NCT03345836

Brief Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants 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
624

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2017

Typical duration for phase_3

Geographic Reach
44 countries

414 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
12 days until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

July 1, 2022

Enrollment Period

3.7 years

First QC Date

November 15, 2017

Results QC Date

July 18, 2022

Last Update Submit

July 18, 2022

Conditions

Keywords

UpadacitinibCrohn's DiseaseEfficacySafety

Outcome Measures

Primary Outcomes (3)

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

    The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI \<150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).

    Week 12

  • Percentage of Participants With Endoscopic Response at Week 12

    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 of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.

    Baseline to Week 12

  • Number of Participants With Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

    From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

Secondary Outcomes (10)

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

    Baseline to Week 12

  • Percentage of Participants With Endoscopic Remission at Week 12

    Baseline to Week 12

  • Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline

    Week 12

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score 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

  • +5 more secondary outcomes

Study Arms (6)

Part 1 (Double-blind): Placebo

PLACEBO COMPARATOR

Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.

Drug: Matching Placebo for Upadacitinib

Part 1 (Double-blind): Upadacitinib 45 mg

EXPERIMENTAL

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.

Drug: Upadacitinib

Part 2 (Open-label): Upadacitinib 45 mg

EXPERIMENTAL

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.

Drug: Upadacitinib

Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo

EXPERIMENTAL

Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.

Drug: Upadacitinib

Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg

EXPERIMENTAL

Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.

Drug: Upadacitinib

Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg

EXPERIMENTAL

Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.

Drug: Upadacitinib

Interventions

Matching placebo tablets

Part 1 (Double-blind): Placebo

Upadacitinib tablets

Also known as: ABT-494, RINVOQ®
Part 1 (Double-blind): Upadacitinib 45 mgPart 2 (Open-label): Upadacitinib 45 mgPart 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mgPart 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB PlaceboPart 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg

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 any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • 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, or any other manifestation that might require surgery while enrolled in the study.
  • Participant with ostomy or ileoanal pouch.
  • Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
  • Screening laboratory and other protocol pre-specified analyses show abnormal results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (428)

East View Medical Research, LLC /ID# 171133

Mobile, Alabama, 36606, United States

Location

CB Flock Research Corporation /ID# 166220

Mobile, Alabama, 36608, United States

Location

Delsol Research Management, Ll /Id# 170179

Chandler, Arizona, 85224, United States

Location

HonorHealth Research Institute - Shea /ID# 164734

Scottsdale, Arizona, 85258, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891

