A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
NCT ID: NCT03345836
Last Updated: 2022-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
624 participants
INTERVENTIONAL
2017-11-29
2021-08-11
Brief Summary
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A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1 (Double-blind): Placebo
Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Matching Placebo for Upadacitinib
Matching placebo tablets
Part 1 (Double-blind): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Upadacitinib
Upadacitinib tablets
Part 2 (Open-label): Upadacitinib 45 mg
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Upadacitinib
Upadacitinib tablets
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo
Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Upadacitinib
Upadacitinib tablets
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Upadacitinib
Upadacitinib tablets
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg
Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
Upadacitinib
Upadacitinib tablets
Interventions
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Matching Placebo for Upadacitinib
Matching placebo tablets
Upadacitinib
Upadacitinib tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
* Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
* Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
* If female, participant must meet the contraception recommendations.
Exclusion Criteria
* Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
* Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
* Participant with ostomy or ileoanal pouch.
* Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
* Screening laboratory and other protocol pre-specified analyses show abnormal results.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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East View Medical Research, LLC /ID# 171133
Mobile, Alabama, United States
CB Flock Research Corporation /ID# 166220
Mobile, Alabama, United States
Delsol Research Management, Ll /Id# 170179
Chandler, Arizona, United States
HonorHealth Research Institute - Shea /ID# 164734
Scottsdale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891
Sun City, Arizona, United States
Southern California Res. Ctr. /ID# 169654
Coronado, California, United States
Citrus Valley Gastroenterology /ID# 166201
Covina, California, United States
United Medical Doctors /ID# 207452
Los Alamitos, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887
Los Angeles, California, United States
Facey Medical Foundation /ID# 203137
Mission Hills, California, United States
United Medical Doctors - Murrieta /ID# 164845
Murrieta, California, United States
Ucsd /Id# 164679
San Diego, California, United States
Medical Assoc Research Grp /ID# 169705
San Diego, California, United States
UCSF Center for Colitis and Crohn's Disease /ID# 202373
San Francisco, California, United States
Univ of California San Francis /ID# 164843
San Francisco, California, United States
Care Access Research /ID# 167766
San Pablo, California, United States
Peak Gastroenterology Associates, PC /ID# 170181
Colorado Springs, Colorado, United States
Delta Waves, Inc. /ID# 164872
Colorado Springs, Colorado, United States
Duplicate_Western States Clinical Research, Inc. /ID# 164895
Wheat Ridge, Colorado, United States
Medical Research Center of CT /ID# 164829
Hamden, Connecticut, United States
Clinical Research of West Florida, Inc /ID# 205825
Clearwater, Florida, United States
Clinical Research of West Florida, Inc /ID# 208117
Clearwater, Florida, United States
Advanced Research - Coral Springs /ID# 218020
Coral Springs, Florida, United States
Encore Borland-Groover Clinical Research /Id# 203498
Jacksonville, Florida, United States
Ctr for Advanced Gastroenterol /ID# 165332
Maitland, Florida, United States
Crystal Pharmacology Research /ID# 166101
Miami, Florida, United States
Coral Research Clinic /ID# 164657
Miami, Florida, United States
Advanced Research Institute, Inc /ID# 164814
New Port Richey, Florida, United States
Endoscopic Research, Inc. /ID# 205893
Orlando, Florida, United States
Omega Research Maitland, LLC /ID# 203480
Orlando, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 203484
Tampa, Florida, United States
AdventHealth Tampa /ID# 171175
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 165460
Macon, Georgia, United States
Gastroenterology Consultants PC - Roswell /ID# 218219
Roswell, Georgia, United States
Atlanta Gastroenterology Spec /ID# 164780
Suwanee, Georgia, United States
University of Chicago Medicine /ID# 165472
Chicago, Illinois, United States
DuPage Medical Group /ID# 205303
Downers Grove, Illinois, United States
MediSphere Medical Research Center /ID# 166209
Evansville, Indiana, United States
Indianapolis Gastroenterology /ID# 164837
Indianapolis, Indiana, United States
Aquiant Research /ID# 205504
New Albany, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 165330
Iowa City, Iowa, United States
Tri-State Gastroenterology /ID# 165484
Crestview Hills, Kentucky, United States
University of Louisville /ID# 168536
Louisville, Kentucky, United States
University of Louisville /ID# 208093
Louisville, Kentucky, United States
CroNOLA, LLC /ID# 164722
Houma, Louisiana, United States
Nola Research Works, LLC /ID# 164897
New Orleans, Louisiana, United States
Louisana Research Center, LLC /ID# 164659
Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine /ID# 211940
Baltimore, Maryland, United States
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835
Chevy Chase, Maryland, United States
Gastro Center of Maryland /ID# 171171
Columbia, Maryland, United States
Lahey Hospital and Medical Center /ID# 214725
Burlington, Massachusetts, United States
University of Michigan Health Systems /ID# 164844
Ann Arbor, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 170178
Chesterfield, Michigan, United States
Digestive Health Associates (DHA) - Farmington Hills /ID# 206099
Farmington Hills, Michigan, United States
Center for Digestive Health /ID# 164733
Troy, Michigan, United States
Mayo Clinic - Rochester /ID# 164868
Rochester, Minnesota, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 165318
Jackson, Mississippi, United States
Quality Clinical Research Inc. /ID# 170177
Omaha, Nebraska, United States
CHI Health Research Center /ID# 168545
Omaha, Nebraska, United States
Las Vegas Medical Research /ID# 168562
Las Vegas, Nevada, United States
AGA Clinical Research Associates, LLC /ID# 164883
Egg Harbor, New Jersey, United States
Rutgers Robert Wood Johnson /ID# 166092
New Brunswick, New Jersey, United States
NY Scientific /ID# 164833
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates /ID# 164830
Lake Success, New York, United States
The Mount Sinai Hospital /ID# 170172
New York, New York, United States
Columbia Univ Medical Center /ID# 164870
New York, New York, United States
Gastro Group of Rochester /ID# 166216
Rochester, New York, United States
Richmond University Medical Center /ID# 201855
Staten Island, New York, United States
Montefiore Medical Center - Moses Campus /ID# 166226
The Bronx, New York, United States
Advantage Clinical Trials /ID# 168557
The Bronx, New York, United States
Atrium Health Carolinas Medical Center /ID# 164834
Charlotte, North Carolina, United States
PMG Research of Charlotte /ID# 171170
Charlotte, North Carolina, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663
Raleigh, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 201225
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 170184
Fargo, North Dakota, United States
Consultants for Clinical Research /ID# 164855
Cincinnati, Ohio, United States
University of Cincinnati /ID# 164720
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 208220
Cleveland, Ohio, United States
The Ohio State University /ID# 170174
Columbus, Ohio, United States
Optimed Research, Ltd. /ID# 205618
Columbus, Ohio, United States
Hometown Urgent Care and Resea /ID# 201290
Dayton, Ohio, United States
Dayton Gastroenterology, Inc. /ID# 167624
Englewood, Ohio, United States
Great Lakes Medical Research, LLC /ID# 202007
Mentor, Ohio, United States
Digestive Disease Specialists /ID# 201062
Oklahoma City, Oklahoma, United States
Options Health Research, LLC /ID# 164737
Tulsa, Oklahoma, United States
