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A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

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ClinicalTrials.gov Identifier: NCT02819635
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission in order to identify the induction dose of upadacitinib for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: Placebo Drug: Updacitinib (ABT-494) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Updacitinib (ABT-494) Dose B
Administered orally, once daily.
Drug: Updacitinib (ABT-494)
Tablet
Other Name: Upadacitinib

Experimental: Updacitinib (ABT-494) Dose A
Administered orally, once daily.
Drug: Updacitinib (ABT-494)
Tablet
Other Name: Upadacitinib

Experimental: Updacitinib (ABT-494) Dose C
Administered orally, once daily.
Drug: Updacitinib (ABT-494)
Tablet
Other Name: Upadacitinib

Experimental: Updacitinib (ABT-494) Dose D
Administered orally, once daily.
Drug: Updacitinib (ABT-494)
Tablet
Other Name: Upadacitinib

Placebo Comparator: Placebo
Administered orally, once daily.
Drug: Placebo
Tablet




Primary Outcome Measures :
  1. Substudy 1/Substudy 2: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1 and not greater than Baseline, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.

  2. Substudy 3: Proportion of participants who achieve clinical remission per adapted Mayo score [ Time Frame: At Week 52 ]
    Clinical remission is defined as stool frequency subscore (SFS) <= 1 and not greater than Baseline, rectal bleeding subscore (RBS) of 0, and endoscopic subscore <= 1.


Secondary Outcome Measures :
  1. Substudy 3: Proportion of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Participants who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score, defined as Stool Frequency Subscore (SFS) <= 1, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore <= 1.

  2. Substudy 1/Substudy 2: Proportion of participants achieving clinical response per Adapted Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in rectal bleeding subscore (RBS) >= 1 or an absolute RBS of 0 or 1.

  3. Substudy 3: Proportion of participants achieving clinical remission per Full Mayo score at Week 44 [ Time Frame: At Week 44 ]
    Clinical remission per Full Mayo score is defined as a Full Mayo score <= 2 with no subscore > 1

  4. Substudy 1/Substudy 2: Proportion of participants achieving clinical remission per Full Mayo score at Week 8 [ Time Frame: At Week 8 ]
    Clinical remission is defined as a Full Mayo score <= 2 with no subscore > 1

  5. Substudy 3: Proportion of participants with endoscopic improvement at Week 44 [ Time Frame: At Week 44 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1

  6. Substudy 1/Substudy 2: Proportion of participants with endoscopic improvement at Week 8 [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <= 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
  • Demonstrated an inadequate response to, loss of response to, or intolerance to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
  • If female, participant must meet the criteria for Contraception Recommendations.
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
  • Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
  • Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any abnormal results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819635


