A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
1,302
42 countries
478
Brief Summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2016
Longer than P75 for phase_2
478 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
September 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedResults Posted
Study results publicly available
June 30, 2022
CompletedJune 30, 2022
June 1, 2022
5.2 years
June 28, 2016
June 3, 2022
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
At Week 8
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
At Week 8
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
At Week 52
Secondary Outcomes (30)
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
At Week 8
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
At Week 2
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
Baseline (Week 0), Week 8
- +25 more secondary outcomes
Study Arms (8)
SS1: Placebo
PLACEBO COMPARATORDuring the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
SS1: Upadacitinib 7.5 mg
EXPERIMENTALDuring the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
SS1: Upadacitinib 15 mg
EXPERIMENTALDuring the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
SS1: Upadacitinib 30 mg
EXPERIMENTALDuring the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
SS1: Upadacitinib 45 mg
EXPERIMENTALDuring the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
SS2: Placebo/Upadacitinib 45 mg
EXPERIMENTALDuring the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
EXPERIMENTALDuring the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
SS3: M14-675 clinical responders
EXPERIMENTALParticipants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
Interventions
Film-coated tablet for oral administration
Film-coated tablet for oral administration
Eligibility Criteria
You may qualify if:
- Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.
- Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.
- Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.
- If female, participant must meet the criteria for Contraception Recommendations
- Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.
You may not qualify if:
- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
- Current diagnosis of fulminant colitis and/or toxic megacolon
- Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
- Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (496)
Birmingham Gastroenterology Associates P.C /ID# 151276
Birmingham, Alabama, 35209, United States
East View Medical Research, LLC /ID# 171183
Mobile, Alabama, 36606, United States
CB Flock Research Corporation /ID# 165980
Mobile, Alabama, 36608, United States
Delsol Research Management, Ll /Id# 170131
Chandler, Arizona, 85224, United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885
Mesa, Arizona, 85206, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822
Sun City, Arizona, 85306, United States
Adobe Clinical Research LLC /ID# 155250
Tucson, Arizona, 85712, United States
University of Arizona /ID# 150553
Tucson, Arizona, 85724, United States
Citrus Valley Gastroenterology /ID# 151914
Covina, California, 91722-3797, United States
Newport Huntington Medical Group /ID# 217005
Huntington Beach, California, 92648-5994, United States
UC San Diego Health System /ID# 155185
La Jolla, California, 92093, United States
United Medical Doctors /ID# 207464
Los Alamitos, California, 90720-3309, United States
TLC Clinical Research Inc /ID# 216829
Los Angeles, California, 90048, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080
Los Angeles, California, 90067-2001, United States
Facey Medical Foundation /ID# 203133
Mission Hills, California, 91345, United States
United Medical Doctors - Murrieta /ID# 151211
Murrieta, California, 92563, United States
InSite Digestive Health Care - Oxnard /ID# 163414
Oxnard, California, 93030, United States
Inland Empire Clinical Trials, LLC /ID# 216038
Rialto, California, 92377, United States
San Diego Clinical Trials /ID# 212120
San Diego, California, 92120, United States
Medical Assoc Research Grp /ID# 169148
San Diego, California, 92123, United States
Univ of California San Francis /ID# 164581
San Francisco, California, 94158, United States
Delta Waves, Inc. /ID# 151721
Colorado Springs, Colorado, 80918, United States
South Denver Gastroenterology /ID# 151223
Lone Tree, Colorado, 80124, United States
Western States Clinical Res /ID# 158076
Wheat Ridge, Colorado, 80033-2896, United States
Western Connecticut Medical Group /ID# 169210
Danbury, Connecticut, 06810, United States
Medical Research Center of CT /ID# 150482
Hamden, Connecticut, 06518, United States
Gastro Florida /ID# 155245
Clearwater, Florida, 33756, United States
Moonshine Research Center, Inc /ID# 152533
Doral, Florida, 33166, United States
Universal Axon Clinical Research /ID# 213461
Doral, Florida, 33166, United States
Palmetto Research, LLC /ID# 151716
Hialeah, Florida, 33016, United States
Nature Coast Clinical Research - Inverness /ID# 154064
Inverness, Florida, 34452-4717, United States
Encore Borland-Groover Clinical Research /Id# 170912
Jacksonville, Florida, 32256, United States
SIH Research Mumtaz, Inc /ID# 163319
Kissimmee, Florida, 34741-4161, United States
Cfagi Llc /Id# 202017
Maitland, Florida, 32751-6108, United States
University of Miami /ID# 215441
Miami, Florida, 33136, United States
Advanced Pharma /ID# 151719
Miami, Florida, 33147, United States
New Horizon Research Center /ID# 152474
Miami, Florida, 33165-3372, United States
Crystal Pharmacology Research /ID# 151841
Miami, Florida, 33165, United States
Coral Research Clinic /ID# 150444
Miami, Florida, 33186-4643, United States
Advanced Research Institute, Inc /ID# 163098
New Port Richey, Florida, 34653, United States
Endoscopic Research, Inc. /ID# 151720
Orlando, Florida, 32803, United States
Omega Research Maitland, LLC /ID# 200269
Orlando, Florida, 32808, United States
Clinical Research Trials of Florida, Inc. /ID# 201790
Tampa, Florida, 33607, United States
University of South Florida /ID# 214493
Tampa, Florida, 33612, United States
AdventHealth Tampa /ID# 200272
Tampa, Florida, 33613-4680, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 165782
Macon, Georgia, 31201, United States
Infinite Clinical Trials /ID# 215340
Riverdale, Georgia, 30274, United States
Atlanta Gastroenterology Spec /ID# 150548
Suwanee, Georgia, 30024, United States
Next Innovative Clinical Research - Chicago /ID# 216060
Chicago, Illinois, 60605-2168, United States
The University of Chicago DCAM /ID# 150547
Chicago, Illinois, 60637, United States
NorthShore University HealthSystem /ID# 150555
Evanston, Illinois, 60201, United States
Northwest Health Care Associates /ID# 151590
Hoffman Estates, Illinois, 60169, United States
Carle Foundation Hospital /ID# 151137
Urbana, Illinois, 61801, United States
MediSphere Medical Research Center /ID# 152064
Evansville, Indiana, 47714-8011, United States
Indianapolis Gastroenterology /ID# 162901
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics /ID# 157058
Iowa City, Iowa, 52242, United States
Cotton-O'Neil Clinical Res Ctr /ID# 167182
Topeka, Kansas, 66606, United States
Tri-State Gastroenterology /ID# 169811
Crestview Hills, Kentucky, 41017, United States
Houma Digestive Health Special /ID# 151844
Houma, Louisiana, 70360, United States
Nola Research Works, LLC /ID# 153356
New Orleans, Louisiana, 70115, United States
Louisana Research Center, LLC /ID# 150446
Shreveport, Louisiana, 71105-6800, United States
University of Maryland Med Ctr /ID# 150449
Baltimore, Maryland, 21201, United States
Gastro Center of Maryland /ID# 200022
Columbia, Maryland, 21045, United States
Massachusetts General Hospital /ID# 165676
Boston, Massachusetts, 02114, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140
Ann Arbor, Michigan, 48109, United States
Huron Gastroenterology Assoc /ID# 152710
Ann Arbor, Michigan, 48197, United States
Clin Res Inst of Michigan, LLC /ID# 153027
Chesterfield, Michigan, 48047, United States
Revival Research Institute, LLC /ID# 207280
Southfield, Michigan, 48034-1659, United States
Center for Digestive Health /ID# 161984
Troy, Michigan, 48098-6363, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484
Wyoming, Michigan, 49519, United States
Mayo Clinic - Rochester /ID# 151677
Rochester, Minnesota, 55905-0001, United States
Minnesota Gastroenterology PA /ID# 151678
Saint Paul, Minnesota, 55114, United States
University of Mississippi Medical Center /ID# 213139
Jackson, Mississippi, 39216-4500, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 170712
Jackson, Mississippi, 39216, United States
Washington University-School of Medicine /ID# 150485
St Louis, Missouri, 63110, United States
Las Vegas Medical Research /ID# 153044
Las Vegas, Nevada, 89113, United States
Dartmouth-Hitchcock Medical Center /ID# 150549
Lebanon, New Hampshire, 03756, United States
AGA Clinical Research Associates, LLC /ID# 153040
Egg Harbor, New Jersey, 08234, United States
Atlantic Digestive Health Inst /ID# 150447
Morristown, New Jersey, 07960, United States
Rutgers Robert Wood Johnson /ID# 155248
New Brunswick, New Jersey, 08901, United States
Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396
Albuquerque, New Mexico, 87131, United States
NY Scientific /ID# 152707
Brooklyn, New York, 11235, United States
NYU Langone Long Island Clinical Research Association /ID# 155272
Great Neck, New York, 11021, United States
Columbia Univ Medical Center /ID# 163410
New York, New York, 10032-3725, United States
DiGiovanna Institute for Medical Education & Research /ID# 201533
North Massapequa, New York, 11758, United States
Premier Medical Group - GI Division /ID# 153357
Poughkeepsie, New York, 12601, United States
Gastoenterology Group of Rochester /ID# 151079
Rochester, New York, 14618-5703, United States
Richmond University Medical Center /ID# 201859
Staten Island, New York, 10310-1664, United States
Montefiore Medical Center - Moses Campus /ID# 150543
The Bronx, New York, 10467, United States
Advantage Clinical Trials /ID# 163938
The Bronx, New York, 10468, United States
Digestive Health Partners, P.A /ID# 167237
Asheville, North Carolina, 28801, United States
Atrium Health Carolinas Medical Center /ID# 156971
Charlotte, North Carolina, 28203, United States
Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545
Charlotte, North Carolina, 28207, United States
Atlantic Gastroenterology Clinical Research /ID# 151899
Greenville, North Carolina, 27834, United States
Clinical Trials of America /ID# 153448
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Medical Center /ID# 150448
Winston-Salem, North Carolina, 27157-0001, United States
Plains Clinical Research Center, LLC /ID# 170290
Fargo, North Dakota, 58104-5925, United States
Consultants for Clinical Research /ID# 151679
Cincinnati, Ohio, 45219, United States
University of Cincinnati /ID# 164582
Cincinnati, Ohio, 45267-0585, United States
The Ohio State University /ID# 169416
Columbus, Ohio, 43210, United States
Optimed Research, Ltd. /ID# 169696
Columbus, Ohio, 43235, United States
Hometown Urgent Care and Resea /ID# 200065
Dayton, Ohio, 45424, United States
Dayton Gastroenterology, Inc. /ID# 167631
Englewood, Ohio, 45415, United States
Great Lakes Medical Research, LLC /ID# 201772
Mentor, Ohio, 44060-6211, United States
Ohio Clinical Research Partner /ID# 154068
Mentor, Ohio, 44060, United States
Hightower Clinical /ID# 216337
Oklahoma City, Oklahoma, 73102, United States
Digestive Disease Specialists /ID# 201056
Oklahoma City, Oklahoma, 73112, United States
Options Health Research, LLC /ID# 150554
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultant /ID# 163100
Tulsa, Oklahoma, 74135, United States
Northwest Gastroenterology Clinic /ID# 152527
Portland, Oregon, 97210, United States
Guthrie Medical Group, PC /ID# 150481
Sayre, Pennsylvania, 18840, United States
Penn State Health Colonnade /ID# 150259
State College, Pennsylvania, 16803-2309, United States
Pharmacorp Clinical Trials /ID# 153354
Charleston, South Carolina, 29412, United States
Gastroenterology Associates, P.A. of Greenville /ID# 150541
Greenville, South Carolina, 29615-3593, United States
Gastro One /ID# 151144
Germantown, Tennessee, 38138, United States
East Tennessee Research Institute /ID# 203610
Johnson City, Tennessee, 37604, United States
Quality Medical Research /ID# 203426
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center /ID# 153355
Nashville, Tennessee, 37232-0011, United States
TX Clinical Research Institute /ID# 151526
Arlington, Texas, 76012, United States
Inquest Clinical Research /ID# 164635
Baytown, Texas, 77521-2415, United States
Texas Digestive Disease Consultants /ID# 209947
Cedar Park, Texas, 78613-5028, United States
Texas Digestive Disease Consultants /ID# 209804
Cedar Park, Texas, 78613, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770
Dallas, Texas, 75246, United States
DHAT Research Institute /ID# 151218
Garland, Texas, 75044-2208, United States
Vilo Research Group Inc /ID# 212624
Houston, Texas, 77017-2337, United States
CliniCore International, LLC /ID# 152062
Houston, Texas, 77027-6812, United States
Baylor College of Medicine - Baylor Medical Center /ID# 150486
Houston, Texas, 77030-3411, United States
Centex Studies, Inc. - Houston /ID# 201216
Houston, Texas, 77058, United States
GI Specialists of Houston /ID# 202327
Houston, Texas, 77070-4347, United States
Caprock Gastro Research, LLC /ID# 214754
Lubbock, Texas, 79424-3017, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 201260
San Antonio, Texas, 78212, United States
Southern Star Research Institute, LLC /ID# 169396
San Antonio, Texas, 78229-5390, United States
Carl R. Meisner Medical Clinic /ID# 171061
Sugar Land, Texas, 77478, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 204499
Temple, Texas, 76508, United States
Tyler Research Institute, LLC /ID# 169146
Tyler, Texas, 75701-4464, United States
Gastro Health & Nutrition - Victoria /ID# 167761
Victoria, Texas, 77904, United States
HP Clinical Research /ID# 163939
Bountiful, Utah, 84010, United States
Advanced Research Institute /ID# 162624
Ogden, Utah, 84403, United States
Utah Gastroenternology - St. Mark's Office /ID# 163101
Salt Lake City, Utah, 84124, United States
Velocity Clinical Research - Salt Lake City /ID# 163181
West Jordan, Utah, 84088, United States
Ctr for Gastrointestinal Healt /ID# 153360
Franklin, Virginia, 23851, United States
Emeritas Research Group, LLC /ID# 150258
Leesburg, Virginia, 20176, United States
Washington Gastroenterology /ID# 163629
Bellevue, Washington, 98004, United States
Virginia Mason Medical Center /ID# 153026
Seattle, Washington, 98101, United States
The Polyclinic /ID# 164369
Seattle, Washington, 98122-4201, United States
The Vancouver Clinic, INC. PS /ID# 162333
Vancouver, Washington, 98664, United States
Aurora Medical Center - Grafto /ID# 151717
Grafton, Wisconsin, 53024, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin /ID# 151843
Milwaukee, Wisconsin, 53226-3522, United States
Cardio Alem /ID# 211280
San Isidro, Buenos Aires, 1642, Argentina
Gedyt /ID# 210015
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1115, Argentina
Mautalen Salud e Investigacion /ID# 171173
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1128, Argentina
Hospital Britanico de Buenos Aires /ID# 209495
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1280, Argentina
Sanatorio 9 de Julio /ID# 150189
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Privado Univesitario /ID# 164185
Córdoba, 5016, Argentina
Macquarie University Hospital /ID# 211951
Macquarie University, New South Wales, 2109, Australia
Mater Misericordiae Limited /ID# 212685
South Brisbane, Queensland, 4101, Australia
Griffith University /ID# 211952
Southport, Queensland, 4222, Australia
Monash Medical Centre /ID# 150206
Clayton, Victoria, 3168, Australia
St Vincent's Hospital Melbourne /ID# 152472
Fitzroy Melbourne, Victoria, 3065, Australia
Fiona Stanley Hospital /ID# 211640
Murdoch, Western Australia, 6150, Australia
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305
Linz, Upper Austria, 4010, Austria
Klinik Landstrasse /ID# 162866
Vienna, Vienna, 1030, Austria
Medizinische Universitaet Wien /ID# 150614
Vienna, Vienna, 1090, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306
Salzburg, 5020, Austria
Vitebsk Regional Advanced Clin /ID# 169612
Vitebsk, 210001, Belarus
Universitair Ziekenhuis Leuven /ID# 150332
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Maria Middelares /ID# 150331
Ghent, 9000, Belgium
AZ-Delta /ID# 150330
Roeselare, 8800, Belgium
University Clinical Centre of the Republic of Srpska /ID# 150209
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 150706
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 150211
Tuzla, Tuzlanski, 75000, Bosnia and Herzegovina
University Clinical Hospital Mostar /ID# 150705
Mostar, 88000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 150208
Sarajevo, 71000, Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742
Goiânia, Goiás, 74535-170, Brazil
Hospital Nossa Senhora das Graças /ID# 152480
Curitiba, Paraná, 80810-040, Brazil
Hospital de Clinicas de Porto Alegre /ID# 153743
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Upeclin Fmb - Unesp /Id# 152485
Botucatu, São Paulo, 18618-686, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484
Ribeirão Preto, São Paulo, 14051-140, Brazil
Faculdade de Medicina do ABC /ID# 152481
Santo André, São Paulo, 09060-870, Brazil
Kaiser Clinica e Hospital Dia /ID# 152483
São José do Rio Preto, São Paulo, 15015-110, Brazil
University of Calgary /ID# 151821
Calgary, Alberta, T2N 4Z6, Canada
Allen Whey Khye Lim Professional Corporation /ID# 211168
Edmonton, Alberta, T5R 1W2, Canada
University of Alberta - Zeidler Ledcor Centre /ID# 151100
Edmonton, Alberta, T6G 2X8, Canada
Covenant Health /ID# 158930
Edmonton, Alberta, T6K 4B2, Canada
Okanagan Clinical Trials /ID# 153178
Kelowna, British Columbia, V1Y 1Z9, Canada
Percuro Clinical Research, Ltd /ID# 150367
Victoria, British Columbia, V8V 3M9, Canada
Medicor Research Inc /ID# 151101
Greater Sudbury, Ontario, P3A 1W8, Canada
Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365
Hamilton, Ontario, L8S 4K1, Canada
Ottawa Hospital Research Institute /ID# 151820
Ottawa, Ontario, K1H 8L6, Canada
Toronto Digestive Disease Asso /ID# 150363
Vaughan, Ontario, L4L 4Y7, Canada
CISSS de la Monteregie /ID# 159215
Greenfield Park, Quebec, J4V 2H1, Canada
CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361
Lévis, Quebec, G6V 3Z1, Canada
Recherche GCP Research /ID# 151822
Montreal, Quebec, H1M 1B1, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169
Montreal, Quebec, H2X 0A9, Canada
Montreal General Hospital - McGill University Health Centre /ID# 170012
Montreal, Quebec, H3G 1A4, Canada
CIUSSS de l'Estrie - CHUS /ID# 150366
Sherbrooke, Quebec, J1G 2E8, Canada
M y F Estudios Clínicos /ID# 200107
Santiago, Region Metropolitana Santiago, 7750495, Chile
Centro de Investigaciones Clínicas Viña del Mar /ID# 150212
Viña del Mar, Región de Valparaíso, 2540488, Chile
Research Group /ID# 203176
Santiago, Santiago Metropolitan, 2540364, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 212424
Concepción, 4070038, Chile
CTR Estudios Clinicos /ID# 200110
Providencia, 7500571, Chile
Hospital Clinico Universidad De Los Andes /ID# 207422
Santiago, 7501504, Chile
The First Affiliated Hospital, Sun Yat-sen University /ID# 150455
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hosp Sun /ID# 150456
Guangzhou, Guangdong, 510655, China
Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405
Shiyan, Hubei, 442700, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088
Wuhan, Hubei, 430022, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078
Wuhan, Hubei, 430022, China
The First Affiliated Hospital of Nanchang University /ID# 211750
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University /ID# 209986
Changchun, Jilin, 130021, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461
Shanghai, Shanghai Municipality, 200065, China
Shanghai Tenth People's Hospital /ID# 150460
Shanghai, Shanghai Municipality, 200072, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815
Shanghai, Shanghai Municipality, 200127, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454
Hangzhou, Zhejiang, 310018, China
Xiangya Hospital Central South University /ID# 167229
Changsha, 410008, China
West China Hospital, Sichuan University /ID# 167040
Chengdu, 610041, China
Shengjing Hospital of China Medical University /ID# 166920
Shenyang, 110022, China
Tianjin Medical University General Hospital /ID# 170604
Tianjin, 300052, China
Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564
Bogota DC, Cundinamarca, 111221, Colombia
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042
Montería, Departamento de Córdoba, 230002, Colombia
Hospital Universitario de San /ID# 155387
Medellín, Colombia
Clinical Hospital Dubrava /ID# 150213
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 150225
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 150709
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 211483
Zagreb, City of Zagreb, 10000, Croatia
Duplicate_Klinicki bolnicki centar Osijek /ID# 150216
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinicki bolnicki centar Rijeka /ID# 150708
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki bolnicki centar Split /ID# 213988
Split, Split-Dalmatia County, 21000, Croatia
Zadar General Hospital /ID# 150221
Zadar, 23000, Croatia
Hepato-Gastroenterologie HK, s.r.o. /ID# 150912
Hradec Králové, 500 12, Czechia
CTCenter MaVe s.r.o. /ID# 150904
Olomouc, 779 00, Czechia
ARTROSCAN s.r.o. /ID# 150401
Ostrava, 722 00, Czechia
Nemocnice Pardubickeho kraje, a.s. /ID# 213539
Pardubice, 530 03, Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221
Prague, 118 33, Czechia
Axon Clinical, s.r.o. /ID# 152479
Prague, 140 00, Czechia
ISCARE a.s. /ID# 209278
Prague, 190 00, Czechia
East Tallinn Central Hospital /ID# 150417
Kesklinn, Harju, 10138, Estonia
North Estonia Medical Centre /ID# 160870
Mustamäe, Harju, 13419, Estonia
Tartu University Hospital /ID# 150418
Tartu, Tartu, 50406, Estonia
West Tallinn Central Hospital /ID# 150419
Tallinn, 10617, Estonia
Tampere University Hospital /ID# 150114
Tampere, Pirkanmaa, 33520, Finland
Duplicate_Helsinki Univ Central Hospital /ID# 150407
Helsinki, 00290, Finland
Keski-Suomen Sairaala Nova /ID# 155666
Jyväskylä, 40620, Finland
Laakarikeskus Ikioma /ID# 150121
Mikkeli, 50100, Finland
Turku University Hospital /ID# 168301
Turku, 20520, Finland
Chu de Nice-Hopital L'Archet Ii /Id# 152606
Nice, Alpes-Maritimes, 06200, France
HCL - Hôpital Lyon Sud /ID# 152539
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
CHU Hopital Nord /ID# 163508
Marseille, Bouches-du-Rhone, 13915, France
CHRU Lille - Hopital Claude Huriez /ID# 152607
Lille, Hauts-de-France, 59037, France
CHU Montpellier - Hôpital Saint Eloi /ID# 200006
Montpellier, Herault, 34295, France
CHU Amiens-Picardie Site Sud /ID# 163456
Amiens, Somme, 80054, France
CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452
La Roche-sur-Yon, 85000, France
CHU de Saint-Etienne, Hopital Nord /ID# 154453
Saint-Etienne, 42270, France
Universitatsklinikum Mannheim /ID# 150173
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinimum Tuebingen /ID# 150767
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitatsklinikum Munster /ID# 150158
Munster, Lower Saxony, 48149, Germany
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574
Herne, North Rhine-Westphalia, 44623, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811
Saarbrücken, Saarland, 66111, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981
Kiel, Schleswig-Holstein, 24105, Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766
Berlin, 10825, Germany
Agaplesion Markus Krankenhaus /ID# 161982
Frankfurt am Main, 60431, Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 207135
Münster, 48155, Germany
Praxis medicum /ID# 150166
Wiesbaden, 65189, Germany
General Hospital of Athens Laiko /ID# 208669
Athens, Attica, 11527, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100
Athens, Attica, 11527, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 150250
Heraklion, Crete, 71500, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309
Athens, 10676, Greece
University General Hospital of Ioannina /ID# 164248
Ioannina, 45500, Greece
Theageneio Anticancer Hospital /ID# 163896
Thessaloniki, 54639, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 209521
Thessaloniki, 54642, Greece
Markusovszky Egyetemi Oktatokorhaz /ID# 150313
Szombathely, Vas County, 9700, Hungary
Bekes Megyei Kozponti Korhaz /ID# 151572
Békéscsaba, 5600, Hungary
Semmelweis Egyetem /ID# 150312
Budapest, 1085, Hungary
Meditres Kft. /ID# 151521
Kecskemét, 6000, Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523
Sopron, 9400, Hungary
Mentahaz Maganorvosi Kozpont /ID# 205884
Székesfehérvár, 8000, Hungary
Beaumont Hospital /ID# 150321
Beaumont, Dublin, D09 XR63, Ireland
St James Hospital /ID# 150320
Dublin, Dublin, D08 NHY1, Ireland
St Vincent's University Hospital /ID# 150318
Elm Park, Dublin, D04 T6F4, Ireland
Mercy University Hospital /ID# 151529
Cork, T12 WE28, Ireland
University Hospital Galway /ID# 150319
Galway, H91 YR71, Ireland
Soroka University Medical Center /ID# 156561
Beersheba, Southern District, 8443901, Israel
Rambam Health Care Campus /ID# 150325
Haifa, 3109601, Israel
Shaare Zedek Medical Center /ID# 161677
Jerusalem, 91031, Israel
Hadassah Medical Center-Hebrew University /ID# 165118
Jerusalem, 91120, Israel
Azienda Ospedaliera San Camillo Forlanini /ID# 151360
Rome, Lazio, 00152, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610
Rho, Milano, 20017, Italy
Istituto Clinico Humanitas /ID# 151361
Rozzano, Milano, 20089, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 150338
Rome, Roma, 00133, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333
Rome, Roma, 00168, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725
Negrar, Verona, 37024, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337
Bologna, 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334
Milan, 20122, Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602
Milan, 20121, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253
Palermo, 90146, Italy
Aichi Medical University Hospital /ID# 151993
Nagakute-shi, Aichi-ken, 480-1195, Japan
Nagoya University Hospital /ID# 152709
Nagoya, Aichi-ken, 4668560, Japan
Nagoya City University Hospital /ID# 151950
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital /ID# 171457
Toyohashi, Aichi-ken, 441-8570, Japan
Ieda Hospital /ID# 157781
Toyota-shi, Aichi-ken, 470-1219, Japan
Hirosaki National Hospital /ID# 152763
Hirosaki-shi, Aomori, 036-8545, Japan
Tokatsu Tsujinaka Hospital /ID# 214962
Abiko-shi, Chiba, 270-1168, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209130
Kashiwa-shi, Chiba, 277-0871, Japan
Toho University Sakura Medical Center /ID# 151936
Sakura-shi, Chiba, 285-8741, Japan
Juntendo University Urayasu Hospital /ID# 208781
Urayasu-shi, Chiba, 279-0021, Japan
Fukui Prefectural Hospital /ID# 210448
Fukui-shi, Fukui, 910-8526, Japan
Fukuoka University Chikushi Hospital /ID# 152628
Chikushino-shi, Fukuoka, 818-8502, Japan
Saiseikai Fukuoka Genaral Hospital /ID# 209479
Fukuoka, Fukuoka, 810-0001, Japan
Kyushu University Hospital /ID# 152526
Fukuoka, Fukuoka, 812-8582, Japan
Kitakyushu Municipal Med Ctr /ID# 152588
Kitakyushu, Fukuoka, 8020077, Japan
Kurume University Hospital /ID# 151976
Kurume-shi, Fukuoka, 830-0011, Japan
Ogaki Municipal Hospital /ID# 208225
Ogaki-shi, Gifu, 503-8502, Japan
NHO Fukuyama Medical Center /ID# 206293
Fukuyama-shi, Hiroshima, 720-8520, Japan
Hiroshima University Hospital /ID# 151951
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa Medical University Hospital /ID# 170289
Asahikawa-shi, Hokkaido, 078-8510, Japan
Obihiro kosei Hospital /ID# 210412
Obihiro-shi, Hokkaido, 080-0024, Japan
Sapporo Tokushukai Hospital /ID# 209397
Sapporo, Hokkaido, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506
Sapporo, Hokkaido, 060-0033, Japan
Sapporo Medical University Hospital /ID# 206492
Sapporo, Hokkaido, 060-8543, Japan
Sapporo Higashi Tokushukai Hospital /ID# 208487
Sapporo, Hokkaido, 065-0033, Japan
Aoyama Clinic /ID# 152049
Kobe, Hyōgo, 650-0015, Japan
Hyogo College of Medicine College Hospital /Id# 152434
Nishinomiya-shi, Hyōgo, 663-8501, Japan
National Hospital Organization Mito Medical Center /ID# 152631
Higashi Ibaraki-gun, Ibaraki, 311-3193, Japan
Kanazawa University Hospital /ID# 205099
Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate Medical University Uchimaru Medical Center /ID# 203411
Morioka, Iwate, 020-8505, Japan
Imamura General Hospital /ID# 227134
Kagoshima, Kagoshima-ken, 890-0064, Japan
Idzuro Imamura Hospital /ID# 206024
Kagoshima, Kagoshima-ken, 892-0824, Japan
Sameshima Hospital /ID# 206672
Kagoshima, Kagoshima-ken, 892-0846, Japan
St. Marianna University School of Medicine Hospital /ID# 208654
Kawasaki-shi, Kanagawa, 216-8511, Japan
Showa University Fujigaoka Hospital /ID# 208222
Yokohama, Kanagawa, 227-8501, Japan
Yokohama City University Medical Center /ID# 169899
Yokohama, Kanagawa, 232-0024, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359
Kyoto, Kyoto, 605-0981, Japan
Kyoto University Hospital /ID# 211758
Kyoto, Kyoto, 606-8507, Japan
Mie University Hospital /ID# 205362
Tsu, Mie-ken, 514-8507, Japan
Yokkaichi Hazu Medical Center /ID# 214347
Yokkaichi-shi, Mie-ken, 510-0016, Japan
National Hospital Organization Sendai Medical Center /ID# 209527
Sendai, Miyagi, 983-8520, Japan
NHO Nagasaki Medical Center /ID# 209531
Omura-shi, Nagasaki, 856-8562, Japan
Kenseikai Dongo Hospital /ID# 208100
Yamatotakada-shi, Nara, 635-0022, Japan
Saiseikai Niigata Hospital /ID# 209916
Niigata, Niigata, 950-1104, Japan
Niigata University Medical & Dental Hospital /ID# 218048
Niigata, Niigata, 951-8520, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 210117
Ōita, Oita Prefecture, 870-0823, Japan
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821
Kurashiki-shi, Okayama-ken, 710-0142, Japan
Okayama University Hospital /ID# 217923
Okayama, Okayama-ken, 700-8558, Japan
Kinshukai Infusion Clinic /ID# 207864
Osaka, Osaka, 530-0011, Japan
Kitano Hospital /ID# 210395
Osaka, Osaka, 530-8480, Japan
Osaka City General Hospital /ID# 152704
Osaka, Osaka, 534-0021, Japan
Japanese Red Cross Osaka Hospital /ID# 209476
Osaka, Osaka, 543-8555, Japan
Osaka City University Hospital /ID# 152682
Osaka, Osaka, 545-8586, Japan
Toyonaka Municipal Hospital /ID# 217079
Toyonaka-shi, Osaka, 560-0055, Japan
Saga University Hospital /ID# 209268
Saga, Saga-ken, 849-8501, Japan
Saitama Medical Center /ID# 152031
Kawagoe-shi, Saitama, 350-8550, Japan
Tokitokai Tokito clinic /ID# 152677
Saitama-shi, Saitama, 336-0963, Japan
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709
Higashi-ohmi-shi, Shiga, 527-8505, Japan
Shimane University Hospital /ID# 208899
Izumo-shi, Shimane, 693-8501, Japan
Hamamatsu University Hospital /ID# 205708
Hamamatsu, Shizuoka, 431-3192, Japan
NHO Shizuoka Medical Center /ID# 163572
Sunto-gun, Shizuoka, 411-8611, Japan
Tokyo Medical And Dental University Hospital /ID# 152016
Bunkyo-ku, Tokyo, 113-8519, Japan
St.Luke's International Hospital /ID# 208074
Chuo-ku, Tokyo, 104-8560, Japan
Tokai University Hachioji Hospital /ID# 152587
Hachioji-shi, Tokyo, 192-0032, Japan
Teikyo University Hospital /ID# 208897
Itabashi-ku, Tokyo, 173-8606, Japan
Kitasato University Kitasato Institute Hospital /ID# 152686
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital /ID# 153194
Mitaka-shi, Tokyo, 181-8611, Japan
Center Hospital of the National Center for Global Health and Medicine /ID# 209267
Shinjuku-ku, Tokyo, 162-8655, Japan
Tokyo Women's Medical University Hospital /ID# 205977
Shinjuku-ku, Tokyo, 162-8666, Japan
Yamagata University Hospital /ID# 171454
Yamagata, Yamagata, 990-9585, Japan
Tokuyama Central Hospital /ID# 216993
Shunan-shi, Yamaguchi, 745-8522, Japan
Yamanashi Prefectural Central Hospital /ID# 151908
Kofu, Yamanashi, 400-8506, Japan
Shoyukai Fujita Gastroenterological Hospital /ID# 216492
Takatsuki-shi, 569-0086, Japan
Pauls Stradins Clinical University Hospital /ID# 151409
Riga, 1002, Latvia
Riga East Clinical University Hospital /ID# 150354
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357
Kaunas, 50161, Lithuania
Klaipeda Seamens Hospital /ID# 154319
Klaipėda, 92288, Lithuania
Klaipeda University Hospital /ID# 158862
Klaipėda, 92288, Lithuania
Vilnius University Hospital /ID# 154318
Vilnius, LT-08661, Lithuania
Hospital Sultanah Bahiyah /ID# 151687
Alor Star, Kedah, 05460, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689
Kuala Lumpur, Selangor, 56000, Malaysia
Hospital Ampang /ID# 151298
Ampang, 68000, Malaysia
Uni Malaya MC /ID# 150359
Kuala Lumpur, 59100, Malaysia
Morales Vargas Centro de Investigacion S.C. /ID# 211325
León, Guanajuato, 37000, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710
Guadalajara, Jalisco, 44650, Mexico
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256
Monterrey, Nuevo León, 64610, Mexico
Radboud Universitair Medisch Centrum /ID# 151700
Nijmegen, Gelderland, 6525 GA, Netherlands
Erasmus Medisch Centrum /ID# 150308
Rotterdam, South Holland, 3015 GD, Netherlands
Academisch Medisch Centrum /ID# 150647
Amsterdam, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum /ID# 152624
Leiden, 2333 ZA, Netherlands
Universitair Medisch Centrum Utrecht /ID# 152775
Utrecht, 3584 CX, Netherlands
Akershus universitetssykehus /ID# 150317
Nordbyhagen, Akershus, 1474, Norway
Universitetssykehuset Nord-Norge /ID# 152835
Tromsø, Troms, 9019, Norway
Gastromed /Id# 216197
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Zdrowia MDM /ID# 150351
Warsaw, Masovian Voivodeship, 00-635, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580
Warsaw, Masovian Voivodeship, 02-507, Poland
Centrum Medyczne Reuma Park /ID# 150349
Warsaw, Masovian Voivodeship, 02-665, Poland
NZOZ Vivamed /ID# 216742
Warsaw, Masovian Voivodeship, 03-580, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732
Warsaw, Masovian Voivodeship, 04-730, Poland
Endoskopia Sp. z o.o. /ID# 150765
Sopot, Pomeranian Voivodeship, 81-756, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607
Guimarães, Braga District, 4835-044, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 152335
Santa Maria DA Feira, Porto District, 4520-211, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Hospital Garcia de Orta, EPE /ID# 151613
Almada, 2805-267, Portugal
CCA Braga - Hospital de Braga /ID# 151608
Braga, 4710-243, Portugal
Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611
Lisbon, 1169-050, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610
Porto, 4200-319, Portugal
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358
San Juan, 00935, Puerto Rico
Immanuel Kant Baltic Federal University /ID# 200719
Kaliningrad, Kaliningrad Oblast, 236016, Russia
NW State Medical Univ na Mechn /ID# 169322
Saint Petersburg, Leningradskaya Oblast', 191015, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386
Perm, Permskiy Kray, 614109, Russia
Medical Company Hepatolog /ID# 200197
Samara, Samara Oblast, 443063, Russia
LLC Novaya Klinika /ID# 208107
Pyatigorsk, Stavropol Kray, 357500, Russia
Kazan State Medical University /ID# 166042
Kazan', Tatarstan, Respublika, 420012, Russia
Olla-Med Clinic /ID# 215332
Moscow, 105554, Russia
City Clinical Hospital #24 /ID# 150395
Moscow, 127015, Russia
Republican hospital named after V.A. Baranov /ID# 206506
Petrozavodsk, 185019, Russia
Euromedservice /ID# 203800
Pushkin, 196603, Russia
Duplicate_Stavropol State Medical Univ /ID# 150387
Stavropol, 355017, Russia
Clinical Hosp Center Zvezdara /ID# 150427
Belgrade, Beograd, 11000, Serbia
Military Medical Academy /ID# 150429
Belgrade, Beograd, 11000, Serbia
University Clinical Center Serbia /ID# 150428
Belgrade, Beograd, 11000, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 150426
Belgrade, Beograd, 11080, Serbia
University Clinical Center of Nis /ID# 151903
Niš, Nisavski Okrug, 18000, Serbia
University Clinical Center Kragujevac /ID# 150430
Kragujevac, Sumadijski Okrug, 34000, Serbia
Clinical Center Vojvodina /ID# 150764
Novi Sad, Vojvodina, 21000, Serbia
General Hospital Leskovac /ID# 217880
Leskovac, 16000, Serbia
National University Hospital /ID# 150453
Singapore, 119074, Singapore
Gleneagles Medical Centre /ID# 206018
Singapore, 258499, Singapore
Tan Tock Seng Hospital /ID# 150443
Singapore, 308433, Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868
Banská Bystrica, 975 17, Slovakia
Medak s.r.o. /ID# 150480
Bratislava, 851 01, Slovakia
Slovak Research Center Team Me /ID# 150257
Ilava, 019 01, Slovakia
B+B MED, s.r.o. /ID# 150471
Košice, 040 01, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370
Nové Zámky, 940 34, Slovakia
GASTRO I., s.r.o. /ID# 150472
Prešov, 080 01, Slovakia
MD Search /ID# 167293
Boksburg North, Gauteng, 1460, South Africa
Clinresco Centers /ID# 163622
Johannesburg, Gauteng, 1619, South Africa
Lenasia Clinical Trial Centre /ID# 214344
Johannesburg, Gauteng, 1820, South Africa
Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785
Johannesburg, Gauteng, 2193, South Africa
Wits Clinical Research Site /ID# 150496
Johannesburg, Gauteng, 2193, South Africa
Kingsbury Hospital /ID# 150497
Cape Town, Western Cape, 7708, South Africa
Private Practice Dr MN Rajabally /ID# 155144
Cape Town, Western Cape, 7800, South Africa
Spoke Research Inc /ID# 162202
CAPE TOWN Milnerton, Western Cape, 7441, South Africa
Hayang University GuriHospital /ID# 150344
Guri-si, Gyeonggido, 11923, South Korea
CHA University Bundang Medical Center /ID# 159479
Seongnam-si, Gyeonggido, 13496, South Korea
The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347
Suwon, Gyeonggido, 16247, South Korea
Kangbuk Samsung Hospital /ID# 150348
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Yonsei University Health System Severance Hospital /ID# 159478
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Dong-A University Hospital /ID# 159480
Busan, 49201, South Korea
Pusan National University Hospital /ID# 159481
Busan, 49241, South Korea
Yeungnam University Medical Center /ID# 150345
Daegu, 42415, South Korea
Asan Medical Center /ID# 150900
Seoul, 05505, South Korea
Samsung Medical Center /ID# 150346
Seoul, 06351, South Korea
Hospital Clínico Universitario de Santiago-CHUS /ID# 151065
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Unversitario Marques de Valdecilla /ID# 216620
Santander, Cantabria, 39008, Spain
Hospital Universitario Dr. Negrin /ID# 203937
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Hospital Universitario A Coruna - CHUAC /ID# 203911
A Coruña, 15006, Spain
Hospital Clinic de Barcelona /ID# 150612
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia /ID# 151066
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal /ID# 151067
Madrid, 28034, Spain
Hospital Universitario La Paz /ID# 214539
Madrid, 28046, Spain
Hospital Universitario de Salamanca /ID# 150509
Salamanca, 37711, Spain
Hospital Universitario y Politecnico La Fe /ID# 150611
Valencia, 46026, Spain
Sahlgrenska University Hospital /ID# 151496
Gothenburg, Västra Götaland County, 413 45, Sweden
Universitätsspital Basel /ID# 161731
Basel, Canton of Basel-City, 4031, Switzerland
Kantonsspital St. Gallen /ID# 152599
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Universitätsspital Zürich /ID# 152591
Zurich, Canton of Zurich, 8091, Switzerland
Inselspital, Universitätsspital Bern /ID# 152590
Bern, 3010, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575
Kaohsiung City, 807, Taiwan
Chung Shan Medical University Hospital /ID# 150573
Taichung, 40201, Taiwan
China Medical University Hospital /ID# 150571
Taichung, 40447, Taiwan
National Cheng Kung University Hospital /ID# 151749
Tainan, 704, Taiwan
National Taiwan University Hospital /ID# 150574
Taipei, 100, Taiwan
Taipei Veterans General Hosp /ID# 151748
Taipei, 11217, Taiwan
Erciyes University Medical Fac /ID# 150129
Melikgazi, Kayseri, 38030, Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125
Istanbul, 34098, Turkey (Türkiye)
Umraniye Training and Res Hosp /ID# 162659
Istanbul, 34764, Turkey (Türkiye)
Marmara University Medical Fac /ID# 213969
Istanbul, 34899, Turkey (Türkiye)
Mersin University Medical /ID# 157849
Mersin, 33343, Turkey (Türkiye)
Gazi Universitesi Tip Fakultes /ID# 150127
Yenimahalle, 06560, Turkey (Türkiye)
Medical Center of the "Health /ID# 151274
Vinnytsia, Vinnytsia Oblast, 21009, Ukraine
Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723
Dnipro, 49005, Ukraine
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940
Kharkiv, 61058, Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 217216
Kropyvnytskyi, 25006, Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 150372
Kyiv, 01030, Ukraine
Medical Center CONSILIUM MEDICAL /ID# 217446
Kyiv, 04050, Ukraine
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372
Kyiv, 04073, Ukraine
Lviv Regional Clinical Hospital /ID# 150375
Lviv, 79010, Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275
Odesa, 65025, Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297
Vinnytsia, 21028, Ukraine
Royal Devon and Exeter NHS Trust Hospital /ID# 150379
Exeter, Devon, EX2 5DW, United Kingdom
Hampshire Hospitals NHS Foundation Trust /ID# 150380
Basingstoke, Essex, RG24 9NA, United Kingdom
Barts Health NHS Trust /ID# 150384
London, London, City of, E1 2ES, United Kingdom
NHS Greater Glasgow and Clyde /ID# 163787
Glasgow, Scotland, G12 0XH, United Kingdom
Royal United Hospitals Bath /ID# 151532
Bath, BA1 3NG, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 150382
Birmingham, B15 2TH, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust /ID# 217658
Huddersfield, HX3 0PW, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 208374
Tooting, SW17 0QT, United Kingdom
Related Publications (13)
Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
PMID: 40875187DERIVEDPanes J, Dubinsky MC, Ishiguro Y, Shukla N, Dubcenco E, Remple V, Sharma D, Panaccione R. Achievement of long-term treatment goals in upadacitinib-treated patients with moderately to severely active ulcerative colitis: a post hoc analysis of phase 3 trial data. J Crohns Colitis. 2025 Jul 3;19(7):jjaf095. doi: 10.1093/ecco-jcc/jjaf095.
PMID: 40488552DERIVEDPanaccione R, Danese S, Zhou W, Klaff J, Ilo D, Yao X, Levy G, Higgins PDR, Loftus EV Jr, Chen S, Gonzalez YS, Leonard C, Hebuterne X, Lindsay JO, Cao Q, Nakase H, Colombel JF, Vermeire S. Efficacy and safety of upadacitinib for 16-week extended induction and 52-week maintenance therapy in patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2024 Feb;59(3):393-408. doi: 10.1111/apt.17816. Epub 2023 Nov 27.
PMID: 38010661DERIVEDRaine T, Ishiguro Y, Rubin DT, Finney-Hayward T, Vladea R, Liu J, Phillips C, Cheng E, Targownik L, Loftus EV Jr. Impact of Baseline Corticosteroid Use on the Efficacy and Safety of Upadacitinib in Patients with Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 Clinical Trial Programme. J Crohns Colitis. 2024 May 31;18(5):695-707. doi: 10.1093/ecco-jcc/jjad190.
PMID: 37942921DERIVEDVermeire S, Danese S, Zhou W, Ilo D, Klaff J, Levy G, Yao X, Chen S, Sanchez Gonzalez Y, Hebuterne X, Lindsay JO, Higgins PDR, Cao Q, Nakase H, Colombel JF, Loftus EV Jr, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction therapy (U-ACHIEVE Maintenance): overall results from the randomised, placebo-controlled, double-blind, phase 3 maintenance study. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):976-989. doi: 10.1016/S2468-1253(23)00208-X. Epub 2023 Sep 9.
PMID: 37683686DERIVEDParkes G, Ungaro RC, Danese S, Abreu MT, Arenson E, Zhou W, Ilo D, Laroux FS, Deng H, Sanchez Gonzalez Y, Peyrin-Biroulet L. Correlation of mucosal healing endpoints with long-term clinical and patient-reported outcomes in ulcerative colitis. J Gastroenterol. 2023 Oct;58(10):990-1002. doi: 10.1007/s00535-023-02013-7. Epub 2023 Jul 25.
PMID: 37490069DERIVEDLoftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9.
PMID: 37296268DERIVEDDanese S, Tran J, D'Haens G, Rubin DT, Aoyama N, Zhou W, Ilo D, Yao X, Sanchez Gonzalez Y, Panaccione R. Upadacitinib Induction and Maintenance Therapy Improves Abdominal Pain, Bowel Urgency, and Fatigue in Patients With Ulcerative Colitis: A Post Hoc Analysis of Phase 3 Data. Inflamm Bowel Dis. 2023 Nov 2;29(11):1723-1729. doi: 10.1093/ibd/izad016.
PMID: 36790041DERIVEDPanes J, Loftus EV, Higgins PDR, Lindsay JO, Zhou W, Yao X, Ilo D, Phillips C, Tran J, Sanchez Gonzalez Y, Vermeire S. Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results. Inflamm Bowel Dis. 2023 Sep 1;29(9):1421-1430. doi: 10.1093/ibd/izac260.
PMID: 36645051DERIVEDPonce-Bobadilla AV, Stodtmann S, Eckert D, Zhou W, Liu W, Mohamed MF. Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients. Clin Pharmacokinet. 2023 Jan;62(1):101-112. doi: 10.1007/s40262-022-01191-6. Epub 2022 Dec 26.
PMID: 36571701DERIVEDLoftus EV Jr, Colombel JF, Takeuchi K, Gao X, Panaccione R, Danese S, Dubinsky M, Schreiber S, Ilo D, Finney-Hayward T, Zhou W, Phillips C, Gonzalez YS, Shu L, Yao X, Zhou Q, Vermeire S. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2347-2358.e6. doi: 10.1016/j.cgh.2022.11.029. Epub 2022 Dec 1.
PMID: 36464141DERIVEDDanese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.
PMID: 35644166DERIVEDSandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22.
PMID: 32092309DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2016
First Posted
June 30, 2016
Study Start
September 26, 2016
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
June 30, 2022
Results First Posted
June 30, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.