Sun City, Arizona, 85306, United States

Location

Southern California Res. Ctr. /ID# 169654

Coronado, California, 92118-1408, United States

Location

Citrus Valley Gastroenterology /ID# 166201

Covina, California, 91722-3797, United States

Location

United Medical Doctors /ID# 207452

Los Alamitos, California, 90720-3309, United States

Location

Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887

Los Angeles, California, 90067-2001, United States

Location

Facey Medical Foundation /ID# 203137

Mission Hills, California, 91345, United States

Location

United Medical Doctors - Murrieta /ID# 164845

Murrieta, California, 92563, United States

Location

Ucsd /Id# 164679

San Diego, California, 92103, United States

Location

Medical Assoc Research Grp /ID# 169705

San Diego, California, 92123, United States

Location

UCSF Center for Colitis and Crohn's Disease /ID# 202373

San Francisco, California, 94115-3011, United States

Location

Univ of California San Francis /ID# 164843

San Francisco, California, 94158, United States

Location

Care Access Research /ID# 167766

San Pablo, California, 94806, United States

Location

Peak Gastroenterology Associates, PC /ID# 170181

Colorado Springs, Colorado, 80907, United States

Location

Delta Waves, Inc. /ID# 164872

Colorado Springs, Colorado, 80918, United States

Location

Duplicate_Western States Clinical Research, Inc. /ID# 164895

Wheat Ridge, Colorado, 80033-2896, United States

Location

Medical Research Center of CT /ID# 164829

Hamden, Connecticut, 06518, United States

Location

Clinical Research of West Florida, Inc /ID# 205825

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida, Inc /ID# 208117

Clearwater, Florida, 33765, United States

Location

Advanced Research - Coral Springs /ID# 218020

Coral Springs, Florida, 33067-3173, United States

Location

Encore Borland-Groover Clinical Research /Id# 203498

Jacksonville, Florida, 32256, United States

Location

Ctr for Advanced Gastroenterol /ID# 165332

Maitland, Florida, 32751-6108, United States

Location

Crystal Pharmacology Research /ID# 166101

Miami, Florida, 33165, United States

Location

Coral Research Clinic /ID# 164657

Miami, Florida, 33186-4643, United States

Location

Advanced Research Institute, Inc /ID# 164814

New Port Richey, Florida, 34653, United States

Location

Endoscopic Research, Inc. /ID# 205893

Orlando, Florida, 32803, United States

Location

Omega Research Maitland, LLC /ID# 203480

Orlando, Florida, 32810-2907, United States

Location

Clinical Research Trials of Florida, Inc. /ID# 203484

Tampa, Florida, 33607, United States

Location

AdventHealth Tampa /ID# 171175

Tampa, Florida, 33613-4680, United States

Location

Gastroenterology Associates of Central Georgia, LLC /ID# 165460

Macon, Georgia, 31201, United States

Location

Gastroenterology Consultants PC - Roswell /ID# 218219

Roswell, Georgia, 30076-4913, United States

Location

Atlanta Gastroenterology Spec /ID# 164780

Suwanee, Georgia, 30024, United States

Location

University of Chicago Medicine /ID# 165472

Chicago, Illinois, 60637-1426, United States

Location

DuPage Medical Group /ID# 205303

Downers Grove, Illinois, 60515-5509, United States

Location

MediSphere Medical Research Center /ID# 166209

Evansville, Indiana, 47714-8011, United States

Location

Indianapolis Gastroenterology /ID# 164837

Indianapolis, Indiana, 46237, United States

Location

Aquiant Research /ID# 205504

New Albany, Indiana, 47150-4053, United States

Location

University of Iowa Hospitals and Clinics /ID# 165330

Iowa City, Iowa, 52242, United States

Location

Tri-State Gastroenterology /ID# 165484

Crestview Hills, Kentucky, 41017, United States

Location

University of Louisville /ID# 168536

Louisville, Kentucky, 40202, United States

Location

University of Louisville /ID# 208093

Louisville, Kentucky, 40202, United States

Location

CroNOLA, LLC /ID# 164722

Houma, Louisiana, 70360, United States

Location

Nola Research Works, LLC /ID# 164897

New Orleans, Louisiana, 70115, United States

Location

Louisana Research Center, LLC /ID# 164659

Shreveport, Louisiana, 71105-6800, United States

Location

Johns Hopkins University School of Medicine /ID# 211940

Baltimore, Maryland, 21287-0010, United States

Location

MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835

Chevy Chase, Maryland, 20815, United States

Location

Gastro Center of Maryland /ID# 171171

Columbia, Maryland, 21045, United States

Location

Lahey Hospital and Medical Center /ID# 214725

Burlington, Massachusetts, 01805, United States

Location

University of Michigan Health Systems /ID# 164844

Ann Arbor, Michigan, 48109, United States

Location

Clin Res Inst of Michigan, LLC /ID# 170178

Chesterfield, Michigan, 48047, United States

Location

Digestive Health Associates (DHA) - Farmington Hills /ID# 206099

Farmington Hills, Michigan, 48334-3230, United States

Location

Center for Digestive Health /ID# 164733

Troy, Michigan, 48098-6363, United States

Location

Mayo Clinic - Rochester /ID# 164868

Rochester, Minnesota, 55905-0001, United States

Location

Southern Therapy and Advanced Research (STAR) LLC /ID# 165318

Jackson, Mississippi, 39216, United States

Location

Quality Clinical Research Inc. /ID# 170177

Omaha, Nebraska, 68114-3723, United States

Location

CHI Health Research Center /ID# 168545

Omaha, Nebraska, 68124, United States

Location

Las Vegas Medical Research /ID# 168562

Las Vegas, Nevada, 89113, United States

Location

AGA Clinical Research Associates, LLC /ID# 164883

Egg Harbor, New Jersey, 08234, United States

Location

Rutgers Robert Wood Johnson /ID# 166092

New Brunswick, New Jersey, 08901, United States

Location

NY Scientific /ID# 164833

Brooklyn, New York, 11235, United States

Location

NYU Langone Long Island Clinical Research Associates /ID# 164830

Lake Success, New York, 11042, United States

Location

The Mount Sinai Hospital /ID# 170172

New York, New York, 10029, United States

Location

Columbia Univ Medical Center /ID# 164870

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

Location

Gastro Group of Rochester /ID# 166216

Rochester, New York, 14618-5703, United States

Location

Richmond University Medical Center /ID# 201855

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

Location

Montefiore Medical Center - Moses Campus /ID# 166226

The Bronx, New York, 10467, United States

Location

Advantage Clinical Trials /ID# 168557

The Bronx, New York, 10468, United States

Location

Atrium Health Carolinas Medical Center /ID# 164834

Charlotte, North Carolina, 28203, United States

Location

PMG Research of Charlotte /ID# 171170

Charlotte, North Carolina, 28209, United States

Location

Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663

Raleigh, North Carolina, 27612, United States

Location

Wake Forest Baptist Medical Center /ID# 201225

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

Location

Plains Clinical Research Center, LLC /ID# 170184

Fargo, North Dakota, 58104-5925, United States

Location

Consultants for Clinical Research /ID# 164855

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati /ID# 164720

Cincinnati, Ohio, 45267-0585, United States

Location

Cleveland Clinic Main Campus /ID# 208220

Cleveland, Ohio, 44195, United States

Location

The Ohio State University /ID# 170174

Columbus, Ohio, 43210, United States

Location

Optimed Research, Ltd. /ID# 205618

Columbus, Ohio, 43235, United States

Location

Hometown Urgent Care and Resea /ID# 201290

Dayton, Ohio, 45424, United States

Location

Dayton Gastroenterology, Inc. /ID# 167624

Englewood, Ohio, 45415, United States

Location

Great Lakes Medical Research, LLC /ID# 202007

Mentor, Ohio, 44060-6211, United States

Location

Digestive Disease Specialists /ID# 201062

Oklahoma City, Oklahoma, 73112, United States

Location

Options Health Research, LLC /ID# 164737

Tulsa, Oklahoma, 74104, United States

Location

Healthcare Research Consultant /ID# 166228

Tulsa, Oklahoma, 74135, United States

Location

University of Pennsylvania /ID# 168402

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Thomas Jefferson University /ID# 168014

Philadelphia, Pennsylvania, 19107-4414, United States

Location

Pharmacorp Clinical Trials /ID# 164809

Charleston, South Carolina, 29412, United States

Location

Gastroenterology Associates, P.A. of Greenville /ID# 164880

Greenville, South Carolina, 29615-3593, United States

Location

Rapid City Medical Center - GI Research /ID# 201734

Rapid City, South Dakota, 57701, United States

Location

Gastro One /ID# 164718

Germantown, Tennessee, 38138, United States

Location

East Tennessee Research Institute /ID# 203612

Johnson City, Tennessee, 37604, United States

Location

Quality Medical Research /ID# 205262

Nashville, Tennessee, 37211, United States

Location

Vanderbilt University Medical Center /ID# 164846

Nashville, Tennessee, 37232-0011, United States

Location

TX Clinical Research Institute /ID# 164848

Arlington, Texas, 76012, United States

Location

Inquest Clinical Research /ID# 164865

Baytown, Texas, 77521-2415, United States

Location

Texas Digestive Disease Consultants /ID# 209952

Cedar Park, Texas, 78613-5028, United States

Location

Texas Digestive Disease Consultants /ID# 209802

Cedar Park, Texas, 78613, United States

Location

CliniCore International, LLC /ID# 164662

Houston, Texas, 77027-6812, United States

Location

Baylor College of Medicine - Baylor Medical Center /ID# 164847

Houston, Texas, 77030-3411, United States

Location

Centex Studies, Inc. - Houston /ID# 201213

Houston, Texas, 77058, United States

Location

GI Specialists of Houston /ID# 202338

Houston, Texas, 77070-4347, United States

Location

Caprock Gastro Research /ID# 215437

Lubbock, Texas, 79424-3017, United States

Location

Clinical Associates in Research Therapeutics of America, LLC /ID# 164863

San Antonio, Texas, 78212, United States

Location

Southern Star Research Institute, LLC /ID# 169754

San Antonio, Texas, 78229-5390, United States

Location

Carl R. Meisner Medical Clinic /ID# 201060

Sugar Land, Texas, 77478, United States

Location

Tyler Research Institute, LLC /ID# 168681

Tyler, Texas, 75701-4464, United States

Location

Gastro Health & Nutrition - Victoria /ID# 167813

Victoria, Texas, 77904, United States

Location

HP Clinical Research /ID# 164929

Bountiful, Utah, 84010, United States

Location

Advanced Research Institute /ID# 164866

Ogden, Utah, 84403, United States

Location

Duplicate_Care Access Research /ID# 164853

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

Location

Velocity Clinical Research - Salt Lake City /ID# 166095

West Jordan, Utah, 84088, United States

Location

Washington Gastroenterology Associates /ID# 164721

Bellevue, Washington, 98004, United States

Location

Virginia Mason - Seattle Orthapedics /ID# 164680

Seattle, Washington, 98101, United States

Location

University of Washington /ID# 164875

Seattle, Washington, 98109, United States

Location

The Vancouver Clinic, INC. PS /ID# 164811

Vancouver, Washington, 98664, United States

Location

Froedtert Memorial Lutheran Hospital /ID# 202286

Milwaukee, Wisconsin, 53226-3522, United States

Location

Allegiance Research Specialists /ID# 165321

Wauwatosa, Wisconsin, 53226, United States

Location

Cardio Alem /ID# 211284

San Isidro, Buenos Aires, 1642, Argentina

Location

Hospital Italiano de Buenos Aires /ID# 215543

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

Location

Gedyt /ID# 210019

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

Location

Cemic /Id# 169184

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

Location

Hospital Provincial del Centenario /ID# 171254

Rosario, Santa Fe Province, 2000, Argentina

Location

Hospital Privado Univesitario /ID# 169228

Córdoba, 5016, Argentina

Location

Concord Repatriation General Hospital /ID# 171509

Concord, New South Wales, 2139, Australia

Location

Coral Sea Clinical Research institute /ID# 212987

North Mackay, Queensland, 4740, Australia

Location

Mater Misericordiae Limited /ID# 204908

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital /ID# 171511

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital /ID# 203734

Box Hill, Victoria, 3128, Australia

Location

Fiona Stanley Hospital /ID# 171510

Murdoch, Western Australia, 6150, Australia

Location

Klinik Landstrasse /ID# 203437

Vienna, Vienna, 1030, Austria

Location

Medizinische Universitaet Wien /ID# 169462

Vienna, Vienna, 1090, Austria

Location

Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467

Salzburg, 5020, Austria

Location

UCL Saint-Luc /ID# 200297

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

Location

CHU de Liege Sart Tilman /ID# 200299

Liège, Liege, 4000, Belgium

Location

CHU UCL Namur - site Godinne /ID# 200300

Godinne, Namur, 5530, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 200298

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Lucas /ID# 200301

Ghent, 9000, Belgium

Location

University Clinical Centre of the Republic of Srpska /ID# 208050

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla /ID# 210324

Tuzla, Tuzlanski, 75000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo /ID# 203885

Sarajevo, 71000, Bosnia and Herzegovina

Location

Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841

Sarajevo, 71000, Bosnia and Herzegovina

Location

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870

Goiânia, Goiás, 74535-170, Brazil

Location

Hospital Nossa Senhora das Graças /ID# 166869

Curitiba, Paraná, 80810-040, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 166872

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

Location

Upeclin Fmb - Unesp /Id# 166876

Botucatu, São Paulo, 18618-686, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Faculdade de Medicina do ABC /ID# 208327

Santo André, São Paulo, 09060-870, Brazil

Location

Kaiser Clinica e Hospital Dia /ID# 166873

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

Location

UMHAT Kaspela EOOD /ID# 167617

Plovdiv, 4001, Bulgaria

Location

Duplicate_Second MHAT Sofia /ID# 167618

Sofia, 1202, Bulgaria

Location

MHAT Trakia /ID# 201678

Stara Zagora, 6004, Bulgaria

Location

University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963

Calgary, Alberta, T2N 4Z6, Canada

Location

Allen Whey Khye Lim Professional Corporation /ID# 168041

Edmonton, Alberta, T5R 1W2, Canada

Location

Covenant Health /ID# 166966

Edmonton, Alberta, T6K 4B2, Canada

Location

Fraser Clinical Trials Inc /ID# 166957

New Westminster, British Columbia, V3L 3W4, Canada

Location

GIRI Gastrointestinal Research Institute /ID# 166964

Vancouver, British Columbia, V6Z 2K5, Canada

Location

QEII - Health Sciences Centre /ID# 169306

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Medicor Research Inc /ID# 166967

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

Scott Shulman Medicine Professional Corporation /ID# 169064

North Bay, Ontario, P1B 2H3, Canada

Location

Taunton Surgical Centre /ID# 168039

Oshawa, Ontario, L1H 7K4, Canada

Location

The Ottawa Hospital /ID# 212413

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Digestive Disease Asso /ID# 166961

Vaughan, Ontario, L4L 4Y7, Canada

Location

CHAU- Hotel-Dieu de Levis /ID# 166958

Lévis, Quebec, G6V 3Z1, Canada

Location

Crchum /Id# 170121

Montreal, Quebec, H2X 0A9, Canada

Location

Montreal General Hospital - McGill University Health Center /ID# 170010

Montreal, Quebec, H3G 1A4, Canada

Location

CIUSSS de l'Estrie - CHUS /ID# 170935

Sherbrooke, Quebec, J1G 2E8, Canada

Location

M y F Estudios Clínicos /ID# 169995

Santiago, Region Metropolitana Santiago, 7750495, Chile

Location

Research Group /ID# 203180

Santiago, Santiago Metropolitan, 2540364, Chile

Location

Hospital Guillermo Grant Benavente de Concepción /ID# 212422

Concepción, 4070038, Chile

Location

CTR Estudios Clinicos /ID# 200650

Providencia, 7500571, Chile

Location

Hospital Clinico Universidad De Los Andes /ID# 207465

Santiago, 7501504, Chile

Location

Zhongshan Hospital Xiamen University /ID# 204985

Fujian, Anhui, 361004, China

Location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226

Guangzhou, Guangdong, 510120, China

Location

The Sixth Affiliated Hosp Sun /ID# 204049

Guangzhou, Guangdong, 510655, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 204869

Nanjing, Jiangsu, 210008, China

Location

The First Affiliated Hospital of Nanchang University /ID# 204070

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University /ID# 206867

Changchun, Jilin, 130021, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072

Shanghai, Shanghai Municipality, 200065, China

Location

The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068

Hangzhou, Zhejiang, 310018, China

Location

Beijing Friendship Hospital /ID# 204536

Beijing, 100032, China

Location

The Second Hospital Central South University /ID# 204075

Changsha, 410011, China

Location

Nanfang Hospital of Southern Medical University /ID# 204074

Guangzhou, 510080, China

Location

Duplicate_Tianjin Med Univ General Hosp /ID# 206993

Tianjin, 300052, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069

Wuhan, 430030, China

Location

Hospital Pablo Tobon Uribe /ID# 202405

Medellín, Antioquia, 50034, Colombia

Location

Hospital San Vicente de Paul /ID# 200028

Medellín, Antioquia, 50034, Colombia

Location

Clinical Hospital Dubrava /ID# 171186

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Sestre milosrdnice /ID# 171190

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 171201

Zagreb, City of Zagreb, 10000, Croatia

Location

Poliklinika Solmed /ID# 211518

Zagreb, City of Zagreb, 10000, Croatia

Location

UHC Split /ID# 171206

Split, 21000, Croatia

Location

Zadar General Hospital /ID# 205534

Zadar, 23000, Croatia

Location

Hepato-Gastroenterologie HK, s.r.o. /ID# 171566

Hradec Králové, 500 12, Czechia

Location

ResTrial s.r.o. /ID# 208652

Prague, 143 00, Czechia

Location

ARTROSCAN s.r.o. /ID# 171592

Třebovice, 722 00, Czechia

Location

Nordsjaellands Hospital /ID# 200613

Frederikssund, Capital Region, 3600, Denmark

Location

Herlev Hospital /ID# 200782

Herlev, Capital Region, 2730, Denmark

Location

Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611

Hvidovre, Capital Region, 2650, Denmark

Location

Duplicate_Sjaellands Universitets Hospital /ID# 200783

Roskilde, Region Sjælland, 4000, Denmark

Location

Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010

Alexandria, 21131, Egypt

Location

Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015

Alexandria, 21131, Egypt

Location

Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557

Cairo, 11559, Egypt

Location

National Hepatology and Tropical Medicine Research Institute /ID# 170990

Cairo, 11559, Egypt

Location

Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565

Cairo, 11566, Egypt

Location

Air Force Specialized Hospital /ID# 170995

Cairo, Egypt

Location

Tartu University Hospital /ID# 203140

Tartu, Tartu, 50406, Estonia

Location

Chu de Nice-Hopital L'Archet Ii /Id# 171009

Nice, Alpes-Maritimes, 06200, France

Location

HCL - Hôpital Lyon Sud /ID# 171014

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

Location

CHU Bordeaux - Hopital Haut Lévêque /ID# 207414

Pessac, Gironde, 33604, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 206539