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
United States, Alabama
CB Flock Research Corporation /ID# 165980 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Delsol Research Management, Ll /Id# 170131 Not yet recruiting
Chandler, Arizona, United States, 85224
Arizona Arthritis & Rheumatolo /ID# 169822 Not yet recruiting
Phoenix, Arizona, United States, 85202
Adobe Clinical Research LLC /ID# 155250 Not yet recruiting
Tucson, Arizona, United States, 85712
Banner University Medical Cent /ID# 150553 Not yet recruiting
Tucson, Arizona, United States, 85724
United States, California
S Paul Sharma Medical Corp /ID# 151914 Recruiting
Covina, California, United States, 91722-3797
Ucsd /Id# 155185 Recruiting
La Jolla, California, United States, 92037
Gastrointestinal Biosciences /ID# 157080 Not yet recruiting
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 203133 Not yet recruiting
Mission Hills, California, United States, 91345
United Gastroenterologists /ID# 151211 Recruiting
Murrieta, California, United States, 92563
UC Irvine /ID# 153777 Not yet recruiting
Orange, California, United States, 92868
Ventura County Gastroenterolog /ID# 163414 Not yet recruiting
Oxnard, California, United States, 93030
Medical Assoc Research Grp /ID# 169148 Not yet recruiting
San Diego, California, United States, 92123
Univ of California San Francis /ID# 164581 Not yet recruiting
San Francisco, California, United States, 94158
Care Access Research /ID# 167018 Not yet recruiting
San Pablo, California, United States, 94806
United States, Colorado
Delta Waves, Inc. /ID# 151721 Recruiting
Colorado Springs, Colorado, United States, 80918
Western States Clinical Res /ID# 158076 Recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Western Connecticut Medical Group /ID# 169210 Not yet recruiting
Danbury, Connecticut, United States, 06810-6000
Medical Research Ctr CT /ID# 150482 Recruiting
Hamden, Connecticut, United States, 06518
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Gastro Florida /ID# 155245 Recruiting
Clearwater, Florida, United States, 33756
Moonshine Research Center, Inc /ID# 152533 Not yet recruiting
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Palmetto Research, LLC /ID# 151716 Recruiting
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Inverness, Florida, United States, 34452
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SIH Research, LLC /ID# 163319 Recruiting
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Miami, Florida, United States, 33165
New Horizon Research Center /ID# 152474 Recruiting
Miami, Florida, United States, 33175
Coral Research Clinic /ID# 150444 Recruiting
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 163098 Recruiting
New Port Richey, Florida, United States, 34653
Omega Research Consultants /ID# 200269 Not yet recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 201790 Not yet recruiting
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 200272 Not yet recruiting
Tampa, Florida, United States, 33613-4680
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Atlanta Gastroenterology Spec /ID# 150548 Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern Medical /ID# 151139 Not yet recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center /ID# 153042 Not yet recruiting
Chicago, Illinois, United States, 60612
University of Chicago /ID# 150547 Not yet recruiting
Chicago, Illinois, United States, 60637
NorthShore Univ HealthSystem /ID# 150555 Recruiting
Evanston, Illinois, United States, 60201
Carle Foundation Hospital /ID# 151137 Not yet recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
MediSphere Medical Research Center /ID# 152064 Not yet recruiting
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 162901 Not yet recruiting
Indianapolis, Indiana, United States, 46237
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University of Iowa Hospitals /ID# 157058 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 167182 Not yet recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Tri-State Gastroenterology /ID# 169811 Not yet recruiting
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United States, Louisiana
Houma Digestive Health Special /ID# 151844 Recruiting
Houma, Louisiana, United States, 70360
Nola Research Works, LLC /ID# 153356 Recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 150446 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
University of Maryland Med Ctr /ID# 150449 Recruiting
Baltimore, Maryland, United States, 21201
Gastro Center of Maryland /ID# 200022 Not yet recruiting
Columbia, Maryland, United States, 21045
United States, Massachusetts
MGH Digestive Health Center /ID# 165676 Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan /ID# 151140 Recruiting
Ann Arbor, Michigan, United States, 48109
Huron Gastroenterology Assoc /ID# 152710 Recruiting
Ann Arbor, Michigan, United States, 48197
Clin Res Inst of Michigan, LLC /ID# 153027 Recruiting
Chesterfield, Michigan, United States, 48047
Digestive Health Associates (DHA) - Farmington Hills /ID# 205792 Not yet recruiting
Farmington Hills, Michigan, United States, 48334-3230
Center for Digestive Health /ID# 161984 Recruiting
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Mayo Clinic - Rochester /ID# 151677 Recruiting
Rochester, Minnesota, United States, 55905-0001
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Saint Paul, Minnesota, United States, 55114
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 170712 Not yet recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University-School of Medicine /ID# 150485 Recruiting
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United States, Nevada
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Las Vegas, Nevada, United States, 89113
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 150549 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC /ID# 153040 Recruiting
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Morristown, New Jersey, United States, 07960
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NY Scientific /ID# 152707 Recruiting
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Plains Clinical Research Center, LLC /ID# 170290 Not yet recruiting
Fargo, North Dakota, United States, 58104
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Consultants for Clinical Res /ID# 151679 Recruiting
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Cincinnati, Ohio, United States, 45267-0585
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Mentor, Ohio, United States, 44060-6211
Ohio Clinical Research Partner /ID# 154068 Not yet recruiting
Mentor, Ohio, United States, 44060
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Options Health Research, LLC /ID# 150554 Not yet recruiting
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Tulsa, Oklahoma, United States, 74135
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Northwest Gastroenterology Cli /ID# 152527 Not yet recruiting
Portland, Oregon, United States, 97210
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Allegheny General Hospital /ID# 163826 Not yet recruiting
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Penn State Health Colonnade /ID# 150259 Not yet recruiting
State College, Pennsylvania, United States, 16803
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Pharmacorp Clinical Trials /ID# 153354 Not yet recruiting
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Greenville Endoscopy Center /ID# 150541 Recruiting
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Greenville, South Carolina, United States, 29615
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Gastro One /ID# 151144 Recruiting
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Quality Medical Research, PLLC /ID# 203426 Not yet recruiting
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Nashville, Tennessee, United States, 37232-0011
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TX Clinical Research Institute /ID# 151526 Recruiting
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Inquest Clinical Research /ID# 164635 Recruiting
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Aztec Clinical Research, Inc. /ID# 152062 Recruiting
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GI Specialists of Houston /ID# 202327 Not yet recruiting
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DCOL Ctr for Clinical Research /ID# 200932 Not yet recruiting
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DHAT Research Institute /ID# 151218 Recruiting
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Tyler Research Institute, LLC /ID# 169146 Not yet recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 167761 Not yet recruiting
Victoria, Texas, United States, 77904
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Val R. Hansen /ID# 163939 Not yet recruiting
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 162624 Recruiting
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Salt Lake City, Utah, United States, 84124
Advanced Clinical Research (ACR) - Salt Lake City /ID# 163181 Not yet recruiting
West Jordan, Utah, United States, 84088
United States, Virginia
Ctr for Gastrointestinal Healt /ID# 153360 Recruiting
Franklin, Virginia, United States, 23851
Emeritas Research Group, LLC /ID# 150258 Recruiting
Leesburg, Virginia, United States, 20176
United States, Washington
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Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 153026 Recruiting
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Seattle, Washington, United States, 98109
The Polyclinic /ID# 164369 Not yet recruiting
Seattle, Washington, United States, 98122-4201
The Vancouver Clinic, INC. PS /ID# 162333 Not yet recruiting
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United States, Wisconsin
Aurora Medical Center - Grafto /ID# 151717 Not yet recruiting
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WI Center for Advanced Res /ID# 151838 Recruiting
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Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Mautalen Salud e Investigacion /ID# 171173 Not yet recruiting
Buenos Aires, Argentina, 1128
Imep /Id# 153795 Not yet recruiting
Buenos Aires, Argentina, 1702
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Cordoba, Argentina, X5003DCE
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Cordoba, Argentina, X5016KEH
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Quilmes, Argentina, 1878
Sanatorio 9 de Julio S.A. /ID# 150189 Not yet recruiting
San Miguel de Tucuman, Argentina, 4000
Australia, Victoria
Monash Health /ID# 150206 Recruiting
Clayton, Victoria, Australia, 3168
St. Vincents Hosp Melbourne /ID# 152472 Recruiting
Fitzroy, Victoria, Australia, 3065
Austria
Krankenanstalt Rudolfstiftung /ID# 162866 Not yet recruiting
Vienna, Wien, Austria, 1030
Medical University of Vienna /ID# 150614 Recruiting
Vienna, Wien, Austria, 1090
KH der Elisabethinen Linz GmbH /ID# 150305 Recruiting
Linz, Austria, 4020
LKH Salzburg and Paracelsus /ID# 150306 Not yet recruiting
Salzburg, Austria, 5020
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Wien, Austria, 1160
Belarus
Vitebsk Regional Advanced Clin /ID# 169612 Not yet recruiting
Vitebsk, Belarus, 210001
Belgium
UZ Leuven /ID# 150332 Recruiting
Leuven, Belgium, 3000
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Bosnia and Herzegovina
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Brazil
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Canada, Alberta
University of Calgary /ID# 151821 Not yet recruiting
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Edmonton, Alberta, Canada, T6G 2X8
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Canada, British Columbia
Okanagan Clinical Trials /ID# 153178 Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Percuro Clinical Research, Ltd /ID# 150367 Not yet recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Ontario
McMaster University Med Cent /ID# 150365 Recruiting
Hamilton, Ontario, Canada, L8S 4K1
The Ottawa Hospital /ID# 151820 Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Medicor Research Inc. /ID# 151101 Recruiting
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Toronto Digestive Disease Asso /ID# 150363 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CISSS de la Monteregie /ID# 159215 Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 150361 Not yet recruiting
Levis, Quebec, Canada, G6V 3Z1
Recherche GCP Research /ID# 151822 Recruiting
Montreal, Quebec, Canada, H1M 1B1
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Montreal, Quebec, Canada, H3G 1A4
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Chile
CECIS SpA /ID# 200110 Not yet recruiting
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Santiago, Chile
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China, Anhui
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Guangzhou, Anhui, China, 510080
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China, Chongqing
Daping Hospital, Research Institute of Surgery Third Military Medical University /ID# 165745 Not yet recruiting
Chongqing, Chongqing, China, 400042
China, Hubei
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Wuhan, Hubei, Hubei, China, 430022
China, Shaanxi
Xijing Hospital /ID# 167255 Not yet recruiting
Xian, Shaanxi, China, 710032
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 150461 Not yet recruiting
Shanghai, Shanghai, China, 200025
China
Xiangya Hosp Central South Uni /ID# 167229 Not yet recruiting
Changsha, China, 410008
West China Univ Hospital /ID# 167040 Not yet recruiting
Chengdu, China, 610041
