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
NCT ID: NCT03345849
Last Updated: 2022-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2017-12-07
2022-01-13
Brief Summary
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Detailed Description
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* Part 1: a randomized double-blind placebo-controlled induction period and
* Part 2: an extended treatment period for non-responders from Part 1.
In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease \[SES-CD\] \< 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, \> 1).
Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline).
Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Upadacitinib
Oral; Tablet
Placebo for Upadacitinib
Oral; Tablet
Upadacitinib
Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.
Upadacitinib
Oral; Tablet
Interventions
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Upadacitinib
Oral; Tablet
Placebo for Upadacitinib
Oral; Tablet
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 one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.
* Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
* 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, \> 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, 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 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# 171176
Mobile, Alabama, United States
CB Flock Research Corporation /ID# 166185
Mobile, Alabama, United States
Delsol Research Management, Ll /Id# 170145
Chandler, Arizona, United States
HonorHealth Research Institute - Shea /ID# 164821
Scottsdale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803
Sun City, Arizona, United States
Southern California Res. Ctr. /ID# 169655
Coronado, California, United States
Citrus Valley Gastroenterology /ID# 166173
Covina, California, United States
Hoag Memorial Hosp Presbyterian /ID# 222540
Irvine, California, United States
United Medical Doctors /ID# 207449
Los Alamitos, California, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762
Los Angeles, California, United States
Facey Medical Foundation /ID# 203136
Mission Hills, California, United States
United Medical Doctors - Murrieta /ID# 164945
Murrieta, California, United States
Ucsd /Id# 164910
San Diego, California, United States
Medical Assoc Research Grp /ID# 169706
San Diego, California, United States
Univ of California San Francis /ID# 164944
San Francisco, California, United States
Care Access Research /ID# 167767
San Pablo, California, United States
Peak Gastroenterology Associates, PC /ID# 170143
Colorado Springs, Colorado, United States
Delta Waves, Inc. /ID# 164776
Colorado Springs, Colorado, United States
Western States Clinical Res /ID# 164760
Wheat Ridge, Colorado, United States
Medical Research Center of CT /ID# 164926
Hamden, Connecticut, United States
Clinical Research of West Florida, Inc /ID# 205827
Clearwater, Florida, United States
Clinical Research of West Florida, Inc /ID# 208118
Clearwater, Florida, United States
Advanced Research - Coral Springs /ID# 218021
Coral Springs, Florida, United States
Encore Borland-Groover Clinical Research /Id# 203499
Jacksonville, Florida, United States
Ctr for Advanced Gastroenterol /ID# 165353
Maitland, Florida, United States
Crystal Pharmacology Research /ID# 166081
Miami, Florida, United States
Coral Research Clinic /ID# 164890
Miami, Florida, United States
Advanced Research Institute, Inc /ID# 164921
New Port Richey, Florida, United States
Endoscopic Research, Inc. /ID# 206136
Orlando, Florida, United States
Omega Research Maitland, LLC /ID# 203481
Orlando, Florida, United States
Clinical Research Trials of Florida, Inc. /ID# 203485
Tampa, Florida, United States
AdventHealth Tampa /ID# 171167
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 165478
Macon, Georgia, United States
Gastroenterology Consultants PC - Roswell /ID# 218220
Roswell, Georgia, United States
Atlanta Gastroenterology Spec /ID# 164799
Suwanee, Georgia, United States
Treasure Valley Medical Research /ID# 215032
