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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653026
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 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 Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Upadacitinib
Administered orally, once daily (QD)
Drug: Upadacitinib (ABT-494)
Upadacitinib will be orally administered

Experimental: Placebo
Administered orally, once daily (QD)
Drug: Placebo
Placebo will be orally administered




Primary Outcome Measures :
  1. Percentage of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
    It is defined by Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and endoscopic subscore.


Secondary Outcome Measures :
  1. Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore.

  2. Percentage of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission defined by endoscopic subscore.

  3. Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo score.

  4. Percentage of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]
    Clinical response per Partial Adapted Mayo score.

  5. Percentage of participants who reported no bowel urgency [ Time Frame: At Week 8 ]
    Bowel urgency is monitored electronically via a handheld device.

  6. Percentage of participants who reported no abdominal pain [ Time Frame: At Week 8 ]
    Abdominal pain information will be collected electronically via a handheld device.

  7. Percentage of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    Defined by Geboes score.

  8. Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]
    Defined by increase of IBDQ bowel symptom domain score.

  9. Percentage of participants with mucosal healing [ Time Frame: At Week 8 ]
    Defined by the endoscopic and histologic variables.

  10. Percentage of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Percentage of participants with UC-related hospitalizations

  11. Percentage of participants with UC-related surgeries [ Time Frame: Through Week 8 ]
    Participants who underwent surgery related to UC will be assessed.

  12. Percentage of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]
    Defined by increase of IBDQ fatigue item score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants >= 16 and <=75 years of age at Baseline
  • Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh >=40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

  • Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
  • Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.

  • 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.
  • If female, participant must meet the contraception recommendation criteria.

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 who received azathioprine or 6-mercaptipurine (6-MP) within 10 days of Baseline.
  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  • Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
  • Screening laboratory and other analyses show any prespecified abnormal hematologic 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): NCT03653026


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

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Locations
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United States, Alabama
Alabama Medical Group, PC /ID# 216933 Not yet recruiting
Mobile, Alabama, United States, 36608-1787
CB Flock Research Corporation /ID# 206094 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Arthritis & Rheumatolo /ID# 211030 Recruiting
Phoenix, Arizona, United States, 85032-9306
Physician's Research Group /ID# 211887 Recruiting
Tempe, Arizona, United States, 85284-2604
University of Arizona /ID# 208856 Recruiting
Tucson, Arizona, United States, 85724
United States, California
TLC Clinical Research Inc /ID# 216831 Not yet recruiting
Beverly Hills, California, United States, 90211-2091
Citrus Valley Gastroenterology /ID# 205627 Recruiting
Covina, California, United States, 91722-3797
Newport Huntington Medical Group /ID# 217003 Not yet recruiting
Huntington Beach, California, United States, 92648
Ucsd /Id# 204919 Recruiting
La Jolla, California, United States, 92093
United Gastroenterologists /ID# 207867 Recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 205314 Recruiting
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 205301 Recruiting
Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 205313 Recruiting
Murrieta, California, United States, 92563
Ventura County Gastroenterology /ID# 205628 Recruiting
Oxnard, California, United States, 93030
Inland Empire Liver Foundation /ID# 216164 Not yet recruiting
Rialto, California, United States, 92377
San Diego Clinical Trials /ID# 212122 Not yet recruiting
San Diego, California, United States, 92120
Medical Assoc Research Grp /ID# 205626 Recruiting
San Diego, California, United States, 92123
University of California, San /ID# 205070 Not yet recruiting
San Francisco, California, United States, 94143-0633
United States, Colorado
Peak Gastroenterology Associat /ID# 214077 Not yet recruiting
Colorado Springs, Colorado, United States, 80907
Delta Waves, Inc. /ID# 206170 Recruiting
Colorado Springs, Colorado, United States, 80918
Western States Clinical Res /ID# 206091 Recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Western Connecticut Medical Group /ID# 208290 Recruiting
Danbury, Connecticut, United States, 06810-6000
Gastroenterology Center of CT /ID# 208291 Not yet recruiting
Hamden, Connecticut, United States, 06518
United States, Florida
Gastro Florida /ID# 206174 Recruiting
Clearwater, Florida, United States, 33756
Universal Axon Clinical Resear /ID# 213462 Recruiting
Doral, Florida, United States, 33166
Palmetto Research, LLC /ID# 208293 Recruiting
Hialeah, Florida, United States, 33016
Nature Coast Clinical Research /ID# 206087 Recruiting
Inverness, Florida, United States, 34452
Borland-Groover Clinic /ID# 208128 Recruiting
Jacksonville, Florida, United States, 32258
Alliance Medical Research /ID# 215091 Not yet recruiting
Lighthouse Point, Florida, United States, 33064
Ctr for Advanced Gastroenterol /ID# 207995 Recruiting
Maitland, Florida, United States, 32751-6108
University of Miami /ID# 215445 Not yet recruiting
Miami, Florida, United States, 33136
Coral Research Clinic /ID# 208292 Recruiting
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 206077 Recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 207360 Recruiting
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 206066 Recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 206068 Recruiting
Tampa, Florida, United States, 33607
University of South Florida /ID# 214495 Not yet recruiting
Tampa, Florida, United States, 33612
Florida Hospital Tampa /ID# 207363 Recruiting
Tampa, Florida, United States, 33613-4680
United States, Georgia
Gastro Assoc of Central GA /ID# 216940 Not yet recruiting
Macon, Georgia, United States, 31201
Infinite Clinical Trials /ID# 215343 Not yet recruiting
Riverdale, Georgia, United States, 30274
Atlanta Gastroenterology Spec /ID# 206173 Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern Medical Group - Saint Clair /ID# 206084 Not yet recruiting
Chicago, Illinois, United States, 60611-5975
Rush University Medical Center /ID# 206158 Not yet recruiting
Chicago, Illinois, United States, 60612
University of Chicago /ID# 206172 Recruiting
Chicago, Illinois, United States, 60637-1443
Carle Foundation Hospital /ID# 207397 Recruiting
Effingham, Illinois, United States, 62401
United States, Indiana
MediSphere Medical Research Center /ID# 206073 Recruiting
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 206381 Not yet recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 206167 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 206175 Recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Tri-State Gastroenterology /ID# 206124 Recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Houma Digestive Health Special /ID# 206176 Recruiting
Houma, Louisiana, United States, 70360
Nola Research Works, LLC /ID# 206089 Not yet recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 206064 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
Gastro Center of Maryland /ID# 206883 Recruiting
Columbia, Maryland, United States, 21045
United States, Michigan
University of Michigan Hospitals /ID# 206918 Recruiting
Ann Arbor, Michigan, United States, 48109
Huron Gastroenterology Assoc /ID# 205109 Recruiting
Ann Arbor, Michigan, United States, 48197
Clin Res Inst of Michigan, LLC /ID# 207078 Recruiting
Chesterfield, Michigan, United States, 48047
Revival Research Institute, LLC /ID# 207282 Recruiting
Southfield, Michigan, United States, 48034-1659
United States, Mississippi
Univ of Mississippi Med Ctr /ID# 213116 Not yet recruiting
Jackson, Mississippi, United States, 39216-4500
Southern Therapy and Advanced Research (STAR) LLC /ID# 206069 Recruiting
Jackson, Mississippi, United States, 39216
United States, Nevada
Las Vegas Medical Research /ID# 206814 Recruiting
Las Vegas, Nevada, United States, 89113
United States, New Jersey
AGA Clinical Research Associates, LLC /ID# 206880 Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Atlantic Digestive Health Inst /ID# 208748 Not yet recruiting
Morristown, New Jersey, United States, 07960
Rutgers Robert Wood Johnson /ID# 207382 Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Univ New Mexico /ID# 214397 Not yet recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Advantage Clinical Trials /ID# 206082 Recruiting
Bronx, New York, United States, 10468
NY Scientific /ID# 206080 Recruiting
Brooklyn, New York, United States, 11235
NYU Langone Long Island CRA /ID# 206079 Recruiting
Great Neck, New York, United States, 11021
DiGiovanna Institute for Medic /ID# 206885 Recruiting
North Massapequa, New York, United States, 11758
Premier Medical Group /ID# 206097 Recruiting
Poughkeepsie, New York, United States, 12601
Gastro Group of Rochester /ID# 206881 Recruiting
Rochester, New York, United States, 14618-5703
Richmond University Medical Center /ID# 213185 Not yet recruiting
Staten Island, New York, United States, 10310-1664
United States, North Carolina
Digestive Health Partners, P.A /ID# 206842 Recruiting
Asheville, North Carolina, United States, 28801
Carolinas Medical Center /ID# 206085 Recruiting
Charlotte, North Carolina, United States, 28203
Wake Forest Baptist Medical Center /ID# 206067 Not yet recruiting
Winston-Salem, North Carolina, United States, 27157-0001
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 205111 Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
University of Cincinnati /ID# 205633 Recruiting
Cincinnati, Ohio, United States, 45267-0585
Cleveland Clinic Main Campus /ID# 209239 Not yet recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University - Columbus /ID# 205637 Recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 205638 Recruiting
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 205630 Recruiting
Dayton, Ohio, United States, 45424
Dayton Gastroenterology, Inc. /ID# 205639 Recruiting
Englewood, Ohio, United States, 45415
Great Lakes Gastroenterology Research LLC /ID# 205631 Recruiting
Mentor, Ohio, United States, 44060-6211
United States, Oklahoma
Hightower Clinical /ID# 216336 Not yet recruiting
Oklahoma City, Oklahoma, United States, 73102
Digestive Disease Specialists /ID# 206076 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC /ID# 206707 Recruiting
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultant /ID# 206706 Completed
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Guthrie Medical Group, PC /ID# 206078 Recruiting
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Pharmacorp Clinical Trials /ID# 206074 Recruiting
Charleston, South Carolina, United States, 29412
Gastroenterology Associates, P.A. /ID# 206098 Recruiting
Greenville, South Carolina, United States, 29615-3593
United States, Tennessee
Gastro One /ID# 206178 Recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 206169 Recruiting
Johnson City, Tennessee, United States, 37604
Quality Medical Research, PLLC /ID# 206088 Recruiting
Nashville, Tennessee, United States, 37211
Vanderbilt Univ Med Ctr /ID# 210405 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
TX Clinical Research Institute /ID# 206718 Recruiting
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 206132 Recruiting
Baytown, Texas, United States, 77521
Texas Digestive Disease Consultants /ID# 209805 Recruiting
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209948 Recruiting
Cedar Park, Texas, United States, 78613-5028
Baylor Scott & White Research /ID# 207484 Recruiting
Dallas, Texas, United States, 75246
DHAT Research Institute /ID# 206716 Recruiting
Garland, Texas, United States, 75044-2208
Vilo Research Group Inc /ID# 212625 Recruiting
Houston, Texas, United States, 77017-2337
Baylor College of Medicine /ID# 206717 Not yet recruiting
Houston, Texas, United States, 77030-3411
Houston Methodist Hospital /ID# 207659 Not yet recruiting
Houston, Texas, United States, 77030
Centex Studies, Inc. - Houston /ID# 206168 Recruiting
Houston, Texas, United States, 77058
GI Specialists of Houston /ID# 206090 Recruiting
Houston, Texas, United States, 77070-4347
Caprock Gastro Research /ID# 215115 Recruiting
Lubbock, Texas, United States, 79424-3017
Clinical Associates in Researc /ID# 206710 Recruiting
San Antonio, Texas, United States, 78212
Southern Star Research Institute, LLC /ID# 205379 Recruiting
San Antonio, Texas, United States, 78229-5390
Baylor Scott & White Health - Temple /ID# 206096 Recruiting
Temple, Texas, United States, 76508
Tyler Research Institue /ID# 206075 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 205378 Recruiting
Victoria, Texas, United States, 77904
United States, Utah
HP Clinical Research /ID# 208890 Not yet recruiting
