NCT03345849

Brief Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
526

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2017

Typical duration for phase_3

Geographic Reach
45 countries

412 active sites

Status
completed

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

November 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

December 7, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2022

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 23, 2022

Completed
Last Updated

November 23, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

November 15, 2017

Results QC Date

October 3, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

UpadacitinibABT-494EfficacySafetyCrohn's Disease

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12

    The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.

    Week 12

  • Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12

    The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline. Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe). The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.

    Week 12

  • Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Baseline and Week 12

Secondary Outcomes (11)

  • Percentage of Participants With Endoscopic Remission at Week 12

    Baseline and Week 12

  • Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12

    Week 12

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12

    Baseline and Week 12

  • Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12

    Baseline and Week 12

  • Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2

    Baseline and Week 2

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: UpadacitinibDrug: Placebo for Upadacitinib

Upadacitinib

EXPERIMENTAL

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.

Drug: Upadacitinib

Interventions

Oral; Tablet

Also known as: ABT-494, RINVOQ
PlaceboUpadacitinib

Oral; Tablet

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • 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.

You may not qualify if:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (432)

East View Medical Research, LLC /ID# 171176

Mobile, Alabama, 36606, United States

Location

CB Flock Research Corporation /ID# 166185

Mobile, Alabama, 36608, United States

Location

Delsol Research Management, Ll /Id# 170145

Chandler, Arizona, 85224, United States

Location

HonorHealth Research Institute - Shea /ID# 164821

Scottsdale, Arizona, 85258, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803

Sun City, Arizona, 85306, United States

Location

Southern California Res. Ctr. /ID# 169655

Coronado, California, 92118-1408, United States

Location

Citrus Valley Gastroenterology /ID# 166173

Covina, California, 91722-3797, United States

Location

Hoag Memorial Hosp Presbyterian /ID# 222540

Irvine, California, 92618, United States

Location

United Medical Doctors /ID# 207449

Los Alamitos, California, 90720-3309, United States

Location

Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762

Los Angeles, California, 90067-2001, United States

Location

Facey Medical Foundation /ID# 203136

Mission Hills, California, 91345, United States

Location

United Medical Doctors - Murrieta /ID# 164945

Murrieta, California, 92563, United States

Location

Ucsd /Id# 164910

San Diego, California, 92103, United States

Location

Medical Assoc Research Grp /ID# 169706

San Diego, California, 92123, United States

Location

Univ of California San Francis /ID# 164944

San Francisco, California, 94158, United States

Location

Care Access Research /ID# 167767

San Pablo, California, 94806, United States

Location

Peak Gastroenterology Associates, PC /ID# 170143

Colorado Springs, Colorado, 80907, United States

Location

Delta Waves, Inc. /ID# 164776

Colorado Springs, Colorado, 80918, United States

Location

Western States Clinical Res /ID# 164760

Wheat Ridge, Colorado, 80033-2896, United States

Location

Medical Research Center of CT /ID# 164926

Hamden, Connecticut, 06518, United States

Location

Clinical Research of West Florida, Inc /ID# 205827

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida, Inc /ID# 208118

Clearwater, Florida, 33765, United States

Location

Advanced Research - Coral Springs /ID# 218021

Coral Springs, Florida, 33067-3173, United States

Location

Encore Borland-Groover Clinical Research /Id# 203499

Jacksonville, Florida, 32256, United States

Location

Ctr for Advanced Gastroenterol /ID# 165353

Maitland, Florida, 32751-6108, United States

Location

Crystal Pharmacology Research /ID# 166081

Miami, Florida, 33165, United States

Location

Coral Research Clinic /ID# 164890

Miami, Florida, 33186-4643, United States

Location

Advanced Research Institute, Inc /ID# 164921

New Port Richey, Florida, 34653, United States

Location

Endoscopic Research, Inc. /ID# 206136

Orlando, Florida, 32803, United States

Location

Omega Research Maitland, LLC /ID# 203481

Orlando, Florida, 32808, United States

Location

Clinical Research Trials of Florida, Inc. /ID# 203485

Tampa, Florida, 33607, United States

Location

AdventHealth Tampa /ID# 171167

Tampa, Florida, 33613-4680, United States

Location

Gastroenterology Associates of Central Georgia, LLC /ID# 165478

Macon, Georgia, 31201, United States

Location

Gastroenterology Consultants PC - Roswell /ID# 218220

Roswell, Georgia, 30076-4913, United States

Location

Atlanta Gastroenterology Spec /ID# 164799

Suwanee, Georgia, 30024, United States

Location

Treasure Valley Medical Research /ID# 215032

Boise, Idaho, 83706, United States

Location

Rush University Medical Center /ID# 165497

Chicago, Illinois, 60612, United States

Location

University of Chicago Medicine /ID# 165503

Chicago, Illinois, 60637-1426, United States

Location

DuPage Medical Group /ID# 205328

Downers Grove, Illinois, 60515-5509, United States

Location

MediSphere Medical Research Center /ID# 166175

Evansville, Indiana, 47714-8011, United States

Location

Indianapolis Gastroenterology /ID# 164938

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Hospitals and Clinics /ID# 165436

Iowa City, Iowa, 52242, United States

Location

Tri-State Gastroenterology /ID# 165496

Crestview Hills, Kentucky, 41017, United States

Location

University of Louisville /ID# 165366

Louisville, Kentucky, 40202, United States

Location

University of Louisville /ID# 168572

Louisville, Kentucky, 40202, United States

Location

CroNOLA, LLC /ID# 164823

Houma, Louisiana, 70360, United States

Location

Nola Research Works, LLC /ID# 164759

New Orleans, Louisiana, 70115, United States

Location

Louisana Research Center, LLC /ID# 164894

Shreveport, Louisiana, 71105-6800, United States

Location

Johns Hopkins University School of Medicine /ID# 211941

Baltimore, Maryland, 21287-0010, United States

Location

MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland /ID# 171161

Columbia, Maryland, 21045, United States

Location

Lahey Hospital and Medical Center /ID# 214726

Burlington, Massachusetts, 01805, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943

Ann Arbor, Michigan, 48109, United States

Location

Digestive Health Associates (DHA) - Farmington Hills /ID# 205793

Farmington Hills, Michigan, 48334-3230, United States

Location

Center for Digestive Health /ID# 164822

Troy, Michigan, 48098-6363, United States

Location

Clin Res Inst of Michigan, LLC /ID# 170133

Troy, Michigan, 48098, United States

Location

Mayo Clinic - Rochester /ID# 164783

Rochester, Minnesota, 55905-0001, United States

Location

Southern Therapy and Advanced Research (STAR) LLC /ID# 165343

Jackson, Mississippi, 39216, United States

Location

Quality Clinical Research Inc. /ID# 170137

Omaha, Nebraska, 68114-3723, United States

Location

Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578

Omaha, Nebraska, 68124, United States

Location

Las Vegas Medical Research /ID# 168588

Las Vegas, Nevada, 89113, United States

Location

AGA Clinical Research Associates, LLC /ID# 164769

Egg Harbor, New Jersey, 08234, United States

Location

Rutgers Robert Wood Johnson /ID# 166073

New Brunswick, New Jersey, 08901, United States

Location

NY Scientific /ID# 164931

Brooklyn, New York, 11235, United States

Location

United Health Services Hospitals, Inc /ID# 217485

Johnson City, New York, 13790-2107, United States

Location

NYU Langone Long Island Clinical Research Associates /ID# 164927

Lake Success, New York, 11042, United States

Location

The Mount Sinai Hospital /ID# 170257

New York, New York, 10029, United States

Location

Columbia Univ Medical Center /ID# 164782

New York, New York, 10032-3725, United States

Location

Gastoenterology Group of Rochester /ID# 166177

Rochester, New York, 14618-5703, United States

Location

Richmond University Medical Center /ID# 201857

Staten Island, New York, 10310-1664, United States

Location

Montefiore Medical Center - Moses Campus /ID# 166193

The Bronx, New York, 10467, United States

Location

Advantage Clinical Trials /ID# 168546

The Bronx, New York, 10468, United States

Location

Atrium Health Carolinas Medical Center /ID# 164932

Charlotte, North Carolina, 28203, United States

Location

PMG Research of Charlotte /ID# 171160

Charlotte, North Carolina, 28209, United States

Location

Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904

Raleigh, North Carolina, 27612, United States

Location

Wake Forest Baptist Medical Center /ID# 164908

Winston-Salem, North Carolina, 27157-0001, United States

Location

Plains Clinical Research Center, LLC /ID# 170140

Fargo, North Dakota, 58104-5925, United States

Location

Gastro Health Research /ID# 164791

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati /ID# 164825

Cincinnati, Ohio, 45267-0585, United States

Location

Cleveland Clinic Main Campus /ID# 209231

Cleveland, Ohio, 44195, United States

Location

The Ohio State University /ID# 170141

Columbus, Ohio, 43210, United States

Location

Optimed Research, Ltd. /ID# 205624

Columbus, Ohio, 43235, United States

Location

Hometown Urgent Care and Resea /ID# 201291

Dayton, Ohio, 45424, United States

Location

Dayton Gastroenterology, Inc. /ID# 167627

Englewood, Ohio, 45415, United States

Location

Great Lakes Medical Research, LLC /ID# 202010

Mentor, Ohio, 44060-6211, United States

Location

Digestive Disease Specialists /ID# 201064

Oklahoma City, Oklahoma, 73112, United States

Location

Options Health Research, LLC /ID# 164820

Tulsa, Oklahoma, 74104, United States

Location

Healthcare Research Consultant /ID# 166195

Tulsa, Oklahoma, 74135, United States

Location

University of Pennsylvania /ID# 168430

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Pharmacorp Clinical Trials /ID# 164916

Charleston, South Carolina, 29412, United States

Location

Gastroenterology Associates, P.A. of Greenville /ID# 164771

Greenville, South Carolina, 29615-3593, United States

Location

Rapid City Medical Center - GI Research /ID# 201735

Rapid City, South Dakota, 57701, United States

Location

Gastro One /ID# 164826

Germantown, Tennessee, 38138, United States

Location

East Tennessee Research Institute /ID# 203613

Johnson City, Tennessee, 37604, United States

Location

Quality Medical Research /ID# 205263

Nashville, Tennessee, 37211, United States

Location

Vanderbilt University Medical Center /ID# 164946

Nashville, Tennessee, 37232-0011, United States

Location

TX Clinical Research Institute /ID# 164896

Arlington, Texas, 76012, United States

Location

Inquest Clinical Research /ID# 164785

Baytown, Texas, 77521-2415, United States

Location

Texas Digestive Disease Consultants /ID# 209953

Cedar Park, Texas, 78613-5028, United States

Location

Texas Digestive Disease Consultants /ID# 209801

Cedar Park, Texas, 78613, United States

Location

Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144

Dallas, Texas, 75246, United States

Location

CliniCore International, LLC /ID# 164902

Houston, Texas, 77027-6812, United States

Location

Baylor College of Medicine - Baylor Medical Center /ID# 164947

Houston, Texas, 77030-3411, United States

Location

Centex Studies, Inc. - Houston /ID# 201214

Houston, Texas, 77058, United States

Location

GI Specialists of Houston /ID# 202339

Houston, Texas, 77070-4347, United States

Location

Caprock Gastro Research, LLC /ID# 215438

Lubbock, Texas, 79424-3017, United States

Location

Clinical Associates in Research Therapeutics of America, LLC /ID# 164786

San Antonio, Texas, 78212, United States

Location

Southern Star Research Institute, LLC /ID# 169755

San Antonio, Texas, 78229-5390, United States

Location

Carl R. Meisner Medical Clinic /ID# 201061

Sugar Land, Texas, 77478, United States

Location

Tyler Research Institute, LLC /ID# 168687

Tyler, Texas, 75701-4464, United States

Location

Gastro Health & Nutrition - Victoria /ID# 167812

Victoria, Texas, 77904, United States

Location

HP Clinical Research /ID# 164933

Bountiful, Utah, 84010, United States

Location

Advanced Research Institute /ID# 164784

Ogden, Utah, 84403, United States

Location

Duplicate_Care Access Research /ID# 164794

Salt Lake City, Utah, 84124-1377, United States

Location

Velocity Clinical Research - Salt Lake City /ID# 166076

West Jordan, Utah, 84088, United States

Location

Washington Gastroenterology /ID# 164824

Bellevue, Washington, 98004, United States

Location

Virginia Mason Medical Center /ID# 164913

Seattle, Washington, 98101, United States

Location

The Vancouver Clinic, INC. PS /ID# 164918

Vancouver, Washington, 98664, United States

Location

Allegiance Research Specialists /ID# 165346

Wauwatosa, Wisconsin, 53226, United States

Location

Cardio Alem /ID# 211285

San Isidro, Buenos Aires, 1642, Argentina

Location

Hospital Italiano de Buenos Aires /ID# 215541

Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199, Argentina

Location

Gedyt /ID# 210020

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1115, Argentina

Location

Cemic /Id# 169182

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1431, Argentina

Location

Hospital Provincial del Centenario /ID# 171252

Rosario, Santa Fe Province, 2000, Argentina

Location

Hospital Privado Univesitario /ID# 169230

Córdoba, 5016, Argentina

Location

Concord Repatriation General Hospital /ID# 171512

Concord, New South Wales, 2139, Australia

Location

Coral Sea Clinical Research institute /ID# 212988

North Mackay, Queensland, 4740, Australia

Location

Mater Misericordiae Limited /ID# 204909

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital /ID# 171514

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital /ID# 203736

Box Hill, Victoria, 3128, Australia

Location

Fiona Stanley Hospital /ID# 171513

Murdoch, Western Australia, 6150, Australia

Location

Medizinische Universitaet Wien /ID# 169465

Vienna, Vienna, 1090, Austria

Location

Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470

Salzburg, 5020, Austria

Location

UCL Saint-Luc /ID# 200303

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

CHU de Liege Sart Tilman /ID# 217534

Liège, Liege, 4000, Belgium

Location

AZ Sint-Lucas /ID# 200302

Ghent, 9000, Belgium

Location

University Clinical Centre of the Republic of Srpska /ID# 208051

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla /ID# 210325

Tuzla, Tuzlanski, 75000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo /ID# 203887

Sarajevo, 71000, Bosnia and Herzegovina

Location

Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842

Sarajevo, 71000, Bosnia and Herzegovina

Location

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852

Goiânia, Goiás, 74535-170, Brazil

Location

Hospital Nossa Senhora das Graças /ID# 166863

Curitiba, Paraná, 80810-040, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 166862

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Upeclin Fmb - Unesp /Id# 166867

Botucatu, São Paulo, 18618-686, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Faculdade de Medicina do ABC /ID# 208323

Santo André, São Paulo, 09060-870, Brazil

Location

Kaiser Clinica e Hospital Dia /ID# 166865

São José do Rio Preto, São Paulo, 15015-110, Brazil

Location

UMHAT Kaspela EOOD /ID# 167613

Plovdiv, 4001, Bulgaria

Location

Duplicate_Second MHAT Sofia /ID# 167614

Sofia, 1202, Bulgaria

Location

MHAT Trakia /ID# 201679

Stara Zagora, 6004, Bulgaria

Location

University of Calgary /ID# 166974

Calgary, Alberta, T2N 4Z6, Canada

Location

Allen Whey Khye Lim Professional Corporation /ID# 168044

Edmonton, Alberta, T5R 1W2, Canada

Location

University of Alberta - Zeidler Ledcor Centre /ID# 166971

Edmonton, Alberta, T6G 2X8, Canada

Location

South Edmonton Gastroenterology Research Clinic /ID# 166978

Edmonton, Alberta, T6K 4B2, Canada

Location

Fraser Clinical Trials Inc /ID# 166968

New Westminster, British Columbia, V3L 3W4, Canada

Location

GIRI Gastrointestinal Research Institute /ID# 166975

Vancouver, British Columbia, V6Z 2K5, Canada

Location

QEII - Health Sciences Centre /ID# 169307

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Medicor Research Inc /ID# 166979

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

London Health Sciences Center /ID# 221038

London, Ontario, N6A 5W9, Canada

Location

Scott Shulman Medicine Professional Corporation /ID# 169066

North Bay, Ontario, P1B 2H3, Canada

Location

Taunton Surgical Centre /ID# 168043

Oshawa, Ontario, L1H 7K4, Canada

Location

Ottawa Hospital Research Institute /ID# 212414

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Digestive Disease Asso /ID# 166972

Vaughan, Ontario, L4L 4Y7, Canada

Location

CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969

Lévis, Quebec, G6V 3Z1, Canada

Location

Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120

Montreal, Quebec, H2X 0A9, Canada

Location

Royal Victoria Hospital / McGill University Health Centre /ID# 170119

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS de l'Estrie - CHUS /ID# 170940

Sherbrooke, Quebec, J1G 2E8, Canada

Location

M y F Estudios Clínicos /ID# 169984

Santiago, Region Metropolitana Santiago, 7750495, Chile

Location

Research Group /ID# 203179

Santiago, Santiago Metropolitan, 2540364, Chile

Location

Hospital Guillermo Grant Benavente de Concepción /ID# 212423

Concepción, 4070038, Chile

Location

CTR Estudios Clinicos /ID# 203941

Providencia, 7500571, Chile

Location

Hospital Clinico Universidad De Los Andes /ID# 207466

Santiago, 7501504, Chile

Location

Zhongshan Hospital Xiamen University /ID# 204984

Xiamen, Fujian, 361004, China

Location

The First Affiliated Hospital, Sun Yat-sen University /ID# 205228

Guangzhou, Guangdong, 510080, China

Location

Nanfang Hospital of Southern Medical University /ID# 204083

Guangzhou, Guangdong, 510515, China

Location

The Sixth Affiliated Hosp Sun /ID# 204077

Guangzhou, Guangdong, 510655, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 204900

Nanjing, Jiangsu, 210008, China

Location

The First Affiliated Hospital of Nanchang University /ID# 204092

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University /ID# 206868

Changchun, Jilin, 130021, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091

Shanghai, Shanghai Municipality, 200065, China

Location

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076

Hangzhou, Zhejiang, 310018, China

Location

Beijing Friendship Hospital /ID# 204173

Beijing, 100032, China

Location

The Second Xiangya Hospital of Central South University /ID# 204082

Changsha, 410011, China

Location

Duplicate_Tianjin Med Univ General Hosp /ID# 206994

Tianjin, 300052, China

Location

Tongji Hospital Tongji Medical College of HUST /ID# 204088

Wuhan, 430030, China

Location

Hospital Pablo Tobon Uribe /ID# 202404

Medellín, Antioquia, 50034, Colombia

Location

Hospital Universitario San Vic /ID# 200029

Medellín, 50010, Colombia

Location

Clinical Hospital Dubrava /ID# 171185

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Sestre milosrdnice /ID# 205535

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 171203

Zagreb, City of Zagreb, 10000, Croatia

Location

Poliklinika Solmed /ID# 211519

Zagreb, City of Zagreb, 10000, Croatia

Location

UHC Split /ID# 171191

Split, 21000, Croatia

Location

Zadar General Hospital /ID# 205536

Zadar, 23000, Croatia

Location

Nemocnice Ceske Budejovice a.s. /ID# 224389

České Budějovice, 370 01, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o. /ID# 171401

Hradec Králové, 500 12, Czechia

Location

ARTROSCAN s.r.o. /ID# 200790

Ostrava, 722 00, Czechia

Location

ResTrial s.r.o. /ID# 208653

Prague, 143 00, Czechia

Location

Herlev Hospital /ID# 202423

Herlev, Capital Region, 2730, Denmark

Location

Nordsjaellands Hospital /ID# 202424

Hilleroed, Capital Region, 3600, Denmark

Location

Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425

Hvidovre, Capital Region, 2650, Denmark

Location

Duplicate_Sjaellands Universitets Hospital /ID# 209445

Roskilde, Region Sjælland, 4000, Denmark

Location

Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012

Alexandria, 21131, Egypt

Location

Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013

Alexandria, 21131, Egypt

Location

Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564

Alexandria, 21131, Egypt

Location

National Hepatology and Tropical Medicine Research Institute /ID# 170989

Cairo, 11559, Egypt

Location

Air Force Specialized Hospital /ID# 170996

Cairo, Egypt

Location

National Liver Institute /ID# 170988

Menoufiya, 35111, Egypt

Location

West Tallinn Central Hospital /ID# 202785

Tallinn, 10617, Estonia

Location

CHU Grenoble - Hopital Michallon /ID# 219034

La Tronche, 38700, France

Location

Clinique Jules Verne /ID# 219073

Nantes, 44300, France

Location

CH Valenciennes /ID# 219035

Valenciennes, 59300, France

Location

Universitatsklinikum Mannheim /ID# 168759

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitaetsklinikum Ulm /ID# 203560

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Erlangen /ID# 203552

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Frankfurt /ID# 203566

Frankfurt am Main, Hesse, 60590, Germany

Location

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741

Saarbrücken, Saarland, 66111, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757

Kiel, Schleswig-Holstein, 24105, Germany

Location

Gastroenterologie am Mexikoplatz /ID# 203575

Berlin, 14163, Germany

Location

Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570

Essen, 45239, Germany

Location

Agaplesion Markus Krankenhaus /ID# 168758

Frankfurt am Main, 60431, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 207455

Halle, 06120, Germany

Location

Medizinisches Versorgungszentrum Portal 10 /ID# 200214

Münster, 48155, Germany

Location

General Hospital of Athens Ippokratio /ID# 167045

Athens, Attica, 11527, Greece

Location

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104

Athens, Attica, 11527, Greece

Location

Tzaneio general hospital of Piraeus /ID# 206433

Piraeus, Attica, 18536, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 167044

Heraklion, Crete, 71500, Greece

Location

General Hospital of Thessaloniki Hippokrateio /ID# 208825

Thessaloniki, 54642, Greece

Location

Tuen Mun Hospital /ID# 171218

Hong Kong, Hong Kong

Location

Mohacsi Korhaz /ID# 209441

Mohács, Baranya, 7700, Hungary

Location

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547

Encs, Borsod-Abauj Zemplen county, 3860, Hungary

Location

Debreceni Egyetem Klinikai Kozpont /ID# 216419

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Bugat Pal Korhaz /ID# 201893

Gyöngyös, Heves County, 3200, Hungary

Location

Szent Borbala Korhaz /ID# 209897

Tatabánya, Komárom-Esztergom, 2800, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. /ID# 201892

Budapest, Pest County, 1036, Hungary

Location

Semmelweis Egyetem /ID# 210167

Budapest, 1085, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724

Budapest, 1134, Hungary

Location

Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723

Debrecen, 4031, Hungary

Location

Pest Megyei Flor Ferenc Korhaz /ID# 206154

Kistarcsa, 2143, Hungary

Location

Mentahaz Maganorvosi Kozpont /ID# 201895

Székesfehérvár, 8000, Hungary

Location

Mercy University Hospital /ID# 206511

Cork, T12 WE28, Ireland

Location

Soroka University Medical Center /ID# 169913

Beersheba, Southern District, 8443901, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 204877

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Assaf Harofeh Medical Center /ID# 204872

Be’er Ya‘aqov, 70300, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 169928

Jerusalem, 91120, Israel

Location

Rabin Medical Center /ID# 202636

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center /ID# 170276

Rehovot, 7661041, Israel

Location

Policlinico Universitario Campus Bio-Medico /ID# 168183

Rome, Lazio, 00128, Italy

Location

Azienda Ospedaliera San Camillo Forlanini /ID# 168184

Rome, Lazio, 00152, Italy

Location

Istituto Clinico Humanitas /ID# 168185

Rozzano, Milano, 20089, Italy

Location

Fondazione PTV Policlinico Tor Vergata /ID# 168188

Rome, Roma, 00133, Italy

Location

Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182

Rome, Roma, 00168, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186

Negrar, Verona, 37024, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187

Bologna, 40138, Italy

Location

A.O. Per L'Emergenza Cannizzaro /ID# 168190

Catania, 95126, Italy

Location

Policlinico San Martino/Univer /ID# 168191

Genova, 16132, Italy

Location

ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181

Milan, 20121, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 170849

Milan, 20162, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 201897

Modena, 41124, Italy

Location

A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189

Palermo, 90146, Italy

Location

Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421

Pisa, 56125, Italy

Location

Aichi Medical University Hospital /ID# 165971

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

Nagoya University Hospital /ID# 165969

Nagoya, Aichi-ken, 4668560, Japan

Location

Nagoya City University Hospital /ID# 165970

Nagoya, Aichi-ken, 467-8602, Japan

Location

Toyohashi Municipal Hospital /ID# 200175

Toyohashi, Aichi-ken, 441-8570, Japan

Location

National Hospital Organization Hirosaki General Medical Center /ID# 165961

Hirosaki-shi, Aomori, 036-8545, Japan

Location

Toho University Sakura Medical Center /ID# 165963

Sakura-shi, Chiba, 285-8741, Japan

Location

Fukuoka University Chikushi Hospital /ID# 214404

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Kurume University Hospital /ID# 166012

Kurume-shi, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Takasaki General Medical Center /ID# 167127

Takasaki-shi, Gunma, 370-0829, Japan

Location

NHO Fukuyama Medical Center /ID# 167131

Fukuyama-shi, Hiroshima, 720-8520, Japan

Location

Hiroshima University Hospital /ID# 166014

Hiroshima, Hiroshima, 734-8551, Japan

Location

Asahikawa Medical University Hospital /ID# 167120

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960

Sapporo, Hokkaido, 060-0033, Japan

Location

Sapporo Medical University Hospital /ID# 167124

Sapporo, Hokkaido, 060-8543, Japan

Location

Sapporo IBD Clinic /ID# 223561

Sapporo, Hokkaido, 064-0919, Japan

Location

Aoyama Clinic /ID# 166009

Kobe, Hyōgo, 650-0015, Japan

Location

Hyogo College of Medicine College Hospital /Id# 165973

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Kanazawa University Hospital /ID# 169218

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Iwate Medical University Uchimaru Medical Center /ID# 202464

Morioka, Iwate, 020-8505, Japan

Location

Imamura General Hospital /ID# 227137

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Idzuro Imamura Hospital /ID# 206654

Kagoshima, Kagoshima-ken, 892-0824, Japan

Location

Sameshima Hospital /ID# 206675

Kagoshima, Kagoshima-ken, 892-0846, Japan

Location

Yokohama City University Medical Center /ID# 167128

Yokohama, Kanagawa, 232-0024, Japan

Location

Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972

Kyoto, Kyoto, 605-0981, Japan

Location

Kyoto University Hospital /ID# 169889

Kyoto, Kyoto, 606-8507, Japan

Location

Yokkaichi Hazu Medical Center /ID# 167196

Yokkaichi-shi, Mie-ken, 510-0016, Japan

Location

Tohoku University Hospital /ID# 167122

Sendai, Miyagi, 9808574, Japan

Location

Nara Medical University Hospital /ID# 169219

Kashihara-shi, Nara, 634-8522, Japan

Location

Kenseikai Dongo Hospital /ID# 208104

Yamatotakada-shi, Nara, 635-0022, Japan

Location

Niigata University Medical & Dental Hospital /ID# 170045

Niigata, Niigata, 951-8520, Japan

Location

Ishida Clinic of IBD and Gastroenterology /ID# 167121

Ōita, Oita Prefecture, 870-0823, Japan

Location

Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010

Kurashiki-shi, Okayama-ken, 710-0142, Japan

Location

Okayama University Hospital /ID# 167356

Okayama, Okayama-ken, 700-8558, Japan

Location

Kinshukai Infusion Clinic /ID# 218872

Osaka, Osaka, 530-0011, Japan

Location

Osaka Metropolitan University Hospital /ID# 166015

Osaka, Osaka, 545-8586, Japan

Location

Osaka University Hospital /ID# 169663

Suita-shi, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 206326

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Tokitokai Tokito clinic /ID# 165962

Saitama-shi, Saitama, 336-0963, Japan

Location

Shiga University of Medical Science Hospital /ID# 167129

Ōtsu, Shiga, 520-2192, Japan

Location

Hamamatsu University Hospital /ID# 224352

Hamamatsu, Shizuoka, 431-3192, Japan

Location

NHO Shizuoka Medical Center /ID# 167125

Sunto-gun, Shizuoka, 411-8611, Japan

Location

Tokyo Medical And Dental University Hospital /ID# 165965

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Tokai University Hachioji Hospital /ID# 165967

Hachioji-shi, Tokyo, 192-0032, Japan

Location

The Jikei University Hospital /ID# 167130

Minato-ku, Tokyo, 105-8471, Japan

Location

Kyorin University Hospital /ID# 165966

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Tokyo Women's Medical University Hospital /ID# 205980

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Toyama Prefectural Central Hospital /ID# 217834

Toyama, Toyama, 930-8550, Japan

Location

Japanese Red Cross Wakayama Medical Center /ID# 200643

Wakayama, Wakayama, 640-8558, Japan

Location

Wakayama Medical University Hospital /ID# 169482

Wakayama, Wakayama, 641-8510, Japan

Location

Yamagata University Hospital /ID# 200157

Yamagata, Yamagata, 990-9585, Japan

Location

VCA Polyclinic Aura /ID# 169498

Riga, 1035, Latvia

Location

Pauls Stradins Clinical University Hospital /ID# 169519

Riga, LV- 1002, Latvia

Location

Digestive Disease Center Gastro /ID# 169508

Riga, LV-1079, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santaros Klinikos /ID# 203286

Vilnius, 08661, Lithuania

Location

Hospital Sultanah Bahiyah /ID# 202626

Alor Star, Kedah, 05460, Malaysia

Location

Universiti Sains Malaysia /ID# 200102

Kelantan, Kelantan, 16150, Malaysia

Location

Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773

Kuala Lumpur, Selangor, 56000, Malaysia

Location

Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579

Durango, Durango, 34000, Mexico

Location

Morales Vargas Centro de Investigacion S.C. /ID# 203494

León, Guanajuato, 37000, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238

Guadalajara, Jalisco, 44650, Mexico

Location

Radboud Universitair Medisch Centrum /ID# 166928

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Zuyderland Medisch Centrum /ID# 169700

Heerlen, Limburg, 6419 PC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis /ID# 166929

Amsterdam, 1091 AC, Netherlands

Location

Academisch Medisch Centrum /ID# 166927

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente /ID# 170298

Enschede, 7512 KZ, Netherlands

Location

Malopolskie Centrum Kliniczne /ID# 202167

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Vistamed /ID# 208572

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

Location

Centrum Zdrowia MDM /ID# 200491

Warsaw, Masovian Voivodeship, 00-635, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus /ID# 224301

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Centrum Medyczne Reuma Park /ID# 200490

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245

Guimarães, Braga District, 4835-044, Portugal

Location

Hospital Egas Moniz /ID# 170253

Lisbon, Porto District, 1349-019, Portugal

Location

Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607

Ponte de Lima, Viana do Castelo District, 4990-041, Portugal

Location

Hospital Garcia de Orta, EPE /ID# 170241

Almada, 2805-267, Portugal

Location

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248

Porto, 4200-319, Portugal

Location

Mindful Medical Research /ID# 203358

San Juan, 00918-3756, Puerto Rico

Location

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771

San Juan, 00935, Puerto Rico

Location

Institutul Clinic Fundeni /ID# 167817

Sector 2, București, 022328, Romania

Location

Clinica GASTRO MED SRL /ID# 206369

Cluj-Napoca, Cluj, 400380, Romania

Location

Cabinet Particular Policlinic Algomed /ID# 167818

Timișoara, 300002, Romania

Location

Immanuel Kant Baltic Federal University /ID# 203811

Kaliningrad, Kaliningrad Oblast, 236016, Russia

Location

LLC Medical Center /ID# 209236

Novosibirsk, Novosibirsk Oblast, 630099, Russia

Location

Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990

Perm, Permskiy Kray, 614109, Russia

Location

LLC Novaya Klinika /ID# 206616

Pyatigorsk, Stavropol Kray, 357500, Russia

Location

Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997

Stavropol, Stavropol Kray, 355012, Russia

Location

Kazan State Medical University /ID# 169638

Kazan', Tatarstan, Respublika, 420012, Russia

Location

Olla-Med Clinic /ID# 208720

Moscow, 105554, Russia

Location

P.A. Bayandin Murmansk Regiona /ID# 169639

Murmansk, 183047, Russia

Location

Republican hospital named after V.A. Baranov /ID# 206488

Petrozavodsk, 185019, Russia

Location

Euromedservice /ID# 206610

Pushkin, 196603, Russia

Location

X7 Clinical Research Center /ID# 216350

Saint Petersburg, 194156, Russia

Location

City Clinical Hospital No. 31 /ID# 208868

Saint Petersburg, 197110, Russia

Location

Clinical Hosp Center Zvezdara /ID# 168214

Belgrade, Beograd, 11000, Serbia

Location

Military Medical Academy /ID# 168783

Belgrade, Beograd, 11000, Serbia

Location

University Clinical Center Serbia /ID# 168215

Belgrade, Beograd, 11000, Serbia

Location

Clin Hosp Ctr Bezanijska Kosa /ID# 168750

Belgrade, Beograd, 11080, Serbia

Location

University Clinical Center Kragujevac /ID# 205859

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Clinical Center Vojvodina /ID# 168213

Novi Sad, Vojvodina, 21000, Serbia

Location

KL Ling Gastroenterology and Liver Clinic /ID# 217962

Singapore, 228510, Singapore

Location

Gleneagles Medical Centre /ID# 206531

Singapore, 258499, Singapore

Location

Tan Tock Seng Hospital /ID# 203160

Singapore, 308433, Singapore

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958

Banská Bystrica, 975 17, Slovakia

Location

KM Management, spol. s.r.o. /ID# 170201

Nitra, 949 01, Slovakia

Location

Univ Medical Ctr Ljubljana /ID# 217795

Ljubljana, 1000, Slovenia

Location

Farmovs (Pty) Ltd /Id# 207535

Bloemfontein, Free State, 9301, South Africa

Location

Lenasia Clinical Trial Centre /ID# 205145

Johannesburg, Gauteng, 1820, South Africa

Location

Wits Clinical Research Site /ID# 170852

Johannesburg, Gauteng, 2193, South Africa

Location

Allergy & Immunology (AIU) /ID# 171431

Cape Town, Western Cape, 7700, South Africa

Location

Dr JP Wright /ID# 170887

Cape Town, Western Cape, 7708, South Africa

Location

Private Practice Dr MN Rajabally /ID# 169853

Cape Town, Western Cape, 7800, South Africa

Location

Hayang University GuriHospital /ID# 167587

Guri-si, Gyeonggido, 11923, South Korea

Location

CHA University Bundang Medical Center /ID# 167592

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Kangbuk Samsung Hospital /ID# 167586

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 167590

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Inje University Haeundae Hospital /ID# 202630

Busan, 48108, South Korea

Location

Dong-A University Hospital /ID# 167591

Busan, 49201, South Korea

Location

Pusan National University Hospital /ID# 167589

Busan, 49241, South Korea

Location

Kyungpook National University Hospital /ID# 207019

Daegu, 41944, South Korea

Location

Samsung Medical Center /ID# 167588

Seoul, 06351, South Korea

Location

Chung-Ang University Hostipal /ID# 207018

Seoul, 06973, South Korea

Location

Hospital Universitari Son Espases /ID# 201998

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario de Navarra /ID# 202355

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario A Coruna - CHUAC /ID# 203910

A Coruña, 15006, Spain

Location

Hospital Clinic de Barcelona /ID# 201990

Barcelona, 08036, Spain

Location

Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645

Girona, 17007, Spain

Location

Hospital Juan Ramon Jimenez /ID# 201995

Huelva, 21005, Spain

Location

Hospital Universitario La Paz /ID# 201994

Madrid, 28046, Spain

Location

Hospital Universitario de Salamanca /ID# 206358

Salamanca, 37711, Spain

Location

Hospital Universitario Virgen Macarena /ID# 201993

Seville, 41009, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 209657

Valencia, 46010, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 201992

Valencia, 46026, Spain

Location

Hallands Hospital Halmstad /ID# 170828

Halmstad, Halland County, 302 33, Sweden

Location

Karolinska University Hospital Solna /ID# 224488

Solna, Stockholm County, 171 64, Sweden

Location

Alingsas lasarett /ID# 170826

Alingsås, Västra Götaland County, 441 33, Sweden

Location

Sodra Alvsborgs sjukhus /ID# 203077

Borås, Västra Götaland County, 501 82, Sweden

Location

Sahlgrenska University Hospital /ID# 169171

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Universitätsspital Zürich /ID# 170998

Zurich, Canton of Zurich, 8091, Switzerland

Location

Inselspital, Universitätsspital Bern /ID# 170997

Bern, 3010, Switzerland

Location

China Medical University Hospital /ID# 169791

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital /ID# 169790

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital /ID# 169792

Taipei, 100, Taiwan

Location

Acibadem Kozyatagi Hospital /ID# 209406

Kadıköy, Istanbul, 34742, Turkey (Türkiye)

Location

Erciyes University Medical Fac /ID# 171331

Melikgazi, Kayseri, 38030, Turkey (Türkiye)

Location

Ankara Univ Medical Faculty /ID# 206409

Ankara, 06590, Turkey (Türkiye)

Location

Inonu Universitesi Turgut Ozal /ID# 201268

Battalgazi/malatya, 44280, Turkey (Türkiye)

Location

Mustafa Kemal University Medic /ID# 171336

Hatay, 31001, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty /ID# 171364

Istanbul, 34093, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332

Istanbul, 34899, Turkey (Türkiye)

Location

Mersin University Medical /ID# 171338

Mersin, 33343, Turkey (Türkiye)

Location

Sisli Etfal Train & Res Hosp /ID# 171334

Şişli, 34371, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultes /ID# 217444

Yenimahalle, 06560, Turkey (Türkiye)

Location

Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738

Kyiv, Kyivska Oblast, 01030, Ukraine

Location

Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907

Kharkiv, 61037, Ukraine

Location

Kyiv Municipal Clinical Hospital #18 /ID# 207889

Kyiv, 01030, Ukraine

Location

MNI KRC Kyiv Regional Clinical Hospital /ID# 202454

Kyiv, 04107, Ukraine

Location

Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908

Lviv, 79000, Ukraine

Location

CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110

Vinnytsia, 21028, Ukraine

Location

South Eastern Health and Social Care Trust /ID# 205323

Belfast, Antrim, BT16 1RH, United Kingdom

Location

Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383

Warrington, Cheshire West And Chester, WA5 1QG, United Kingdom

Location

Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086

Warrington, Cheshire West And Chester, WA5 1QG, United Kingdom

Location

Royal United Hospitals Bath /ID# 169074

Bath, BA1 3NG, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 169070

Birmingham, B15 2TH, United Kingdom

Location

The Dudley Group NHS Foundation Trust /ID# 169069

Dudley, DY1 2HQ, United Kingdom

Location

King's College Hospital NHS Foundation Trust /ID# 169072

London, SE5 9RS, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Stockport NHS foundation trust /ID# 208719

Stockport, SK2 7JE, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust /ID# 209665

Taunton, TA1 5DA, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust /ID# 205552

Tooting, SW17 0QT, United Kingdom

Location

The Royal Wolverhampton NHS Trust /ID# 171382

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (7)

  • 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.

  • Dubinsky MC, D'Haens G, Dewit O, Juillerat P, Panaccione R, Fujii T, Dubcenco E, Lacerda AP, Anyanwu SI, Ford S, Cunneen C, Fish I, Joshi N, Garrison A, Loftus EV. Efficacy and Safety with Upadacitinib by Baseline Corticosteroid Use in Patients with Moderately to Severely Active Crohn's Disease. Inflamm Bowel Dis. 2025 Nov 4:izaf250. doi: 10.1093/ibd/izaf250. Online ahead of print.

  • 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.

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

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

November 15, 2017

First Posted

November 17, 2017

Study Start

December 7, 2017

Primary Completion

October 15, 2021

Study Completion

January 13, 2022

Last Updated

November 23, 2022

Results First Posted

November 23, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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, analyses plans, 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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
More information

Locations