Shengjing Hosp China Med Univ /ID# 166920 Not yet recruiting
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 170604 Not yet recruiting
Tianjin, China, 300052
Union Hosp, Tongji Med College /ID# 167078 Not yet recruiting
Wuhan, China, 430022
Colombia
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 151564 Not yet recruiting
Bogota DC, Cundinamarca, Colombia, 11411
Hospital Univ San Ignacio /ID# 152678 Not yet recruiting
Bogota, Colombia, 110231
Fundacion Cardioinfantil /ID# 168641 Not yet recruiting
Bogota, Colombia
Instituto de Coloproctologia /ID# 152535 Not yet recruiting
Medellin, Colombia, 050024
Hospital Universitario de San /ID# 155387 Not yet recruiting
Medellin, Colombia
Hospital Pablo Tobon Uribe /ID# 159095 Not yet recruiting
Medellín, Colombia
Croatia
Klinicki bolnicki centar Zagreb /ID# 150225 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 150709 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 150216 Recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Rijeka /ID# 150708 Not yet recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Zadar General Hospital /ID# 150221 Not yet recruiting
Zadar, Croatia, 23000
Clinical Hospital Dubrava /ID# 150213 Not yet recruiting
Zagreb, Croatia, 10000
Czechia
CTCenter MaVe, s.r.o. /ID# 150904 Recruiting
Olomouc, Olomoucky Kraj, Czechia, 779 00
Axon Clinical, s.r.o. /ID# 152479 Recruiting
Praha, Praha 5, Czechia, 150 00
Hepato-Gastroenterologie HK s.r.o. /ID# 150912 Recruiting
Hradec Kralove, Czechia, 500 12
Artroscan s.r.o. /ID# 150401 Recruiting
Ostrava, Czechia, 722 00
Estonia
East Tallinn Central Hospital /ID# 150417 Not yet recruiting
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 150419 Recruiting
Tallinn, Estonia, 10617
North Estonian Medical Centre /ID# 160870 Not yet recruiting
Tallinn, Estonia, 13419
Finland
Helsinki Univ Central Hospital /ID# 150407 Recruiting
Helsinki, Finland, 00290
Keski-Suomen Keskussairaala /ID# 155666 Recruiting
Jyvaskyla, Finland, 40620
Laakarikeskus Ikioma /ID# 150121 Recruiting
Mikkeli, Finland, 50100
Tampere University Hospital /ID# 150114 Recruiting
Tampere, Finland, 33521
Tyks /Id# 168301 Recruiting
Turku, Finland, 20521
France
Chu de Nice-Hopital L'Archet Ii /Id# 152606 Recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
Centre Hospitalier Lyon Sud /ID# 152539 Not yet recruiting
Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
CHU Hopital Nord /ID# 163508 Not yet recruiting
Marseille, Bouches-du-Rhone, France, 13915
CHRU Lille - Hôpital Claude Huriez /ID# 152607 Recruiting
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 200006 Not yet recruiting
Montpellier CEDEX 5, Herault, France, 34295
CHU NANCY - Hôpital Brabois Adultes /ID# 150150 Not yet recruiting
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
CHU Amiens Picardie /ID# 163456 Not yet recruiting
Amiens CEDEX 1, Somme, France, 80054
CHD Vendee /ID# 154452 Recruiting
La Roche Sur Yon, France, 85000
Hopital Saint Antoine /ID# 170222 Not yet recruiting
Paris, France, 75012
Hopital Nord /ID# 154453 Not yet recruiting
Saint Priest En Jarez, France, 42270
Germany
Universitatsklinikum Mannheim /ID# 150173 Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitatsklinikum Munster /ID# 150158 Not yet recruiting
Munster, Niedersachsen, Germany, 48149
Univ Hosp Schleswig-Holstein /ID# 161981 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Praxis am Bayerischen Platz /ID# 150766 Recruiting
Berlin, Germany, 10825
Agaplesion Markus Krankenhaus /ID# 161982 Recruiting
Frankfurt, Germany, 60341
Universitatsklinikum Tubingen /ID# 150767 Recruiting
Tuebingen, Germany, 72076
Gastro Data Wiesbaden /ID# 150166 Recruiting
Wiesbaden, Germany, 65189
Greece
University Hospital of Heraklion /ID# 150250 Not yet recruiting
Heraklion, Kriti, Greece, 711 10
Genl Hosp Athens, Evangelismos /ID# 150309 Recruiting
Athens, Greece, 10676
Gen Hosp Chest Athens Sotiria /ID# 202100 Not yet recruiting
Athens, Greece, 11527
Univ Gen Hosp Ioannina /ID# 164248 Not yet recruiting
Ioannina, Greece, 45500
Theageneio Cancer Hospital /ID# 163896 Not yet recruiting
Thessaloniki, Greece, 546 39
Hungary
Markusovszky Egyetemi Oktatókórház /ID# 150313 Recruiting
Szombathely, Vas, Hungary, 9700
Bekes Megyei Kozponti Korhaz /ID# 151572 Not yet recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem /ID# 150312 Recruiting
Budapest, Hungary, 1085
Meditres Kft. /ID# 151521 Not yet recruiting
Kecskemet, Hungary, 6000
Soproni Erzsebet Oktato Korhaz /ID# 151523 Not yet recruiting
Sopron, Hungary, 9400
Ireland
Mercy University Hospital /ID# 151529 Recruiting
Cork, Ireland, T12 WE28
Trinity College Dublin - St. J /ID# 150320 Recruiting
Dublin, Ireland, 8580
St Vincent's University Hosp /ID# 150318 Recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 150321 Recruiting
Dublin, Ireland, D09 XR63
Galway University Hospital /ID# 150319 Not yet recruiting
Galway, Ireland, H91 YR71
Israel
Soroka Medical Center /ID# 156561 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Hadassah Ein Kerem Medical Ctr /ID# 165118 Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Rambam Health Care Campus /ID# 150325 Active, not recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 161677 Recruiting
Jerusalem, Israel, 91031
Sheba Medical Center /ID# 150324 Not yet recruiting
Ramat Gan, Israel, 5262100
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 150337 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliera San Camillo Forlanini /ID# 151360 Not yet recruiting
Rome, Lazio, Italy, 00152
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150334 Recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 151361 Not yet recruiting
Rozzano, Milano, Italy, 20089
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253 Recruiting
Palermo, Sicilia, Italy, 90146
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602 Recruiting
Milano, Italy, 20121
Policlinico Tor Vergata /ID# 150338 Not yet recruiting
Rome, Italy, 00133
Complesso integrato Columbus /ID# 150333 Recruiting
Rome, Italy, 00168
Japan
Aichi Medical University Hosp /ID# 151993 Recruiting
Nagakute, Aichi, Japan, 4801195
Nagoya University Hospital /ID# 152709 Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 151950 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 152763 Recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Med Ctr /ID# 151936 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Kyushu University Hospital /ID# 152526 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 151976 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Asahikawa Medical University Hospital /ID# 170289 Not yet recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido Sapporo-Kosei Gen Hos /ID# 151506 Recruiting
Sapporo, Hokkaido, Japan, 060-0033
Aoyama Clinic /ID# 152049 Recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 152434 Recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center /ID# 152631 Not yet recruiting
Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
Yokohama City Univ Med Center /ID# 169899 Not yet recruiting
Yokohama-shi, Kanagawa, Japan, 232-0024
JP Red Cross Kyoto Daiichi Hos /ID# 152359 Recruiting
Kyoto-shi, Kyoto, Japan, 605-0981
Osaka City University Hospital /ID# 152682 Recruiting
Osaka-shi, Osaka, Japan, 545-0051
Saitama Medical Center, Saitama Medical University /ID# 152031 Not yet recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic /ID# 152677 Recruiting
Saitama-shi, Saitama, Japan, 336-0963
Medical Hospital of Tokyo Medical and Dental University /ID# 152016 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokai University Hachioji Hosp /ID# 152587 Recruiting
Hachioji, Tokyo, Japan, 〒192-0032
Kitasato Univ Kitasato Inst Ho /ID# 152686 Recruiting
Minato-ku, Tokyo, Japan, 108-8642
Kyorin University Hospital /ID# 153194 Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Yamanashi Prefectural Ctr Hosp /ID# 151908 Recruiting
Kofu-shi, Yamanashi, Japan, 400-8506
Hiroshima University Hospital /ID# 151951 Recruiting
Hiroshima, Japan, 734-8551
Kitakyushu Municipal Med Ctr /ID# 152588 Not yet recruiting
Kitakyushu, Japan, 802-0077
Chikuba Hospital /ID# 157821 Recruiting
Kurashiki, Japan, 710-0142
NHO Shizuoka Medical Center /ID# 163572 Not yet recruiting
Shimizu-sho, Japan
Toyohashi Municipal Hospital /ID# 171457 Not yet recruiting
Toyohashi, Japan, 441-8570
Ieda Hospital /ID# 157781 Not yet recruiting
Toyota-shi, Japan, 470-1219
Korea, Republic of
Dong-A University Hospital /ID# 159480 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 159481 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 150345 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
CHA Bundang Medical center, CHA University /ID# 159479 Not yet recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
St. Vincent's Hospital /ID# 150347 Recruiting
Suwon, Gyeonggido, Korea, Republic of, 16247
Kangbuk Samsung Hospital /ID# 150348 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Severance Hospital /ID# 159478 Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 150346 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Hanyang University Guri Hosp /ID# 150344 Not yet recruiting
Guri-si, Korea, Republic of, 471-701
Asan Medical Center /ID# 150900 Recruiting
Seoul, Korea, Republic of, 05505
Latvia
Riga East Clinical Univ Hosp /ID# 150354 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 151409 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 150357 Not yet recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 158862 Not yet recruiting
Klaipeda, Lithuania, 92288
Klaipeda Seamens Hospital /ID# 154319 Not yet recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 154318 Not yet recruiting
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Sultanah Bahiyah /ID# 151687 Recruiting
Alor Setar, Kedah, Malaysia, 05460
UKM Medical Centre /ID# 151689 Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Hospital Ampang /ID# 151298 Recruiting
Ampang, Selangor, Malaysia, 68000
Uni Malaya MC /ID# 150359 Recruiting
Kuala Lumpur, Malaysia, 59100
Mexico
CIRO - CLIN de Reum y Obesidad /ID# 150710 Not yet recruiting
Guadalajara Jalisco, Mexico, CP 44650
Issste /Id# 150255 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44600
Centro Regiomontano de Estudio /ID# 150256 Not yet recruiting
Monterrey, Mexico, 64610
Netherlands
Univ Med Ctr, St. Radboud /ID# 151700 Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Academisch Medisch Centrum /ID# 150647 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Cen /ID# 152624 Recruiting
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum /ID# 150308 Recruiting
Rotterdam, Netherlands, 3015 CE
UMC Utrecht /ID# 152775 Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Akershus universitetssykehus /ID# 150317 Recruiting
Nordbyhagen, Akershus, Norway, 1474
Universitetssykehuset Nord-Norge /ID# 152835 Recruiting
Tromsø, Troms, Norway, 9019
Poland
Zespol Przychodni Prima /Id# 150580 Recruiting
Warsaw, Mazowieckie, Poland, 02-018
Centrum Zdrowia MDM /ID# 150351 Recruiting
Warszawa, Mazowieckie, Poland, 00-635
Endoterapia PFG Sp. z.o.o. /ID# 150349 Recruiting
Warszawa, Mazowieckie, Poland, 02-653
Endoskopia Sp. z o.o. /ID# 150765 Recruiting
Sopot, Zachodniopomorskie, Poland, 81-756
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 151607 Not yet recruiting
Guimarães, Braga, Portugal, 4835-044
Hospital Garcia de Orta, E.P.E /ID# 151613 Recruiting
Almada, Lisboa, Portugal, 2805-267
Centro Hosp de Lisboa Central /ID# 151611 Not yet recruiting
Lisbon, Lisboa, Portugal, 1169-050
CCA Braga - Hospital de Braga /ID# 151608 Not yet recruiting
Braga, Portugal, 4710-243
Centro Hospitalar Lisboa Norte, EPE /ID# 151606 Not yet recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE /ID# 151610 Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 152335 Not yet recruiting
Santa Maria Da Feira, Portugal, 4520-211
Unidade Local De Saude Do Alto Minho /ID# 151609 Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 150358 Recruiting
San Juan, Puerto Rico, 00935
Romania
Clinic Fundeni Institute /ID# 150368 Not yet recruiting
Bucharest, Bucuresti, Romania, 022328
Clinic Fundeni Institute /ID# 150983 Not yet recruiting
Bucharest, Bucuresti, Romania, 022328
Cabinet Particular Algomed SRL /ID# 150369 Not yet recruiting
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University /ID# 200719 Not yet recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
LLC Meditsinskiy Dom /ID# 200207 Not yet recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 109451
Perm Clinical Center of FMBA /ID# 150386 Recruiting
Perm, Permskiy Kray, Russian Federation, 614105
LLC Medical Company Hepatolog /ID# 200197 Not yet recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
LLC Uromed /ID# 200724 Not yet recruiting
Smolensk, Smolenskaya Oblast, Russian Federation, 214031
Kazan State Medical University /ID# 166042 Not yet recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
City Clinical Hospital 24 /ID# 150395 Not yet recruiting
Moscow, Russian Federation, 127015
Republican Clin Hos n.a. Baran /ID# 206506 Not yet recruiting
Petrozavodsk, Russian Federation, 185019
Stavropol State Medical Univ /ID# 150387 Recruiting
Stavropol, Russian Federation, 355017
Serbia
Clinical Center Serbia /ID# 150428 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 150429 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 150427 Not yet recruiting
Belgrade, Beograd, Serbia, 11050
Clin Hosp Ctr Bezanijska Kosa /ID# 150426 Not yet recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 151903 Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Clinical Center Kragujevac /ID# 150430 Not yet recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 150764 Not yet recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital /ID# 150453 Not yet recruiting
Singapore, Singapore, 119074
Tan Tock Seng Hospital /ID# 150443 Not yet recruiting
Singapore, Singapore, 308433
Slovakia
Medak s.r.o., gastroenterologi /ID# 150480 Not yet recruiting
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve /ID# 150868 Recruiting
Banska Bystrica, Slovakia, 97517
Slovak Research Center Team Me /ID# 150257 Not yet recruiting
Ilava, Slovakia, 019 01
B and B MED s.r.o. /ID# 150471 Not yet recruiting
Kosice, Slovakia, 040 01
Gastro I.S.R.O. /ID# 150472 Recruiting
Presov, Slovakia, 08001
South Africa
Clinresco Centres /ID# 163622 Recruiting
Johannesburg, Gauteng, South Africa, 1619
Chris Hani Baragwanath Hosp /ID# 150785 Recruiting
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site /ID# 150496 Not yet recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 162202 Not yet recruiting
CAPE TOWN,Milnerton, Western Cape, South Africa, 7441
Kingsbury Hospital /ID# 150497 Recruiting
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg /ID# 155144 Not yet recruiting
Cape Town, Western Cape, South Africa, 7800
MD Search /ID# 167293 Not yet recruiting
Boksburg North, South Africa, 1460
Spain
Comple Hospi Univ de Santiago /ID# 151065 Not yet recruiting
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitario y Politecnico La Fe /ID# 150611 Recruiting
Valencia, Valenciana, Spain, 46026
Comple Hosp Univ de A Coruna /ID# 203911 Not yet recruiting
A Coruna, Spain, 15006
Hospital Clinic de Barcelona /ID# 150612 Not yet recruiting
Barcelona, Spain, 08036
Hospital Reina Sofia de Cordob /ID# 151066 Not yet recruiting
Cordoba, Spain, 14004
Hospital Univ Dr. Negrin /ID# 203937 Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Univ Ramon y Cajal /ID# 151067 Not yet recruiting
Madrid, Spain, 28034
Complejo Asistencial de Salama /ID# 150509 Not yet recruiting
Salamanca, Spain, 37007
Sweden
Sahlgrenska University Hosp /ID# 151496 Not yet recruiting
Goteborg, Sweden, 413 45
Switzerland
Kantonsspital St. Gallen /ID# 152599 Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 161731 Recruiting
Basel, Switzerland, 4056
Inselspital, Universitaetsklin /ID# 152590 Recruiting
Bern, Switzerland, 3010
University Hospital Zurich /ID# 152591 Recruiting
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 150571 Recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 151749 Not yet recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 150574 Recruiting
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University /ID# 150575 Not yet recruiting
Kaohsiung, Taiwan, 80708
Chung Shan Medical University /ID# 150573 Not yet recruiting
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp /ID# 151748 Recruiting
Taipei City, Taiwan, 11217
Turkey
Erciyes University Medical Fac /ID# 150129 Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Gazi Universitesi Tip Fakultes /ID# 150127 Not yet recruiting
Ankara, Turkey, 06500
Istanbul University Cerrahpasa Medical Faculty /ID# 150125 Not yet recruiting
Istanbul, Turkey, 34098
Umraniye Training and Res Hosp /ID# 162659 Not yet recruiting
Istanbul, Turkey, 34764
Mersin University Medical /ID# 157849 Not yet recruiting
Mersin, Turkey, 33343
Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 150372 Not yet recruiting
Kiev, Kyiv, Ukraine, 1030
Medical Center of the "Health /ID# 151274 Not yet recruiting
Вінниця, Vinnytska Oblast, Ukraine, 21009
Lviv Regional Clinical Hospita /ID# 150375 Recruiting
Lviv, Ukraine, 79010
Odessa Regional Clinical Hosp /ID# 151275 Not yet recruiting
Odesa, Ukraine, 65025
United Kingdom
RD&E Hospital /ID# 150379 Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Queen Elizabeth University Hos /ID# 163787 Recruiting
Glasgow, Glasgow City, United Kingdom, G51 4TF
The Royal London Hospital /ID# 150384 Recruiting
London, London, City Of, United Kingdom, E1 1BB
Basingstoke & North Hampshire /ID# 150380 Recruiting
Basingstoke, United Kingdom, RG24 9NA
Royal United Hospitals Bath /ID# 151532 Recruiting
Bath, United Kingdom, BA1 3NG
Univ Hospitals Birmingham NHS Foundation trust /ID# 150382 Not yet recruiting
Birmingham, United Kingdom, B15 2TG
Royal Liverpool and Broadgreen /ID# 203856 Not yet recruiting
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02819635     History of Changes
Other Study ID Numbers: M14-234
2016-000641-31 ( EudraCT Number )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Upadacitinib (ABT-494)
Moderately to Severely Active UC

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases