Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT02914522
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1351
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
- Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
- A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
- Moderately to severely active UC
- Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Key
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction Study (Cohort B): Filgotinib 200 mg Filgotinib Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Induction Study (Cohort B): Filgotinib 100 mg Filgotinib Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Filgotinib Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58). Maintenance Study: Placebo From Induction Filgotinib 100 mg PTM filgotinib Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg PTM filgotinib Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58). Induction Study (Cohort A): Filgotinib 200 mg PTM filgotinib Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. Induction Study (Cohort A): Placebo PTM filgotinib Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Induction Study (Cohort B): Placebo PTM filgotinib Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg PTM filgotinib Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58). Maintenance Study: Placebo From Induction Placebo PTM filgotinib Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58). Induction Study (Cohort B): Filgotinib 100 mg PTM filgotinib Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Maintenance Study: Placebo From Induction Filgotinib 200 mg PTM filgotinib Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Induction Study (Cohort A): Filgotinib 100 mg PTM filgotinib Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Induction Study (Cohort B): Filgotinib 200 mg PTM filgotinib Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Induction Study (Cohort A): Filgotinib 200 mg Filgotinib Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. Induction Study (Cohort A): Filgotinib 100 mg Filgotinib Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Filgotinib Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).
- Primary Outcome Measures
Name Time Method Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 Week 58 EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 Week 10 EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
- Secondary Outcome Measures
Name Time Method Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 Week 10 Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 Week 58 Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 Week 10 Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of \<= 0.3, Grade 1 of \<= 1.1, Grade 2A of \<= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=\>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 Cmax is defined as the maximum observed concentration of drug.
Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 Tmax is defined as the time to reach maximum observed concentration of drug.
Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 Ctau is defined as the observed drug concentration at the end of the dosing interval.
Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 Week 10 MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58 Week 58 Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58 Week 58 MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 Week 10 MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58 Week 58 MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 Week 58 Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 Week 26 (any Time) and Week 58 (predose) Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58 Week 58 Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of \<= 0.3, Grade 1 of \<= 1.1, Grade 2A of \<= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=\>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Trial Locations
- Locations (342)
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
State Healthcare Institution "Regional Clinical Hospital"
🇷🇺Saratov, Russian Federation
State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
🇷🇺Tyumen, Russian Federation
Peermed Clinical Trial Centre
🇿🇦Johannesburg, South Africa
Centro Medico Teknon
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Skane University Hospital
🇸🇪Malmo, Sweden
Danderyds Sjukhus AB
🇸🇪Danderyd, Sweden
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
🇨🇳Taoyuan, Taiwan
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
🇺🇦Ivano-Frankivs'k, Ukraine
Kyiv City Clinical Hospital No. 18, Proctology Department
🇺🇦Kyiv, Ukraine
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
🇺🇦Kyiv, Ukraine
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
🇺🇦Odessa, Ukraine
Cambridge University Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
The Pennine Acute Hospitals NHS Trust
🇬🇧Bury, United Kingdom
NHS Lothian
🇬🇧Edinburgh, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom
Wycombe Hospital
🇬🇧High Wycombe, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
🇬🇧Norwich, United Kingdom
Biomedical Research Unit
🇬🇧Nottingham, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
🇬🇧London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
🇬🇧Southampton, United Kingdom
St Helens and Knowsley Teaching Hospitals NHS Trust
🇬🇧Prescot, United Kingdom
CHU de Caen
🇫🇷Caen, France
Baylor College of Medicine- Baylor Medical Center
🇺🇸Houston, Texas, United States
Massachusetts General Hospital - Crohn's and Colitis Center
🇺🇸Boston, Massachusetts, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Connecticut GI PC-Research Division
🇺🇸Farmington, Connecticut, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Toronto Digestive Disease Associates Inc.
🇨🇦Vaughan, Canada
Clinical Hospital Dubrava
🇭🇷Zagreb, Croatia
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
CHU Amiens Picardie
🇫🇷Amiens, France
CHU de Nancy - Hopital Brabois Adultes
🇫🇷Vandœuvre-lès-Nancy, France
Asklepios Westklinikum Hamburg
🇩🇪Hamburg, Germany
CHU de Dijon Bourgogne - Hopital Francois Mitterand
🇫🇷Dijon, France
Gastroenterologische Gemeinschaftspraxis Herne
🇩🇪Herne, Germany
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
🇩🇪Ulm, Germany
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
🇭🇺Békéscsaba, Hungary
Bugat Pal Korhaz, Belgyogyaszat
🇭🇺Gyöngyös, Hungary
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Grant Medical Foundation Ruby Hall Clinic
🇮🇳Pune, India
Gandhi Hospital
🇮🇳Secunderabad, India
Bnai Zion Medical Center
🇮🇱Haifa, Israel
Ofuna Chuo Hospital
🇯🇵Kamakura, Japan
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
🇮🇹Pisa, Italy
Yokohama Health Medicine Association Kannai Suzuki Clinic
🇯🇵Yokohama-shi, Japan
Osaka City University Hospital
🇯🇵Ōsaka, Japan
Wellington Hospital
🇳🇿Newtown, New Zealand
Gabinet Lekarski Janusz Rudzinski
🇵🇱Bydgoszcz, Poland
Gabinet Endoskopii Przewodu Pokarmowego
🇵🇱Kraków, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
🇷🇺Moscow, Russian Federation
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
🇷🇺Novosibirsk, Russian Federation
"Riat" LLC
🇷🇺Saint Petersburg, Russian Federation
Singapore General Hospital
🇸🇬Singapore, Singapore
"PolyClinic EXPERT" LLC
🇷🇺Saint Petersburg, Russian Federation
Dr MJ Prins
🇿🇦Cape Town, South Africa
Mackay Memorial Hospital, Taipei
🇨🇳Taipei, Taiwan
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
🇷🇺Saint-Petersburg, Russian Federation
"Scientific Research Centre ECO-safety" LLC
🇷🇺Saint-Petersburg, Russian Federation
Gastroenterologische Praxis Balsiger, Seibold und Partner
🇨🇭Bern, Switzerland
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
🇷🇺Smolensk, Russian Federation
Zvezdara University Medical Center
🇷🇸Belgrade, Serbia
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
🇸🇰Nitra, Slovakia
Universitatsspital Zurich
🇨🇭Zürich, Switzerland
Changhua Christian Hospital
🇨🇳Chang-hua, Taiwan
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
🇺🇦Cherkasy, Ukraine
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
🇺🇦Chernivtsi, Ukraine
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
🇺🇦Kharkiv, Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
🇺🇦Chernivtsi, Ukraine
Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
🇺🇦Kropyvnytskyi, Ukraine
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
🇺🇦Vinnytsya, Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
🇺🇦Dnipropetrovsk, Ukraine
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
🇺🇦Kharkiv, Ukraine
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
🇺🇦Kharkiv, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
🇺🇦Odessa, Ukraine
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
🇺🇦Ternopil, Ukraine
Medical Center LLC "Health Clinic"
🇺🇦Vinnytsia, Ukraine
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
🇺🇦Vinnytsya, Ukraine
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
🇺🇦Zaporizhzhya, Ukraine
Universitaetsklinik Koln
🇩🇪Koln, Germany
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
South Denver Gastroenterology, PC
🇺🇸Lone Tree, Colorado, United States
Fargo Gastroenterology and Hepatology Clinic
🇺🇸Fargo, North Dakota, United States
University of Miami Crohn's and Colitis Center
🇺🇸Miami, Florida, United States
Gleneagles Global Hospitals
🇮🇳Hyderabad, India
Cordova Research Institute
🇺🇸Miami, Florida, United States
Citizens Specialty Hospital
🇮🇳Hyderabad, India
Centre for Liver Research & Diagnostics
🇮🇳Hyderabad, India
UC Health Physicians Clifton
🇺🇸Cincinnati, Ohio, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - IBD Clinic
🇺🇸Nashville, Tennessee, United States
Clinical Associates in Research Therapeutics of America, LLC
🇺🇸San Antonio, Texas, United States
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
UF Health at Shands Hospital
🇺🇸Gainesville, Florida, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
🇺🇸Macon, Georgia, United States
Atlanta Gastroenterology Specialist, PC
🇺🇸Suwanee, Georgia, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
NYU Langone Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Carolina's GI Research, LLC
🇺🇸Raleigh, North Carolina, United States
Rapid City Medical Center
🇺🇸Rapid City, South Dakota, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Associates of Orangeburg
🇺🇸Orangeburg, South Carolina, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
DHAT Research Institute
🇺🇸Garland, Texas, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
Spring Gastroenterology
🇺🇸The Woodlands, Texas, United States
Texas Digestive Disease Consultants
🇺🇸Southlake, Texas, United States
HP Clinical Research
🇺🇸Bountiful, Utah, United States
Gastroenterology Associates Of Tidewater
🇺🇸Chesapeake, Virginia, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Emeritas Research Group LLC
🇺🇸Lansdowne Town Center, Virginia, United States
Allegiance Research Specialists, LLC
🇺🇸Wauwatosa, Wisconsin, United States
Instituto de Investigaciones Clinicas Mar del Plata
🇦🇷Mar del Plata, Argentina
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Instituto Médico Cer
🇦🇷Quilmes, Argentina
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Coastal Digestive Health
🇦🇺Mountain Creek, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Footscray Hospital
🇦🇺Footscray, Victoria, Australia
Mater Misericordiae Ltd
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Universitatsklinik Innsbruck
🇦🇹Innsbruck, Austria
AKH-Medizinische Universitat Wien
🇦🇹Wien, Austria
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
GZA Ziekenhuizen campus Sint-Vincentius
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
CUB Hopital Erasme
🇧🇪Brussels, Belgium
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
🇧🇪Liège, Belgium
MHAT Sveti Pantaleymon - Pleven OOD
🇧🇬Pleven, Bulgaria
"MDHAT Dr. St.Cherkezov" AD
🇧🇬Veliko Tŭrnovo, Bulgaria
MHAT "Sveta Petka" AD
🇧🇬Vidin, Bulgaria
University of Calgary, Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
The Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
University Hospital Center Zagreb
🇭🇷Zagreb, Croatia
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
🇨🇿Praha 9, Czechia
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
🇨🇿Mladá Boleslav, Czechia
G.E.P. Clinic, s r.o.
🇨🇿Praha 3, Czechia
CHU Grenoble Alpes
🇫🇷La Tronche, France
CHU de Clermont-Ferrand - Hopital d'Estaing
🇫🇷Clermont-Ferrand, France
APHP - Hopital Beaujon - Clichy - Universite Paris VII
🇫🇷Clichy, France
Hopital Universitaire de Bicetre
🇫🇷Le Kremlin-Bicêtre, France
Centre Hospitalier Regional Universitaire de Lille
🇫🇷Lille, France
CHU de Montpellier-Hopital Saint Eloi
🇫🇷Montpellier, France
Hopital de l'Archet 2
🇫🇷Nice, France
CHU Hotel-Dieu
🇫🇷Nantes, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Hopital Nord
🇫🇷Marseille, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
🇫🇷Rennes Cedex 9, France
Centre Hospitalier Universitaire de Lyon Sud
🇫🇷Pierre-Benite, France
CHU de Bordeaux - Hopital Haut Leveque
🇫🇷Pessac, France
CHU de Saint-Etienne - Hopital Nord
🇫🇷Saint Priest en Jarez, France
Medi Club Georgia LLC
🇬🇪Tbilisi, Georgia
CHU de Toulouse - Hopital Rangueil
🇫🇷Toulouse, France
Unimed Ajara LLC - Batumi Referral Hospital
🇬🇪Batumi, Georgia
Charite - Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Ltd. Unimed Kakheti - Telavi Referral Hospital
🇬🇪Telavi, Georgia
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Stadtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
🇩🇪Berlin, Germany
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt am Main, Germany
Medizinische Hochschule Hannover
🇩🇪Hannöver, Germany
Klinikum Luneburg
🇩🇪Lüneburg, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Germany
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
Klinikum der Universitat Munchen - Grosshadern
🇩🇪Muenchen, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
🇬🇷Athens, Greece
General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department
🇬🇷Athens, Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
🇭🇺Debrecen, Hungary
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
🇭🇺Budapest, Hungary
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
🇭🇺Mosonmagyaróvár, Hungary
Kaizen Hospital
🇮🇳Ahmedabad, India
M S Ramaiah Medical College and Hospital
🇮🇳Bangalore, India
Apollo Speciality Hospital
🇮🇳Chennai, India
VGM Hospital Institute of Gastroenterology
🇮🇳Coimbatore, India
S.R.KallaMemorial Gastro.&General Hospital,
🇮🇳Jaipur, India
S.M.S Medical College & Hospitals
🇮🇳Jaipur, India
School of Digestive & Liver Diseases
🇮🇳Kolkata, India
Kasturba Medical College (KMC) Hospital
🇮🇳Mangaluru, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, India
Lokmanya Tilak Municipal General Hospital
🇮🇳Mumbai, India
Midas Multispeciality Hospital Pvt. Ltd
🇮🇳Nagpur, India
Suretech Hospital & Research Centre Ltd
🇮🇳Nagpur, India
Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
🇮🇳Secunderabad, India
Sterling Hospital
🇮🇳Vadodara, India
Kasturba Hospital Medical College
🇮🇳Udupi, India
Surat Institute of Digestive Sciences
🇮🇳Surat, India
Samvedana Hospital
🇮🇳Varanasi, India
Beaumont Hospital
🇮🇪Dublin, Ireland
Soroka Medical Center
🇮🇱Beer-Sheva, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
UOC Gastroenterologia II
🇮🇹Castellana Grotte, Italy
U.O. Fisiopatologia Digestiva
🇮🇹Catanzaro, Italy
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
🇮🇹Chieti, Italy
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
🇮🇹Milano, Italy
UOC Gastroenterologia
🇮🇹Padova, Italy
UOC Gastroenterologia ed Endoscopia Digestiva
🇮🇹Roma, Italy
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
🇯🇵Chuo-Ku, Japan
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Medical Hospital, Tokyo Medical and Dental University
🇯🇵Bunkyo-ku, Japan
Fukuoka University Chikushi Hospital
🇯🇵Chikushino-shi, Japan
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka-shi, Japan
Tokai University Hachioji Hospital
🇯🇵Hachioji-shi, Japan
Hiroshima University Hospital
🇯🇵Hiroshima-shi, Japan
Fukuoka University Hospital
🇯🇵Jonan-ku, Japan
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
🇯🇵Kitakyushu-shi, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu-shi, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Japan
The Jikei University Hospital
🇯🇵Minato-Ku, Japan
Hidaka Coloproctology Clinic
🇯🇵Kurume-shi, Japan
Kyorin University Hospital
🇯🇵Mitaka-shi, Japan
Saiseikai Niigata Daini Hospital
🇯🇵Nishi-ku, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-ku, Japan
Iwate Medical University Hospital
🇯🇵Morioka-shi, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Japan
Aichi Medical University Hospital
🇯🇵Nagakute-shi, Japan
Hyogo College of Medicine College Hospital
🇯🇵Nishinomiya, Japan
Ishida IBD Clinic
🇯🇵Oita-shi, Japan
Sapporo Tokushukai Hospital
🇯🇵Sapporo, Japan
Okayama University Hospital
🇯🇵Okayama-city, Japan
Saga University Hospital
🇯🇵Saga, Japan
Saga-Ken Medical Centre Koseikan
🇯🇵Saga-shi, Japan
Wakakusa-Daiichi Hospital
🇯🇵Osaka, Japan
Kitasato University Hospital, THE KITASATO INSTITUTE
🇯🇵Sagamihara, Japan
Tokito Clinic
🇯🇵Saitama, Japan
Toho University Sakura Medical Center
🇯🇵Sakura, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo-shi, Japan
Tokyo Yamate Medical Center
🇯🇵Shinjuku-ku, Japan
National Hospital Organization Sendai Medical Center
🇯🇵Sendai, Japan
Osaka University Hospital
🇯🇵Suita, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu-shi, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Japan
Colo-proctology Center Matsushima Clinic
🇯🇵Yokohama-shi, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki, Japan
National Hospital Organization Takasaki General Medical Center
🇯🇵Takasaki-shi, Japan
Ieda Hospital
🇯🇵Toyota-shi, Japan
Kinshukai Infusion Clinic
🇯🇵Ōsaka, Japan
Shiga University of Medical Science Hospital
🇯🇵Ōtsu, Japan
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
University Kebangsaan Malaysia Medical Centre
🇲🇾Cheras, Malaysia
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Hyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Pulau Pinang
🇲🇾George Town, Malaysia
Hospital Queen Elizabeth
🇲🇾Kota Kinabalu, Malaysia
Gelre Hospital
🇳🇱Apeldoorn, Netherlands
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
🇲🇽Cuautitlán Izcalli, Mexico
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Academic Medical Center (AMC)
🇳🇱Amsterdam, Netherlands
Auckland City Hospital
🇳🇿Grafton, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Vestre Viken Hospital Trust, Baerum Hospital
🇳🇴Drammen, Norway
Bay of Plenty District Health Board - Tauranga Hospital
🇳🇿Tauranga, New Zealand
Akerskus University Hospital
🇳🇴Lørenskog, Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
🇵🇱Białystok, Poland
VITAMED Galaj i Cichomski spolka jawna
🇵🇱Bydgoszcz, Poland
NZOZ INTER-MED, Centrum Endoskopowe
🇵🇱Częstochowa, Poland
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
🇵🇱Katowice, Poland
Krakowskie Centrum Medyczne Sp. z o.o
🇵🇱Kraków, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J.
🇵🇱Ksawerów, Poland
Centrum Innowacyjnych Terapii Sp. z o.o.
🇵🇱Piaseczno, Poland
Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. k.
🇵🇱Poznan, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
🇵🇱Rzeszów, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
🇵🇱Toruń, Poland
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
🇵🇱Tychy, Poland
Bodyclinic
🇵🇱Warszawa, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
🇵🇱Warszawa, Poland
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
🇷🇴Bucuresti, Romania
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
🇵🇱Warszawa, Poland
Centro Hospitalar de Sao Joao, EPE
🇵🇹Porto, Portugal
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
🇵🇱Łódź, Poland
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
🇵🇹Guimarães, Portugal
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
🇷🇴Oradea, Romania
SC MedLife SA, Gastroenterologie
🇷🇴Bucuresti, Romania
Cabinet Particular Policlinic Algomed SRL
🇷🇴Timişoara, Romania
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
🇷🇺Novosibirsk, Russian Federation
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
🇷🇺Moscow, Russian Federation
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
🇷🇺Irkutsk, Russian Federation
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
🇷🇺Chelyabinsk, Russian Federation
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
🇷🇺Nizhniy Novgorod, Russian Federation
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
🇷🇺Moscow, Russian Federation
NY Scientific
🇺🇸Brooklyn, New York, United States
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Louisville, Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
University of Wisconsin Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
🇭🇰Sha Tin, Hong Kong
Princess Margaret Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong