷Kozyata?i, Turkey
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
🇺🇦Kharkiv, Kharkiv Governorate, Ukraine
CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine
🇺🇦Kharkiv, Kharkiv Governorate, Ukraine
LLC Gastroenterology Center IBD Team
🇺🇦Zaporizhzhia, Kharkiv Governorate, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
🇺🇦Kyiv, KIEV Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
🇺🇦Kyiv, KIEV Governorate, Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
🇺🇦Kyiv, KIEV Governorate, Ukraine
Ivano-Frankivsk Regional Clinical Hospital
🇺🇦Ivano-Frankivsk, Kuban People's Republica, Ukraine
Lviv Regional Clinical Hospital
🇺🇦Lviv, KIEV Governorate, Ukraine
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
🇺🇦Chernivtsi, Ukraine
CHI Kharkiv City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2
🇺🇦Odesa, Ukraine
Private Small Enterprise Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
🇺🇦Vinnytsia, Ukraine
MCIC MC LLC Health Clinic
🇺🇦Vinnytsia, Ukraine
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, United Kingdom
Queen Elizabeth Hospital
🇬🇧Kings Lynn, United Kingdom
St James University Hospital
🇬🇧Leeds, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
Whipps Cross Hospital
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Fairfield General Hospital
🇬🇧Manchester, United Kingdom
Royal Victoria Infirmary; Stroke unit
🇬🇧Newcastle Upon Tyne, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom