Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT02065622
- Lead Sponsor
- AbbVie
- Brief Summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 952
- Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.
- Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
- Chronic recurring infections or active tuberculosis (TB).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Induction (Main Study + Japan Sub-study): I-SD Placebo Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. Maintenance (Main Study + Japan Sub-study): M-SD Placebo Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. Maintenance (Main Study): TDM Regimen Placebo Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. Induction (Main Study + Japan Sub-study): I-SD Adalimumab Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. Maintenance (Main Study + Japan Sub-study): M-SD Adalimumab Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. Induction (Main Study + Japan Sub-study): I-HD Adalimumab Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4, and 40 mg at Week 6. Maintenance (Main Study): TDM Regimen Adalimumab Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. Maintenance (Main Study + Japan Sub-study): M-HD Adalimumab Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
- Primary Outcome Measures
Name Time Method Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
- Secondary Outcome Measures
Name Time Method Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8 Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8 Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8 Week 8 The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8 Week 8 The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.
Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore \> 1.
Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.
Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1.
Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1.
Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8 Week 8 Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore \[RBS\] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1.
Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1.
Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore \[RBS\] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.
Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 \[severe problem\] to 7 \[normal health\]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.
Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8 Week 8 The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8 Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0.
Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1. Endoscopy subscore provided by the central reader.
Trial Locations
- Locations (173)
Atlanta Gastro Assoc /ID# 122336
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 122183
🇺🇸Chicago, Illinois, United States
University of Pittsburgh MC /ID# 122331
🇺🇸Pittsburgh, Pennsylvania, United States
Biopharma Informatic Research /ID# 171150
🇺🇸Houston, Texas, United States
Research Associates of South Florida,LLC /ID# 170309
🇺🇸Miami, Florida, United States
New River Valley Research Inst /ID# 127801
🇺🇸Christiansburg, Virginia, United States
Consultants for Clinical Res /ID# 122304
🇺🇸Cincinnati, Ohio, United States
Gastro United of Tulsa /ID# 125436
🇺🇸Tulsa, Oklahoma, United States
Icahn School of Med Mt. Sinai /ID# 127047
🇺🇸New York, New York, United States
University of Washington /ID# 169721
🇺🇸Seattle, Washington, United States
Charlotte Gastro Hepatology /ID# 122235
🇺🇸Charlotte, North Carolina, United States
Texas Digestive Disease Consul /ID# 141677