Healthcare Research Consultant /ID# 166228
Tulsa, Oklahoma, United States
University of Pennsylvania /ID# 168402
Philadelphia, Pennsylvania, United States
Thomas Jefferson University /ID# 168014
Philadelphia, Pennsylvania, United States
Pharmacorp Clinical Trials /ID# 164809
Charleston, South Carolina, United States
Gastroenterology Associates, P.A. of Greenville /ID# 164880
Greenville, South Carolina, United States
Rapid City Medical Center - GI Research /ID# 201734
Rapid City, South Dakota, United States
Gastro One /ID# 164718
Germantown, Tennessee, United States
East Tennessee Research Institute /ID# 203612
Johnson City, Tennessee, United States
Quality Medical Research /ID# 205262
Nashville, Tennessee, United States
Vanderbilt University Medical Center /ID# 164846
Nashville, Tennessee, United States
TX Clinical Research Institute /ID# 164848
Arlington, Texas, United States
Inquest Clinical Research /ID# 164865
Baytown, Texas, United States
Texas Digestive Disease Consultants /ID# 209952
Cedar Park, Texas, United States
Texas Digestive Disease Consultants /ID# 209802
Cedar Park, Texas, United States
CliniCore International, LLC /ID# 164662
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 164847
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 201213
Houston, Texas, United States
GI Specialists of Houston /ID# 202338
Houston, Texas, United States
Caprock Gastro Research /ID# 215437
Lubbock, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 164863
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 169754
San Antonio, Texas, United States
Carl R. Meisner Medical Clinic /ID# 201060
Sugar Land, Texas, United States
Tyler Research Institute, LLC /ID# 168681
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 167813
Victoria, Texas, United States
HP Clinical Research /ID# 164929
Bountiful, Utah, United States
Advanced Research Institute /ID# 164866
Ogden, Utah, United States
Duplicate_Care Access Research /ID# 164853
Salt Lake City, Utah, United States
Velocity Clinical Research - Salt Lake City /ID# 166095
West Jordan, Utah, United States
Washington Gastroenterology Associates /ID# 164721
Bellevue, Washington, United States
Virginia Mason - Seattle Orthapedics /ID# 164680
Seattle, Washington, United States
University of Washington /ID# 164875
Seattle, Washington, United States
The Vancouver Clinic, INC. PS /ID# 164811
Vancouver, Washington, United States
Froedtert Memorial Lutheran Hospital /ID# 202286
Milwaukee, Wisconsin, United States
Allegiance Research Specialists /ID# 165321
Wauwatosa, Wisconsin, United States
Cardio Alem /ID# 211284
San Isidro, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires /ID# 215543
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina
Gedyt /ID# 210019
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Cemic /Id# 169184
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Hospital Provincial del Centenario /ID# 171254
Rosario, Santa Fe Province, Argentina
Hospital Privado Univesitario /ID# 169228
Córdoba, , Argentina
Concord Repatriation General Hospital /ID# 171509
Concord, New South Wales, Australia
Coral Sea Clinical Research institute /ID# 212987
North Mackay, Queensland, Australia
Mater Misericordiae Limited /ID# 204908
South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 171511
Adelaide, South Australia, Australia
Box Hill Hospital /ID# 203734
Box Hill, Victoria, Australia
Fiona Stanley Hospital /ID# 171510
Murdoch, Western Australia, Australia
Klinik Landstrasse /ID# 203437
Vienna, Vienna, Austria
Medizinische Universitaet Wien /ID# 169462
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467
Salzburg, , Austria
UCL Saint-Luc /ID# 200297
Woluwe-Saint-Lambert, Brussels Capital, Belgium
CHU de Liege Sart Tilman /ID# 200299
Liège, Liege, Belgium
CHU UCL Namur - site Godinne /ID# 200300
Godinne, Namur, Belgium
Universitair Ziekenhuis Leuven /ID# 200298
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Lucas /ID# 200301
Ghent, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 208050
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 210324
Tuzla, Tuzlanski, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 203885
Sarajevo, , Bosnia and Herzegovina
Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841
Sarajevo, , Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870
Goiânia, Goiás, Brazil
Hospital Nossa Senhora das Graças /ID# 166869
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 166872
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin Fmb - Unesp /Id# 166876
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC /ID# 208327
Santo André, São Paulo, Brazil
Kaiser Clinica e Hospital Dia /ID# 166873
São José do Rio Preto, São Paulo, Brazil
UMHAT Kaspela EOOD /ID# 167617
Plovdiv, , Bulgaria
Duplicate_Second MHAT Sofia /ID# 167618
Sofia, , Bulgaria
MHAT Trakia /ID# 201678
Stara Zagora, , Bulgaria
University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 168041
Edmonton, Alberta, Canada
Covenant Health /ID# 166966
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 166957
New Westminster, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 166964
Vancouver, British Columbia, Canada
QEII - Health Sciences Centre /ID# 169306
Halifax, Nova Scotia, Canada
Medicor Research Inc /ID# 166967
Greater Sudbury, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 169064
North Bay, Ontario, Canada
Taunton Surgical Centre /ID# 168039
Oshawa, Ontario, Canada
The Ottawa Hospital /ID# 212413
Ottawa, Ontario, Canada
Toronto Digestive Disease Asso /ID# 166961
Vaughan, Ontario, Canada
CHAU- Hotel-Dieu de Levis /ID# 166958
Lévis, Quebec, Canada
Crchum /Id# 170121
Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Center /ID# 170010
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 170935
Sherbrooke, Quebec, Canada
M y F Estudios Clínicos /ID# 169995
Santiago, Region Metropolitana Santiago, Chile
Research Group /ID# 203180
Santiago, Santiago Metropolitan, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 212422
Concepción, , Chile
CTR Estudios Clinicos /ID# 200650
Providencia, , Chile
Hospital Clinico Universidad De Los Andes /ID# 207465
Santiago, , Chile
Zhongshan Hospital Xiamen University /ID# 204985
Fujian, Anhui, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226
Guangzhou, Guangdong, China
The Sixth Affiliated Hosp Sun /ID# 204049
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096
Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 204869
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 204070
Nanchang, Jiangxi, China
The First Hospital of Jilin University /ID# 206867
Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072
Shanghai, Shanghai Municipality, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068
Hangzhou, Zhejiang, China
Beijing Friendship Hospital /ID# 204536
Beijing, , China
The Second Hospital Central South University /ID# 204075
Changsha, , China
Nanfang Hospital of Southern Medical University /ID# 204074
Guangzhou, , China
Duplicate_Tianjin Med Univ General Hosp /ID# 206993
Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069
Wuhan, , China
Hospital Pablo Tobon Uribe /ID# 202405
Medellín, Antioquia, Colombia
Hospital San Vicente de Paul /ID# 200028
Medellín, Antioquia, Colombia
Clinical Hospital Dubrava /ID# 171186
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 171190
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 171201
Zagreb, City of Zagreb, Croatia
Poliklinika Solmed /ID# 211518
Zagreb, City of Zagreb, Croatia
UHC Split /ID# 171206
Split, , Croatia
Zadar General Hospital /ID# 205534
Zadar, , Croatia
Hepato-Gastroenterologie HK, s.r.o. /ID# 171566
Hradec Králové, , Czechia
ResTrial s.r.o. /ID# 208652
Prague, , Czechia
ARTROSCAN s.r.o. /ID# 171592
Třebovice, , Czechia
Nordsjaellands Hospital /ID# 200613
Frederikssund, Capital Region, Denmark
Herlev Hospital /ID# 200782
Herlev, Capital Region, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611
Hvidovre, Capital Region, Denmark
Duplicate_Sjaellands Universitets Hospital /ID# 200783
Roskilde, Region Sjælland, Denmark
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557
Cairo, , Egypt
National Hepatology and Tropical Medicine Research Institute /ID# 170990
Cairo, , Egypt
Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565
Cairo, , Egypt
Air Force Specialized Hospital /ID# 170995
Cairo, , Egypt
Tartu University Hospital /ID# 203140
Tartu, Tartu, Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 171009
Nice, Alpes-Maritimes, France
HCL - Hôpital Lyon Sud /ID# 171014
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHU Bordeaux - Hopital Haut Lévêque /ID# 207414
Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 206539
Lille, Hauts-de-France, France
Duplicate_Hopital Saint Eloi /ID# 170646
Montpellier, Herault, France
CHRU Nancy - Hôpitaux de Brabois /ID# 170985
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 171018
Saint Priest EN Jarez, Pays de la Loire Region, France
CHU Amiens-Picardie Site Sud /ID# 171016
Amiens, Somme, France
CHRU Tours - Hopital Trousseau /ID# 169786
Chambray-lès-Tours, , France
Duplicate_CHU Henri Mondor /ID# 169787
Créteil, , France
Polyclinique Grand Sud /ID# 170649
Nîmes, , France
CHU Toulouse - Hopital Rangueil /ID# 169785
Toulouse, , France
Hopital Beaujon /ID# 171011
Clichy, Île-de-France Region, France
Universitatsklinikum Mannheim /ID# 168778
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 203563
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 203551
Erlangen, Bavaria, Germany
Universitaetsklinikum Frankfurt /ID# 203565
Frankfurt am Main, Hesse, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740
Saarbrücken, Saarland, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067
Berlin, , Germany
Gastroenterologie am Mexikoplatz /ID# 203573
Berlin, , Germany
Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571
Essen, , Germany
Agaplesion Markus Krankenhaus /ID# 168777
Frankfurt am Main, , Germany
Universitaetsklinikum Halle (Saale) /ID# 207454
Halle, , Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 200213
Münster, , Germany
General Hospital of Athens Ippokratio /ID# 167036
Athens, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103
Athens, Attica, Greece
Tzaneio general hospital of Piraeus /ID# 206432
Piraeus, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 167035
Heraklion, Crete, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037
Athens, , Greece
Genl Hosp Thess Ippokrateio /ID# 208824
Thessaloniki, , Greece
Queen Mary Hospital /ID# 171217
Hong Kong, , Hong Kong
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bugat Pal Korhaz /ID# 201889
Gyöngyös, Heves County, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 201891
Budapest, Pest County, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720
Debrecen, , Hungary
Mentahaz Maganorvosi Kozpont /ID# 201890
Székesfehérvár, , Hungary
Mercy University Hospital /ID# 206510
Cork, , Ireland
Soroka University Medical Center /ID# 169912
Beersheba, Southern District, Israel
Tel Aviv Sourasky Medical Center /ID# 204876
Tel Aviv, Tel Aviv, Israel
Barzilai Medical Center /ID# 223372
Ashkelon, , Israel
Assaf Harofeh Medical Center /ID# 204870
Be’er Ya‘aqov, , Israel
Hadassah Medical Center-Hebrew University /ID# 169927
Jerusalem, , Israel
Rabin Medical Center /ID# 202635
Petah Tikva, , Israel
Kaplan Medical Center /ID# 170277
Rehovot, , Israel
University of Catanzaro /ID# 201920
Catanzaro, Calabria, Italy
Policlinico Universitario Campus Bio-Medico /ID# 168169
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 168170
Rome, Lazio, Italy
Istituto Clinico Humanitas /ID# 168171
Rozzano, Milano, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 168174
Rome, Roma, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172
Negrar, Verona, Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173
Bologna, , Italy
A.O. Per L'Emergenza Cannizzaro /ID# 168176
Catania, , Italy
Policlinico San Martino/Univer /ID# 168177
Genova, , Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 200008
Modena, , Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420
Pisa, , Italy
Aichi Medical University Hospital /ID# 165957
Nagakute-shi, Aichi-ken, Japan
Nagoya University Hospital /ID# 165955
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 165956
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital /ID# 200174
Toyohashi, Aichi-ken, Japan
Hirosaki National Hospital /ID# 165944
Hirosaki-shi, Aomori, Japan
Toho University Sakura Medical Center /ID# 165949
Sakura-shi, Chiba, Japan
Kurume University Hospital /ID# 166004
Kurume-shi, Fukuoka, Japan
National Hospital Organization Takasaki General Medical Center /ID# 167136
Takasaki-shi, Gunma, Japan
NHO Fukuyama Medical Center /ID# 167139
Fukuyama-shi, Hiroshima, Japan
Hiroshima University Hospital /ID# 166006
Hiroshima, Hiroshima, Japan
Asahikawa Medical University Hospital /ID# 167133
Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 167137
Sapporo, Hokkaido, Japan
Aoyama Clinic /ID# 166001
Kobe, Hyōgo, Japan
Hyogo College of Medicine College Hospital /Id# 200173
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 169215
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Uchimaru Medical Center /ID# 202407
Morioka, Iwate, Japan
Imamura General Hospital /ID# 227136
Kagoshima, Kagoshima-ken, Japan
Idzuro Imamura Hospital /ID# 206651
Kagoshima, Kagoshima-ken, Japan
Sameshima Hospital /ID# 206674
Kagoshima, Kagoshima-ken, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 169888
Kyoto, Kyoto, Japan
Yokkaichi Hazu Medical Center /ID# 167191
Yokkaichi-shi, Mie-ken, Japan
Tohoku University Hospital /ID# 167135
Sendai, Miyagi, Japan
Nara Medical University Hospital /ID# 169216
Kashihara-shi, Nara, Japan
Kenseikai Dongo Hospital /ID# 208103
Yamatotakada-shi, Nara, Japan
Niigata University Medical & Dental Hospital /ID# 170044
Niigata, Niigata, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 167134
Ōita, Oita Prefecture, Japan
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002
Kurashiki-shi, Okayama-ken, Japan
Okayama University Hospital /ID# 167355
Okayama, Okayama-ken, Japan
Kinshukai Infusion Clinic /ID# 218871
Osaka, Osaka, Japan
Osaka City University Hospital /ID# 166007
Osaka, Osaka, Japan
Osaka University Hospital /ID# 169662
Suita-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 206324
Takatsuki-shi, Osaka, Japan
Tokitokai Tokito clinic /ID# 165945
Saitama-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 167141
Ōtsu, Shiga, Japan
NHO Shizuoka Medical Center /ID# 167138
Sunto-gun, Shizuoka, Japan
Tokyo Medical And Dental University, Medical Hospital /ID# 165948
Bunkyo-ku, Tokyo, Japan
Duplicate_Tokai University Hachioji Hospital /ID# 165951
Hachioji-shi, Tokyo, Japan
The Jikei University Hospital /ID# 167142
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 165950
Mitaka-shi, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 205981
Shinjuku-ku, Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 217833
Toyama, Toyama, Japan
Japanese Red Cross Wakayama Medical Center /ID# 200638
Wakayama, Wakayama, Japan
Wakayama Medical University Hospital /ID# 169481
Wakayama, Wakayama, Japan
Yamagata University Hospital /ID# 200156
Yamagata, Yamagata, Japan
Pauls Stradins Clinical University Hospital /ID# 169493
Riga, , Latvia
Digestive Disease Center Gastro /ID# 169517
Riga, , Latvia
Riga East Clinical University Hospital /ID# 169496
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 203285
Vilnius, , Lithuania
Hospital Sultanah Bahiyah /ID# 202627
Alor Star, Kedah, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778
Kuala Lumpur, Selangor, Malaysia
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143
Durango, Durango, Mexico
Morales Vargas Centro de Investigacion S.C. /ID# 203495
León, Guanajuato, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779
Guadalajara, Jalisco, Mexico
Radboud Universitair Medisch Centrum /ID# 166925
Nijmegen, Gelderland, Netherlands
Zuyderland Medisch Centrum /ID# 169698
Heerlen, Limburg, Netherlands
Academisch Medisch Centrum /ID# 166924
Amsterdam, , Netherlands
Medisch Spectrum Twente /ID# 170297
Enschede, , Netherlands
Malopolskie Centrum Kliniczne /ID# 202166
Krakow, Lesser Poland Voivodeship, Poland
Vistamed /ID# 208570
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Zdrowia MDM /ID# 200486
Warsaw, Masovian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus /ID# 224300
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 200488
Warsaw, Masovian Voivodeship, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225
Guimarães, Braga District, Portugal
Hospital Egas Moniz /ID# 170249
Lisbon, Porto District, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606
Ponte de Lima, Viana do Castelo District, Portugal
Hospital Garcia de Orta, EPE /ID# 170234
Almada, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231
Porto, , Portugal
Mindful Medical Research /ID# 203357
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770
San Juan, , Puerto Rico
Institutul Clinic Fundeni /ID# 167826
Sector 2, București, Romania
Clinica GASTRO MED SRL /ID# 206367
Cluj-Napoca, Cluj, Romania
Cabinet Particular Policlinic Algomed /ID# 167827
Timișoara, , Romania
Immanuel Kant Baltic Federal University /ID# 202128
Kaliningrad, Kaliningrad Oblast, Russia
LLC Medical Center /ID# 209233
Novosibirsk, Novosibirsk Oblast, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988
Perm, Permskiy Kray, Russia
LLC Novaya Klinika /ID# 206615
Pyatigorsk, Stavropol Kray, Russia
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995
Stavropol, Stavropol Kray, Russia
Kazan State Medical University /ID# 169574
Kazan', Tatarstan, Respublika, Russia
Olla-Med Clinic /ID# 208721
Moscow, , Russia
P.A. Bayandin Murmansk Regiona /ID# 169575
Murmansk, , Russia
Republican hospital named after V.A. Baranov /ID# 206487
Petrozavodsk, , Russia
Euromedservice /ID# 206609
Pushkin, , Russia
X7 Clinical Research Center /ID# 216349
Saint Petersburg, , Russia
City Clinical Hospital No. 31 /ID# 208870
Saint Petersburg, , Russia
Clinical Hosp Center Zvezdara /ID# 168221
Belgrade, Beograd, Serbia
Military Medical Academy /ID# 168784
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 168220
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 168799
Belgrade, Beograd, Serbia
University Clinical Center Kragujevac /ID# 205858
Kragujevac, Sumadijski Okrug, Serbia
Clinical Center Vojvodina /ID# 168222
Novi Sad, Vojvodina, Serbia
KL Ling Gastroenterology and Liver Clinic /ID# 217963
Singapore, , Singapore
Gleneagles Medical Centre /ID# 206530
Singapore, , Singapore
Tan Tock Seng Hospital /ID# 203159
Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952
Banská Bystrica, , Slovakia
KM Management, spol. s.r.o. /ID# 170199
Nitra, , Slovakia
Univ Medical Ctr Ljubljana /ID# 211042
Ljubljana, , Slovenia
Farmovs (Pty) Ltd /Id# 207536
Bloemfontein, Free State, South Africa
Lenasia Clinical Trial Centre /ID# 205144
Johannesburg, Gauteng, South Africa
Wits Clinical Research Site /ID# 170851
Johannesburg, Gauteng, South Africa
Dr JP Wright /ID# 170885
Cape Town, Western Cape, South Africa
Private Practice Dr MN Rajabally /ID# 169852
Cape Town, Western Cape, South Africa
Hayang University GuriHospital /ID# 167578
Guri-si, Gyeonggido, South Korea
CHA University Bundang Medical Center /ID# 167583
Seongnam-si, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 167577
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 167581
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Hospital /ID# 202629
Busan, , South Korea
Dong-A University Hospital /ID# 167582
Busan, , South Korea
Pusan National University Hospital /ID# 167580
Busan, , South Korea
Kyungpook National Univ Hosp /ID# 207015
Daegu, , South Korea
Samsung Medical Center /ID# 167579
Seoul, , South Korea
Chung-Ang University Hostipal /ID# 207017
Seoul, , South Korea
Hospital Universitari Son Espases /ID# 201997
Palma de Mallorca, Balearic Islands, Spain
Hospital Unversitario Marques de Valdecilla /ID# 202039
Santander, Cantabria, Spain
Hospital Universitario Dr. Negrin /ID# 171238
Las Palmas de Gran Canaria, Las Palmas, Spain
Complejo Hospitalario de Navarra /ID# 202038
Pamplona, Navarre, Spain
Hospital Universitario A Coruna - CHUAC /ID# 203908
A Coruña, , Spain
Hospital Universitario Vall d'Hebron /ID# 171237
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 171242
Barcelona, , Spain
Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040
Girona, , Spain
Hospital Juan Ramon Jimenez /ID# 171243
Huelva, , Spain
Hospital Universitario La Paz /ID# 171241
Madrid, , Spain
Hospital Universitario Virgen Macarena /ID# 171240
Seville, , Spain
Hospital Universitario y Politecnico La Fe /ID# 201988
Valencia, , Spain
Hallands Hospital Halmstad /ID# 170840
Halmstad, Halland County, Sweden
Alingsas lasarett /ID# 170838
Alingsås, Västra Götaland County, Sweden
Sodra Alvsborgs sjukhus /ID# 202889
Borås, Västra Götaland County, Sweden
Sahlgrenska University Hospital /ID# 169031
Gothenburg, Västra Götaland County, Sweden
Universitätsspital Zürich /ID# 170999
Zurich, Canton of Zurich, Switzerland
Inselspital, Universitätsspital Bern /ID# 171006
Bern, , Switzerland
National Taiwan University Hospital /ID# 169789
Taipei, , Taiwan
Linkou Chang Gung Memorial Ho /ID# 169788
Taoyuan, , Taiwan
Acibadem Kozyatagi Hospital /ID# 209405
Kadıköy, Istanbul, Turkey (Türkiye)
Erciyes University Medical Fac /ID# 171321
Melikgazi, Kayseri, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 206412
Ankara, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 201267
Battalgazi/malatya, , Turkey (Türkiye)
Mustafa Kemal University Medic /ID# 171318
Hatay, , Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316
Istanbul, , Turkey (Türkiye)
Mersin University Medical /ID# 171320
Mersin, , Turkey (Türkiye)
Sisli Etfal Train & Res Hosp /ID# 171317
Şişli, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultes /ID# 217443
Yenimahalle, , Turkey (Türkiye)
South Eastern Health and Social Care Trust /ID# 205322
Belfast, Antrim, United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388
Warrington, Cheshire West And Chester, United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085
Warrington, Cheshire West And Chester, United Kingdom
Barts Health NHS Trust /ID# 218829
London, London, City of, United Kingdom
Royal United Hospitals Bath /ID# 169084
Bath, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 169080
Birmingham, , United Kingdom
The Dudley Group NHS Foundation Trust /ID# 169079
Dudley, , United Kingdom
London North West University Healthcare NHS Trust /ID# 169078
Harrow, , United Kingdom
King's College Hospital NHS Foundation Trusts /ID# 169082
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085
Newcastle upon Tyne, , United Kingdom
Stockport NHS foundation trust /ID# 208718
Stockport, , United Kingdom
Taunton and Somerset NHS Foundation Trust /ID# 209664
Taunton, , United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 205551
Tooting, , United Kingdom
The Royal Wolverhampton NHS Trust /ID# 171387
Wolverhampton, , United Kingdom
Countries
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References
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Colombel JF, Lacerda AP, Irving PM, Panaccione R, Reinisch W, Rieder F, Steinlauf A, Schwartz D, Feng T, Dubcenco E, Anyanwu SI, Laroux FS, Cunneen C, Powell N. Efficacy and Safety of Upadacitinib for Perianal Fistulizing Crohn's Disease: A Post Hoc Analysis of 3 Phase 3 Trials. Clin Gastroenterol Hepatol. 2025 May;23(6):1019-1029. doi: 10.1016/j.cgh.2024.08.032. Epub 2024 Sep 24.
Panes J, Louis E, Bossuyt P, Joshi N, Lee WJ, Lacerda AP, Kligys K, Xuan S, Shukla N, Loftus EV Jr. Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease. Inflamm Bowel Dis. 2025 Feb 6;31(2):394-403. doi: 10.1093/ibd/izae200.
Peyrin-Biroulet L, Panaccione R, Louis E, Atreya R, Rubin DT, Lindsay JO, Siffledeen J, Lukin DJ, Wright J, Watanabe K, Ford S, Remple VP, Lacerda AP, Dubcenco E, Garrison A, Zhou Q, Berg S, Anyanwu SI, Schreiber S. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn's Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2096-2106. doi: 10.1016/j.cgh.2024.02.026. Epub 2024 Mar 15.
Colombel JF, Hisamatsu T, Atreya R, Bresso F, Thin L, Panaccione R, Parra RS, Ford S, Remple VP, Lacerda AP, Anyanwu SI, Mallick M, Garrison A, Regueiro M. Upadacitinib Reduces Crohn's Disease Symptoms Within the First Week of Induction Therapy. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1668-1677. doi: 10.1016/j.cgh.2024.02.027. Epub 2024 Mar 15.
Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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RINVOQ® (upadacitinib) extended-release tablets prescribing information
Other Identifiers
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2017-001226-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-431
Identifier Type: -
Identifier Source: org_study_id
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