Lille, Hauts-de-France, 59037, France

Location

Duplicate_Hopital Saint Eloi /ID# 170646

Montpellier, Herault, 34295, France

Location

CHRU Nancy - Hôpitaux de Brabois /ID# 170985

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

CHU de SAINT ETIENNE - Hopital Nord /ID# 171018

Saint Priest EN Jarez, Pays de la Loire Region, 42270, France

Location

CHU Amiens-Picardie Site Sud /ID# 171016

Amiens, Somme, 80054, France

Location

CHRU Tours - Hopital Trousseau /ID# 169786

Chambray-lès-Tours, 37170, France

Location

Duplicate_CHU Henri Mondor /ID# 169787

Créteil, 94000, France

Location

Polyclinique Grand Sud /ID# 170649

Nîmes, 30932, France

Location

CHU Toulouse - Hopital Rangueil /ID# 169785

Toulouse, 31400, France

Location

Hopital Beaujon /ID# 171011

Clichy, Île-de-France Region, 92110, France

Location

Universitatsklinikum Mannheim /ID# 168778

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitaetsklinikum Ulm /ID# 203563

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Erlangen /ID# 203551

Erlangen, Bavaria, 91054, Germany

Location

Universitaetsklinikum Frankfurt /ID# 203565

Frankfurt am Main, Hesse, 60590, Germany

Location

Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740

Saarbrücken, Saarland, 66111, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067

Berlin, 12203, Germany

Location

Gastroenterologie am Mexikoplatz /ID# 203573

Berlin, 14163, Germany

Location

Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571

Essen, 45239, Germany

Location

Agaplesion Markus Krankenhaus /ID# 168777

Frankfurt am Main, 60431, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 207454

Halle, 06120, Germany

Location

Medizinisches Versorgungszentrum Portal 10 /ID# 200213

Münster, 48155, Germany

Location

General Hospital of Athens Ippokratio /ID# 167036

Athens, Attica, 11527, Greece

Location

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103

Athens, Attica, 11527, Greece

Location

Tzaneio general hospital of Piraeus /ID# 206432

Piraeus, Attica, 18536, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 167035

Heraklion, Crete, 71500, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037

Athens, 10676, Greece

Location

Genl Hosp Thess Ippokrateio /ID# 208824

Thessaloniki, 54642, Greece

Location

Queen Mary Hospital /ID# 171217

Hong Kong, 999077, Hong Kong

Location

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

Bugat Pal Korhaz /ID# 201889

Gyöngyös, Heves County, 3200, Hungary

Location

Obudai Egeszsegugyi Centrum Kft. /ID# 201891

Budapest, Pest County, 1036, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719

Budapest, 1134, Hungary

Location

Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720

Debrecen, 4031, Hungary

Location

Mentahaz Maganorvosi Kozpont /ID# 201890

Székesfehérvár, 8000, Hungary

Location

Mercy University Hospital /ID# 206510

Cork, T12 WE28, Ireland

Location

Soroka University Medical Center /ID# 169912

Beersheba, Southern District, 8443901, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 204876

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Barzilai Medical Center /ID# 223372

Ashkelon, 7830604, Israel

Location

Assaf Harofeh Medical Center /ID# 204870

Be’er Ya‘aqov, 70300, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 169927

Jerusalem, 91120, Israel

Location

Rabin Medical Center /ID# 202635

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center /ID# 170277

Rehovot, 7661041, Israel

Location

University of Catanzaro /ID# 201920

Catanzaro, Calabria, 88100, Italy

Location

Policlinico Universitario Campus Bio-Medico /ID# 168169

Rome, Lazio, 00128, Italy

Location

Azienda Ospedaliera San Camillo Forlanini /ID# 168170

Rome, Lazio, 00152, Italy

Location

Istituto Clinico Humanitas /ID# 168171

Rozzano, Milano, 20089, Italy

Location

Fondazione PTV Policlinico Tor Vergata /ID# 168174

Rome, Roma, 00133, Italy

Location

Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168

Rome, Roma, 00168, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172

Negrar, Verona, 37024, Italy

Location

A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173

Bologna, 40138, Italy

Location

A.O. Per L'Emergenza Cannizzaro /ID# 168176

Catania, 95126, Italy

Location

Policlinico San Martino/Univer /ID# 168177

Genova, 16132, Italy

Location

ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167

Milan, 20121, Italy

Location

Azienda Ospedaliero-Universitaria di Modena /ID# 200008

Modena, 41124, Italy

Location

A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175

Palermo, 90146, Italy

Location

Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420

Pisa, 56125, Italy

Location

Aichi Medical University Hospital /ID# 165957

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

Location

Nagoya University Hospital /ID# 165955

Nagoya, Aichi-ken, 4668560, Japan

Location

Nagoya City University Hospital /ID# 165956

Nagoya, Aichi-ken, 467-8602, Japan

Location

Toyohashi Municipal Hospital /ID# 200174

Toyohashi, Aichi-ken, 441-8570, Japan

Location

Hirosaki National Hospital /ID# 165944

Hirosaki-shi, Aomori, 036-8545, Japan

Location

Toho University Sakura Medical Center /ID# 165949

Sakura-shi, Chiba, 285-8741, Japan

Location

Kurume University Hospital /ID# 166004

Kurume-shi, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Takasaki General Medical Center /ID# 167136

Takasaki-shi, Gunma, 370-0829, Japan

Location

NHO Fukuyama Medical Center /ID# 167139

Fukuyama-shi, Hiroshima, 720-8520, Japan

Location

Hiroshima University Hospital /ID# 166006

Hiroshima, Hiroshima, 734-8551, Japan

Location

Asahikawa Medical University Hospital /ID# 167133

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943

Sapporo, Hokkaido, 060-0033, Japan

Location

Sapporo Medical University Hospital /ID# 167137

Sapporo, Hokkaido, 060-8543, Japan

Location

Aoyama Clinic /ID# 166001

Kobe, Hyōgo, 650-0015, Japan

Location

Hyogo College of Medicine College Hospital /Id# 200173

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Kanazawa University Hospital /ID# 169215

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Iwate Medical University Uchimaru Medical Center /ID# 202407

Morioka, Iwate, 020-8505, Japan

Location

Imamura General Hospital /ID# 227136

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Idzuro Imamura Hospital /ID# 206651

Kagoshima, Kagoshima-ken, 892-0824, Japan

Location

Sameshima Hospital /ID# 206674

Kagoshima, Kagoshima-ken, 892-0846, Japan

Location

Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958

Kyoto, Kyoto, 605-0981, Japan

Location

Kyoto University Hospital /ID# 169888

Kyoto, Kyoto, 606-8507, Japan

Location

Yokkaichi Hazu Medical Center /ID# 167191

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

Location

Tohoku University Hospital /ID# 167135

Sendai, Miyagi, 9808574, Japan

Location

Nara Medical University Hospital /ID# 169216

Kashihara-shi, Nara, 634-8522, Japan

Location

Kenseikai Dongo Hospital /ID# 208103

Yamatotakada-shi, Nara, 635-0022, Japan

Location

Niigata University Medical & Dental Hospital /ID# 170044

Niigata, Niigata, 951-8520, Japan

Location

Ishida Clinic of IBD and Gastroenterology /ID# 167134

Ōita, Oita Prefecture, 870-0823, Japan

Location

Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002

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

Location

Okayama University Hospital /ID# 167355

Okayama, Okayama-ken, 700-8558, Japan

Location

Kinshukai Infusion Clinic /ID# 218871

Osaka, Osaka, 530-0011, Japan

Location

Osaka City University Hospital /ID# 166007

Osaka, Osaka, 545-8586, Japan

Location

Osaka University Hospital /ID# 169662

Suita-shi, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 206324

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Tokitokai Tokito clinic /ID# 165945

Saitama-shi, Saitama, 336-0963, Japan

Location

Shiga University of Medical Science Hospital /ID# 167141

Ōtsu, Shiga, 520-2192, Japan

Location

NHO Shizuoka Medical Center /ID# 167138

Sunto-gun, Shizuoka, 411-8611, Japan

Location

Tokyo Medical And Dental University, Medical Hospital /ID# 165948

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Duplicate_Tokai University Hachioji Hospital /ID# 165951

Hachioji-shi, Tokyo, 192-0032, Japan

Location

The Jikei University Hospital /ID# 167142

Minato-ku, Tokyo, 105-8471, Japan

Location

Kyorin University Hospital /ID# 165950

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Tokyo Women's Medical University Hospital /ID# 205981

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Toyama Prefectural Central Hospital /ID# 217833

Toyama, Toyama, 930-8550, Japan

Location

Japanese Red Cross Wakayama Medical Center /ID# 200638

Wakayama, Wakayama, 640-8558, Japan

Location

Wakayama Medical University Hospital /ID# 169481

Wakayama, Wakayama, 641-8510, Japan

Location

Yamagata University Hospital /ID# 200156

Yamagata, Yamagata, 990-9585, Japan

Location

Pauls Stradins Clinical University Hospital /ID# 169493

Riga, 1002, Latvia

Location

Digestive Disease Center Gastro /ID# 169517

Riga, LV-1079, Latvia

Location

Riga East Clinical University Hospital /ID# 169496

Riga, LV-1079, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santaros Klinikos /ID# 203285

Vilnius, 08661, Lithuania

Location

Hospital Sultanah Bahiyah /ID# 202627

Alor Star, Kedah, 05460, Malaysia

Location

Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778

Kuala Lumpur, Selangor, 56000, Malaysia

Location

Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143

Durango, Durango, 34000, Mexico

Location

Morales Vargas Centro de Investigacion S.C. /ID# 203495

León, Guanajuato, 37000, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779

Guadalajara, Jalisco, 44650, Mexico

Location

Radboud Universitair Medisch Centrum /ID# 166925

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Zuyderland Medisch Centrum /ID# 169698

Heerlen, Limburg, 6419 PC, Netherlands

Location

Academisch Medisch Centrum /ID# 166924

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente /ID# 170297

Enschede, 7512 KZ, Netherlands

Location

Malopolskie Centrum Kliniczne /ID# 202166

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Vistamed /ID# 208570

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

Location

Centrum Zdrowia MDM /ID# 200486

Warsaw, Masovian Voivodeship, 00-635, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus /ID# 224300

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Centrum Medyczne Reuma Park w Warszawie /ID# 200488

Warsaw, Masovian Voivodeship, 02-691, Poland

Location

Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225

Guimarães, Braga District, 4835-044, Portugal

Location

Hospital Egas Moniz /ID# 170249

Lisbon, Porto District, 1349-019, Portugal

Location

Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606

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

Location

Hospital Garcia de Orta, EPE /ID# 170234

Almada, 2805-267, Portugal

Location

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231

Porto, 4200-319, Portugal

Location

Mindful Medical Research /ID# 203357

San Juan, 00918-3756, Puerto Rico

Location

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770

San Juan, 00935, Puerto Rico

Location

Institutul Clinic Fundeni /ID# 167826

Sector 2, București, 022328, Romania

Location

Clinica GASTRO MED SRL /ID# 206367

Cluj-Napoca, Cluj, 400380, Romania

Location

Cabinet Particular Policlinic Algomed /ID# 167827

Timișoara, 300002, Romania

Location

Immanuel Kant Baltic Federal University /ID# 202128

Kaliningrad, Kaliningrad Oblast, 236016, Russia

Location

LLC Medical Center /ID# 209233

Novosibirsk, Novosibirsk Oblast, 630099, Russia

Location

Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988

Perm, Permskiy Kray, 614109, Russia

Location

LLC Novaya Klinika /ID# 206615

Pyatigorsk, Stavropol Kray, 357500, Russia

Location

Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995

Stavropol, Stavropol Kray, 355012, Russia

Location

Kazan State Medical University /ID# 169574

Kazan', Tatarstan, Respublika, 420012, Russia

Location

Olla-Med Clinic /ID# 208721

Moscow, 105554, Russia

Location

P.A. Bayandin Murmansk Regiona /ID# 169575

Murmansk, 183047, Russia

Location

Republican hospital named after V.A. Baranov /ID# 206487

Petrozavodsk, 185019, Russia

Location

Euromedservice /ID# 206609

Pushkin, 196603, Russia

Location

X7 Clinical Research Center /ID# 216349

Saint Petersburg, 194156, Russia

Location

City Clinical Hospital No. 31 /ID# 208870

Saint Petersburg, 197110, Russia

Location

Clinical Hosp Center Zvezdara /ID# 168221

Belgrade, Beograd, 11000, Serbia

Location

Military Medical Academy /ID# 168784

Belgrade, Beograd, 11000, Serbia

Location

University Clinical Center Serbia /ID# 168220

Belgrade, Beograd, 11000, Serbia

Location

Clin Hosp Ctr Bezanijska Kosa /ID# 168799

Belgrade, Beograd, 11080, Serbia

Location

University Clinical Center Kragujevac /ID# 205858

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Clinical Center Vojvodina /ID# 168222

Novi Sad, Vojvodina, 21000, Serbia

Location

KL Ling Gastroenterology and Liver Clinic /ID# 217963

Singapore, 228510, Singapore

Location

Gleneagles Medical Centre /ID# 206530

Singapore, 258499, Singapore

Location

Tan Tock Seng Hospital /ID# 203159

Singapore, 308433, Singapore

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952

Banská Bystrica, 975 17, Slovakia

Location

KM Management, spol. s.r.o. /ID# 170199

Nitra, 949 01, Slovakia

Location

Univ Medical Ctr Ljubljana /ID# 211042

Ljubljana, 1000, Slovenia

Location

Farmovs (Pty) Ltd /Id# 207536

Bloemfontein, Free State, 9301, South Africa

Location

Lenasia Clinical Trial Centre /ID# 205144

Johannesburg, Gauteng, 1820, South Africa

Location

Wits Clinical Research Site /ID# 170851

Johannesburg, Gauteng, 2193, South Africa

Location

Dr JP Wright /ID# 170885

Cape Town, Western Cape, 7708, South Africa

Location

Private Practice Dr MN Rajabally /ID# 169852

Cape Town, Western Cape, 7800, South Africa

Location

Hayang University GuriHospital /ID# 167578

Guri-si, Gyeonggido, 11923, South Korea

Location

CHA University Bundang Medical Center /ID# 167583

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Kangbuk Samsung Hospital /ID# 167577

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 167581

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Inje University Haeundae Hospital /ID# 202629

Busan, 48108, South Korea

Location

Dong-A University Hospital /ID# 167582

Busan, 49201, South Korea

Location

Pusan National University Hospital /ID# 167580

Busan, 49241, South Korea

Location

Kyungpook National Univ Hosp /ID# 207015

Daegu, 41944, South Korea

Location

Samsung Medical Center /ID# 167579

Seoul, 06351, South Korea

Location

Chung-Ang University Hostipal /ID# 207017

Seoul, 06973, South Korea

Location

Hospital Universitari Son Espases /ID# 201997

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Unversitario Marques de Valdecilla /ID# 202039

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Dr. Negrin /ID# 171238

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Complejo Hospitalario de Navarra /ID# 202038

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario A Coruna - CHUAC /ID# 203908

A Coruña, 15006, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 171237

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona /ID# 171242

Barcelona, 08036, Spain

Location

Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040

Girona, 17007, Spain

Location

Hospital Juan Ramon Jimenez /ID# 171243

Huelva, 21005, Spain

Location

Hospital Universitario La Paz /ID# 171241

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Macarena /ID# 171240

Seville, 41009, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 201988

Valencia, 46026, Spain

Location

Hallands Hospital Halmstad /ID# 170840

Halmstad, Halland County, 302 33, Sweden

Location

Alingsas lasarett /ID# 170838

Alingsås, Västra Götaland County, 441 33, Sweden

Location

Sodra Alvsborgs sjukhus /ID# 202889

Borås, Västra Götaland County, 501 82, Sweden

Location

Sahlgrenska University Hospital /ID# 169031

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Universitätsspital Zürich /ID# 170999

Zurich, Canton of Zurich, 8091, Switzerland

Location

Inselspital, Universitätsspital Bern /ID# 171006

Bern, 3010, Switzerland

Location

National Taiwan University Hospital /ID# 169789

Taipei, 100, Taiwan

Location

Linkou Chang Gung Memorial Ho /ID# 169788

Taoyuan, 333, Taiwan

Location

Acibadem Kozyatagi Hospital /ID# 209405

Kadıköy, Istanbul, 34742, Turkey (Türkiye)

Location

Erciyes University Medical Fac /ID# 171321

Melikgazi, Kayseri, 38030, Turkey (Türkiye)

Location

Ankara Univ Medical Faculty /ID# 206412

Ankara, 06590, Turkey (Türkiye)

Location

Inonu Universitesi Turgut Ozal /ID# 201267

Battalgazi/malatya, 44280, Turkey (Türkiye)

Location

Mustafa Kemal University Medic /ID# 171318

Hatay, 31001, Turkey (Türkiye)

Location

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280

Istanbul, 34098, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316

Istanbul, 34899, Turkey (Türkiye)

Location

Mersin University Medical /ID# 171320

Mersin, 33343, Turkey (Türkiye)

Location

Sisli Etfal Train & Res Hosp /ID# 171317

Şişli, 34371, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultes /ID# 217443

Yenimahalle, 06560, Turkey (Türkiye)

Location

South Eastern Health and Social Care Trust /ID# 205322

Belfast, Antrim, BT16 1RH, United Kingdom

Location

Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388

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

Location

Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085

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

Location

Barts Health NHS Trust /ID# 218829

London, London, City of, E1 2ES, United Kingdom

Location

Royal United Hospitals Bath /ID# 169084

Bath, BA1 3NG, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 169080

Birmingham, B15 2TH, United Kingdom

Location

The Dudley Group NHS Foundation Trust /ID# 169079

Dudley, DY1 2HQ, United Kingdom

Location

London North West University Healthcare NHS Trust /ID# 169078

Harrow, HA1 3UJ, United Kingdom

Location

King's College Hospital NHS Foundation Trusts /ID# 169082

London, SE5 9RS, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Stockport NHS foundation trust /ID# 208718

Stockport, SK2 7JE, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust /ID# 209664

Taunton, TA1 5DA, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust /ID# 205551

Tooting, SW17 0QT, United Kingdom

Location

The Royal Wolverhampton NHS Trust /ID# 171387

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.

  • Colombel JF, Lacerda AP, Irving PM, Panaccione R, Reinisch W, Rieder F, Steinlauf A, Schwartz D, Feng T, Dubcenco E, Anyanwu SI, Laroux FS, Cunneen C, Powell N. Efficacy and Safety of Upadacitinib for Perianal Fistulizing Crohn's Disease: A Post Hoc Analysis of 3 Phase 3 Trials. Clin Gastroenterol Hepatol. 2025 May;23(6):1019-1029. doi: 10.1016/j.cgh.2024.08.032. Epub 2024 Sep 24.

  • Panes J, Louis E, Bossuyt P, Joshi N, Lee WJ, Lacerda AP, Kligys K, Xuan S, Shukla N, Loftus EV Jr. Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease. Inflamm Bowel Dis. 2025 Feb 6;31(2):394-403. doi: 10.1093/ibd/izae200.

  • Peyrin-Biroulet L, Panaccione R, Louis E, Atreya R, Rubin DT, Lindsay JO, Siffledeen J, Lukin DJ, Wright J, Watanabe K, Ford S, Remple VP, Lacerda AP, Dubcenco E, Garrison A, Zhou Q, Berg S, Anyanwu SI, Schreiber S. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn's Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2096-2106. doi: 10.1016/j.cgh.2024.02.026. Epub 2024 Mar 15.

  • Colombel JF, Hisamatsu T, Atreya R, Bresso F, Thin L, Panaccione R, Parra RS, Ford S, Remple VP, Lacerda AP, Anyanwu SI, Mallick M, Garrison A, Regueiro M. Upadacitinib Reduces Crohn's Disease Symptoms Within the First Week of Induction Therapy. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1668-1677. doi: 10.1016/j.cgh.2024.02.027. Epub 2024 Mar 15.

  • Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.

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

November 29, 2017

Primary Completion

August 11, 2021

Study Completion

August 11, 2021

Last Updated

August 15, 2022

Results First Posted

August 15, 2022

Record last verified: 2022-07

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 and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For details on when studies are available for sharing, please refer to the link below.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
More information

Locations