Boise, Idaho, United States
Rush University Medical Center /ID# 165497
Chicago, Illinois, United States
University of Chicago Medicine /ID# 165503
Chicago, Illinois, United States
DuPage Medical Group /ID# 205328
Downers Grove, Illinois, United States
MediSphere Medical Research Center /ID# 166175
Evansville, Indiana, United States
Indianapolis Gastroenterology /ID# 164938
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics /ID# 165436
Iowa City, Iowa, United States
Tri-State Gastroenterology /ID# 165496
Crestview Hills, Kentucky, United States
University of Louisville /ID# 165366
Louisville, Kentucky, United States
University of Louisville /ID# 168572
Louisville, Kentucky, United States
CroNOLA, LLC /ID# 164823
Houma, Louisiana, United States
Nola Research Works, LLC /ID# 164759
New Orleans, Louisiana, United States
Louisana Research Center, LLC /ID# 164894
Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine /ID# 211941
Baltimore, Maryland, United States
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935
Chevy Chase, Maryland, United States
Gastro Center of Maryland /ID# 171161
Columbia, Maryland, United States
Lahey Hospital and Medical Center /ID# 214726
Burlington, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943
Ann Arbor, Michigan, United States
Digestive Health Associates (DHA) - Farmington Hills /ID# 205793
Farmington Hills, Michigan, United States
Center for Digestive Health /ID# 164822
Troy, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 170133
Troy, Michigan, United States
Mayo Clinic - Rochester /ID# 164783
Rochester, Minnesota, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 165343
Jackson, Mississippi, United States
Quality Clinical Research Inc. /ID# 170137
Omaha, Nebraska, United States
Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578
Omaha, Nebraska, United States
Las Vegas Medical Research /ID# 168588
Las Vegas, Nevada, United States
AGA Clinical Research Associates, LLC /ID# 164769
Egg Harbor, New Jersey, United States
Rutgers Robert Wood Johnson /ID# 166073
New Brunswick, New Jersey, United States
NY Scientific /ID# 164931
Brooklyn, New York, United States
United Health Services Hospitals, Inc /ID# 217485
Johnson City, New York, United States
NYU Langone Long Island Clinical Research Associates /ID# 164927
Lake Success, New York, United States
The Mount Sinai Hospital /ID# 170257
New York, New York, United States
Columbia Univ Medical Center /ID# 164782
New York, New York, United States
Gastoenterology Group of Rochester /ID# 166177
Rochester, New York, United States
Richmond University Medical Center /ID# 201857
Staten Island, New York, United States
Montefiore Medical Center - Moses Campus /ID# 166193
The Bronx, New York, United States
Advantage Clinical Trials /ID# 168546
The Bronx, New York, United States
Atrium Health Carolinas Medical Center /ID# 164932
Charlotte, North Carolina, United States
PMG Research of Charlotte /ID# 171160
Charlotte, North Carolina, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904
Raleigh, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 164908
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 170140
Fargo, North Dakota, United States
Gastro Health Research /ID# 164791
Cincinnati, Ohio, United States
University of Cincinnati /ID# 164825
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus /ID# 209231
Cleveland, Ohio, United States
The Ohio State University /ID# 170141
Columbus, Ohio, United States
Optimed Research, Ltd. /ID# 205624
Columbus, Ohio, United States
Hometown Urgent Care and Resea /ID# 201291
Dayton, Ohio, United States
Dayton Gastroenterology, Inc. /ID# 167627
Englewood, Ohio, United States
Great Lakes Medical Research, LLC /ID# 202010
Mentor, Ohio, United States
Digestive Disease Specialists /ID# 201064
Oklahoma City, Oklahoma, United States
Options Health Research, LLC /ID# 164820
Tulsa, Oklahoma, United States
Healthcare Research Consultant /ID# 166195
Tulsa, Oklahoma, United States
University of Pennsylvania /ID# 168430
Philadelphia, Pennsylvania, United States
Pharmacorp Clinical Trials /ID# 164916
Charleston, South Carolina, United States
Gastroenterology Associates, P.A. of Greenville /ID# 164771
Greenville, South Carolina, United States
Rapid City Medical Center - GI Research /ID# 201735
Rapid City, South Dakota, United States
Gastro One /ID# 164826
Germantown, Tennessee, United States
East Tennessee Research Institute /ID# 203613
Johnson City, Tennessee, United States
Quality Medical Research /ID# 205263
Nashville, Tennessee, United States
Vanderbilt University Medical Center /ID# 164946
Nashville, Tennessee, United States
TX Clinical Research Institute /ID# 164896
Arlington, Texas, United States
Inquest Clinical Research /ID# 164785
Baytown, Texas, United States
Texas Digestive Disease Consultants /ID# 209953
Cedar Park, Texas, United States
Texas Digestive Disease Consultants /ID# 209801
Cedar Park, Texas, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144
Dallas, Texas, United States
CliniCore International, LLC /ID# 164902
Houston, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 164947
Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 201214
Houston, Texas, United States
GI Specialists of Houston /ID# 202339
Houston, Texas, United States
Caprock Gastro Research, LLC /ID# 215438
Lubbock, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 164786
San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 169755
San Antonio, Texas, United States
Carl R. Meisner Medical Clinic /ID# 201061
Sugar Land, Texas, United States
Tyler Research Institute, LLC /ID# 168687
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 167812
Victoria, Texas, United States
HP Clinical Research /ID# 164933
Bountiful, Utah, United States
Advanced Research Institute /ID# 164784
Ogden, Utah, United States
Duplicate_Care Access Research /ID# 164794
Salt Lake City, Utah, United States
Velocity Clinical Research - Salt Lake City /ID# 166076
West Jordan, Utah, United States
Washington Gastroenterology /ID# 164824
Bellevue, Washington, United States
Virginia Mason Medical Center /ID# 164913
Seattle, Washington, United States
The Vancouver Clinic, INC. PS /ID# 164918
Vancouver, Washington, United States
Allegiance Research Specialists /ID# 165346
Wauwatosa, Wisconsin, United States
Cardio Alem /ID# 211285
San Isidro, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires /ID# 215541
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina
Gedyt /ID# 210020
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Cemic /Id# 169182
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Hospital Provincial del Centenario /ID# 171252
Rosario, Santa Fe Province, Argentina
Hospital Privado Univesitario /ID# 169230
Córdoba, , Argentina
Concord Repatriation General Hospital /ID# 171512
Concord, New South Wales, Australia
Coral Sea Clinical Research institute /ID# 212988
North Mackay, Queensland, Australia
Mater Misericordiae Limited /ID# 204909
South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 171514
Adelaide, South Australia, Australia
Box Hill Hospital /ID# 203736
Box Hill, Victoria, Australia
Fiona Stanley Hospital /ID# 171513
Murdoch, Western Australia, Australia
Medizinische Universitaet Wien /ID# 169465
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470
Salzburg, , Austria
UCL Saint-Luc /ID# 200303
Woluwe-Saint-Lambert, Brussels Capital, Belgium
CHU de Liege Sart Tilman /ID# 217534
Liège, Liege, Belgium
AZ Sint-Lucas /ID# 200302
Ghent, , Belgium
University Clinical Centre of the Republic of Srpska /ID# 208051
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla /ID# 210325
Tuzla, Tuzlanski, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 203887
Sarajevo, , Bosnia and Herzegovina
Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842
Sarajevo, , Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852
Goiânia, Goiás, Brazil
Hospital Nossa Senhora das Graças /ID# 166863
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 166862
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin Fmb - Unesp /Id# 166867
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866
Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC /ID# 208323
Santo André, São Paulo, Brazil
Kaiser Clinica e Hospital Dia /ID# 166865
São José do Rio Preto, São Paulo, Brazil
UMHAT Kaspela EOOD /ID# 167613
Plovdiv, , Bulgaria
Duplicate_Second MHAT Sofia /ID# 167614
Sofia, , Bulgaria
MHAT Trakia /ID# 201679
Stara Zagora, , Bulgaria
University of Calgary /ID# 166974
Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 168044
Edmonton, Alberta, Canada
University of Alberta - Zeidler Ledcor Centre /ID# 166971
Edmonton, Alberta, Canada
South Edmonton Gastroenterology Research Clinic /ID# 166978
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 166968
New Westminster, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 166975
Vancouver, British Columbia, Canada
QEII - Health Sciences Centre /ID# 169307
Halifax, Nova Scotia, Canada
Medicor Research Inc /ID# 166979
Greater Sudbury, Ontario, Canada
London Health Sciences Center /ID# 221038
London, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 169066
North Bay, Ontario, Canada
Taunton Surgical Centre /ID# 168043
Oshawa, Ontario, Canada
Ottawa Hospital Research Institute /ID# 212414
Ottawa, Ontario, Canada
Toronto Digestive Disease Asso /ID# 166972
Vaughan, Ontario, Canada
CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969
Lévis, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120
Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 170119
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 170940
Sherbrooke, Quebec, Canada
M y F Estudios Clínicos /ID# 169984
Santiago, Region Metropolitana Santiago, Chile
Research Group /ID# 203179
Santiago, Santiago Metropolitan, Chile
Hospital Guillermo Grant Benavente de Concepción /ID# 212423
Concepción, , Chile
CTR Estudios Clinicos /ID# 203941
Providencia, , Chile
Hospital Clinico Universidad De Los Andes /ID# 207466
Santiago, , Chile
Zhongshan Hospital Xiamen University /ID# 204984
Xiamen, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University /ID# 205228
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 204083
Guangzhou, Guangdong, China
The Sixth Affiliated Hosp Sun /ID# 204077
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081
Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 204900
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 204092
Nanchang, Jiangxi, China
The First Hospital of Jilin University /ID# 206868
Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091
Shanghai, Shanghai Municipality, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076
Hangzhou, Zhejiang, China
Beijing Friendship Hospital /ID# 204173
Beijing, , China
The Second Xiangya Hospital of Central South University /ID# 204082
Changsha, , China
Duplicate_Tianjin Med Univ General Hosp /ID# 206994
Tianjin, , China
Tongji Hospital Tongji Medical College of HUST /ID# 204088
Wuhan, , China
Hospital Pablo Tobon Uribe /ID# 202404
Medellín, Antioquia, Colombia
Hospital Universitario San Vic /ID# 200029
Medellín, , Colombia
Clinical Hospital Dubrava /ID# 171185
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 205535
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 171203
Zagreb, City of Zagreb, Croatia
Poliklinika Solmed /ID# 211519
Zagreb, City of Zagreb, Croatia
UHC Split /ID# 171191
Split, , Croatia
Zadar General Hospital /ID# 205536
Zadar, , Croatia
Nemocnice Ceske Budejovice a.s. /ID# 224389
České Budějovice, , Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 171401
Hradec Králové, , Czechia
ARTROSCAN s.r.o. /ID# 200790
Ostrava, , Czechia
ResTrial s.r.o. /ID# 208653
Prague, , Czechia
Herlev Hospital /ID# 202423
Herlev, Capital Region, Denmark
Nordsjaellands Hospital /ID# 202424
Hilleroed, Capital Region, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425
Hvidovre, Capital Region, Denmark
Duplicate_Sjaellands Universitets Hospital /ID# 209445
Roskilde, Region Sjælland, Denmark
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013
Alexandria, , Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564
Alexandria, , Egypt
National Hepatology and Tropical Medicine Research Institute /ID# 170989
Cairo, , Egypt
Air Force Specialized Hospital /ID# 170996
Cairo, , Egypt
National Liver Institute /ID# 170988
Menoufiya, , Egypt
West Tallinn Central Hospital /ID# 202785
Tallinn, , Estonia
CHU Grenoble - Hopital Michallon /ID# 219034
La Tronche, , France
Clinique Jules Verne /ID# 219073
Nantes, , France
CH Valenciennes /ID# 219035
Valenciennes, , France
Universitatsklinikum Mannheim /ID# 168759
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 203560
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 203552
Erlangen, Bavaria, Germany
Universitaetsklinikum Frankfurt /ID# 203566
Frankfurt am Main, Hesse, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741
Saarbrücken, Saarland, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757
Kiel, Schleswig-Holstein, Germany
Gastroenterologie am Mexikoplatz /ID# 203575
Berlin, , Germany
Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570
Essen, , Germany
Agaplesion Markus Krankenhaus /ID# 168758
Frankfurt am Main, , Germany
Universitaetsklinikum Halle (Saale) /ID# 207455
Halle, , Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 200214
Münster, , Germany
General Hospital of Athens Ippokratio /ID# 167045
Athens, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104
Athens, Attica, Greece
Tzaneio general hospital of Piraeus /ID# 206433
Piraeus, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 167044
Heraklion, Crete, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 208825
Thessaloniki, , Greece
Tuen Mun Hospital /ID# 171218
Hong Kong, , Hong Kong
Mohacsi Korhaz /ID# 209441
Mohács, Baranya, Hungary
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547
Encs, Borsod-Abauj Zemplen county, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 216419
Debrecen, Hajdú-Bihar, Hungary
Bugat Pal Korhaz /ID# 201893
Gyöngyös, Heves County, Hungary
Szent Borbala Korhaz /ID# 209897
Tatabánya, Komárom-Esztergom, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 201892
Budapest, Pest County, Hungary
Semmelweis Egyetem /ID# 210167
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723
Debrecen, , Hungary
Pest Megyei Flor Ferenc Korhaz /ID# 206154
Kistarcsa, , Hungary
Mentahaz Maganorvosi Kozpont /ID# 201895
Székesfehérvár, , Hungary
Mercy University Hospital /ID# 206511
Cork, , Ireland
Soroka University Medical Center /ID# 169913
Beersheba, Southern District, Israel
Tel Aviv Sourasky Medical Center /ID# 204877
Tel Aviv, Tel Aviv, Israel
Assaf Harofeh Medical Center /ID# 204872
Be’er Ya‘aqov, , Israel
Hadassah Medical Center-Hebrew University /ID# 169928
Jerusalem, , Israel
Rabin Medical Center /ID# 202636
Petah Tikva, , Israel
Kaplan Medical Center /ID# 170276
Rehovot, , Israel
Policlinico Universitario Campus Bio-Medico /ID# 168183
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 168184
Rome, Lazio, Italy
Istituto Clinico Humanitas /ID# 168185
Rozzano, Milano, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 168188
Rome, Roma, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182
Rome, Roma, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186
Negrar, Verona, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187
Bologna, , Italy
A.O. Per L'Emergenza Cannizzaro /ID# 168190
Catania, , Italy
Policlinico San Martino/Univer /ID# 168191
Genova, , Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 170849
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 201897
Modena, , Italy
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421
Pisa, , Italy
Aichi Medical University Hospital /ID# 165971
Nagakute-shi, Aichi-ken, Japan
Nagoya University Hospital /ID# 165969
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 165970
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital /ID# 200175
Toyohashi, Aichi-ken, Japan
National Hospital Organization Hirosaki General Medical Center /ID# 165961
Hirosaki-shi, Aomori, Japan
Toho University Sakura Medical Center /ID# 165963
Sakura-shi, Chiba, Japan
Fukuoka University Chikushi Hospital /ID# 214404
Chikushino-shi, Fukuoka, Japan
Kurume University Hospital /ID# 166012
Kurume-shi, Fukuoka, Japan
National Hospital Organization Takasaki General Medical Center /ID# 167127
Takasaki-shi, Gunma, Japan
NHO Fukuyama Medical Center /ID# 167131
Fukuyama-shi, Hiroshima, Japan
Hiroshima University Hospital /ID# 166014
Hiroshima, Hiroshima, Japan
Asahikawa Medical University Hospital /ID# 167120
Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 167124
Sapporo, Hokkaido, Japan
Sapporo IBD Clinic /ID# 223561
Sapporo, Hokkaido, Japan
Aoyama Clinic /ID# 166009
Kobe, Hyōgo, Japan
Hyogo College of Medicine College Hospital /Id# 165973
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 169218
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Uchimaru Medical Center /ID# 202464
Morioka, Iwate, Japan
Imamura General Hospital /ID# 227137
Kagoshima, Kagoshima-ken, Japan
Idzuro Imamura Hospital /ID# 206654
Kagoshima, Kagoshima-ken, Japan
Sameshima Hospital /ID# 206675
Kagoshima, Kagoshima-ken, Japan
Yokohama City University Medical Center /ID# 167128
Yokohama, Kanagawa, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972
Kyoto, Kyoto, Japan
Kyoto University Hospital /ID# 169889
Kyoto, Kyoto, Japan
Yokkaichi Hazu Medical Center /ID# 167196
Yokkaichi-shi, Mie-ken, Japan
Tohoku University Hospital /ID# 167122
Sendai, Miyagi, Japan
Nara Medical University Hospital /ID# 169219
Kashihara-shi, Nara, Japan
Kenseikai Dongo Hospital /ID# 208104
Yamatotakada-shi, Nara, Japan
Niigata University Medical & Dental Hospital /ID# 170045
Niigata, Niigata, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 167121
Ōita, Oita Prefecture, Japan
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010
Kurashiki-shi, Okayama-ken, Japan
Okayama University Hospital /ID# 167356
Okayama, Okayama-ken, Japan
Kinshukai Infusion Clinic /ID# 218872
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 166015
Osaka, Osaka, Japan
Osaka University Hospital /ID# 169663
Suita-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 206326
Takatsuki-shi, Osaka, Japan
Tokitokai Tokito clinic /ID# 165962
Saitama-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 167129
Ōtsu, Shiga, Japan
Hamamatsu University Hospital /ID# 224352
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 167125
Sunto-gun, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 165965
Bunkyo-ku, Tokyo, Japan
Tokai University Hachioji Hospital /ID# 165967
Hachioji-shi, Tokyo, Japan
The Jikei University Hospital /ID# 167130
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 165966
Mitaka-shi, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 205980
Shinjuku-ku, Tokyo, Japan
Toyama Prefectural Central Hospital /ID# 217834
Toyama, Toyama, Japan
Japanese Red Cross Wakayama Medical Center /ID# 200643
Wakayama, Wakayama, Japan
Wakayama Medical University Hospital /ID# 169482
Wakayama, Wakayama, Japan
Yamagata University Hospital /ID# 200157
Yamagata, Yamagata, Japan
VCA Polyclinic Aura /ID# 169498
Riga, , Latvia
Pauls Stradins Clinical University Hospital /ID# 169519
Riga, , Latvia
Digestive Disease Center Gastro /ID# 169508
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936
Kaunas, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 203286
Vilnius, , Lithuania
Hospital Sultanah Bahiyah /ID# 202626
Alor Star, Kedah, Malaysia
Universiti Sains Malaysia /ID# 200102
Kelantan, Kelantan, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773
Kuala Lumpur, Selangor, Malaysia
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579
Durango, Durango, Mexico
Morales Vargas Centro de Investigacion S.C. /ID# 203494
León, Guanajuato, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238
Guadalajara, Jalisco, Mexico
Radboud Universitair Medisch Centrum /ID# 166928
Nijmegen, Gelderland, Netherlands
Zuyderland Medisch Centrum /ID# 169700
Heerlen, Limburg, Netherlands
Onze Lieve Vrouwe Gasthuis /ID# 166929
Amsterdam, , Netherlands
Academisch Medisch Centrum /ID# 166927
Amsterdam, , Netherlands
Medisch Spectrum Twente /ID# 170298
Enschede, , Netherlands
Malopolskie Centrum Kliniczne /ID# 202167
Krakow, Lesser Poland Voivodeship, Poland
Vistamed /ID# 208572
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Zdrowia MDM /ID# 200491
Warsaw, Masovian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus /ID# 224301
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 200490
Warsaw, Masovian Voivodeship, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245
Guimarães, Braga District, Portugal
Hospital Egas Moniz /ID# 170253
Lisbon, Porto District, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607
Ponte de Lima, Viana do Castelo District, Portugal
Hospital Garcia de Orta, EPE /ID# 170241
Almada, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248
Porto, , Portugal
Mindful Medical Research /ID# 203358
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771
San Juan, , Puerto Rico
Institutul Clinic Fundeni /ID# 167817
Sector 2, București, Romania
Clinica GASTRO MED SRL /ID# 206369
Cluj-Napoca, Cluj, Romania
Cabinet Particular Policlinic Algomed /ID# 167818
Timișoara, , Romania
Immanuel Kant Baltic Federal University /ID# 203811
Kaliningrad, Kaliningrad Oblast, Russia
LLC Medical Center /ID# 209236
Novosibirsk, Novosibirsk Oblast, Russia
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990
Perm, Permskiy Kray, Russia
LLC Novaya Klinika /ID# 206616
Pyatigorsk, Stavropol Kray, Russia
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997
Stavropol, Stavropol Kray, Russia
Kazan State Medical University /ID# 169638
Kazan', Tatarstan, Respublika, Russia
Olla-Med Clinic /ID# 208720
Moscow, , Russia
P.A. Bayandin Murmansk Regiona /ID# 169639
Murmansk, , Russia
Republican hospital named after V.A. Baranov /ID# 206488
Petrozavodsk, , Russia
Euromedservice /ID# 206610
Pushkin, , Russia
X7 Clinical Research Center /ID# 216350
Saint Petersburg, , Russia
City Clinical Hospital No. 31 /ID# 208868
Saint Petersburg, , Russia
Clinical Hosp Center Zvezdara /ID# 168214
Belgrade, Beograd, Serbia
Military Medical Academy /ID# 168783
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 168215
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 168750
Belgrade, Beograd, Serbia
University Clinical Center Kragujevac /ID# 205859
Kragujevac, Sumadijski Okrug, Serbia
Clinical Center Vojvodina /ID# 168213
Novi Sad, Vojvodina, Serbia
KL Ling Gastroenterology and Liver Clinic /ID# 217962
Singapore, , Singapore
Gleneagles Medical Centre /ID# 206531
Singapore, , Singapore
Tan Tock Seng Hospital /ID# 203160
Singapore, , Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958
Banská Bystrica, , Slovakia
KM Management, spol. s.r.o. /ID# 170201
Nitra, , Slovakia
Univ Medical Ctr Ljubljana /ID# 217795
Ljubljana, , Slovenia
Farmovs (Pty) Ltd /Id# 207535
Bloemfontein, Free State, South Africa
Lenasia Clinical Trial Centre /ID# 205145
Johannesburg, Gauteng, South Africa
Wits Clinical Research Site /ID# 170852
Johannesburg, Gauteng, South Africa
Allergy & Immunology (AIU) /ID# 171431
Cape Town, Western Cape, South Africa
Dr JP Wright /ID# 170887
Cape Town, Western Cape, South Africa
Private Practice Dr MN Rajabally /ID# 169853
Cape Town, Western Cape, South Africa
Hayang University GuriHospital /ID# 167587
Guri-si, Gyeonggido, South Korea
CHA University Bundang Medical Center /ID# 167592
Seongnam-si, Gyeonggido, South Korea
Kangbuk Samsung Hospital /ID# 167586
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 167590
Seoul, Seoul Teugbyeolsi, South Korea
Inje University Haeundae Hospital /ID# 202630
Busan, , South Korea
Dong-A University Hospital /ID# 167591
Busan, , South Korea
Pusan National University Hospital /ID# 167589
Busan, , South Korea
Kyungpook National University Hospital /ID# 207019
Daegu, , South Korea
Samsung Medical Center /ID# 167588
Seoul, , South Korea
Chung-Ang University Hostipal /ID# 207018
Seoul, , South Korea
Hospital Universitari Son Espases /ID# 201998
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Navarra /ID# 202355
Pamplona, Navarre, Spain
Hospital Universitario A Coruna - CHUAC /ID# 203910
A Coruña, , Spain
Hospital Clinic de Barcelona /ID# 201990
Barcelona, , Spain
Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645
Girona, , Spain
Hospital Juan Ramon Jimenez /ID# 201995
Huelva, , Spain
Hospital Universitario La Paz /ID# 201994
Madrid, , Spain
Hospital Universitario de Salamanca /ID# 206358
Salamanca, , Spain
Hospital Universitario Virgen Macarena /ID# 201993
Seville, , Spain
Hospital Clinico Universitario de Valencia /ID# 209657
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 201992
Valencia, , Spain
Hallands Hospital Halmstad /ID# 170828
Halmstad, Halland County, Sweden
Karolinska University Hospital Solna /ID# 224488
Solna, Stockholm County, Sweden
Alingsas lasarett /ID# 170826
Alingsås, Västra Götaland County, Sweden
Sodra Alvsborgs sjukhus /ID# 203077
Borås, Västra Götaland County, Sweden
Sahlgrenska University Hospital /ID# 169171
Gothenburg, Västra Götaland County, Sweden
Universitätsspital Zürich /ID# 170998
Zurich, Canton of Zurich, Switzerland
Inselspital, Universitätsspital Bern /ID# 170997
Bern, , Switzerland
China Medical University Hospital /ID# 169791
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 169790
Taichung, , Taiwan
National Taiwan University Hospital /ID# 169792
Taipei, , Taiwan
Acibadem Kozyatagi Hospital /ID# 209406
Kadıköy, Istanbul, Turkey (Türkiye)
Erciyes University Medical Fac /ID# 171331
Melikgazi, Kayseri, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 206409
Ankara, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 201268
Battalgazi/malatya, , Turkey (Türkiye)
Mustafa Kemal University Medic /ID# 171336
Hatay, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty /ID# 171364
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332
Istanbul, , Turkey (Türkiye)
Mersin University Medical /ID# 171338
Mersin, , Turkey (Türkiye)
Sisli Etfal Train & Res Hosp /ID# 171334
Şişli, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultes /ID# 217444
Yenimahalle, , Turkey (Türkiye)
Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738
Kyiv, Kyivska Oblast, Ukraine
Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907
Kharkiv, , Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 207889
Kyiv, , Ukraine
MNI KRC Kyiv Regional Clinical Hospital /ID# 202454
Kyiv, , Ukraine
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908
Lviv, , Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110
Vinnytsia, , Ukraine
South Eastern Health and Social Care Trust /ID# 205323
Belfast, Antrim, United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383
Warrington, Cheshire West And Chester, United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086
Warrington, Cheshire West And Chester, United Kingdom
Royal United Hospitals Bath /ID# 169074
Bath, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 169070
Birmingham, , United Kingdom
The Dudley Group NHS Foundation Trust /ID# 169069
Dudley, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 169072
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075
Newcastle upon Tyne, , United Kingdom
Stockport NHS foundation trust /ID# 208719
Stockport, , United Kingdom
Taunton and Somerset NHS Foundation Trust /ID# 209665
Taunton, , United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 205552
Tooting, , United Kingdom
The Royal Wolverhampton NHS Trust /ID# 171382
Wolverhampton, , United Kingdom
Countries
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References
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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.
Ghosh S, Feagan BG, Parra RS, Lopes S, Steinlauf A, Kakuta Y, Joshi N, Lee WJ, Lacerda AP, Zhou Q, Xuan S, Kligys K, Shukla N, Louis E. Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease. J Crohns Colitis. 2024 Nov 4;18(11):1804-1818. doi: 10.1093/ecco-jcc/jjae083.
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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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2017-001240-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-433
Identifier Type: -
Identifier Source: org_study_id
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