🇺🇸Southlake, Texas, United States
Gastro One /ID# 122339
🇺🇸Germantown, Tennessee, United States
NYU Langone Long Island CRA /ID# 122177
🇺🇸Great Neck, New York, United States
Dayton Gastroenterology, Inc. /ID# 127804
🇺🇸Englewood, Ohio, United States
DHAT Research Institute /ID# 170616
🇺🇸Garland, Texas, United States
Austin Center for Clinical Research /ID# 125396
🇺🇸Pflugerville, Texas, United States
Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
🇦🇹Salzburg, Austria
Universitatsklinikum Magdeburg /ID# 127200
🇩🇪Magdeburg, Germany
University of Calgary /ID# 125715
🇨🇦Calgary, Alberta, Canada
KH der Barmherzigen Brueder /ID# 127183
🇦🇹St Veit An Der Glan, Austria
CHU de Liege /ID# 126740
🇧🇪Liege, Belgium
Universita di Padova /ID# 127214
🇮🇹Padova, Italy
CHU de Grenoble - Albet Michal /ID# 127195
🇫🇷Grenoble, France
Tel Aviv Sourasky Medical Center /ID# 201365
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Universitatsklinik Regensburg /ID# 201265
🇩🇪Ratisbon, Bayern, Germany
Universitatsklinikum Frankfurt /ID# 170300
🇩🇪Frankfurt, Hessen, Germany
AZ Sint-Lucas /ID# 127187
🇧🇪Ghent, Belgium
UZ Leuven /ID# 126739
🇧🇪Leuven, Belgium
Texas Digestive Disease Consul /ID# 141678
🇺🇸Southlake, Texas, United States
McGill Univ HC /ID# 127046
🇨🇦Montreal, Quebec, Canada
Winnipeg Regional Health Autho /ID# 125712
🇨🇦Winnipeg, Manitoba, Canada
ISCARE a.s. /ID# 127837
🇨🇿Praha 9, Czechia
Medizinische Universitat Wien /ID# 127186
🇦🇹Vienna, Wien, Austria
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
🇭🇺Pécs, Pecs, Hungary
Soroka University Medical Center /ID# 127213
🇮🇱Be'er Sheva, Israel
Policlinico Agostino Gemelli /ID# 127217
🇮🇹Rome, Lazio, Italy
Mount Sinai Hosp.-Toronto /ID# 126590
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre /ID# 127055
🇨🇦London, Ontario, Canada
Azienda Ospedaliera San Camillo Forlanini /ID# 127216
🇮🇹Rome, Lazio, Italy
Hadassah University Hospital /ID# 127211
🇮🇱Jerusalem, Israel
Hepato-Gastroenterologie HK s.r.o. /ID# 127188
🇨🇿Hradec Kralove, Czechia
Universitaetsklinikum Jena /ID# 127205
🇩🇪Jena, Germany
Hopital Rangueil /ID# 127192
🇫🇷Toulouse, France
Asklepios Westklinikum Hamburg /ID# 127198
🇩🇪Hamburg, Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
🇮🇹Milan, Lombardia, Italy
IRCCS Casa Sollievo /ID# 127811
🇮🇹San Giovanni Rotondo, Italy
EUGASTRO GmbH /ID# 127202
🇩🇪Leipzig, Germany
Pannonia Maganorvosi Centrum Kft. /ID# 127207
🇭🇺Budapest, Hungary
Policlinico Univ Tor Vergata /ID# 129321
🇮🇹Rome, Italy
Hiroshima University Hospital /ID# 124496
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
🇯🇵Sapporo-shi, Hokkaido, Japan
Hamamatsu South Hospital /ID# 124481
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Shiga University of Medical Science Hospital /ID# 127675
🇯🇵Otsu-shi, Shiga, Japan
Saitama Medical Center /ID# 128875
🇯🇵Kawagoe-shi, Saitama, Japan
Southampton General Hospital /ID# 127228
🇬🇧Southampton, United Kingdom
Hospital Clinic de Barcelona /ID# 138147
🇪🇸Barcelona, Spain
CHU NANCY - Hôpital Brabois Adultes /ID# 127196
🇫🇷Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
🇩🇪Kiel, Schleswig-Holstein, Germany
Vanderbilt Univ Med Ctr /ID# 125496
🇺🇸Nashville, Tennessee, United States
University of Utah /ID# 122333
🇺🇸Salt Lake City, Utah, United States
Herlev Hospital /ID# 127191
🇩🇰Herlev, Hovedstaden, Denmark
Regionhospital Silkeborg /ID# 127190
🇩🇰Silkeborg, Denmark
CHU Estaing /ID# 127848
🇫🇷Clermont Ferrand, France
CHU Saint ELOI /ID# 169007
🇫🇷Montpellier Cedex 5, France
Mayo Clinic - Rochester /ID# 122244
🇺🇸Rochester, Minnesota, United States
WI Center for Advanced Res /ID# 122178
🇺🇸Milwaukee, Wisconsin, United States