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 206133 Recruiting
Ogden, Utah, United States, 84403
United States, Virginia
Ctr for Gastrointestinal Healt /ID# 208475 Recruiting
Franklin, Virginia, United States, 23851
United States, Washington
Washington Gastroenterology /ID# 206177 Recruiting
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 206070 Recruiting
Seattle, Washington, United States, 98101
United States, Wisconsin
WI Center for Advanced Res /ID# 206917 Recruiting
Milwaukee, Wisconsin, United States, 53215
Froedtert and Medical College /ID# 206945 Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Hospital Italiano de Buenos Aires /ID# 215539 Not yet recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
Cardio Alem /ID# 211282 Not yet recruiting
San Isidro, Buenos Aires, Argentina, 1642
Mautalen Salud e Investigacion /ID# 206033 Recruiting
Buenos Aires, Argentina, 1128
Hospital Britanico de Bs As /ID# 209497 Recruiting
Caba, Argentina, 1280
Gedyt /ID# 210017 Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, 1125
Hospital Privado Univesitario /ID# 206030 Not yet recruiting
Cordoba, Argentina, 5016
Instituto Medico DAMIC /ID# 206470 Not yet recruiting
Cordoba, Argentina, X5003DCE
Australia, New South Wales
Macquarie University /ID# 211955 Not yet recruiting
Macquarie Park, New South Wales, Australia, 2113
Australia, Queensland
Mater Misericordiae /ID# 212687 Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Griffith University /ID# 211956 Recruiting
Southport, Queensland, Australia, 4222
Australia, Victoria
St. Vincents Hosp Melbourne /ID# 205758 Recruiting
Fitzroy, Victoria, Australia, 3065
Monash Medical Centre /ID# 206486 Recruiting
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Fiona Stanley Hospital /ID# 211642 Recruiting
Murdoch, Western Australia, Australia, 6150
Austria
Krankenanstalt Rudolfstiftung /ID# 205764 Recruiting
Vienna, Wien, Austria, 1030
Medical University of Vienna /ID# 205763 Recruiting
Vienna, Wien, Austria, 1090
LKH Salzburg and Paracelsus /ID# 208788 Recruiting
Salzburg, Austria, 5020
Belgium
AZ Maria Middelares /ID# 210928 Not yet recruiting
Ghent, Belgium, 9000
UZ Leuven /ID# 205988 Recruiting
Leuven, Belgium, 3000
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 208053 Not yet recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 208055 Not yet recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Center Tuzla /ID# 208057 Not yet recruiting
Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
University Clinical Hospital Mostar /ID# 208054 Not yet recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo /ID# 208058 Not yet recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda /ID# 206983 Not yet recruiting
Goiania, Goias, Brazil, 74535-170
Hospital Nossa Senhora das Graças /ID# 206981 Not yet recruiting
Curitiba, Parana, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre /ID# 206985 Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Upeclin Fmb - Unesp /Id# 206986 Not yet recruiting
Botucatu, Sao Paulo, Brazil, 18618-686
Faculdade de Medicina do ABC /ID# 206984 Not yet recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Kaiser Clinica e Hospital Dia /ID# 206982 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
Hospital Universitario Clement /ID# 210651 Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
University of Calgary /ID# 205755 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 211167 Recruiting
Edmonton, Alberta, Canada, T5R 1W2
Zeidler Ledcor Centre /ID# 207383 Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 205500 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 205501 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, New Brunswick
Dr. Everett Chalmers Reg Hosp. /ID# 211439 Not yet recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Ontario
Toronto Digestive Disease Asso /ID# 205498 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Crchum /Id# 207387 Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
CRCHUS Hotel-Dieu /ID# 205499 Not yet recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Chile
Research Group Ltda /ID# 208037 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 2540364
M y F Estudios Clínicos Ltda. /ID# 208035 Recruiting
Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495
Hospital Guillermo Grant Benavente de Concepción /ID# 212426 Not yet recruiting
Concepción, Chile, 4070038
CTR Estudios SpA /ID# 208036 Recruiting
Providencia, Chile, 7500571
Hospital Clinico Universidad De Los Andes /ID# 207426 Not yet recruiting
Santiago, Chile, 7501504
Hospital Clinico San Borja Arr /ID# 216530 Not yet recruiting
Santiago, Chile, 8360160
Clinica Las Condes /ID# 212735 Not yet recruiting
Santiago, Chile
China, Anhui
The First Affiliated Hosp, Sun /ID# 205267 Not yet recruiting
Guangzhou, Anhui, China, 510080
Shanghai Tenth People's Hosp /ID# 211033 Not yet recruiting
Shanghai, Anhui, China, 200072
China, Guangdong
The Sixth Affiliated Hosp, Sun /ID# 205268 Not yet recruiting
Guangzhou, Guangdong, China, 510655
China, Hubei
Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406 Not yet recruiting
Shiyan, Hubei, China, 442700
China, Hunan
Xiangya Hospital Central South University /ID# 205245 Not yet recruiting
Changsha, Hunan, China, 410008
China, Jiangsu
Wuxi People's Hospital /ID# 216143 Not yet recruiting
Wuxi, Jiangsu, China, 214023
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 212186 Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hosp of Jilin Univ /ID# 210088 Recruiting
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 205333 Not yet recruiting
Shanghai, Shanghai, China, 200025
Renji Hosp, Shanghai Jiaotong /ID# 205269 Not yet recruiting
Shanghai, Shanghai, China, 200127
China, Zhejiang
The second affiliated hospital of Zhejiang University school of medicine /ID# 205271 Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 205270 Not yet recruiting
Hangzhou, Zhejiang, China, 310016
China
West China Hospital, Sichuan University /ID# 205332 Not yet recruiting
Chengdu, China, 610041
Shengjing Hospital of China Medical University /ID# 205244 Not yet recruiting
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 205246 Recruiting
Tianjin, China, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266 Not yet recruiting
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 205265 Recruiting
Wuhan, China, 430030
Colombia
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 208886 Recruiting
Bogota DC, Cundinamarca, Colombia, 11411
Instituto de Coloproctologia /ID# 208885 Not yet recruiting
Antioquia, Colombia
Hospital Univ San Ignacio /ID# 209160 Not yet recruiting
Bogota, Colombia, 110231
Hospital Universitario San Vic /ID# 208888 Recruiting
Medellin, Colombia, 50010
Inst Med Alta Tec Onc (IMAT) /ID# 208887 Recruiting
Montería, Colombia, 230002
Croatia
Klinicka bolnica Dubrava Zagreb /ID# 208460 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 207904 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 207906 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Poliklinika Solmed /ID# 211568 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 207903 Not yet recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Rijeka /ID# 208650 Not yet recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Zadar General Hospital /ID# 207905 Not yet recruiting
Zadar, Croatia, 23000
Czechia
CTCenter MaVe, s.r.o. /ID# 205671 Completed
Olomouc, Olomoucky Kraj, Czechia, 779 00
Axon Clinical, s.r.o. /ID# 205670 Recruiting
Praha, Praha 5, Czechia, 150 00
Hepato-Gastroenterologie HK s.r.o. /ID# 205672 Recruiting
Hradec Kralove, Czechia, 500 12
Artroscan s.r.o. /ID# 205668 Recruiting
Ostrava, Czechia, 722 00
Nemocnice Pardubickeho kraje, a.s. /ID# 213540 Not yet recruiting
Pardubice, Czechia, 53203
Nemocnice Milosrdnych sester /ID# 216223 Not yet recruiting
Prague 1, Czechia, 118 33
ISCARE I.V.F. a.s. /ID# 209240 Recruiting
Prague, Czechia, 170 00
Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 213820 Not yet recruiting
Alexandria, Egypt, 21131
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 213821 Not yet recruiting
Alexandria, Egypt, 21131
Nat Hep & Trop Med Res Inst /ID# 213822 Not yet recruiting
Cairo, Egypt, 11559
Air Force Specialized Hospital /ID# 214475 Not yet recruiting
Cairo, Egypt
Estonia
East Tallinn Central Hospital /ID# 207564 Recruiting
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 207356 Recruiting
Tallinn, Estonia, 10617
North Estonian Medical Centre /ID# 207357 Recruiting
Tallinn, Estonia, 13419
Tartu University Hospital /ID# 212282 Recruiting
Tartu, Estonia, 51014
Finland
Tampere University Hospital /ID# 206161 Recruiting
Tampere, Pirkanmaa, Finland, 33520
Keski-Suomen Keskussairaala /ID# 206159 Recruiting
Jyvaskyla, Finland, 40620
Laakarikeskus Ikioma /ID# 205814 Recruiting
Mikkeli, Finland, 50100
Tyks /Id# 205813 Recruiting
Turku, Finland, 20521
France
Chu de Nice-Hopital L'Archet Ii /Id# 209118 Not yet recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
Hopital Haut-Lévêque /ID# 213832 Not yet recruiting
Pessac CEDEX, Gironde, France, 33604
CHRU Lille - Hôpital Claude Huriez /ID# 209125 Not yet recruiting
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Beaujon /ID# 209128 Not yet recruiting
Clichy, Ile-de-France, France, 92110
CHU de SAINT ETIENNE - Hopital Nord /ID# 209123 Not yet recruiting
St. Priest En Jarez, Loire, France, 42270
CHU NANCY - Hôpital Brabois Adultes /ID# 209120 Not yet recruiting
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
Centre Hospitalier Lyon Sud /ID# 209121 Not yet recruiting
Pierre Benite CEDEX, Rhone, France, 69495
CHU Amiens Picardie - Site Sud /ID# 209119 Not yet recruiting
Amiens Cedex 1, France, 80054
CHD Vendee /ID# 209122 Not yet recruiting
La Roche Sur Yon, France, 85000
CHU de Montpellier - Hôpital S /ID# 209127 Not yet recruiting
Montpellier Cedex 5, France, 34295
Polyclinique Grand Sud /ID# 214081 Not yet recruiting
Nimes Cedex, France, 30932
Germany
Universitatsklinikum Mannheim /ID# 206811 Not yet recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576 Not yet recruiting
Herne, Nordrhein-Westfalen, Germany, 44623
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813 Not yet recruiting
Saarbrücken, Saarland, Germany, 66111
Praxis am Bayrischen Platz /ID# 206733 Recruiting
Berlin, Germany, 10825
Agaplesion Markus Krankenhaus /ID# 206731 Recruiting
Frankfurt, Germany, 60341
Univ Hosp Schleswig-Holstein /ID# 206791 Not yet recruiting
Kiel, Germany, 24105
Medizinisches Versorgungszentrum Portal 10 /ID# 207137 Recruiting
Munster, Germany, 48155
Helwig, Oldenburg, DE /ID# 213438 Not yet recruiting
Oldenburg, Germany, 26123
Universitatsklinikum Tubingen /ID# 206737 Not yet recruiting
Tuebingen, Germany, 72076
Greece
General Hospital of Athens Laiko /ID# 208671 Recruiting
Athens, Attiki, Greece, 115 27
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332 Recruiting
Athens, Greece, 10676
University General Hospital of Heraklion "PA.G.N.I" /ID# 207061 Not yet recruiting
Heraklion, Greece, 71110
Theageneio Anticancer Hospital /ID# 206331 Not yet recruiting
Thessaloniki, Greece, 54639
Genl Hosp Thessaloniki Hipp /ID# 208822 Not yet recruiting
Thessaloniki, Greece, 54642
Hungary
Bekes Megyei Kozponti Korhaz /ID# 205885 Recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem /ID# 205883 Recruiting
Budapest, Hungary, 1085
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992 Recruiting
Sopron, Hungary, 9400
Mentahaz Maganorvosi Kozpont /ID# 205882 Recruiting
Szekesfehervar, Hungary, 8000
Ireland
St. James's Hospital /ID# 209649 Not yet recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
St Vincent's University Hosp /ID# 209210 Not yet recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 206509 Not yet recruiting
Dublin, Ireland, D09 XR63
Israel
Rambam Health Care Campus /ID# 206362 Recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 206365 Recruiting
Jerusalem, Israel, 91031
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351 Not yet recruiting
Bologna, Emilia-Romagna, Italy, 40138
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 206349 Recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 206346 Not yet recruiting
Rozzano, Milano, Italy, 20089
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 206347 Recruiting
Rome, Roma, Italy, 00168
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350 Recruiting
Palermo, Sicilia, Italy, 90146
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 206354 Recruiting
Negrar, Verona, Italy, 37024
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 206348 Not yet recruiting
Milano, Italy, 20121
Japan
Nagoya University Hospital /ID# 206355 Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 206058 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 206387 Recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Tokatsu Tsujinaka Hospital /ID# 214963 Not yet recruiting
Abiko-shi, Chiba, Japan, 2701168
Toho University Sakura Medical Center /ID# 207705 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Juntendo University Urayasu Hospital /ID# 208784 Recruiting
Urayasu Shi, Chiba, Japan, 279-0021
Fukuoka University Chikushi Hospital /ID# 214405 Not yet recruiting
Chikushino, Fukuoka, Japan, 818-8502
Kurume University Hospital /ID# 206385 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Ogaki Municipal Hospital /ID# 208227 Recruiting
Ogaki-shi, Gifu, Japan, 503-8502
NHO Fukuyama Medical Center /ID# 206295 Recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 206404 Recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 206314 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Sapporo Tokushukai Hospital /ID# 209448 Recruiting
Sapporo, Hokkaido, Japan, 004-0041
Aoyama Clinic /ID# 206452 Recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 206455 Recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8501
Kanazawa University Ho /ID# 206316 Recruiting
Kanazawa, Ishikawa, Japan, 92086-41
Iwate Medical University Hospital /ID# 207051 Recruiting
Morioka-shi, Iwate, Japan, 020-8505
Idzuro Imamura Hospital /ID# 207639 Recruiting
Kagishimashi, Kagoshima, Japan, 8920824
Mie University Hospital /ID# 206803 Recruiting
Tsu-shi, Mie, Japan, 514-8507
National Hospital Organization Sendai Medical Center /ID# 209528 Recruiting
Sendai-shi, Miyagi, Japan, 983-0045
Ishida Clinic of IBD and Gastroenterology /ID# 210119 Recruiting
Oita-shi, Oita, Japan, 870-0823
Kinshukai Infusion Clinic /ID# 207865 Recruiting
Osaka-shi, Osaka, Japan, 530-0011
Japanese Red Cross Osaka Hospi /ID# 209478 Recruiting
Osaka-shi, Osaka, Japan, 543-8555
Osaka City University Hospital /ID# 206457 Recruiting
Osaka-shi, Osaka, Japan, 545-0051
Saga University Hospital /ID# 209270 Recruiting
Saga-shi, Saga, Japan, 849-8501
Saitama Medical Center, Saitama Medical University /ID# 206393 Recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic /ID# 206313 Recruiting
Saitama-shi, Saitama, Japan, 336-0963
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710 Recruiting
Higashiohmi-shi, Shiga, Japan, 527-8505
Hamamatsu University Hospital /ID# 206459 Recruiting
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Medical Hospital of Tokyo Medical and Dental University /ID# 206453 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
St.Luke's International Hospital /ID# 208076 Recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Tokai University Hachioji Hospital /ID# 208903 Recruiting
Hachioji, Tokyo, Japan, 192-0032
Teikyo University Hospital /ID# 209866 Recruiting
Itabashi-ku, Tokyo, Japan, 173-8605
Center hospital of the National Center for Global Health and Medicine /ID# 209532 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8655
Tokyo Women's Medical University Hospital /ID# 206460 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 206465 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Fukui Prefectural Hospital /ID# 210449 Recruiting
Fukui, Japan, 910-0846
Saiseikai Fukuoka General Hosp /ID# 209482 Recruiting
Fukuoka, Japan, 810-0001
Hiroshima University Hospital /ID# 206464 Recruiting
Hiroshima, Japan, 734-8551
Shimane University School of Medicine /ID# 208905 Recruiting
Izumo, Japan, 693-0021
Sameshima Hospital /ID# 207935 Recruiting
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209573 Recruiting
Kashiwa, Japan
St. Marianna Univ Hospital /ID# 209451 Recruiting
Kawasaki, Japan, 216-8511
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646 Recruiting
Kurashiki, Japan, 710-0142
Saiseikai Niigata Hosp /ID# 209921 Recruiting
Niigata, Japan, 950-1104
Obihiro-Kosei General Hospital /ID# 210424 Recruiting
Obihiro, Japan, 080-0016
NHO Nagasaki Medical Center /ID# 210822 Recruiting
Omura-shi, Japan, 856-8562
Kitano Hospital /ID# 210397 Recruiting
Osaka, Japan, 530-8480
Kyoto University Hospital /ID# 211809 Recruiting
Sakyo-ku, Japan, 606-8507
Sapporo Higashi Tokushukai /ID# 208494 Recruiting
Sapporo, Japan, 065-0033
NHO Shizuoka Medical Center /ID# 208785 Recruiting
Shimizu-sho, Japan
Toyohashi Municipal Hospital /ID# 207625 Recruiting
Toyohashi, Japan, 441-8570
Toyonaka Municipal Hospital /ID# 217082 Not yet recruiting
Toyonaka, Japan, 560-8565
Ieda Hospital /ID# 207479 Recruiting
Toyota-shi, Japan, 470-1219
Kenseikai Dongo Hospital /ID# 208101 Recruiting
Yamatotakada, Japan, 635-0022
Yokkaichi Hazu Medical Center /ID# 214348 Recruiting
Yokkaichi-shi, Japan, 510-0016
Showa Univ Fujigaoka Hosp /ID# 208224 Recruiting
Yokohama-shi, Japan, 227-0043
Korea, Republic of
Dong-A University Hospital /ID# 206955 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 206956 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 206959 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
Kangbuk Samsung Hospital /ID# 206960 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
CHA Bundang Medical Center /ID# 207432 Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Severance Hospital /ID# 206958 Recruiting
Seoul, Korea, Republic of, 03722
Latvia
Riga East Clinical Univ Hosp /ID# 206828 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 206827 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 209052 Recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 208790 Recruiting
Klaipeda, Lithuania, 92288
Klaipeda Seamens Hospital /ID# 208791 Recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 209051 Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
UKM Medical Centre /ID# 207662 Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Hospital Ampang /ID# 213530 Not yet recruiting
Ampang, Selangor, Malaysia, 68000
Uni Malaya MC /ID# 208936 Recruiting
Kuala Lumpur, Malaysia, 59100
Mexico
Morales Vargas Centro de Investigacion S.C. /ID# 211326 Not yet recruiting
Leon, Guanajuato, Mexico, 37000
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44650
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067 Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64610
Netherlands
Erasmus Medisch Centrum /ID# 205280 Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Norway
Akershus Universitetssykehus_MAIN /ID# 205293 Recruiting
Lorenskog, Akershus, Norway, 1478
Universitetssykehuset Nord-Norge /ID# 205691 Recruiting
Tromsø, Troms, Norway, 9019
Poland
Centrum Zdrowia MDM /ID# 205874 Not yet recruiting
Warsaw, Mazowieckie, Poland, 00-635
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070 Not yet recruiting
Warsaw, Mazowieckie, Poland, 04-730
Endoterapia PFG Sp. z.o.o. /ID# 212913 Recruiting
Warszawa, Mazowieckie, Poland, 02-653
Endoskopia Sp. z o.o. /ID# 212964 Recruiting
Sopot, Zachodniopomorskie, Poland, 81-756
Gastromed /Id# 216108 Not yet recruiting
Toruń, Poland, 87-100
NZOZ Vivamed /ID# 216697 Not yet recruiting
Warsaw, Poland, 03-580
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 205554 Recruiting
Guimarães, Braga, Portugal, 4835-044
Hospital Garcia de Orta, E.P.E /ID# 206143 Not yet recruiting
Almada, Setubal, Portugal, 2805-267
Hospital de Braga /ID# 206144 Not yet recruiting
Braga, Portugal, 4710-423
Centro Hospitalar Lisboa Norte, EPE /ID# 206117 Recruiting
Lisboa, Portugal, 1649-035
Hospital Santo Antonio dos Cap /ID# 206145 Not yet recruiting
Lisbon, Portugal, 1150-069
Centro Hospitalar de Sao Joao /ID# 206142 Not yet recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 205563 Not yet recruiting
Santa Maria Da Feira, Portugal, 4520-211
Unidade Local De Saude Do Alto Minho /ID# 205556 Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 209626 Recruiting
San Juan, Puerto Rico, 00935
Romania
Institutul Clinic Fundeni /ID# 206011 Not yet recruiting
Bucharest, Romania, 022328
Institutul Clinic Fundeni /ID# 206012 Not yet recruiting
Bucharest, Romania, 022328
Cabinet Particular Policlinic Algomed /ID# 206010 Not yet recruiting
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University /ID# 208264 Recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
NW State Medical Univ na Mechn /ID# 208258 Recruiting
St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
Perm Clinical Center of FMBA /ID# 211653 Recruiting
Perm, Permskiy Kray, Russian Federation, 614109
LLC Medical Company Hepatolog /ID# 208261 Recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
Private institution Center of educational and clinical gastroenterology, hepatol /ID# 211652 Recruiting
Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
Kazan State Medical University /ID# 208256 Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Llc Olla-Med /Id# 215335 Recruiting
Moscow, Russian Federation, 105554
Republican Clin Hos n.a. Baran /ID# 206507 Recruiting
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 208265 Recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 208260 Recruiting
Pyatigorsk, Russian Federation, 357532
Serbia
Clinical Center Serbia /ID# 205256 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 205258 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 205257 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 206413 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 206411 Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Clinical Center Kragujevac /ID# 206410 Not yet recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 205259 Not yet recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital /ID# 209099 Not yet recruiting
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 206954 Recruiting
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 207663 Not yet recruiting
Singapore, Singapore, 308433
Slovakia
Medak s.r.o., gastroenterologi /ID# 205191 Recruiting
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve /ID# 205147 Recruiting
Banska Bystrica, Slovakia, 97517
B and B MED s.r.o. /ID# 205213 Recruiting
Kosice, Slovakia, 040 01
Fakultna nemocnica s poliklini /ID# 211372 Not yet recruiting
Nove Zamky, Slovakia, 94002
Gastro I.S.R.O. /ID# 205148 Recruiting
Presov, Slovakia, 08001
South Africa
Clinresco Centres /ID# 208083 Recruiting
Johannesburg, Gauteng, South Africa, 1619
Lenasia Clinical Trial Centre /ID# 214359 Not yet recruiting
Johannesburg, Gauteng, South Africa, 1820
Chris Hani Baragwanath Hosp /ID# 208082 Recruiting
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site /ID# 208949 Recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 207979 Recruiting
CAPE TOWN,Milnerton, Western Cape, South Africa, 7441
Allergy & Immunology (AIU) /ID# 214360 Not yet recruiting
Cape Town, Western Cape, South Africa, 7700
Kingsbury Hospital /ID# 205281 Recruiting
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg /ID# 205273 Not yet recruiting
Cape Town, Western Cape, South Africa, 7800
MD Search /ID# 208084 Recruiting
Boksburg North, South Africa, 1460
Spain
Comple Hospi Univ de Santiago /ID# 204411 Recruiting
Santiago de Compostela, A Coruna, Spain, 15706
Comple Hosp Univ de A Coruna /ID# 206907 Recruiting
A Coruna, Spain, 15006
Hospital Clinico y Provincial Barcelona /ID# 206906 Recruiting
Barcelona, Spain, 08036
Hospital Universitario Reina S /ID# 204412 Not yet recruiting
Cordoba, Spain, 14004
Hospital Univ Dr. Negrin /ID# 206905 Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Univ Ramon y Cajal /ID# 204410 Completed
Madrid, Spain, 28034
Hospital Universitario La Paz /ID# 214540 Not yet recruiting
Madrid, Spain, 28046
Complejo Asistencial de Salama /ID# 205013 Recruiting
Salamanca, Spain, 37007
Hospital Universitario La Fe /ID# 206904 Recruiting
Valencia, Spain, 46026
Sweden
Sodersjukhuset /ID# 216618 Not yet recruiting
Stockholm, Sweden, 11883
Switzerland
Kantonsspital St. Gallen /ID# 211310 Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 211381 Recruiting
Basel, Switzerland, 4031
Inselspital, Universitaetsklinik /ID# 211312 Recruiting
Bern, Switzerland, 3010
Universitaetsspital Zuerich /ID# 211308 Recruiting
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 207845 Recruiting
Taichung City, Taichung, Taiwan, 40447
National Taiwan University Hospital /ID# 207847 Recruiting
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University /ID# 207848 Recruiting
Kaohsiung, Taiwan, 80708
Taipei Veterans General Hosp /ID# 207849 Recruiting
Taipei City, Taiwan, 11217
Turkey
Erciyes University Medical Fac /ID# 207506 Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Gazi University Med. Faculty /ID# 208040 Not yet recruiting
Ankara GAZI, Turkey, 06500
Istanbul University Cerrahpasa Medical Faculty /ID# 207507 Not yet recruiting
Istanbul, Turkey, 34098
Umraniye Training and Res Hosp /ID# 208206 Not yet recruiting
Istanbul, Turkey, 34764
Marmara University Medical Fac /ID# 214727 Not yet recruiting
Istanbul, Turkey, 34899
Mersin University Medical /ID# 208039 Not yet recruiting
Mersin, Turkey, 33343
Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939 Recruiting
Kharkiv, Kharkivska Oblast, Ukraine, 61204
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300 Not yet recruiting
Vinnytsia, Vinnytska Oblast, Ukraine, 21018
Regional Clin Hosp Mechnykov /ID# 207725 Not yet recruiting
Dnipro, Ukraine, 49005
United Kingdom
RD&E Hospital /ID# 206750 Not yet recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Basingstoke & North Hampshire /ID# 207985 Not yet recruiting
Basingstoke, United Kingdom, RG24 9NA
Royal United Hospitals Bath /ID# 207095 Not yet recruiting
Bath, United Kingdom, BA1 3NG
Queen Elizabeth University Hos /ID# 205154 Recruiting
Glasgow, United Kingdom, G514TF
St. George's Healthcare NHS /ID# 208375 Not yet recruiting
London, United Kingdom, SW17 0QT
Barts and the London NHS Trust /ID# 205153 Recruiting
Whitechapel, United Kingdom, E1 1 BB
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03653026     History of Changes
Other Study ID Numbers: M14-675
2016-000642-62 ( EudraCT Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
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

Layout table for additional information
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
Ulcerative Colitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents