A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
U-Accomplish
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
522
42 countries
369
Brief Summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
369 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
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2021
CompletedResults Posted
Study results publicly available
November 26, 2021
CompletedMarch 2, 2022
February 1, 2022
2.1 years
August 28, 2018
October 29, 2021
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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. Clinical remission is defined as an Adapted Mayo score ≤ 2, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1.
Week 8
Secondary Outcomes (11)
Percentage of Participants With Endoscopic Improvement at Week 8
Week 8
Percentage of Participants With Endoscopic Remission at Week 8
Week 8
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8
Week 8
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2
Week 2
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Week 8
- +6 more secondary outcomes
Study Arms (2)
Upadacitinib 45 mg
EXPERIMENTALParticipants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Placebo
PLACEBO COMPARATORParticipants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Interventions
Tablet for oral administration
Eligibility Criteria
You may qualify if:
- \- Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
- Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
- Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
- Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
- 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 as defined above.
- 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.
- If female, participant must meet the contraception recommendation criteria.
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 who received azathioprine or 6-mercaptopurine (6-MP) 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).
- Screening laboratory and other analyses show any prespecified abnormal hematologic results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (379)
East View Medical Research, LLC /ID# 216933
Mobile, Alabama, 36606, United States
CB Flock Research Corporation /ID# 206094
Mobile, Alabama, 36608, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030
Sun City, Arizona, 85306, United States
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887
Tempe, Arizona, 85284-2604, United States
University of Arizona /ID# 208856
Tucson, Arizona, 85724, United States
Citrus Valley Gastroenterology /ID# 205627
Covina, California, 91722-3797, United States
Care Access Research /ID# 217003
Huntington Beach, California, 92648-5994, United States
Moore UC San Diego Cancer Center /ID# 204919
La Jolla, California, 92093, United States
United Medical Doctors /ID# 207867
Los Alamitos, California, 90720-3309, United States
TLC Clinical Research Inc /ID# 216831
Los Angeles, California, 90048, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314
Los Angeles, California, 90067-2001, United States
Facey Medical Foundation /ID# 205301
Mission Hills, California, 91345, United States
United Medical Doctors - Murrieta /ID# 205313
Murrieta, California, 92563, United States
InSite Digestive Health Care - Oxnard /ID# 205628
Oxnard, California, 93030, United States
Inland Empire Clinical Trials, LLC /ID# 216164
Rialto, California, 92377, United States
San Diego Clinical Trials /ID# 212122
San Diego, California, 92120, United States
Medical Assoc Research Grp /ID# 205626
San Diego, California, 92123, United States
Delta Waves, Inc. /ID# 206170
Colorado Springs, Colorado, 80918, United States
Western States Clinical Res /ID# 206091
Wheat Ridge, Colorado, 80033-2896, United States
Western Connecticut Medical Group /ID# 208290
Danbury, Connecticut, 06810-6000, United States
Gastroenterology Center of CT /ID# 208291
Hamden, Connecticut, 06518, United States
Gastro Florida /ID# 206174
Clearwater, Florida, 33756, United States
Universal Axon Clinical Research /ID# 213462
Doral, Florida, 33166, United States
Palmetto Research, LLC /ID# 208293
Hialeah, Florida, 33016, United States
Nature Coast Clinical Research - Inverness /ID# 206087
Inverness, Florida, 34452-4717, United States
Encore Borland-Groover Clinical Research /Id# 208128
Jacksonville, Florida, 32256, United States
Cfagi Llc /Id# 207995
Maitland, Florida, 32751-6108, United States
University of Miami /ID# 215445
Miami, Florida, 33136, United States
Coral Research Clinic /ID# 208292
Miami, Florida, 33186-4643, United States
Advanced Research Institute, Inc /ID# 206077
New Port Richey, Florida, 34653, United States
Endoscopic Research, Inc. /ID# 207360
Orlando, Florida, 32803, United States
Omega Research Consultants /ID# 206066
Orlando, Florida, 32810, United States
Clinical Research Trials of Florida, Inc. /ID# 206068
Tampa, Florida, 33607, United States
University of South Florida /ID# 214495
Tampa, Florida, 33612, United States
AdventHealth Tampa /ID# 207363
Tampa, Florida, 33613-4680, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 216940
Macon, Georgia, 31201, United States
Infinite Clinical Trials /ID# 215343
Riverdale, Georgia, 30274, United States
Atlanta Gastroenterology Spec /ID# 206173
Suwanee, Georgia, 30024, United States
Next Innovative Clinical Research - Chicago /ID# 217324
Chicago, Illinois, 60605-2168, United States
The University of Chicago Medical Center /ID# 206172
Chicago, Illinois, 60637-1443, United States
Carle Foundation Hospital /ID# 207397
Effingham, Illinois, 62401, United States
MediSphere Medical Research Center /ID# 206073
Evansville, Indiana, 47714-8011, United States
Indianapolis Gastroenterology /ID# 206381
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics /ID# 206167
Iowa City, Iowa, 52242, United States
Cotton-O'Neil Clinical Res Ctr /ID# 206175
Topeka, Kansas, 66606, United States
Tri-State Gastroenterology /ID# 206124
Crestview Hills, Kentucky, 41017, United States
Houma Digestive Health Special /ID# 206176
Houma, Louisiana, 70360, United States
Louisana Research Center, LLC /ID# 206064
Shreveport, Louisiana, 71105-6800, United States
Gastro Center of Maryland /ID# 206883
Columbia, Maryland, 21045, United States
University of Michigan Health Systems /ID# 206918
Ann Arbor, Michigan, 48109, United States
Huron Gastroenterology Assoc /ID# 205109
Ann Arbor, Michigan, 48197, United States
Clin Res Inst of Michigan, LLC /ID# 207078
Chesterfield, Michigan, 48047, United States
Revival Research Institute, LLC /ID# 207282
Southfield, Michigan, 48034-1659, United States
Center for Digestive Health /ID# 207080
Troy, Michigan, 48098-6363, United States
Mayo Clinic /ID# 205645
Rochester, Minnesota, 55905-0001, United States
University of Mississippi Medical Center /ID# 213116
Jackson, Mississippi, 39216-4500, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 206069
Jackson, Mississippi, 39216, United States
Las Vegas Medical Research /ID# 206814
Las Vegas, Nevada, 89113, United States
AGA Clinical Research Associates, LLC /ID# 206880
Egg Harbor, New Jersey, 08234, United States
Atlantic Digestive Health Inst /ID# 208748
Morristown, New Jersey, 07960, United States
Rutgers Robert Wood Johnson /ID# 207382
New Brunswick, New Jersey, 08901, United States
University of New Mexico Department of Internal Medicine /ID# 214397
Albuquerque, New Mexico, 87131-0001, United States
NY Scientific /ID# 206080
Brooklyn, New York, 11235, United States
NYU Langone Long Island Clinical Research Associates /ID# 206079
Lake Success, New York, 11042, United States
DiGiovanna Institute for Medical Education & Research /ID# 206885
North Massapequa, New York, 11758, United States
Premier Medical Group - GI Division /ID# 206097
Poughkeepsie, New York, 12601, United States
Gastro Group of Rochester /ID# 206881
Rochester, New York, 14618-5703, United States
Richmond University Medical Center /ID# 213185
Staten Island, New York, 10310-1664, United States
Advantage Clinical Trials /ID# 206082
The Bronx, New York, 10468, United States
Digestive Health Partners, P.A /ID# 206842
Asheville, North Carolina, 28801, United States
Atrium Health Carolinas Medical Center /ID# 206085
Charlotte, North Carolina, 28203, United States
Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138
Charlotte, North Carolina, 28207, United States
Wake Forest Baptist Medical Center /ID# 206067
Winston-Salem, North Carolina, 27157-0001, United States
Duplicate_Plains Clinical Research Center, LLC /ID# 205111
Fargo, North Dakota, 58104, United States
University of Cincinnati /ID# 205633
Cincinnati, Ohio, 45267-0585, United States
The Ohio State University /ID# 205637
Columbus, Ohio, 43210, United States
Optimed Research, Ltd. /ID# 205638
Columbus, Ohio, 43235, United States
Hometown Urgent Care and Resea /ID# 205630
Dayton, Ohio, 45424, United States
Dayton Gastroenterology, Inc. /ID# 205639
Englewood, Ohio, 45415, United States
Great Lakes Gastroenterology Research LLC /ID# 205631
Mentor, Ohio, 44060-6211, United States
Hightower Clinical /ID# 216336
Oklahoma City, Oklahoma, 73102, United States
Digestive Disease Specialists /ID# 206076
Oklahoma City, Oklahoma, 73112, United States
Options Health Research, LLC /ID# 206707
Tulsa, Oklahoma, 74104, United States
Healthcare Research Consultant /ID# 206706
Tulsa, Oklahoma, 74135, United States
Guthrie Medical Group, PC /ID# 206078
Sayre, Pennsylvania, 18840, United States
Pharmacorp Clinical Trials /ID# 206074
Charleston, South Carolina, 29412, United States
Gastroenterology Associates, P.A. of Greenville /ID# 206098
Greenville, South Carolina, 29615-3593, United States
Gastro One /ID# 206178
Germantown, Tennessee, 38138, United States
East Tennessee Research Institute /ID# 206169
Johnson City, Tennessee, 37604, United States
Quality Medical Research /ID# 206088
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center /ID# 210405
Nashville, Tennessee, 37232-0011, United States
TX Clinical Research Institute /ID# 206718
Arlington, Texas, 76012, United States
Inquest Clinical Research /ID# 206132
Baytown, Texas, 77521, United States
Texas Digestive Disease Consultants /ID# 209805
Cedar Park, Texas, 78613-5028, United States
Texas Digestive Disease Consultants /ID# 209948
Cedar Park, Texas, 78613-5028, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484
Dallas, Texas, 75246, United States
DHAT Research Institute /ID# 206716
Garland, Texas, 75044-2208, United States
Vilo Research Group Inc /ID# 212625
Houston, Texas, 77017-2337, United States
Baylor College of Medicine - Baylor Medical Center /ID# 206717
Houston, Texas, 77030-3411, United States
Centex Studies, Inc. - Houston /ID# 206168
Houston, Texas, 77058, United States
GI Specialists of Houston /ID# 206090
Houston, Texas, 77070-4347, United States
Caprock Gastro Research /ID# 215115
Lubbock, Texas, 79424-3017, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 206710
San Antonio, Texas, 78212, United States
Southern Star Research Institute, LLC /ID# 205379
San Antonio, Texas, 78229-5390, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 206096
Temple, Texas, 76508, United States
Duplicate_Tyler Research Institue /ID# 206075
Tyler, Texas, 75701, United States
Gastro Health & Nutrition - Victoria /ID# 205378
Victoria, Texas, 77904, United States
Advanced Research Institute /ID# 206133
Ogden, Utah, 84403, United States
Ctr for Gastrointestinal Healt /ID# 208475
Franklin, Virginia, 23851, United States
Washington Gastroenterology Associates /ID# 206177
Bellevue, Washington, 98004, United States
Virginia Mason - Seattle Orthapedics /ID# 206070
Seattle, Washington, 98101, United States
The Vancouver Clinic, INC. PS /ID# 204973
Vancouver, Washington, 98664, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917
Milwaukee, Wisconsin, 53215, United States
Froedtert Memorial Lutheran Hospital /ID# 206945
Milwaukee, Wisconsin, 53226-3522, United States
Cardio Alem /ID# 211282
San Isidro, Buenos Aires, 1642, Argentina
Mautalen Salud e Investigacion /ID# 206033
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1128, Argentina
Hospital Britanico de Buenos Aires /ID# 209497
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1280, Argentina
Gedyt /ID# 210017
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1426, Argentina
Hospital Privado Univesitario /ID# 206030
Córdoba, 5016, Argentina
Macquarie University Hospital /ID# 211955
Macquarie University, New South Wales, 2109, Australia
Duplicate_Mater Misericordiae /ID# 212687
South Brisbane, Queensland, 4101, Australia
Griffith University /ID# 211956
Southport, Queensland, 4222, Australia
St Vincent's Hospital Melbourne /ID# 205758
Fitzroy, Victoria, 3065, Australia
Monash Medical Centre /ID# 206486
Melbourne, Victoria, 3168, Australia
Fiona Stanley Hospital /ID# 211642
Murdoch, Western Australia, 6150, Australia
Klinik Landstrasse /ID# 205764
Vienna, Vienna, 1030, Austria
Medical University of Vienna /ID# 205763
Vienna, Vienna, 1090, Austria
LKH Salzburg and Paracelsus /ID# 208788
Salzburg, 5020, Austria
Universitair Ziekenhuis Leuven /ID# 205988
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Maria Middelares /ID# 210928
Ghent, 9000, Belgium
University Clinical Centre of the Republic of Srpska /ID# 208053
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 208055
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 208057
Tuzla, Tuzlanski, 75000, Bosnia and Herzegovina
University Clinical Hospital Mostar /ID# 208054
Mostar, 88000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 208058
Sarajevo, 71000, Bosnia and Herzegovina
Hospital Nossa Senhora das Graças /ID# 206981
Curitiba, Paraná, 80810-040, Brazil
Hospital de Clinicas de Porto Alegre /ID# 206985
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Upeclin Fmb - Unesp /Id# 206986
Botucatu, São Paulo, 18618-686, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504
Ribeirão Preto, São Paulo, 14051-140, Brazil
Faculdade de Medicina do ABC /ID# 206984
Santo André, São Paulo, 09060-870, Brazil
Kaiser Clinica e Hospital Dia /ID# 206982
São José do Rio Preto, São Paulo, 15015-110, Brazil
University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755
Calgary, Alberta, T2N 4Z6, Canada
Allen Whey Khye Lim Professional Corporation /ID# 211167
Edmonton, Alberta, T5R 1W2, Canada
Covenant Health /ID# 205500
Edmonton, Alberta, T6K 4B2, Canada
Percuro Clinical Research, Ltd /ID# 205501
Victoria, British Columbia, V8V 3M9, Canada
Duplicate_Toronto Digestive Disease Asso /ID# 205498
Vaughan, Ontario, L4L 4Y7, Canada
Crchum /Id# 207387
Montreal, Quebec, H2X 0A9, Canada
CIUSSS de l'Estrie - CHUS /ID# 205499
Sherbrooke, Quebec, J1G 2E8, Canada
Research Group /ID# 208037
Santiago, Santiago Metropolitan, 2540364, Chile
M y F Estudios Clínicos Ltda. /ID# 208035
Santiago, Santiago Metropolitan, 7750495, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 212426
Concepción, 4070038, Chile
CTR Estudios Clinicos /ID# 208036
Providencia, 7500571, Chile
Hospital Clinico Universidad De Los Andes /ID# 207426
Santiago, 7501504, Chile
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267
Guangzhou, Guangdong, 510120, China
The Sixth Affiliated Hosp Sun /ID# 205268
Guangzhou, Guangdong, 510655, China
Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406
Shiyan, Hubei, 442700, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266
Wuhan, Hubei, 430022, China
The First Affiliated Hospital of Nanchang University /ID# 212186
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University /ID# 210088
Changchun, Jilin, 130021, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333
Shanghai, Shanghai Municipality, 200025, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271
Hangzhou, Zhejiang, 310009, China
West China Hospital, Sichuan University /ID# 205332
Chengdu, 610041, China
Duplicate_Tianjin Med Univ General Hosp /ID# 205246
Tianjin, 300052, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265
Wuhan, 430030, China
Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886
Bogota DC, Cundinamarca, 111221, Colombia
Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887
Montería, Departamento de Córdoba, 230002, Colombia
Hospital Universitario San Vic /ID# 208888
Medellín, 50010, Colombia
Klinicka bolnica Dubrava Zagreb /ID# 208460
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 211568
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Rijeka /ID# 208650
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki bolnicki centar Split /ID# 217027
Split, 21000, Croatia
Hepato-Gastroenterologie HK, s.r.o. /ID# 205672
Hradec Králové, 500 12, Czechia
CTCenter MaVe s.r.o. /ID# 205671
Olomouc, 779 00, Czechia
Artroscan s.r.o. /ID# 205668
Ostrava, 722 00, Czechia
Nemocnice Pardubickeho kraje, a.s. /ID# 213540
Pardubice, 530 03, Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223
Prague, 118 33, Czechia
Axon Clinical, s.r.o. /ID# 205670
Prague, 140 00, Czechia
ISCARE a.s. /ID# 209240
Prague, 190 00, Czechia
East Tallinn Central Hospital /ID# 207564
Tallinn, Harju, 10138, Estonia
West Tallinn Central Hospital /ID# 207356
Tallinn, 10617, Estonia
North Estonia Medical Centre /ID# 207357
Tallinn, 13419, Estonia
Tartu University Hospital /ID# 212282
Tartu, 51014, Estonia
Tampere University Hospital /ID# 206161
Tampere, Pirkanmaa, 33520, Finland
Keski-Suomen Sairaala Nova /ID# 206159
Jyväskylä, 40620, Finland
Laakarikeskus Ikioma /ID# 205814
Mikkeli, 50100, Finland
Tyks /Id# 205813
Turku, 20521, Finland
Chu de Nice-Hopital L'Archet Ii /Id# 209118
Nice, Alpes-Maritimes, 06202, France
Centre Hospitalier Lyon Sud /ID# 209121
Pierre-Bénite, Rhone, 69495, France
Universitatsklinikum Mannheim /ID# 206811
Mannheim, Baden-Wurttemberg, 68167, Germany
Duplicate_Universitaetsklinikum Tuebingen /ID# 206737
Tübingen, Baden-Wurttemberg, 72076, Germany
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576
Herne, North Rhine-Westphalia, 44623, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813
Saarbrücken, Saarland, 66111, Germany
Duplicate_Praxis am Bayrischen Platz /ID# 206733
Berlin, 10825, Germany
Agaplesion Markus Krankenhaus /ID# 206731
Frankfurt am Main, 60431, Germany
Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791
Kiel, 24105, Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 207137
Münster, 48155, Germany
General Hospital of Athens Laiko /ID# 208671
Athens, Attica, 11527, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 207061
Heraklion, Crete, 711 10, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332
Athens, 10676, Greece
Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822
Thessaloniki, 54642, Greece
Bekes Megyei Kozponti Korhaz /ID# 205885
Békéscsaba, 5600, Hungary
Semmelweis Egyetem /ID# 205883
Budapest, 1085, Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992
Sopron, 9400, Hungary
Mentahaz Maganorvosi Kozpont /ID# 205882
Székesfehérvár, 8000, Hungary
Beaumont Hospital /ID# 206509
Dublin, D09 XR63, Ireland
University Hospital Galway /ID# 218035
Galway, H91 YR71, Ireland
Rambam Health Care Campus /ID# 206362
Haifa, 3109601, Israel
Shaare Zedek Medical Center /ID# 206365
Jerusalem, 91031, Israel
A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351
Bologna, Emilia-Romagna, 40138, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611
Rho, Milano, 20017, Italy
Istituto Clinico Humanitas /ID# 206346
Rozzano, Milano, 20089, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347
Rome, Roma, 00168, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354
Negrar, Verona, 37024, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349
Milan, 20122, Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350
Palermo, 90146, Italy
Nagoya University Hospital /ID# 206355
Nagoya, Aichi-ken, 4668560, Japan
Nagoya City University Hospital /ID# 206058
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital /ID# 207625
Toyohashi, Aichi-ken, 441-8570, Japan
Ieda Hospital /ID# 207479
Toyota-shi, Aichi-ken, 470-1219, Japan
Hirosaki National Hospital /ID# 206387
Hirosaki-shi, Aomori, 036-8545, Japan
Tokatsu Tsujinaka Hospital /ID# 214963
Abiko-shi, Chiba, 270-1168, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209573
Kashiwa-shi, Chiba, 277-0871, Japan
Toho University Medical Center Sakura Hospital /ID# 207705
Sakura-shi, Chiba, 285-8741, Japan
Juntendo University Urayasu Hospital /ID# 208784
Urayasu-shi, Chiba, 279-0021, Japan
Fukui Prefectural Hospital /ID# 210449
Fukui-shi, Fukui, 910-8526, Japan
Fukuoka University Chikushi Hospital /ID# 214405
Chikushino-shi, Fukuoka, 818-8502, Japan
Saiseikai Fukuoka Genaral Hospital /ID# 209482
Fukuoka, Fukuoka, 810-0001, Japan
Kurume University Hospital /ID# 206385
Kurume-shi, Fukuoka, 830-0011, Japan
Ogaki Municipal Hospital /ID# 208227
Ogaki-shi, Gifu, 503-8502, Japan
NHO Fukuyama Medical Center /ID# 206295
Fukuyama-shi, Hiroshima, 720-8520, Japan
Hiroshima University Hospital /ID# 206464
Hiroshima, Hiroshima, 734-8551, Japan
Asahikawa Medical University Hospital /ID# 206404
Midorigaokahiga-shi, Hokkaido, 078-8510, Japan
Obihiro kosei Hospital /ID# 210424
Obihiro-shi, Hokkaido, 080-0024, Japan
Sapporo Tokushukai Hospital /ID# 209448
Sapporo, Hokkaido, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059
Sapporo, Hokkaido, 060-0033, Japan
Sapporo Medical University Hospital /ID# 206314
Sapporo, Hokkaido, 060-8543, Japan
Sapporo Higashi Tokushukai Hospital /ID# 208494
Sapporo, Hokkaido, 065-0033, Japan
Aoyama Clinic /ID# 206452
Kobe, Hyōgo, 650-0015, Japan
Hyogo College of Medicine Hospital /ID# 206455
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Kanazawa University Hospital /ID# 206316
Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate Medical University Uchimaru Medical Center /ID# 207051
Morioka, Iwate, 020-8505, Japan
Idzuro Imamura Hospital /ID# 207639
Kagoshima, Kagoshima-ken, 892-0824, Japan
Sameshima Hospital /ID# 207935
Kagoshima, Kagoshima-ken, 892-0846, Japan
St. Marianna University School of Medicine Hospital /ID# 209451
Kawasaki-shi, Kanagawa, 216-8511, Japan
Showa University Fujigaoka Hospital /ID# 208224
Yokohama, Kanagawa, 227-8501, Japan
Kyoto University Hospital /ID# 211809
Kyoto, Kyoto, 606-8507, Japan
Mie University Hospital /ID# 206803
Tsu, Mie-ken, 514-8507, Japan
Yokkaichi Hazu Medical Center /ID# 214348
Yokkaichi-shi, Mie-ken, 510-0016, Japan
National Hospital Organization Sendai Medical Center /ID# 209528
Sendai, Miyagi, 983-8520, Japan
NHO Nagasaki Medical Center /ID# 210822
Omura-shi, Nagasaki, 856-8562, Japan
Kenseikai Dongo Hospital /ID# 208101
Yamatotakada-shi, Nara, 635-0022, Japan
Saiseikai Niigata Hospital /ID# 209921
Niigata, Niigata, 950-1104, Japan
Niigata University Medical & Dental Hospital /ID# 218049
Niigata, Niigata, 951-8520, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 210119
Ōita, Oita Prefecture, 870-0823, Japan
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646
Kurashiki-shi, Okayama-ken, 710-0142, Japan
Okayama University Hospital /ID# 217925
Okayama, Okayama-ken, 700-8558, Japan
Kinshukai Infusion Clinic /ID# 207865
Osaka, Osaka, 530-0011, Japan
Kitano Hospital /ID# 210397
Osaka, Osaka, 530-8480, Japan
Japanese Red Cross Osaka Hospital /ID# 209478
Osaka, Osaka, 543-8555, Japan
Osaka City University Hospital /ID# 206457
Osaka, Osaka, 545-8586, Japan
Toyonaka Municipal Hospital /ID# 217082
Toyonaka-shi, Osaka, 560-0055, Japan
Saga University Hospital /ID# 209270
Saga, Saga-ken, 849-8501, Japan
Saitama Medical Center /ID# 206393
Kawagoe-shi, Saitama, 350-8550, Japan
Tokitokai Tokito clinic /ID# 206313
Saitama-shi, Saitama, 336-0963, Japan
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710
Higashi-ohmi-shi, Shiga, 527-8505, Japan
Shimane University School of Medicine /ID# 208905
Izumo-shi, Shimane, 693-0021, Japan
Hamamatsu University Hospital /ID# 206459
Hamamatsu, Shizuoka, 431-3192, Japan
NHO Shizuoka Medical Center /ID# 208785
Sunto-gun, Shizuoka, 411-8611, Japan
Tokyo Medical And Dental University, Medical Hospital /ID# 206453
Bunkyo-ku, Tokyo, 113-8519, Japan
St.Luke's International Hospital /ID# 208076
Chuo-ku, Tokyo, 104-8560, Japan
Tokai University Hachioji Hospital /ID# 208903
Hachioji-shi, Tokyo, 192-0032, Japan
Teikyo University Hospital /ID# 209866
Itabashi-ku, Tokyo, 173-8606, Japan
Center Hospital of the National Center for Global Health and Medicine /ID# 209532
Shinjuku-ku, Tokyo, 162-8655, Japan
Tokyo Women's Medical University Hospital /ID# 206460
Shinjuku-ku, Tokyo, 162-8666, Japan
Yamagata University Hospital /ID# 206465
Yamagata, Yamagata, 990-9585, Japan
Tokuyama Central Hospital /ID# 216994
Shunan-shi, Yamaguchi, 745-8522, Japan
Shoyukai Fujita Gastroenterological Hospital /ID# 216493
Takatsuki-shi, 569-0086, Japan
Riga East Clinical Univ Hosp /ID# 206828
Riga, 1038, Latvia
P. Stradins Clinical Univ Hosp /ID# 206827
Riga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052
Kaunas, 50161, Lithuania
Klaipeda Seamens Hospital /ID# 208791
Klaipėda, 92288, Lithuania
Klaipeda University Hospital /ID# 208790
Klaipėda, 92288, Lithuania
Vilnius University Hospital /ID# 209051
Vilnius, LT-08661, Lithuania
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662
Kuala Lumpur, Selangor, 56000, Malaysia
Duplicate_Uni Malaya MC /ID# 208936
Kuala Lumpur, 59100, Malaysia
Morales Vargas Centro de Investigacion S.C. /ID# 211326
León, Guanajuato, 37000, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068
Guadalajara, Jalisco, 44650, Mexico
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067
Monterrey, Nuevo León, 64610, Mexico
Erasmus Medisch Centrum /ID# 205280
Rotterdam, 3015 GD, Netherlands
Akershus Universitetssykehus_MAIN /ID# 205293
Lorenskog, Akershus, 1478, Norway
Universitetssykehuset Nord-Norge /ID# 205691
Tromsø, Troms, 9019, Norway
Gastromed /Id# 216108
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Zdrowia MDM /ID# 205874
Warsaw, Masovian Voivodeship, 00-635, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 212913
Warsaw, Masovian Voivodeship, 02-691, Poland
NZOZ Vivamed /ID# 216697
Warsaw, Masovian Voivodeship, 03-580, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070
Warsaw, Masovian Voivodeship, 04-730, Poland
Endoskopia Sp. z o.o. /ID# 212964
Sopot, Pomeranian Voivodeship, 81-756, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554
Guimarães, Braga District, 4835-044, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 205563
Santa Maria DA Feira, Porto District, 4520-211, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Hospital Garcia de Orta, EPE /ID# 206143
Almada, 2805-267, Portugal
CCA Braga - Hospital de Braga /ID# 206144
Braga, 4710-243, Portugal
Hospital Santo Antonio dos Cap /ID# 206145
Lisbon, 1150-069, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142
Porto, 4200-319, Portugal
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626
San Juan, 00935, Puerto Rico
Immanuel Kant Baltic Federal University /ID# 208264
Kaliningrad, Kaliningrad Oblast, 236016, Russia
NW State Medical Univ na Mechn /ID# 208258
Saint Petersburg, Leningradskaya Oblast', 191015, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653
Perm, Permskiy Kray, 614109, Russia
Medical Company Hepatolog /ID# 208261
Samara, Samara Oblast, 443063, Russia
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652
Stavropol, Stavropol Kray, 355012, Russia
Kazan State Medical University /ID# 208256
Kazan', Tatarstan, Respublika, 420012, Russia
Olla-Med Clinic /ID# 215335
Moscow, 105554, Russia
Republican hospital named after V.A. Baranov /ID# 206507
Petrozavodsk, 185019, Russia
Euromedservice /ID# 208265
Pushkin, 196603, Russia
LLC Novaya Clinica /ID# 208260
Pyatigorsk, 357532, Russia
Clinical Hosp Center Zvezdara /ID# 205258
Belgrade, Beograd, 11000, Serbia
Military Medical Academy /ID# 205257
Belgrade, Beograd, 11000, Serbia
University Clinical Center Serbia /ID# 205256
Belgrade, Beograd, 11000, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 206413
Belgrade, Beograd, 11080, Serbia
University Clinical Center of Nis /ID# 206411
Niš, Nisavski Okrug, 18000, Serbia
University Clinical Center Kragujevac /ID# 206410
Kragujevac, Sumadijski Okrug, 34000, Serbia
Clinical Center Vojvodina /ID# 205259
Novi Sad, Vojvodina, 21000, Serbia
General Hospital Leskovac /ID# 217881
Leskovac, 16000, Serbia
National University Hospital /ID# 209099
Singapore, 119074, Singapore
Gleneagles Medical Centre /ID# 206954
Singapore, 258499, Singapore
Tan Tock Seng Hospital /ID# 207663
Singapore, 308433, Singapore
Medak s.r.o. /ID# 205191
Bratislava, Bratislava Region, 851 01, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147
Banská Bystrica, 975 17, Slovakia
B+B MED, s.r.o. /ID# 205213
Košice, 040 01, Slovakia
Fakultna nemocnica s poliklini /ID# 211372
Nové Zámky, 940 34, Slovakia
GASTRO I., s.r.o. /ID# 205148
Prešov, 080 01, Slovakia
MD Search /ID# 208084
Boksburg North, Gauteng, 1460, South Africa
Clinresco Centers /ID# 208083
Johannesburg, Gauteng, 1619, South Africa
Lenasia Clinical Trial Centre /ID# 214359
Johannesburg, Gauteng, 1820, South Africa
Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082
Johannesburg, Gauteng, 2193, South Africa
Wits Clinical Research Site /ID# 208949
Johannesburg, Gauteng, 2193, South Africa
Kingsbury Hospital /ID# 205281
Cape Town, Western Cape, 7708, South Africa
Private Practice Dr MN Rajabally /ID# 205273
Cape Town, Western Cape, 7800, South Africa
Mediclinic Milnerton /ID# 207979
CAPE TOWN Milnerton, Western Cape, 7441, South Africa
Kangbuk Samsung Hospital /ID# 206960
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Dong-A University Hospital /ID# 206955
Busan, 49201, South Korea
Pusan National University Hospital /ID# 206956
Busan, 49241, South Korea
Yeungnam University Medical Center /ID# 206959
Daegu, 42415, South Korea
Duplicate_CHA Bundang Medical Center /ID# 207432
Seongnam-si, Gyeonggi-do, 13496, South Korea
Yonsei University Health System, Severance hospital /ID# 206958
Seoul, 03722, South Korea
Hospital Clínico Universitario de Santiago-CHUS /ID# 204411
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Unversitario Marques de Valdecilla /ID# 216622
Santander, Cantabria, 39008, Spain
Hospital Universitario Dr. Negrin /ID# 206905
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario A Coruna - CHUAC /ID# 206907
A Coruña, 15006, Spain
Hospital Clinic de Barcelona /ID# 206906
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia /ID# 204412
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal /ID# 204410
Madrid, 28034, Spain
Hospital Universitario La Paz /ID# 214540
Madrid, 28046, Spain
Hospital Clinico Universitario de Salamanca /ID# 205013
Salamanca, 37007, Spain
Hospital Universitario y Politecnico La Fe /ID# 206904
Valencia, 46026, Spain
Kantonsspital St. Gallen /ID# 211310
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Universitaetsspital Basel /ID# 211381
Basel, 4031, Switzerland
Inselspital, Universitaetsklinik /ID# 211312
Bern, 3010, Switzerland
Universitaetsspital Zuerich /ID# 211308
Zurich, 8091, Switzerland
China Medical University Hosp /ID# 207845
Taichung, Taichung, 40447, Taiwan
National Taiwan University Hospital /ID# 207847
Taipei City, Taipei, 100, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848
Kaohsiung City, 80708, Taiwan
Taipei Veterans General Hosp /ID# 207849
Taipei, 11217, Taiwan
Erciyes University Medical Fac /ID# 207506
Melikgazi, Kayseri, 38030, Turkey (Türkiye)
Gazi University Med. Faculty /ID# 208040
Ankara GAZI, 06500, Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507
Istanbul, 34098, Turkey (Türkiye)
Umraniye Training and Res Hosp /ID# 208206
Istanbul, 34764, Turkey (Türkiye)
Mersin University Medical /ID# 208039
Mersin, 33343, Turkey (Türkiye)
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939
Kharkiv, Kharkivs’ka Oblast’, 61204, Ukraine
Kyiv Regional Hospital /ID# 217373
Kyiv, Kyivska Oblast, 04073, Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 217218
Kropyvnytskyi, 25006, Ukraine
Medical centre of CONSILIUM MEDICAL LLC /ID# 217447
Kyiv, 04050, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300
Vinnytsia, 21018, Ukraine
Basingstoke & North Hampshire /ID# 207985
Basingstoke, RG24 9NA, United Kingdom
Queen Elizabeth University Hos /ID# 205154
Glasgow, G514TF, United Kingdom
Huddersfield Royal Infirmary /ID# 217660
Huddersfield, HD3 3EA, United Kingdom
St. George's Healthcare NHS /ID# 208375
London, SW17 0QT, United Kingdom
Barts and the London NHS Trust /ID# 205153
Whitechapel, E1 1 BB, United Kingdom
Related Publications (9)
Vermeire S, Colombel JF, Danese S, Panaccione R, Peyrin-Biroulet L, Beck K, Chaparro M, Gisbert JP, Dubcenco E, Klaff J, Naling G, Ford S, Remple V, Joshi N, Suravaram S, Duncan B, Wang Y, Wick-Urban B, Loftus EV. Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease. J Crohns Colitis. 2026 Jan 9;20(1):jjaf198. doi: 10.1093/ecco-jcc/jjaf198.
PMID: 41264726DERIVEDPanes 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: 37942921DERIVEDDanese 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: 35644166DERIVED
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 3
- 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
August 28, 2018
First Posted
August 31, 2018
Study Start
December 6, 2018
Primary Completion
January 14, 2021
Study Completion
January 14, 2021
Last Updated
March 2, 2022
Results First Posted
November 26, 2021
Record last verified: 2022-02
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.