The Oregon Clinic- Gastro West /ID# 135273
🇺🇸Portland, Oregon, United States
Froedtert & the Medical College of Wisconsin /ID# 122261
🇺🇸Milwaukee, Wisconsin, United States
Kaplan Medical Center /ID# 127210
🇮🇱Rehovot, Israel
Digestive Health Specialists of the Southeast /ID# 127844
🇺🇸Dothan, Alabama, United States
Gastroenterology Group Naples /ID# 127806
🇺🇸Naples, Florida, United States
Shafran Gastroenterology Ctr /ID# 122320
🇺🇸Winter Park, Florida, United States
Ucsd /Id# 122313
🇺🇸La Jolla, California, United States
Rocky Mountain Clinical Resear /ID# 122180
🇺🇸Wheat Ridge, Colorado, United States
Medical Research Ctr CT /ID# 122179
🇺🇸Hamden, Connecticut, United States
Gastro Florida /ID# 170619
🇺🇸Clearwater, Florida, United States
Gastro Assoc of Central GA /ID# 122318
🇺🇸Macon, Georgia, United States
Carle Foundation Hospital /ID# 135955
🇺🇸Urbana, Illinois, United States
University of Chicago /ID# 122302
🇺🇸Chicago, Illinois, United States
University of Maryland Med Ctr /ID# 169734
🇺🇸Baltimore, Maryland, United States
Louisiana Research Ctr. LLC /ID# 141655
🇺🇸Shreveport, Louisiana, United States
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
🇺🇸Chevy Chase, Maryland, United States
Ctr for Digest and Liver Dis /ID# 122182
🇺🇸Mexico, Missouri, United States
Wake Research Associates, LLC /ID# 122157
🇺🇸Raleigh, North Carolina, United States
Erlanger Institute for Clinica /ID# 129009
🇺🇸Chattanooga, Tennessee, United States
Advanced Research Institute /ID# 126147
🇺🇸Ogden, Utah, United States
KH der Elisabethinen Linz GmbH /ID# 127184
🇦🇹Linz, Oberoesterreich, Austria
Zeidler Ledcor Centre /ID# 125713
🇨🇦Edmonton, Alberta, Canada
Qe Ii Hsc /Id# 127045
🇨🇦Halifax, Nova Scotia, Canada
Toronto Digestive Disease Asso /ID# 127075
🇨🇦Vaughan, Ontario, Canada
CHU Dijon /ID# 127861
🇫🇷Dijon, France
CHU de Saint-Etienne, Hopital Nord /ID# 134490
🇫🇷SAINT-ETIENNE Cedex 1, France
CHU de Nice /ID# 127193
🇫🇷Nice, France
Mross, Berlin, DE /ID# 127201
🇩🇪Berlin, Germany
Gastrostudien GbR /ID# 169246
🇩🇪Berlin, Germany
Gastro Campus Research GbR /ID# 126743
🇩🇪Munster, Germany
Szegedi Tudomanyegyetem /ID# 127208
🇭🇺Szeged, Hungary
A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
🇮🇹Bologna, Emilia-Romagna, Italy
Rabin Medical Center /ID# 127212
🇮🇱Petakh Tikva, Tel-Aviv, Israel
Ospedali Riuniti Villa Sofia-C /ID# 129323
🇮🇹Palermo, Italy
Azienda Ospedaliera Spedali Civili /ID# 127236
🇮🇹Brescia, Italy
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
🇮🇹Rozzano, Milano, Italy
Nagoya City University Hospital /ID# 124517
🇯🇵Nagoya-shi, Aichi, Japan
Yokoyama IBD Clinic /ID# 151560
🇯🇵Nagoya, Aichi, Japan
Toho University Sakura Medical Center /ID# 124497
🇯🇵Sakura-shi, Chiba, Japan
Kyushu University Hospital /ID# 124495
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Chikushi Hospital /ID# 124155
🇯🇵Chikushino, Fukuoka, Japan
Kurume University Hospital /ID# 125275
🇯🇵Kurume-shi, Fukuoka, Japan
Aoyama Clinic /ID# 127836
🇯🇵Kobe-shi, Hyogo, Japan
Hyogo College of Medicine College Hospital /Id# 127539
🇯🇵Nishinomiya-shi, Hyogo, Japan
Kitasato University Hospital /ID# 137694
🇯🇵Sagamihara-shi, Kanagawa, Japan
COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
🇯🇵Yokohama, Kanagawa, Japan
Susaki Kuroshio Hospital /ID# 125202
🇯🇵Susaki-shi, Kochi, Japan
Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
🇯🇵Kyoto-shi, Kyoto, Japan
Osaka Medical College Hospital /ID# 126451
🇯🇵Takatsuki-shi, Osaka, Japan
Kitasato Univ Kitasato Inst Ho /ID# 127001
🇯🇵Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 148184
🇯🇵Mitaka-shi, Tokyo, Japan
Tokyo Yamate Medical Center /ID# 125201
🇯🇵Tokyo, Japan
Wakayama Medical University /ID# 124635
🇯🇵Wakayama-shi, Wakayama, Japan
Endoterapia PFG Sp. z.o.o. /ID# 126513
🇵🇱Warszawa, Mazowieckie, Poland
Academisch Medisch Centrum /ID# 126741
🇳🇱Amsterdam, Noord-Holland, Netherlands
Centrum Medyczne Pratia Gdynia /ID# 170301
🇵🇱Gdynia, Pomorskie, Poland
H-T.Centrum Medyczne-Endoterapia /ID# 170305
🇵🇱Tychy, Slaskie, Poland
Centrum Medyczne Sw. Lukaza /ID# 126515
🇵🇱Czestochowa, Poland
Centrum Diagnostyczno Lecznicze Barska /ID# 170304
🇵🇱Lodz, Poland
KO-Med Centra Kliniczne Pulawy /ID# 127219
🇵🇱Pulawy, Poland
NZOZ Vivamed /ID# 127218
🇵🇱Warsaw, Poland
Institutul Clinic Fundeni /ID# 127839
🇷🇴Sector 2, Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta /ID# 125418
🇷🇴Cluj, Romania
CMDTA Neomed SRL /ID# 127142
🇷🇴Brasov, Romania
Tvm Med Serv Srl /Id# 127221
🇷🇴Cluj, Romania
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
🇸🇰Bratislava, Slovakia
Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
🇷🇴Oradea, Romania
Salvo-San-Ciobanca SRL /ID# 127140
🇷🇴Zalau, Romania
Hospital General Universitario de Alicante /ID# 129261
🇪🇸Alicante, Spain
Hospital General Universitario Gregorio Maranon /ID# 127224
🇪🇸Madrid, Spain
Hospital Univ de la Princesa /ID# 135828
🇪🇸Madrid, Spain
Complejo Hospitalario Universitario de Ferrol /ID# 127840
🇪🇸Ferrol, Spain
Hospital Univ Dr. Negrin /ID# 127841
🇪🇸Las Palmas de Gran Canaria, Spain
Hosp Univ 12 de Octubre /ID# 129257
🇪🇸Madrid, Spain
Hosp Clin Univ de Valencia /ID# 170306
🇪🇸València, Spain
Hosp Clin Univ Lozano Blesa /ID# 129255
🇪🇸Zaragoza, Spain
Hospital Universitario La Paz /ID# 127223
🇪🇸Madrid, Spain
University Hospital Zurich /ID# 127842
🇨🇭Zurich, Zuerich, Switzerland
Kantonsspital St. Gallen /ID# 127843
🇨🇭St. Gallen, Sankt Gallen, Switzerland
GI National Institute of Therapy named by L.T. Malaya /ID# 127231
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
St. Mark's Hospital /ID# 127226
🇬🇧Harrow, United Kingdom
Western General Hospital /ID# 204801
🇬🇧Edinburgh, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
🇬🇧Hull, United Kingdom
The Royal Wolverhampton NHS Tr /ID# 127227
🇬🇧Wolverhampton, United Kingdom
Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
🇬🇧Oxford, United Kingdom
Hidaka Clinic of Coloproctology /ID# 125477
🇯🇵Kurume, Fukuoka, Japan
University of Michigan Hospitals /ID# 122240
🇺🇸Ann Arbor, Michigan, United States
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
🇩🇪Berlin, Germany
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
🇺🇦Kherson, Ukraine
Ordination Hainburg an der Don /ID# 127185
🇦🇹Hainburg An Der Donau, Austria
NZOZ All-Medicus /ID# 128740
🇵🇱Katowice, Slaskie, Poland
Municipal Clinical Hospital #8 /ID# 127235
🇺🇦Kiev, Ukraine
Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Zdrowia MDM /ID# 170303
🇵🇱Warsaw, Mazowieckie, Poland
Centrum Medyczne LukaMed Joanna Luka /ID# 170302
🇵🇱Chojnice, Poland
Lviv City Clinical Hospital NO.4 /ID# 127232
🇺🇦Lviv, Ukraine
CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
🇺🇦Zaporizhzhia, Ukraine
Norfolk and Norwich Univ Hosp /ID# 127139
🇬🇧Norwich, Norfolk, United Kingdom
CHU Amiens Picardie /ID# 127194
🇫🇷Amiens CEDEX 1, Somme, France
Medical Hospital of Tokyo Medical and Dental University /ID# 128315
🇯🇵Bunkyo-ku, Tokyo, Japan
Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
🇸🇰Lucenec, Slovakia
C.M. Szpital Swietej Rodziny /ID# 127838
🇵🇱Lodz, Lodzkie, Poland
Gastroenterologicka Ambulancia /ID# 125632
🇸🇰Bratislava, Slovakia
CHRU Lille - Hôpital Claude Huriez /ID# 127197
🇫🇷Lille CEDEX, Hauts-de-France, France
Magyar Elhizastudomanyi KKft. /ID# 126589
🇭🇺Budapest, Hungary
Royal Hampshire County Hosp /ID# 169250
🇬🇧Winchester, Hampshire, United Kingdom