Trial record 4 of 31 for:    Upadacitinib

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. Identifier: NCT03653026
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : February 5, 2019
Information provided by (Responsible Party):

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 subjects 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

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 29, 2018
Estimated Primary Completion Date : February 23, 2022
Estimated Study Completion Date : February 23, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Upadacitinib Drug: Upadacitinib (ABT-494)
Upadacitinib will be orally administered

Experimental: Placebo Drug: Placebo
Placebo will be orally administered

Primary Outcome Measures :
  1. Proportion of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
    It 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. Proportion of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement is defined as an endoscopic subscore <=1.

  2. Proportion of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore =0.

  3. Proportion of participants achieving clinical response per Adapted Mayo score [ 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 RBS >= 1 or an absolute RBS <= 1.

  4. Proportion of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]
    It is defined as a decrease in the partial adapted mayo score >= 1 points and >= 30% from Baseline, PLUS a decrease in RBS>=1 or an absolute RBS<=1.

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

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

  7. Proportion of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    It is defined as decrease from Baseline in Geboes score

  8. Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]
    It is defined as the increase of IBDQ bowel symptom domain score >=6

  9. Proportion of participants with mucosal healing [ Time Frame: At Week 8 ]
    It is defined as the endoscopic and histologic remission

  10. Proportion of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Participants with an US related event that results in admission to the hospital will be assessed.

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

  12. Proportion of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]
    It is defined as the increase of IBDQ fatigue item score >=1

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.

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

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 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.
  • 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 during the Screening endoscopy.
  • Received cyclosporine, tacrolimus, or mycophenolate mofetil 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 identifier (NCT number): NCT03653026

Contact: ABBVIE CALL CENTER 847.283.8955

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United States, Alabama
CB Flock Research Corporation /ID# 206094 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Delsol Research Management, Ll /Id# 208889 Not yet recruiting
Chandler, Arizona, United States, 85224
AZ Arthritis and Rheum Researc /ID# 211030 Not yet recruiting
Phoenix, Arizona, United States, 85032-9306
University of Arizona /ID# 208856 Not yet recruiting
Tucson, Arizona, United States, 85724
United States, California
Citrus Valley Gastroenterology /ID# 205627 Not yet recruiting
Covina, California, United States, 91722-3797
Ucsd /Id# 204919 Not yet recruiting
La Jolla, California, United States, 92037
United Gastroenterologists /ID# 207867 Not yet recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 205314 Not yet recruiting
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 205301 Not yet recruiting
Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 205313 Not yet recruiting
Murrieta, California, United States, 92563
UC Irvine /ID# 205315 Not yet recruiting
Orange, California, United States, 92868
Ventura County Gastroenterology /ID# 205628 Not yet recruiting
Oxnard, California, United States, 93030
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
Delta Waves, Inc. /ID# 206170 Not yet recruiting
Colorado Springs, Colorado, United States, 80918
Western States Clinical Res /ID# 206091 Not yet recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Western Connecticut Medical Group /ID# 208290 Not yet recruiting
Danbury, Connecticut, United States, 06810-6000
United States, Florida
Gastro Florida /ID# 206174 Not yet recruiting
Clearwater, Florida, United States, 33756
Palmetto Research, LLC /ID# 208293 Not yet recruiting
Hialeah, Florida, United States, 33016
Nature Coast Clinical Research /ID# 206087 Recruiting
Inverness, Florida, United States, 34452
Borland-Groover Clinic /ID# 208128 Not yet recruiting
Jacksonville, Florida, United States, 32258
Ctr for Advanced Gastroenterol /ID# 207995 Not yet recruiting
Maitland, Florida, United States, 32751-6108
Coral Research Clinic /ID# 208292 Not yet recruiting
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 206077 Not yet recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 207360 Not yet recruiting
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 206066 Not yet recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 206068 Not yet recruiting
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 207363 Not yet recruiting
Tampa, Florida, United States, 33613-4680
United States, Georgia
Atlanta Gastroenterology Spec /ID# 206173 Not yet 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 Not yet recruiting
Chicago, Illinois, United States, 60637-1443
Carle Foundation Hospital /ID# 207397 Not yet recruiting
Effingham, Illinois, United States, 62401
United States, Indiana
MediSphere Medical Research Center /ID# 206073 Not yet 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 /ID# 206167 Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Tri-State Gastroenterology /ID# 206124 Not yet recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Houma Digestive Health Special /ID# 206176 Not yet 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 Not yet recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
Gastro Center of Maryland /ID# 206883 Not yet recruiting
Columbia, Maryland, United States, 21045
United States, Michigan
University of Michigan Hospitals /ID# 206918 Not yet recruiting
Ann Arbor, Michigan, United States, 48109-5008
Huron Gastroenterology Assoc /ID# 205109 Not yet recruiting
Ann Arbor, Michigan, United States, 48197
Caro Health Plaza /ID# 208048 Not yet recruiting
Caro, Michigan, United States, 48723-9686
Clin Res Inst of Michigan, LLC /ID# 207078 Not yet recruiting
Chesterfield, Michigan, United States, 48047
Revival Research Institute, LLC /ID# 207282 Not yet recruiting
Southfield, Michigan, United States, 48034-1659
United States, Minnesota
Minneapolis VA Medical Center /ID# 206104 Not yet recruiting
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 206069 Not yet recruiting
Jackson, Mississippi, United States, 39216
United States, Nevada
Las Vegas Medical Research /ID# 206814 Not yet 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 Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Advantage Clinical Trials /ID# 206082 Not yet 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 Not yet recruiting
Great Neck, New York, United States, 11021
DiGiovanna Institute for Medic /ID# 206885 Not yet recruiting
North Massapequa, New York, United States, 11758
Premier Medical Group /ID# 206097 Not yet recruiting
Poughkeepsie, New York, United States, 12601
Gastro Group of Rochester /ID# 206881 Not yet recruiting
Rochester, New York, United States, 14618-5703
United States, North Carolina
Digestive Health Partners, P.A /ID# 206842 Not yet recruiting
Asheville, North Carolina, United States, 28801
Carolinas Medical Center /ID# 206085 Not yet 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 Not yet recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
University of Cincinnati /ID# 205633 Not yet recruiting
Cincinnati, Ohio, United States, 45267-0585
The Ohio State University - Columbus /ID# 205637 Not yet recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 205638 Not yet recruiting
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 205630 Not yet recruiting
Dayton, Ohio, United States, 45424
Dayton Gastroenterology, Inc. /ID# 205639 Not yet recruiting
Englewood, Ohio, United States, 45415
Great Lakes Gastroenterology Research LLC /ID# 205631 Recruiting
Mentor, Ohio, United States, 44060-6211
United States, Oklahoma
Digestive Disease Specialists /ID# 206076 Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC /ID# 206707 Not yet recruiting
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultant /ID# 206706 Not yet recruiting
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Guthrie Medical Group, PC /ID# 206078 Not yet recruiting
Sayre, Pennsylvania, United States, 18840
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Pharmacorp Clinical Trials /ID# 206074 Not yet recruiting
Charleston, South Carolina, United States, 29412
Greenville Endoscopy Center /ID# 206098 Not yet recruiting
Greenville, South Carolina, United States, 29615
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Gastro One /ID# 206178 Not yet recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 206169 Not yet recruiting
Johnson City, Tennessee, United States, 37604
Quality Medical Research, PLLC /ID# 206088 Not yet recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
TX Clinical Research Institute /ID# 206718 Not yet recruiting
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 206132 Not yet recruiting
Baytown, Texas, United States, 77521
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Cedar Park, Texas, United States, 78613-5028
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Cedar Park, Texas, United States, 78613-5028
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DHAT Research Institute /ID# 206716 Not yet recruiting
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CliniCore International, LLC /ID# 206065 Not yet recruiting
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Houston, Texas, United States, 77030-3411
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Houston, Texas, United States, 77030
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GI Specialists of Houston /ID# 206090 Not yet recruiting
Houston, Texas, United States, 77070-4347
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Sagact Pllc /Id# 205379 Not yet recruiting
San Antonio, Texas, United States, 78229
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Temple, Texas, United States, 76508
Tyler Research Institue /ID# 206075 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 205378 Not yet 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 Not yet recruiting
Ogden, Utah, United States, 84403
United States, Virginia
Ctr for Gastrointestinal Healt /ID# 208475 Not yet recruiting
Franklin, Virginia, United States, 23851
United States, Washington
Washington Gastroenterology /ID# 206177 Not yet recruiting
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 206070 Not yet recruiting
Seattle, Washington, United States, 98101
United States, Wisconsin
WI Center for Advanced Res /ID# 206917 Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Froedtert and Medical College /ID# 206945 Not yet recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Mautalen Salud e Investigacion /ID# 206033 Not yet recruiting
Buenos Aires, Argentina, 1128
Hospital Britanico de Bs As /ID# 209497 Not yet recruiting
Caba, Argentina, 1280
Instituto Medico DAMIC /ID# 206470 Not yet recruiting
Cordoba, Argentina, X5003DCE
Hospital Privado Univesitario /ID# 206030 Not yet recruiting
Cordoba, Argentina, X5016
Instituto Medico CER /ID# 206032 Not yet recruiting
Quilmes, Argentina, 1878
Sanatorio 9 de Julio S.A. /ID# 206469 Not yet recruiting
San Miguel de Tucuman, Argentina, 4000
Australia, Victoria
St. Vincents Hosp Melbourne /ID# 205758 Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Monash Medical Centre /ID# 206486 Not yet recruiting
Melbourne, Victoria, Australia, 3168
Krankenanstalt Rudolfstiftung /ID# 205764 Not yet recruiting
Vienna, Wien, Austria, 1030
Medical University of Vienna /ID# 205763 Not yet recruiting
Vienna, Wien, Austria, 1090
Vitebsk Regional Advanced Clin /ID# 208321 Not yet recruiting
Vitebsk, Belarus, 210001
UZ Leuven /ID# 205988 Not yet recruiting
Leuven, Belgium, 3000
AZ-Delta /ID# 205989 Not yet recruiting
Roeselare, Belgium, 8800
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
Instituto Goiano de Gastroenterologia /ID# 206983 Not yet recruiting
Goiânia, 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
Canada, Alberta
University of Calgary /ID# 205755 Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre /ID# 207383 Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 205500 Not yet recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 205501 Not yet recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Ontario
Toronto Digestive Disease Asso /ID# 205498 Not yet 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
Research Group Ltda /ID# 208037 Not yet recruiting
Santiago, Region Metropolitana De Santiago, Chile, 2540364
Hospital Clinico Universidad /ID# 209979 Not yet recruiting
Santiago, Region Metropolitana De Santiago, Chile, 8380456
M y F Estudios Clínicos Ltda. /ID# 208035 Not yet recruiting
Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495
Centro de Investigaciones Clínicas Viña del Mar /ID# 208038 Not yet recruiting
Viña del Mar, Valparaíso, Chile, 2540488
CTR Estudios SpA /ID# 208036 Not yet recruiting
Providencia, Chile, 7500571
Hospital Clinico Universidad De Los Andes /ID# 207426 Not yet recruiting
Santiago, Chile, 7501504
China, Anhui
The First Affiliated Hosp, Sun /ID# 205267 Not yet recruiting
Guangzhou, Anhui, China, 510080
The Sixth Affiliated Hosp, Sun /ID# 205268 Not yet recruiting
Guangzhou, Anhui, China, 510655
Shanghai Tenth People's Hosp /ID# 211033 Not yet recruiting
Shanghai, Anhui, China, 200072
Renji Hosp, Shanghai Jiaotong /ID# 205269 Not yet recruiting
Shanghai, Anhui, China, 200127
China, Jilin
The First Hosp of Jilin Univ /ID# 210088 Not yet recruiting
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 205333 Not yet recruiting
Shanghai, Shanghai, China, 200025
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
Xiangya Hosp Central South Uni /ID# 205245 Not yet recruiting
Changsha, China, 410008
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 Not yet 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 Not yet recruiting
Wuhan, China, 430030
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 208886 Not yet 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 Not yet recruiting
Medellin, Colombia, 50010
Inst Med Alta Tec Onc (IMAT) /ID# 208887 Not yet recruiting
Montería, Colombia, 230002
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
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
CTCenter MaVe, s.r.o. /ID# 205671 Not yet recruiting
Olomouc, Olomoucky Kraj, Czechia, 779 00
Axon Clinical, s.r.o. /ID# 205670 Not yet recruiting
Praha, Praha 5, Czechia, 150 00
Hepato-Gastroenterologie HK s.r.o. /ID# 205672 Not yet recruiting
Hradec Kralove, Czechia, 500 12
Artroscan s.r.o. /ID# 205668 Not yet recruiting
Ostrava, Czechia, 722 00
ISCARE I.V.F. a.s. /ID# 209240 Not yet recruiting
Prague, Czechia, 170 00
East Tallinn Central Hospital /ID# 207564 Not yet recruiting
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 207356 Not yet recruiting
Tallinn, Estonia, 10617
North Estonian Medical Centre /ID# 207357 Not yet recruiting
Tallinn, Estonia, 13419
Tampere University Hospital /ID# 206161 Not yet recruiting
Tampere, Pirkanmaa, Finland, 33520
Keski-Suomen Keskussairaala /ID# 206159 Not yet recruiting
Jyvaskyla, Finland, 40620
Laakarikeskus Ikioma /ID# 205814 Not yet recruiting
Mikkeli, Finland, 50100
Tyks /Id# 205813 Not yet recruiting
Turku, Finland, 20521
Chu de Nice-Hopital L'Archet Ii /Id# 209118 Not yet recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
CHRU Lille - Hôpital Claude Huriez /ID# 209125 Not yet recruiting
Lille CEDEX, Hauts-de-France, France, 59045
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
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
Universitatsklinikum Mannheim /ID# 206811 Not yet recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Gastroenterologie am Bayerisch /ID# 206733 Not yet recruiting
Berlin, Germany, 10825
Agaplesion Markus Krankenhaus /ID# 206731 Not yet recruiting
Frankfurt, Germany, 60341
Univ Hosp Schleswig-Holstein /ID# 206791 Not yet recruiting
Kiel, Germany, 24105
Medizinisches Versorgungszentrum Portal 10 /ID# 207137 Not yet recruiting
Munster, Germany, 48155
Universitatsklinikum Tubingen /ID# 206737 Not yet recruiting
Tuebingen, Germany, 72076
General Hospital of Athens Laiko /ID# 208671 Not yet recruiting
Athens, Attiki, Greece, 115 27
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332 Not yet 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
Markusovszky Egyetemi Oktatókórház /ID# 205881 Not yet recruiting
Szombathely, Vas, Hungary, 9700
Bekes Megyei Kozponti Korhaz /ID# 205885 Not yet recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem /ID# 205883 Not yet recruiting
Budapest, Hungary, 1085
Meditres Kft. /ID# 205886 Not yet recruiting
Kecskemet, Hungary, 6000
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992 Not yet recruiting
Sopron, Hungary, 9400
Mentahaz Maganorvosi Kozpont /ID# 205882 Not yet recruiting
Szekesfehervar, Hungary, 8000
St. James's Hospital /ID# 209649 Not yet recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
Mercy University Hospital /ID# 206580 Not yet recruiting
Cork, Ireland, T12 WE28
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
Rambam Health Care Campus /ID# 206362 Not yet recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 206365 Not yet recruiting
Jerusalem, Israel, 91031
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 Not yet 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 Not yet recruiting
Rome, Roma, Italy, 00168
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350 Not yet recruiting
Palermo, Sicilia, Italy, 90146
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 206354 Not yet recruiting
Negrar, Verona, Italy, 37024
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 206348 Not yet recruiting
Milano, Italy, 20121
Nagoya University Hospital /ID# 206355 Not yet recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 206058 Not yet recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 206387 Not yet recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Medical Center /ID# 207705 Not yet recruiting
Sakura-shi, Chiba, Japan, 285-8741
Juntendo University Urayasu Hospital /ID# 208784 Not yet recruiting
Urayasu Shi, Chiba, Japan, 279-0021
Kurume University Hospital /ID# 206385 Not yet recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Ogaki Municipal Hospital /ID# 208227 Not yet recruiting
Ogaki-shi, Gifu, Japan, 503-8502
NHO Fukuyama Medical Center /ID# 206295 Not yet recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 206404 Not yet recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059 Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 206314 Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Sapporo Tokushukai Hospital /ID# 209448 Not yet recruiting
Sapporo, Hokkaido, Japan, 004-0041
Aoyama Clinic /ID# 206452 Not yet recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 206455 Not yet recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8501
Kanazawa University Ho /ID# 206316 Not yet recruiting
Kanazawa, Ishikawa, Japan, 92086-41
Iwate Medical University Hospital /ID# 207051 Not yet recruiting
Morioka-shi, Iwate, Japan, 020-8505
Idzuro Imamura Hospital /ID# 207639 Not yet recruiting
Kagishimashi, Kagoshima, Japan, 8920824
Mie University Hospital /ID# 206803 Not yet recruiting
Tsu-shi, Mie, Japan, 514-8507
National Hospital Organization Sendai Medical Center /ID# 209528 Not yet recruiting
Sendai-shi, Miyagi, Japan, 983-0045
Ishida Clinic of IBD and Gastroenterology /ID# 210119 Not yet recruiting
Oita-shi, Oita, Japan, 870-0823
Japanese Red Cross Osaka Hospi /ID# 209478 Not yet recruiting
Osaka-shi, Osaka, Japan, 543-8555
Osaka City University Hospital /ID# 206457 Not yet recruiting
Osaka-shi, Osaka, Japan, 545-0051
Saitama Medical Center, Saitama Medical University /ID# 206393 Not yet recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic /ID# 206313 Recruiting
Saitama-shi, Saitama, Japan, 336-0963
Hamamatsu University Hospital /ID# 206459 Not yet recruiting
Higashi-ku, Shizuoka, Japan, 431-3192
Medical Hospital of Tokyo Medical and Dental University /ID# 206453 Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
St.Luke's International Hospital /ID# 208076 Not yet recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Tokai University Hachioji Hospital /ID# 208903 Not yet recruiting
Hachioji, Tokyo, Japan, 192-0032
Teikyo University Hospital /ID# 209866 Not yet recruiting
Itabashi-ku, Tokyo, Japan, 173-8605
Kyorin University Hospital /ID# 206356 Not yet recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Tokyo Women's Medical University Hospital /ID# 206460 Not yet recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 206465 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Fukui Prefectural Hospital /ID# 210449 Not yet recruiting
Fukui, Japan, 910-0846
Saiseikai Fukuoka General Hosp /ID# 209482 Not yet recruiting
Fukuoka, Japan, 810-0001
NHO Higashi-Ohmi Gen Med Ctr /ID# 210710 Not yet recruiting
Higashiomi, Japan
Hiroshima University Hospital /ID# 206464 Not yet recruiting
Hiroshima, Japan, 734-8551
Shimane University School of Medicine /ID# 208905 Not yet recruiting
Izumo, Japan, 693-0021
Sameshima Hospital /ID# 207935 Not yet recruiting
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209573 Not yet recruiting
Kashiwa, Japan
St. Marianna Univ Hospital /ID# 209451 Not yet recruiting
Kawasaki, Japan, 216-8511
Chikuba Hospital /ID# 206646 Not yet recruiting
Kurashiki, Japan, 710-0142
Saiseikai Niigata Daini Hosp /ID# 209921 Not yet recruiting
Niigata, Japan, 950-1104
Obihiro-Kosei General Hospital /ID# 210424 Not yet recruiting
Obihiro, Japan, 080-0016
NHO Nagasaki Medical Center /ID# 210822 Not yet recruiting
Omura-shi, Japan, 856-8562
Kitano Hospital /ID# 210397 Not yet recruiting
Osaka, Japan, 530-8480
Kinshukai Infusion Clinic /ID# 207865 Not yet recruiting
Osaka, Japan
Kyoto University Hospital /ID# 206500 Not yet recruiting
Sakyo-ku, Japan, 606-8507
Sapporo Higashi Tokushukai /ID# 208494 Not yet recruiting
Sapporo, Japan, 065-0033
NHO Shizuoka Medical Center /ID# 208785 Not yet recruiting
Shimizu-sho, Japan
Center hospital of the National Center for Global Health and Medicine /ID# 209532 Not yet recruiting
Tokyo, Japan, 162-8655
Toyohashi Municipal Hospital /ID# 207625 Not yet recruiting
Toyohashi, Japan, 441-8570
Ieda Hospital /ID# 207479 Not yet recruiting
Toyota-shi, Japan, 470-1219
Kenseikai Dongo Hospital /ID# 208101 Not yet recruiting
Yamatotakada, Japan, 635-0022
Showa Univ Fujigaoka Hosp /ID# 208224 Not yet recruiting
Yokohama-shi, Japan, 227-0043
Korea, Republic of
Dong-A University Hospital /ID# 206955 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 206956 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 206959 Not yet recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
Kangbuk Samsung Hospital /ID# 206960 Not yet recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
CHA Bundang Medical Center /ID# 207432 Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Severance Hospital /ID# 206958 Not yet recruiting
Seoul, Korea, Republic of, 03722
Riga East Clinical Univ Hosp /ID# 206828 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 206827 Not yet recruiting
Riga, Latvia, LV-1002
Hosp Lithuanian Univ Health Sc /ID# 209052 Not yet recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 208790 Not yet recruiting
Klaipeda, Lithuania, 92288
Klaipeda Seamens Hospital /ID# 208791 Not yet recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 209051 Not yet recruiting
Vilnius, Lithuania, LT-08661
UKM Medical Centre /ID# 207662 Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Uni Malaya MC /ID# 208936 Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067 Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64610
CIRO - CLIN de Reum y Obesidad /ID# 208068 Not yet recruiting
Guadalajara Jalisco, Mexico, CP 44650
Issste /Id# 208066 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44600
Erasmus Medisch Centrum /ID# 205280 Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Akershus Universitetssykehus_MAIN /ID# 205293 Not yet recruiting
Lorenskog, Akershus, Norway, 1478
Universitetssykehuset Nord-Norge /ID# 205691 Not yet recruiting
Tromsø, Troms, Norway, 9019
Centrum Zdrowia MDM /ID# 205874 Not yet recruiting
Warszawa, Mazowieckie, Poland, 00-635
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 205554 Not yet 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 Not yet 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 Not yet recruiting
Viana Do Castelo, Portugal, 4901-858
Institutul Clinic Fundeni /ID# 206011 Not yet recruiting
Bucharest, Romania, 22328
Institutul Clinic Fundeni /ID# 206012 Not yet recruiting
Bucharest, Romania, 22328
Cabinet Particular Policlinic Algomed /ID# 206010 Not yet recruiting
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University /ID# 208264 Not yet recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
NW State Medical Univ na Mechn /ID# 208258 Not yet recruiting
St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
LLC Medical Company Hepatolog /ID# 208261 Not yet recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
LLC Uromed /ID# 208257 Not yet recruiting
Smolensk, Smolenskaya Oblast, Russian Federation, 214031
Kazan State Medical University /ID# 208256 Not yet recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
P.A. Bayandin Murmansk Regiona /ID# 208259 Not yet recruiting
Murmansk, Russian Federation, 183047
Republican Clin Hos n.a. Baran /ID# 206507 Not yet recruiting
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 208265 Not yet recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 208260 Not yet recruiting
Pyatigorsk, Russian Federation, 357532
Clinical Center Serbia /ID# 205256 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 205258 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 205257 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 206413 Not yet 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
National University Hospital /ID# 209099 Not yet recruiting
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 206954 Not yet recruiting
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 207663 Not yet recruiting
Singapore, Singapore, 308433
Medak s.r.o., gastroenterologi /ID# 205191 Not yet recruiting
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve /ID# 205147 Not yet recruiting
Banska Bystrica, Slovakia, 97517
B and B MED s.r.o. /ID# 205213 Not yet recruiting
Kosice, Slovakia, 040 01
Gastro I.S.R.O. /ID# 205148 Not yet recruiting
Presov, Slovakia, 08001
South Africa
Clinresco Centres /ID# 208083 Not yet recruiting
Johannesburg, Gauteng, South Africa, 1619
Chris Hani Baragwanath Hosp /ID# 208082 Not yet recruiting
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site /ID# 208949 Not yet recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 207979 Not yet recruiting
CAPE TOWN,Milnerton, Western Cape, South Africa, 7441
Kingsbury Hospital /ID# 205281 Not yet recruiting
Cape Town, Western Cape, South Africa, 7708
Comple Hospi Univ de Santiago /ID# 204411 Not yet recruiting
Santiago de Compostela, A Coruna, Spain, 15706
Comple Hosp Univ de A Coruna /ID# 206907 Not yet recruiting
A Coruna, Spain, 15006
Hospital Clinico y Provincial Barcelona /ID# 206906 Not yet recruiting
Barcelona, Spain, 08036
Hospital Universitario Reina S /ID# 204412 Not yet recruiting
Cordoba, Spain, 14004
Hospital Univ Dr. Negrin /ID# 206905 Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Univ Ramon y Cajal /ID# 204410 Not yet recruiting
Madrid, Spain, 28034
Complejo Asistencial de Salama /ID# 205013 Not yet recruiting
Salamanca, Spain, 37007
Hospital Universitario La Fe /ID# 206904 Not yet recruiting
Valencia, Spain, 46026
Sahlgrenska US Gbg /ID# 205294 Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
China Medical University Hosp /ID# 207845 Not yet recruiting
Taichung City, Taichung, Taiwan, 40447
National Taiwan University Hospital /ID# 207847 Not yet recruiting
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University /ID# 207848 Not yet recruiting
Kaohsiung, Taiwan, 80708
Taipei Veterans General Hosp /ID# 207849 Not yet recruiting
Taipei City, Taiwan, 11217
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
Mersin University Medical /ID# 208039 Not yet recruiting
Mersin, Turkey, 33343
Regional Clinical Hospital - Center for Emergency Medical Care and Disaster Med /ID# 206939 Not yet recruiting
Kharkiv, Kharkivska Oblast, Ukraine, 61204
Medical Center of the "Health /ID# 206743 Not yet recruiting
Vinnytsya, Vinnytska Oblast, Ukraine, 21009
Regional Clin Hosp Mechnykov /ID# 207725 Not yet recruiting
Dnipropetrovsk, 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
Univ Hospitals Birmingham NHS Foundation trust /ID# 206536 Not yet recruiting
Birmingham, United Kingdom, B15 2TG
Queen Elizabeth University Hos /ID# 205154 Not yet 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 Not yet recruiting
Whitechapel, United Kingdom, E1 1 BB
Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie 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: February 5, 2019
Last Verified: February 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.

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:
Ulcerative Colitis

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