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

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: NCT02819635
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 844 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 26, 2016
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : February 24, 2022

Resource links provided by the National Library of Medicine


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

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

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

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

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




Primary Outcome Measures :
  1. Substudy 1/Substudy 2: Percentage of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission per Adapted Mayo score

  2. Substudy 3: Percentage of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 44 or Week 52 ]
    Clinical remission per Adapted Mayo score


Secondary Outcome Measures :
  1. Substudy 1: Change in Full Mayo score [ Time Frame: Week 0 to Week 8 ]
    Change in Full Mayo score

  2. Substudy 1/Substudy 2: Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo

  3. Substudy 1/Substudy 2: Percentage of participants achieving clinical remission per Full Mayo score [ Time Frame: At Week 8 ]
    Clinical remission per Full Mayo score

  4. Substudy 1/Substudy 2: Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic improvement defined by endoscopic subscore

  5. Substudy 1/Substudy 2: Percentage of participants achieving clinical response per Partial Mayo score [ Time Frame: At Week 2 ]
    Percentage of participants achieving clinical response per Partial Mayo score

  6. Substudy 1/Substudy 2: Percentage of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Remission defined by endoscopic subscore

  7. Substudy 1/Substudy 2: Percentage of participants who achieved histologic improvement [ Time Frame: At Week 8 ]
    Histologic improvement defined by Geboes score

  8. Substudy 2: Percentage of participants who report no bowel urgency [ Time Frame: At Week 8 ]
    Percentage of participants who report no bowel urgency

  9. Substudy 2: Percentage of participants who reported no abdominal pain [ Time Frame: At Week 8 ]
    Percentage of participants who reported no abdominal pain

  10. Substudy 2: Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]
    Response defined by IBDQ Bowel Symptom domain

  11. Substudy 2: Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Percentage of participants achieving clinical response per Adapted Mayo score

  12. Substudy 2: Percentage of participants with mucosal healing [ Time Frame: At Week 8 ]
    Percentage of participants with mucosal healing

  13. Substudy 2: Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) fatigue item [ Time Frame: At Week 8 ]
    Defined by IBDQ fatigue item scores

  14. Substudy 2: Percentage of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]
    Percentage of participants with UC-related hospitalizations

  15. Substudy 2: Percentage of participants with UC-related surgeries [ Time Frame: Through Week 8 ]
    Percentage of participants with UC-related surgeries

  16. Substudy 3: Percentage of participants with endoscopic improvement [ Time Frame: At Week 44 or Week 52 ]
    Endoscopic improvement defined by endoscopic subscore

  17. Substudy 3: Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for >= 90 days and achieved clinical remission per Adapted Mayo score [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants who discontinued corticosteroid use, remained corticosteroid free and achieved clinical remission per Adapted Mayo score

  18. Substudy 3: Percentage of participants who maintain clinical remission per Adapted Mayo score among participants who received clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or M14-675 [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants who maintain clinical remission per Adapted Mayo score among participants who received clinical remission per Adapted Mayo score in Study M14-234 (Substudy 1 or 2) or M14-675

  19. Substudy 3: Percentage of participants with endoscopic improvement among participants who had endoscopic improvement in Study M14-234 (Substudy 1 or 2) or Study M14-675 [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants with endoscopic improvement among participants who had endoscopic improvement in Study M14-234 (Substudy 1 or 2) or Study M14-675

  20. Substudy 3: Percentage of participants with endoscopic remission [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants with endoscopic remission

  21. Substudy 3: Percentage of participants with mucosal healing [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants with mucosal healing

  22. Substudy 3: Percentage of participants who reported no bowel urgency [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants who reported no bowel urgency

  23. Substudy 3: Percentage of participants who reported no abdominal pain [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants who reported no abdominal pain

  24. Substudy 3: Incidence of Ulcerative Colitis (UC)-related hospitalization [ Time Frame: At Week 44 or Week 52 ]
    Incidence of UC-related hospitalization

  25. Substudy 3: Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 44 or Week 52 ]
    Defined by IBDQ bowel symptom domain scores

  26. Substudy 3: Incidence rate of Ulcerative Colitis (UC)-related surgeries [ Time Frame: At Week 44 or Week 52 ]
    Incidence rate of UC-related surgeries

  27. Substudy 3: Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) fatigue item [ Time Frame: At Week 44 or Week 52 ]
    Defined by IBDQ fatigue item scores

  28. Substudy 3: Percentage of participants who maintain clinical response per Adapted Mayo score [ Time Frame: At Week 44 or Week 52 ]
    Percentage of participants who maintain clinical response per Adapted Mayo score

  29. Substudy 3: Percentage of participants who discontinued corticosteroid use that achieved clinical remission per Adapted Mayo score [ Time Frame: At Week 44 or Week 52 ]
    Clinical remission per Adapted Mayo 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.


Layout table for eligibility information
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:

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 authority. If approval has not been granted, only participants >= 18 years old will be enrolled.

Adolescents must weigh >= 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
  • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
  • Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.

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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.

  • If female, participant must meet the criteria for Contraception Recommendations.
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

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

Information from the National Library of Medicine

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

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


Contacts
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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
Birmingham Gastroenterology /ID# 151276 Completed
Birmingham, Alabama, United States, 35209
CB Flock Research Corporation /ID# 165980 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Delsol Research Management, Ll /Id# 170131 Recruiting
Chandler, Arizona, United States, 85224
Arizona Arthritis & Rheumatolo /ID# 169822 Recruiting
Phoenix, Arizona, United States, 85032-9306
Physician's Research Group /ID# 211885 Recruiting
Tempe, Arizona, United States, 85284-2604
Adobe Clinical Research LLC /ID# 155250 Completed
Tucson, Arizona, United States, 85712
Banner University Medical Cent /ID# 150553 Recruiting
Tucson, Arizona, United States, 85724
United States, California
Citrus Valley Gastroenterology /ID# 151914 Recruiting
Covina, California, United States, 91722-3797
UC San Diego Health System /ID# 155185 Recruiting
La Jolla, California, United States, 92093
United Gastroenterologists /ID# 207464 Recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 157080 Recruiting
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 203133 Recruiting
Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 151211 Recruiting
Murrieta, California, United States, 92563
Ventura County Gastroenterology /ID# 163414 Recruiting
Oxnard, California, United States, 93030
San Diego Clinical Trials /ID# 212120 Not yet recruiting
San Diego, California, United States, 92120
Medical Assoc Research Grp /ID# 169148 Recruiting
San Diego, California, United States, 92123
Univ of California San Francis /ID# 164581 Recruiting
San Francisco, California, United States, 94158
United States, Colorado
Peak Gastroenterology Associat /ID# 214076 Not yet recruiting
Colorado Springs, Colorado, United States, 80907
Delta Waves, Inc. /ID# 151721 Recruiting
Colorado Springs, Colorado, United States, 80918
South Denver Gastroenterology /ID# 151223 Completed
Lone Tree, Colorado, United States, 80124
Western States Clinical Res /ID# 158076 Recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Western Connecticut Medical Group /ID# 169210 Recruiting
Danbury, Connecticut, United States, 06810-6000
Medical Research Ctr CT /ID# 150482 Recruiting
Hamden, Connecticut, United States, 06518
United States, Florida
Gastro Florida /ID# 155245 Recruiting
Clearwater, Florida, United States, 33756
Moonshine Research Center, Inc /ID# 152533 Completed
Doral, Florida, United States, 33166
Universal Axon Clinical Resear /ID# 213461 Recruiting
Doral, Florida, United States, 33166
Palmetto Research, LLC /ID# 151716 Recruiting
Hialeah, Florida, United States, 33016
Nature Coast Clinical Research /ID# 154064 Recruiting
Inverness, Florida, United States, 34452
Borland-Groover Clinic /ID# 170912 Recruiting
Jacksonville, Florida, United States, 32258
SIH Research, LLC /ID# 163319 Completed
Kissimmee, Florida, United States, 34759
Alliance Medical Research /ID# 215089 Not yet recruiting
Lighthouse Point, Florida, United States, 33064
Ctr for Advanced Gastroenterol /ID# 202017 Recruiting
Maitland, Florida, United States, 32751-6108
University of Miami /ID# 215441 Not yet recruiting
Miami, Florida, United States, 33136
Advanced Pharma CR, LLC /ID# 151719 Completed
Miami, Florida, United States, 33147
Crystal Pharmacology Research /ID# 151841 Completed
Miami, Florida, United States, 33165
New Horizon Research Center /ID# 152474 Completed
Miami, Florida, United States, 33175
Coral Research Clinic /ID# 150444 Recruiting
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 163098 Recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 151720 Recruiting
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 200269 Recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 201790 Recruiting
Tampa, Florida, United States, 33607
University of South Florida /ID# 214493 Not yet recruiting
Tampa, Florida, United States, 33612
Florida Hospital Tampa /ID# 200272 Recruiting
Tampa, Florida, United States, 33613-4680
United States, Georgia
Infinite Clinical Trials /ID# 215340 Not yet recruiting
Riverdale, Georgia, United States, 30274
Atlanta Gastroenterology Spec /ID# 150548 Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern Medical /ID# 151139 Not yet recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center /ID# 153042 Not yet recruiting
Chicago, Illinois, United States, 60612
University of Chicago /ID# 150547 Recruiting
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem - Evanston /ID# 150555 Recruiting
Evanston, Illinois, United States, 60201
Northwest Health Care Associat /ID# 151590 Completed
Hoffman Estates, Illinois, United States, 60169
Carle Foundation Hospital /ID# 151137 Recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
MediSphere Medical Research Center /ID# 152064 Recruiting
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 162901 Not yet recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 157058 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 167182 Recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
Tri-State Gastroenterology /ID# 169811 Recruiting
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Houma Digestive Health Special /ID# 151844 Recruiting
Houma, Louisiana, United States, 70360
Nola Research Works, LLC /ID# 153356 Recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 150446 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
University of Maryland Med Ctr /ID# 150449 Recruiting
Baltimore, Maryland, United States, 21201
Gastro Center of Maryland /ID# 200022 Recruiting
Columbia, Maryland, United States, 21045
United States, Massachusetts
Massachusetts General Hospital /ID# 165676 Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Hospitals /ID# 151140 Recruiting
Ann Arbor, Michigan, United States, 48109
Huron Gastroenterology Assoc /ID# 152710 Recruiting
Ann Arbor, Michigan, United States, 48197
Clin Res Inst of Michigan, LLC /ID# 153027 Recruiting
Chesterfield, Michigan, United States, 48047
Revival Research Institute, LLC /ID# 207280 Recruiting
Southfield, Michigan, United States, 48034-1659
Center for Digestive Health /ID# 161984 Recruiting
Troy, Michigan, United States, 48098-6363
Gastroenterology Associates of Western Michigan, PLC /ID# 157484 Recruiting
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mayo Clinic - Rochester /ID# 151677 Recruiting
Rochester, Minnesota, United States, 55905-0001
Minnesota Gastroenterology P.A /ID# 151678 Completed
Saint Paul, Minnesota, United States, 55114
United States, Mississippi
Univ of Mississippi Med Ctr /ID# 213139 Not yet recruiting
Jackson, Mississippi, United States, 39216-4500
Southern Therapy and Advanced Research (STAR) LLC /ID# 170712 Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University-School of Medicine /ID# 150485 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Medical Research /ID# 153044 Recruiting
Las Vegas, Nevada, United States, 89113
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 150549 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC /ID# 153040 Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Atlantic Digestive Health Inst /ID# 150447 Recruiting
Morristown, New Jersey, United States, 07960
Rutgers Robert Wood Johnson /ID# 155248 Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Ladan Golestaneh, MD, MS /ID# 150543 Recruiting
Bronx, New York, United States, 10467
Advantage Clinical Trials /ID# 163938 Recruiting
Bronx, New York, United States, 10468
NY Scientific /ID# 152707 Recruiting
Brooklyn, New York, United States, 11235
NYU Langone Long Island Clin. Res. Assoc. /ID# 155272 Recruiting
Great Neck, New York, United States, 11021
Weill Cornell Medicine /ID# 163410 Completed
New York, New York, United States, 10032-3725
DiGiovanna Institute for Medic /ID# 201533 Recruiting
North Massapequa, New York, United States, 11758
Premier Medical Group /ID# 153357 Recruiting
Poughkeepsie, New York, United States, 12601
Gastro Group of Rochester /ID# 151079 Recruiting
Rochester, New York, United States, 14618-5703
Richmond University Medical Center /ID# 201859 Recruiting
Staten Island, New York, United States, 10310-1664
United States, North Carolina
Digestive Health Partners, P.A /ID# 167237 Recruiting
Asheville, North Carolina, United States, 28801
Carolinas Medical Center /ID# 156971 Recruiting
Charlotte, North Carolina, United States, 28203
Charlotte Gastro Hepatology /ID# 150545 Recruiting
Charlotte, North Carolina, United States, 28207
AG Clinical Research, PLLC /ID# 151899 Completed
Greenville, North Carolina, United States, 27834
Clinical Trials of America /ID# 153448 Completed
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Medical Center /ID# 150448 Recruiting
Winston-Salem, North Carolina, United States, 27157-0001
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 170290 Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Consultants for Clinical Res /ID# 151679 Recruiting
Cincinnati, Ohio, United States, 45219
University of Cincinnati /ID# 164582 Recruiting
Cincinnati, Ohio, United States, 45267-0585
The Ohio State University - Columbus /ID# 169416 Recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 169696 Recruiting
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 200065 Recruiting
Dayton, Ohio, United States, 45424
Dayton Gastroenterology, Inc. /ID# 167631 Recruiting
Englewood, Ohio, United States, 45415
Great Lakes Gastroenterology Research LLC /ID# 201772 Recruiting
Mentor, Ohio, United States, 44060-6211
Ohio Clinical Research Partner /ID# 154068 Completed
Mentor, Ohio, United States, 44060
United States, Oklahoma
Digestive Disease Specialists /ID# 201056 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC /ID# 150554 Recruiting
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultant /ID# 163100 Recruiting
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Northwest Gastroenterology Cli /ID# 152527 Completed
Portland, Oregon, United States, 97210
United States, Pennsylvania
Allegheny General Hospital /ID# 163826 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Group, PC /ID# 150481 Recruiting
Sayre, Pennsylvania, United States, 18840
Penn State Health Colonnade /ID# 150259 Recruiting
State College, Pennsylvania, United States, 16803
United States, South Carolina
Pharmacorp Clinical Trials /ID# 153354 Recruiting
Charleston, South Carolina, United States, 29412
Gastroenterology Associates, P.A. /ID# 150541 Recruiting
Greenville, South Carolina, United States, 29615-3593
United States, Tennessee
Gastro One /ID# 151144 Recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 203610 Recruiting
Johnson City, Tennessee, United States, 37604
Quality Medical Research, PLLC /ID# 203426 Recruiting
Nashville, Tennessee, United States, 37211
Vanderbilt Univ Med Ctr /ID# 153355 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
TX Clinical Research Institute /ID# 151526 Recruiting
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 164635 Recruiting
Baytown, Texas, United States, 77521-2415
Texas Digestive Disease Consultants /ID# 209804 Recruiting
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209947 Recruiting
Cedar Park, Texas, United States, 78613-5028
Baylor Scott & White Research /ID# 200770 Recruiting
Dallas, Texas, United States, 75246
DHAT Research Institute /ID# 151218 Recruiting
Garland, Texas, United States, 75044-2208
Vilo Research Group Inc /ID# 212624 Recruiting
Houston, Texas, United States, 77017-2337
CliniCore International, LLC /ID# 152062 Completed
Houston, Texas, United States, 77027-6812
Baylor College of Medicine /ID# 150486 Recruiting
Houston, Texas, United States, 77030-3411
Houston Methodist Hospital /ID# 207658 Not yet recruiting
Houston, Texas, United States, 77030
Centex Studies, Inc. - Houston /ID# 201216 Recruiting
Houston, Texas, United States, 77058
GI Specialists of Houston /ID# 202327 Recruiting
Houston, Texas, United States, 77070-4347
Caprock Gastro Research /ID# 214754 Not yet recruiting
Lubbock, Texas, United States, 79424-3017
Clinical Associates in Researc /ID# 201260 Recruiting
San Antonio, Texas, United States, 78212
Sagact Pllc /Id# 169396 Recruiting
San Antonio, Texas, United States, 78229
Carl R. Meisner Medical Clinic /ID# 171061 Completed
Sugar Land, Texas, United States, 77478
Baylor Scott & White Health - Temple /ID# 204499 Recruiting
Temple, Texas, United States, 76508
Tyler Research Institute, LLC /ID# 169146 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 167761 Recruiting
Victoria, Texas, United States, 77904
United States, Utah
HP Clinical Research /ID# 163939 Recruiting
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 162624 Recruiting
Ogden, Utah, United States, 84403
Utah Gastroenterology /ID# 163101 Completed
Salt Lake City, Utah, United States, 84124
Advanced Clinical Research (ACR) - Salt Lake City /ID# 163181 Recruiting
West Jordan, Utah, United States, 84088
United States, Virginia
Ctr for Gastrointestinal Healt /ID# 153360 Recruiting
Franklin, Virginia, United States, 23851
Emeritas Research Group, LLC /ID# 150258 Completed
Leesburg, Virginia, United States, 20176
United States, Washington
Washington Gastroenterology /ID# 163629 Recruiting
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 153026 Recruiting
Seattle, Washington, United States, 98101
University of Washington /ID# 153041 Not yet recruiting
Seattle, Washington, United States, 98109
The Polyclinic /ID# 164369 Completed
Seattle, Washington, United States, 98122-4201
The Vancouver Clinic, INC. PS /ID# 162333 Recruiting
Vancouver, Washington, United States, 98664
United States, Wisconsin
Aurora Medical Center - Grafto /ID# 151717 Recruiting
Grafton, Wisconsin, United States, 53024
WI Center for Advanced Res /ID# 151838 Recruiting
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin /ID# 151843 Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Hospital Italiano de Buenos Aires /ID# 215538 Not yet recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
Cardio Alem /ID# 211280 Not yet recruiting
San Isidro, Buenos Aires, Argentina, 1642
Mautalen Salud e Investigacion /ID# 171173 Recruiting
Buenos Aires, Argentina, 1128
Hospital Britanico de Bs As /ID# 209495 Recruiting
Caba, Argentina, 1280
Gedyt /ID# 210015 Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, 1125
Hospital Privado Univesitario /ID# 164185 Recruiting
Cordoba, Argentina, 5016
Instituto Medico DAMIC /ID# 152547 Not yet recruiting
Cordoba, Argentina, X5003DCE
Sanatorio 9 de Julio S.A. /ID# 150189 Recruiting
San Miguel de Tucuman, Argentina, 4000
Australia, New South Wales
Macquarie University /ID# 211951 Not yet recruiting
Macquarie Park, New South Wales, Australia, 2113
Australia, Queensland
Mater Misericordiae /ID# 212685 Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Griffith University /ID# 211952 Not yet recruiting
Southport, Queensland, Australia, 4222
Australia, Victoria
Monash Health /ID# 150206 Recruiting
Clayton, Victoria, Australia, 3168
St. Vincents Hosp Melbourne /ID# 152472 Recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Fiona Stanley Hospital /ID# 211640 Not yet recruiting
Murdoch, Western Australia, Australia, 6150
Austria
Ordensklinikum Linz GmbH, Barmherzige Schwestern /ID# 150305 Recruiting
Linz, Oberoesterreich, Austria, 4010
Krankenanstalt Rudolfstiftung /ID# 162866 Recruiting
Vienna, Wien, Austria, 1030
Medical University of Vienna /ID# 150614 Recruiting
Vienna, Wien, Austria, 1090
LKH Salzburg and Paracelsus /ID# 150306 Recruiting
Salzburg, Austria, 5020
Belarus
Vitebsk Regional Advanced Clin /ID# 169612 Recruiting
Vitebsk, Belarus, 210001
Belgium
AZ Maria Middelares /ID# 150331 Not yet recruiting
Ghent, Belgium, 9000
UZ Leuven /ID# 150332 Recruiting
Leuven, Belgium, 3000
AZ-Delta /ID# 150330 Recruiting
Roeselare, Belgium, 8800
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 150209 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 150706 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Center Tuzla /ID# 150211 Recruiting
Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
University Clinical Hospital Mostar /ID# 150705 Recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo /ID# 150208 Not yet recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda /ID# 153742 Recruiting
Goiania, Goias, Brazil, 74535-170
Hospital Nossa Senhora das Graças /ID# 152480 Recruiting
Curitiba, Parana, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre /ID# 153743 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Upeclin Fmb - Unesp /Id# 152485 Recruiting
Botucatu, Sao Paulo, Brazil, 18618-686
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 152484 Recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina do ABC /ID# 152481 Recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Kaiser Clinica e Hospital Dia /ID# 152483 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
Hospital Universitario Clement /ID# 152487 Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
University of Calgary /ID# 151821 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 211168 Recruiting
Edmonton, Alberta, Canada, T5R 1W2
Zeidler Ledcor Centre /ID# 151100 Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 158930 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Okanagan Clinical Trials /ID# 153178 Completed
Kelowna, British Columbia, Canada, V1Y 1Z9
Percuro Clinical Research, Ltd /ID# 150367 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, New Brunswick
Dr. Everett Chalmers Reg Hosp. /ID# 212256 Not yet recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Ontario
McMaster University Med Cent /ID# 150365 Recruiting
Hamilton, Ontario, Canada, L8S 4K1
The Ottawa Hospital /ID# 151820 Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Medicor Research Inc. /ID# 151101 Recruiting
Sudbury, Ontario, Canada, P3E 5M4
Toronto Digestive Disease Asso /ID# 150363 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CISSS de la Monteregie /ID# 159215 Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 150361 Recruiting
Levis, Quebec, Canada, G6V 3Z1
Recherche GCP Research /ID# 151822 Completed
Montreal, Quebec, Canada, H1M 1B1
Crchum /Id# 167169 Recruiting
Montreal, Quebec, Canada, H2X 0A9
Montreal General Hospital - McGill University Health Centre /ID# 170012 Recruiting
Montréal, Quebec, Canada, H3G 1A4
CRCHUS Hotel-Dieu /ID# 150366 Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Chile
Research Group Ltda /ID# 203176 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 2540364
M y F Estudios Clínicos Ltda. /ID# 200107 Recruiting
Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495
Centro de Investigaciones Clínicas Viña del Mar /ID# 150212 Completed
Viña del Mar, Valparaíso, Chile, 2540488
Hospital Guillermo Grant Benavente de Concepción /ID# 212424 Not yet recruiting
Concepción, Chile, 4070038
CTR Estudios SpA /ID# 200110 Recruiting
Providencia, Chile, 7500571
Hospital Clinico Universidad De Los Andes /ID# 207422 Not yet recruiting
Santiago, Chile, 7501504
Clinica Las Condes /ID# 153754 Not yet recruiting
Santiago, Chile
China, Anhui
The First Affiliated Hosp, Sun /ID# 150455 Recruiting
Guangzhou, Anhui, China, 510080
Shanghai Tenth People's Hosp /ID# 150460 Recruiting
Shanghai, Anhui, China, 200072
Renji Hosp, Shanghai Jiaotong /ID# 165815 Not yet recruiting
Shanghai, Anhui, China, 200127
China, Guangdong
The Sixth Affiliated Hosp, Sun /ID# 150456 Recruiting
Guangzhou, Guangdong, China, 510655
China, Hubei
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088 Recruiting
Wuhan, Hubei, Hubei, China, 430022
China, Hunan
Xiangya Hospital Central South University /ID# 167229 Not yet recruiting
Changsha, Hunan, China, 410008
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 211750 Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hosp of Jilin Univ /ID# 209986 Not yet recruiting
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 150461 Recruiting
Shanghai, Shanghai, China, 200025
China, Zhejiang
The second affiliated hospital of Zhejiang University school of medicine /ID# 165807 Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 150454 Recruiting
Hangzhou, Zhejiang, China, 310016
China
West China Hospital, Sichuan University /ID# 167040 Recruiting
Chengdu, China, 610041
Shengjing Hospital of China Medical University /ID# 166920 Recruiting
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 170604 Recruiting
Tianjin, China, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078 Recruiting
Wuhan, China, 430022
Colombia
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 151564 Not yet recruiting
Bogota DC, Cundinamarca, Colombia, 11411
Hospital Univ San Ignacio /ID# 152678 Not yet recruiting
Bogota, Colombia, 110231
Instituto de Coloproctologia /ID# 152535 Not yet recruiting
Medellin, Colombia, 050024
Hospital Universitario de San /ID# 155387 Not yet recruiting
Medellin, Colombia
Hospital Pablo Tobon Uribe /ID# 159095 Not yet recruiting
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) /ID# 207042 Not yet recruiting
Montería, Colombia, 230002
Croatia
Klinicki bolnicki centar Zagreb /ID# 150225 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 150709 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Poliklinika Solmed /ID# 211483 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 150216 Recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Rijeka /ID# 150708 Recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Klinicki bolnicki centar Split /ID# 213988 Not yet recruiting
Split, Croatia, 21000
Zadar General Hospital /ID# 150221 Recruiting
Zadar, Croatia, 23000
Clinical Hospital Dubrava /ID# 150213 Recruiting
Zagreb, Croatia, 10000
Czechia
CTCenter MaVe, s.r.o. /ID# 150904 Completed
Olomouc, Olomoucky Kraj, Czechia, 779 00
Axon Clinical, s.r.o. /ID# 152479 Recruiting
Praha, Praha 5, Czechia, 150 00
Hepato-Gastroenterologie HK s.r.o. /ID# 150912 Recruiting
Hradec Kralove, Czechia, 500 12
Artroscan s.r.o. /ID# 150401 Recruiting
Ostrava, Czechia, 722 00
Nemocnice Pardubickeho kraje, /ID# 213539 Not yet recruiting
Pardubice, Czechia, 53203
ISCARE I.V.F. a.s. /ID# 209278 Recruiting
Prague, Czechia, 170 00
Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 213818 Not yet recruiting
Alexandria, Egypt, 21131
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 213819 Not yet recruiting
Alexandria, Egypt, 21131
Nat Hep & Trop Med Res Inst /ID# 213816 Not yet recruiting
Cairo, Egypt, 11559
Air Force Specialized Hospital /ID# 214472 Not yet recruiting
Cairo, Egypt
Estonia
East Tallinn Central Hospital /ID# 150417 Recruiting
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 150419 Recruiting
Tallinn, Estonia, 10617
North Estonian Medical Centre /ID# 160870 Recruiting
Tallinn, Estonia, 13419
Tartu University Hospital /ID# 150418 Recruiting
Tartu, Estonia, 51014
Finland
Helsinki Univ Central Hospital /ID# 150407 Recruiting
Helsinki, Finland, 00290
Keski-Suomen Keskussairaala /ID# 155666 Recruiting
Jyvaskyla, Finland, 40620
Laakarikeskus Ikioma /ID# 150121 Recruiting
Mikkeli, Finland, 50100
Tampere University Hospital /ID# 150114 Recruiting
Tampere, Finland, 33521
Tyks /Id# 168301 Recruiting
Turku, Finland, 20521
France
Chu de Nice-Hopital L'Archet Ii /Id# 152606 Recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
Centre Hospitalier Lyon Sud /ID# 152539 Recruiting
Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
CHU Hopital Nord /ID# 163508 Recruiting
Marseille, Bouches-du-Rhone, France, 13915
Hopital Haut-Lévêque /ID# 213828 Not yet recruiting
Pessac CEDEX, Gironde, France, 33604
CHRU Lille - Hôpital Claude Huriez /ID# 152607 Recruiting
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 200006 Not yet recruiting
Montpellier CEDEX 5, Herault, France, 34295
Hopital Beaujon /ID# 211421 Not yet recruiting
Clichy, Ile-de-France, France, 92110
CHU NANCY - Hôpital Brabois Adultes /ID# 150150 Not yet recruiting
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
CHU Amiens Picardie /ID# 163456 Recruiting
Amiens CEDEX 1, Somme, France, 80054
CHD Vendee /ID# 154452 Recruiting
La Roche Sur Yon, France, 85000
Polyclinique Grand Sud /ID# 214080 Not yet recruiting
Nimes Cedex, France, 30932
Hopital Saint Antoine /ID# 170222 Not yet recruiting
Paris, France, 75012
Hopital Nord /ID# 154453 Recruiting
Saint Priest En Jarez, France, 42270
Germany
Universitatsklinikum Mannheim /ID# 150173 Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitatsklinikum Munster /ID# 150158 Recruiting
Munster, Niedersachsen, Germany, 48149
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574 Not yet recruiting
Herne, Nordrhein-Westfalen, Germany, 44623
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811 Not yet recruiting
Saarbrücken, Saarland, Germany, 66111
Univ Hosp Schleswig-Holstein /ID# 161981 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Praxis am Bayerischen Platz /ID# 150766 Recruiting
Berlin, Germany, 10825
Agaplesion Markus Krankenhaus /ID# 161982 Recruiting
Frankfurt, Germany, 60341
Medizinisches Versorgungszentrum Portal 10 /ID# 207135 Recruiting
Munster, Germany, 48155
Helwig, Oldenburg, DE /ID# 150768 Not yet recruiting
Oldenburg, Germany, 26123
Universitatsklinikum Tubingen /ID# 150767 Recruiting
Tuebingen, Germany, 72076
Gastro Data Wiesbaden /ID# 150166 Completed
Wiesbaden, Germany, 65189
Greece
General Hospital of Athens Laiko /ID# 208669 Recruiting
Athens, Attiki, Greece, 115 27
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309 Recruiting
Athens, Greece, 10676
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100 Recruiting
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 150250 Recruiting
Heraklion, Greece, 71110
University General Hospital of Ioannina /ID# 164248 Recruiting
Ioannina, Greece, 45500
Theageneio Anticancer Hospital /ID# 163896 Recruiting
Thessaloniki, Greece, 54639
Genl Hosp Thessaloniki Hipp /ID# 209521 Not yet recruiting
Thessaloniki, Greece, 54642
Hungary
Markusovszky Egyetemi Oktatókórház /ID# 150313 Recruiting
Szombathely, Vas, Hungary, 9700
Bekes Megyei Kozponti Korhaz /ID# 151572 Recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem /ID# 150312 Recruiting
Budapest, Hungary, 1085
Meditres Kft. /ID# 151521 Completed
Kecskemet, Hungary, 6000
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523 Recruiting
Sopron, Hungary, 9400
Mentahaz Maganorvosi Kozpont /ID# 205884 Recruiting
Szekesfehervar, Hungary, 8000
Ireland
Mercy University Hospital /ID# 151529 Recruiting
Cork, Ireland, T12 WE28
Trinity College Dublin - St. J /ID# 150320 Recruiting
Dublin, Ireland, 8580
St Vincent's University Hosp /ID# 150318 Recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 150321 Recruiting
Dublin, Ireland, D09 XR63
Galway University Hospital /ID# 150319 Recruiting
Galway, Ireland, H91 YR71
Israel
Soroka Medical Center /ID# 156561 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Hadassah Ein Kerem Medical Ctr /ID# 165118 Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Rambam Health Care Campus /ID# 150325 Recruiting
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 161677 Recruiting
Jerusalem, Israel, 91031
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 150337 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliera San Camillo Forlanini /ID# 151360 Recruiting
Rome, Lazio, Italy, 00152
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150334 Recruiting
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 151361 Recruiting
Rozzano, Milano, Italy, 20089
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253 Recruiting
Palermo, Sicilia, Italy, 90146
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 201725 Recruiting
Negrar, Verona, Italy, 37024
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602 Recruiting
Milano, Italy, 20121
Policlinico Tor Vergata /ID# 150338 Recruiting
Rome, Italy, 00133
Complesso integrato Columbus /ID# 150333 Recruiting
Rome, Italy, 00168
Japan
Aichi Medical University Hosp /ID# 151993 Recruiting
Nagakute, Aichi, Japan, 4801195
Nagoya University Hospital /ID# 152709 Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 151950 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 152763 Recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Tokatsu Tsujinaka Hospital /ID# 214962 Not yet recruiting
Abiko-shi, Chiba, Japan, 2701168
Toho University Sakura Medical Center /ID# 151936 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Juntendo University Urayasu Hospital /ID# 208781 Recruiting
Urayasu Shi, Chiba, Japan, 279-0021
Fukuoka University Chikushi Hospital /ID# 152628 Not yet recruiting
Chikushino, Fukuoka, Japan, 818-8502
Kyushu University Hospital /ID# 152526 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 151976 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Ogaki Municipal Hospital /ID# 208225 Recruiting
Ogaki-shi, Gifu, Japan, 503-8502
NHO Fukuyama Medical Center /ID# 206293 Recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 170289 Recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 206492 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Sapporo Tokushukai Hospital /ID# 209397 Recruiting
Sapporo, Hokkaido, Japan, 004-0041
Aoyama Clinic /ID# 152049 Recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 152434 Recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center /ID# 152631 Completed
Higashi Ibaraki-gun, Ibaraki, Japan, 3113193
Kanazawa University Ho /ID# 205099 Recruiting
Kanazawa, Ishikawa, Japan, 92086-41
Iwate Medical University Hospital /ID# 203411 Recruiting
Morioka-shi, Iwate, Japan, 020-8505
Idzuro Imamura Hospital /ID# 206024 Recruiting
Kagishimashi, Kagoshima, Japan, 8920824
Yokohama City Univ Med Center /ID# 169899 Recruiting
Yokohama-shi, Kanagawa, Japan, 232-0024
JP Red Cross Kyoto Daiichi Hos /ID# 152359 Recruiting
Kyoto-shi, Kyoto, Japan, 605-0981
Mie University Hospital /ID# 205362 Recruiting
Tsu-shi, Mie, Japan, 514-8507
National Hospital Organization Sendai Medical Center /ID# 209527 Recruiting
Sendai-shi, Miyagi, Japan, 983-0045
Ishida Clinic of IBD and Gastroenterology /ID# 210117 Recruiting
Oita-shi, Oita, Japan, 870-0823
Kinshukai Infusion Clinic /ID# 207864 Recruiting
Osaka-shi, Osaka, Japan, 530-0011
Japanese Red Cross Osaka Hospi /ID# 209476 Recruiting
Osaka-shi, Osaka, Japan, 543-8555
Osaka City University Hospital /ID# 152682 Recruiting
Osaka-shi, Osaka, Japan, 545-0051
Saga University Hospital /ID# 209268 Recruiting
Saga-shi, Saga, Japan, 849-8501
Saitama Medical Center, Saitama Medical University /ID# 152031 Recruiting
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic /ID# 152677 Recruiting
Saitama-shi, Saitama, Japan, 336-0963
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709 Recruiting
Higashiohmi-shi, Shiga, Japan, 527-8505
Hamamatsu University Hospital /ID# 205708 Recruiting
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Medical Hospital of Tokyo Medical and Dental University /ID# 152016 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
St.Luke's International Hospital /ID# 208074 Recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Tokai University Hachioji Hospital /ID# 152587 Recruiting
Hachioji, Tokyo, Japan, 192-0032
Teikyo University Hospital /ID# 208897 Recruiting
Itabashi-ku, Tokyo, Japan, 173-8605
Kitasato Univ Kitasato Inst Ho /ID# 152686 Recruiting
Minato-ku, Tokyo, Japan, 108-8642
Kyorin University Hospital /ID# 153194 Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Center hospital of the National Center for Global Health and Medicine /ID# 209267 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8655
Tokyo Women's Medical University Hospital /ID# 205977 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 171454 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Yamanashi Prefectural Ctr Hosp /ID# 151908 Recruiting
Kofu-shi, Yamanashi, Japan, 400-8506
Fukui Prefectural Hospital /ID# 210448 Recruiting
Fukui, Japan, 910-0846
Saiseikai Fukuoka General Hosp /ID# 209479 Recruiting
Fukuoka, Japan, 810-0001
Hiroshima University Hospital /ID# 151951 Recruiting
Hiroshima, Japan, 734-8551
Shimane University School of Medicine /ID# 208899 Recruiting
Izumo, Japan, 693-0021
Sameshima Hospital /ID# 206672 Recruiting
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209130 Recruiting
Kashiwa, Japan
St. Marianna Univ Hospital /ID# 208654 Recruiting
Kawasaki, Japan, 216-8511
Kitakyushu Municipal Med Ctr /ID# 152588 Completed
Kitakyushu, Japan, 802-0077
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821 Recruiting
Kurashiki, Japan, 710-0142
Saiseikai Niigata Hosp /ID# 209916 Recruiting
Niigata, Japan, 950-1104
Obihiro-Kosei General Hospital /ID# 210412 Recruiting
Obihiro, Japan, 080-0016
NHO Nagasaki Medical Center /ID# 209531 Recruiting
Omura-shi, Japan, 856-8562
Kitano Hospital /ID# 210395 Recruiting
Osaka, Japan, 530-8480
Osaka City General Hospital /ID# 152704 Completed
Osaka, Japan, 534-0021
Kyoto University Hospital /ID# 211758 Recruiting
Sakyo-ku, Japan, 606-8507
Sapporo Higashi Tokushukai /ID# 208487 Recruiting
Sapporo, Japan, 065-0033
NHO Shizuoka Medical Center /ID# 163572 Recruiting
Shimizu-sho, Japan
Tokyo Yamate Medical Center /ID# 214025 Not yet recruiting
Tokyo, Japan, 169-0073
Toyohashi Municipal Hospital /ID# 171457 Recruiting
Toyohashi, Japan, 441-8570
Ieda Hospital /ID# 157781 Recruiting
Toyota-shi, Japan, 470-1219
Kenseikai Dongo Hospital /ID# 208100 Recruiting
Yamatotakada, Japan, 635-0022
Yokkaichi Hazu Medical Center /ID# 214347 Not yet recruiting
Yokkaichi-shi, Japan, 510-0016
Showa Univ Fujigaoka Hosp /ID# 208222 Recruiting
Yokohama-shi, Japan, 227-0043
Korea, Republic of
Dong-A University Hospital /ID# 159480 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 159481 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 150345 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
CHA Bundang Medical center, CHA University /ID# 159479 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
St. Vincent's Hospital /ID# 150347 Recruiting
Suwon, Gyeonggido, Korea, Republic of, 16247
Kangbuk Samsung Hospital /ID# 150348 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Severance Hospital /ID# 159478 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 150346 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Hanyang University Guri Hosp /ID# 150344 Recruiting
Guri-si, Korea, Republic of, 471-701
Asan Medical Center /ID# 150900 Recruiting
Seoul, Korea, Republic of, 05505
Latvia
Riga East Clinical Univ Hosp /ID# 150354 Recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 151409 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 150357 Recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 158862 Recruiting
Klaipeda, Lithuania, 92288
Klaipeda Seamens Hospital /ID# 154319 Recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 154318 Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Sultanah Bahiyah /ID# 151687 Recruiting
Alor Setar, Kedah, Malaysia, 05460
UKM Medical Centre /ID# 151689 Recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Hospital Ampang /ID# 151298 Recruiting
Ampang, Selangor, Malaysia, 68000
Uni Malaya MC /ID# 150359 Recruiting
Kuala Lumpur, Malaysia, 59100
Mexico
Morales Vargas Centro de Investigación S.C /ID# 211325 Not yet recruiting
León de los Aldama, Guanajuato, Mexico, 37000
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710 Recruiting
Guadalajara, Jalisco, Mexico, 44650
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256 Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64610
Netherlands
Radboud Universitair Medisch Centrum /ID# 151700 Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Academisch Medisch Centrum /ID# 150647 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Centrum /ID# 152624 Recruiting
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum /ID# 150308 Recruiting
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht /ID# 152775 Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Akershus universitetssykehus /ID# 150317 Recruiting
Nordbyhagen, Akershus, Norway, 1474
Universitetssykehuset Nord-Norge /ID# 152835 Recruiting
Tromsø, Troms, Norway, 9019
Poland
Centrum Zdrowia MDM /ID# 150351 Recruiting
Warsaw, Mazowieckie, Poland, 00-635
Zespol Przychodni Prima /Id# 150580 Recruiting
Warsaw, Mazowieckie, Poland, 02-018
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732 Not yet recruiting
Warsaw, Mazowieckie, Poland, 04-730
Endoterapia PFG Sp. z.o.o. /ID# 150349 Recruiting
Warszawa, Mazowieckie, Poland, 02-653
Endoskopia Sp. z o.o. /ID# 150765 Recruiting
Sopot, Zachodniopomorskie, Poland, 81-756
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 151607 Recruiting
Guimarães, Braga, Portugal, 4835-044
Centro Hosp de Lisboa Central /ID# 151611 Recruiting
Lisbon, Lisboa, Portugal, 1169-050
Hospital Garcia de Orta, E.P.E /ID# 151613 Recruiting
Almada, Setubal, Portugal, 2805-267
CCA Braga - Hospital de Braga /ID# 151608 Recruiting
Braga, Portugal, 4710-243
Centro Hospitalar Lisboa Norte, EPE /ID# 151606 Recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE /ID# 151610 Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 152335 Recruiting
Santa Maria Da Feira, Portugal, 4520-211
Unidade Local De Saude Do Alto Minho /ID# 151609 Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 150358 Recruiting
San Juan, Puerto Rico, 00935
Romania
Institutul Clinic Fundeni /ID# 150368 Not yet recruiting
Sector 2, Bucuresti, Romania, 22 328
Institutul Clinic Fundeni /ID# 150983 Not yet recruiting
Sector 2, Bucuresti, Romania, 22 328
Cabinet Particular Policlinic Algomed /ID# 150369 Not yet recruiting
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University /ID# 200719 Recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
NW State Medical Univ na Mechn /ID# 169322 Recruiting
St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
Perm Clinical Center of FMBA /ID# 150386 Recruiting
Perm, Permskiy Kray, Russian Federation, 614109
LLC Medical Company Hepatolog /ID# 200197 Recruiting
Samara, Samarskaya Oblast, Russian Federation, 443063
LLC Novaya Klinika /ID# 208107 Recruiting
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Kazan State Medical University /ID# 166042 Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Llc Olla-Med /Id# 215332 Not yet recruiting
Moscow, Russian Federation, 105554
City Clinical Hospital 24 /ID# 150395 Recruiting
Moscow, Russian Federation, 127015
Republican Clin Hos n.a. Baran /ID# 206506 Recruiting
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 203800 Recruiting
Pushkin, Russian Federation, 196603
Stavropol State Medical Univ /ID# 150387 Recruiting
Stavropol, Russian Federation, 355017
Serbia
Clinical Center Serbia /ID# 150428 Recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 150427 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 150429 Recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 150426 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 151903 Recruiting
NIS, Nisavski Okrug, Serbia, 18000
Clinical Center Kragujevac /ID# 150430 Recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 150764 Recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital /ID# 150453 Recruiting
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 206018 Not yet recruiting
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 150443 Recruiting
Singapore, Singapore, 308433
Slovakia
Medak s.r.o., gastroenterologi /ID# 150480 Recruiting
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve /ID# 150868 Recruiting
Banska Bystrica, Slovakia, 97517
Slovak Research Center Team Me /ID# 150257 Completed
Ilava, Slovakia, 019 01
B and B MED s.r.o. /ID# 150471 Recruiting
Kosice, Slovakia, 040 01
Fakultna nemocnica s poliklini /ID# 211370 Not yet recruiting
Nove Zamky, Slovakia, 94002
Gastro I.S.R.O. /ID# 150472 Recruiting
Presov, Slovakia, 08001
South Africa
Clinresco Centres /ID# 163622 Recruiting
Johannesburg, Gauteng, South Africa, 1619
Lenasia Clinical Trial Centre /ID# 214344 Not yet recruiting
Johannesburg, Gauteng, South Africa, 1820
Chris Hani Baragwanath Hosp /ID# 150785 Recruiting
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site /ID# 150496 Recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 162202 Recruiting
CAPE TOWN,Milnerton, Western Cape, South Africa, 7441
Allergy & Immunology (AIU) /ID# 214343 Not yet recruiting
Cape Town, Western Cape, South Africa, 7700
Kingsbury Hospital /ID# 150497 Recruiting
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg /ID# 155144 Recruiting
Cape Town, Western Cape, South Africa, 7800
MD Search /ID# 167293 Recruiting
Boksburg North, South Africa, 1460
Spain
Comple Hospi Univ de Santiago /ID# 151065 Recruiting
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitario y Politecnico La Fe /ID# 150611 Recruiting
Valencia, Valenciana, Spain, 46026
Comple Hosp Univ de A Coruna /ID# 203911 Recruiting
A Coruna, Spain, 15006
Hospital Clinic de Barcelona /ID# 150612 Recruiting
Barcelona, Spain, 08036
Hospital Reina Sofia de Cordob /ID# 151066 Recruiting
Cordoba, Spain, 14004
Hospital Univ Dr. Negrin /ID# 203937 Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Univ Ramon y Cajal /ID# 151067 Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz /ID# 214539 Not yet recruiting
Madrid, Spain, 28046
Complejo Asistencial de Salama /ID# 150509 Recruiting
Salamanca, Spain, 37007
Sweden
Sahlgrenska University Hosp /ID# 151496 Completed
Goteborg, Sweden, 413 45
Switzerland
Kantonsspital St. Gallen /ID# 152599 Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 161731 Recruiting
Basel, Switzerland, 4031
Inselspital, Universitaetsklinik /ID# 152590 Recruiting
Bern, Switzerland, 3010
University Hospital Zurich /ID# 152591 Recruiting
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 150571 Recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 151749 Completed
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 150574 Recruiting
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University /ID# 150575 Recruiting
Kaohsiung, Taiwan, 80708
Chung Shan Medical University /ID# 150573 Completed
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp /ID# 151748 Recruiting
Taipei City, Taiwan, 11217
Turkey
Erciyes University Medical Fac /ID# 150129 Recruiting
Melikgazi, Kayseri, Turkey, 38030
Gazi Universitesi Tip Fakultes /ID# 150127 Recruiting
Ankara, Turkey, 06500
Istanbul University Cerrahpasa Medical Faculty /ID# 150125 Recruiting
Istanbul, Turkey, 34098
Umraniye Training and Res Hosp /ID# 162659 Recruiting
Istanbul, Turkey, 34764
Marmara University Medical Fac /ID# 213969 Not yet recruiting
Istanbul, Turkey, 34899
Mersin University Medical /ID# 157849 Recruiting
Mersin, Turkey, 33343
Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206940 Recruiting
Kharkiv, Kharkivska Oblast, Ukraine, 61204
Kyiv Municipal Clinical Hospital #18 /ID# 150372 Completed
Kiev, Kyiv, Ukraine, 03134
Medical Center of the "Health /ID# 151274 Completed
Vinnytsya, Vinnytska Oblast, Ukraine, 21009
Volyn regional clinical hospital /ID# 206926 Not yet recruiting
Lutsk, Volynska Oblast, Ukraine, 43005
Regional Clin Hosp Mechnykov /ID# 207723 Not yet recruiting
Dnipro, Ukraine, 49005
Lviv Regional Clinical Hospita /ID# 150375 Completed
Lviv, Ukraine, 79010
Odessa Regional Clinical Hosp /ID# 151275 Completed
Odesa, Ukraine, 65025
Poltava Reg Clin Hosp Sklifoso /ID# 215569 Not yet recruiting
Poltava, Ukraine, 36011
United Kingdom
RD&E Hospital /ID# 150379 Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Queen Elizabeth University Hos /ID# 163787 Recruiting
Glasgow, Glasgow City, United Kingdom, G51 4TF
The Royal London Hospital /ID# 150384 Recruiting
London, London, City Of, United Kingdom, E1 1BB
Basingstoke & North Hampshire /ID# 150380 Recruiting
Basingstoke, United Kingdom, RG24 9NA
Royal United Hospitals Bath /ID# 151532 Recruiting
Bath, United Kingdom, BA1 3NG
Univ Hospitals Birmingham NHS Foundation trust /ID# 150382 Recruiting
Birmingham, United Kingdom, B15 2TG
St. George's Healthcare NHS /ID# 208374 Recruiting
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02819635     History of Changes
Other Study ID Numbers: M14-234
2016-000641-31 ( EudraCT Number )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Upadacitinib (ABT-494)
Moderately to Severely Active UC
Additional relevant MeSH terms:
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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