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A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03006068
Recruitment Status : Enrolling by invitation
First Posted : December 30, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 7, 2022
Estimated Study Completion Date : August 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants receiving Upadacitinib (ABT-494) Dose A
The participants in this arm will receive Upadacitinib (ABT-494) dose A.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib

Experimental: Participants receiving Upadacitinib (ABT-494) Dose B
The participants in this arm will receive Upadacitinib (ABT-494) dose B.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib

Experimental: Participants receiving Upadacitinib (ABT-494) Dose C
The participants in this arm will receive Upadacitinib (ABT-494) dose C.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib

Experimental: Participants receiving Placebo
The participants in this arm will receive placebo until study is unblinded.
Drug: Placebo
Placebo will be administered orally.

Experimental: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.
Drug: Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
Other Name: Upadacitinib




Primary Outcome Measures :
  1. Assessing Treatment-Emergent Adverse Events [ Time Frame: Up to 288 Weeks ]
    Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.


Secondary Outcome Measures :
  1. Percentage of participants achieving clinical response per Partial Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical response per Partial Mayo score

  2. Percentage of participants achieving clinical remission per Adapted Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Adapted Mayo score

  3. Percentage of participants in clinical remission per Full Mayo score at Week 0 who maintain remission at Week 48 [ Time Frame: At Week 0, Week 48, and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Full Mayo score

  4. Percentage of participants achieving clinical remission per Partial Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Partial Mayo score

  5. Percentage of participants in clinical remission per Adapted Mayo score at Week 0 who maintain remission at Week 48 [ Time Frame: At Week 0, Week 48, and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Adapted Mayo score

  6. Percentage of participants achieving clinical remission per Full Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Full Mayo score

  7. Percentage of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical response per Adapted Mayo score

  8. Percentage of participants with Stool Frequency Subscore (SFS) of 0, Rectal Bleeding Subscore (RBS) of 0, and endoscopic subscore of <=1 [ Time Frame: At Week 48 and every 48 Weeks thereafter through 288 weeks ]
    Percentage of participants with specific Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and endoscopic subscore

  9. Percentage of participants who had upadacitinib dose-escalation and achieved clinical remission per Full Mayo Score [ Time Frame: At Week 8 in Cohort 2 ]
    Clinical remission per Full Mayo score

  10. Percentage of participants who had upadacitinib dose-escalation and achieved endoscopic improvement [ Time Frame: At Week 8 in Cohort 2 ]
    Endoscopic improvement defined by endoscopic subscore

  11. Percentage of participants who had upadacitinib dose-escalation and achieved endoscopic remission [ Time Frame: At Week 8 in Cohort 2 ]
    Endoscopic remission identified by endoscopic subscore

  12. Percentage of participants achieving clinical remission [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical remission will be assessed by Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and endoscopic subscore

  13. Percentage of participants who had upadacitinib dose-escalation and achieved clinical response per Adapted Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical response per Adapted Mayo score

  14. Percentage of participants who had upadacitinib dose-escalation and achieved clinical remission (after dose-escalation) per Adapted Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical response per Adapted Mayo score

  15. Percentage of participants who had upadacitinib dose-escalation and achieved clinical remission (after dose-escalation) per Full Mayo score [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Clinical remission per Full Mayo score

  16. Percentage of participants with endoscopic improvement [ Time Frame: At Week 0, Week 48, and every 48 weeks thereafter through 288 Weeks ]
    Endoscopic improvement assessed by endoscopic subscore

  17. Percentage of participants with endoscopic remission [ Time Frame: At Week 0, Week 48, and every 48 Weeks thereafter through 288 Weeks ]
    Endoscopic remission defined by endoscopic subscore

  18. Percentage of Participants with endoscopic remission at Week 0 and maintained at Week 48 and every 48 Weeks [ Time Frame: At Week 0, Week 48 and every 48 Weeks thereafter through 288 Weeks ]
    Endoscopic remission defined by endoscopic subscore

  19. Percentage of participants taking steroids at Baseline (Week 0) who are steroid-free over time [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants taking steroids who are steroid-free over time

  20. Percentage of participants taking steroids at Baseline (Week 0) who discontinued corticosteroid use and achieved clinical remission per Adapted Mayo score [ Time Frame: At Week 48 and every 48 Weeks thereafter through 288 Weeks ]
    Percentage of participants who discontinued corticosteroids and achieved clinical remission per Adapted Mayo score

  21. Percentage of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants achieving IBDQ response

  22. Percentage of participants with Inflammatory Bowel Disease Questionnaire (IBDQ) remission [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Remission defined by IBDQ total score

  23. Percentage of participants who reported no abdominal pain [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants who reported no abdominal pain

  24. Percentage of participants who reported no bowel urgency [ Time Frame: At Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants who reported no bowel urgency

  25. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total and domain score [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in IBDQ total and domain score

  26. Change from Baseline in individual Inflammatory Bowel Disease Questionnaire (IBDQ) item under Bowel Symptom domain (for Q1, Q5, Q9, Q13, Q17, Q20, Q22, Q24, Q26, and Q29) [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in individual IBDQ item under Bowel Symptom domain

  27. Change from Baseline in corticosteroid dose [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in corticosteroid dose

  28. Change from Baseline in Adapted Mayo score, Full Mayo score, Partial Mayo score, and Mayo subscores [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in Adapted Mayo score, Full Mayo score, Partial Mayo score, and Mayo subscores

  29. Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in hs-CRP

  30. Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) scores [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in WPAI scores

  31. Change from Baseline in fecal calprotectin [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in fecal calprotectin

  32. Change from Baseline in European Quality of Life 5 -Dimensions 5 Levels (EQ-5D-5L) score [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in EQ-5D-5L score

  33. Change from Baseline in subject-reported stool frequency (absolute values) [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in subject-reported stool frequency

  34. Change from Baseline in Short Form 36 (SF-36) scores [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in SF-36 scores

  35. Percentage of participants by Patient Global Impression of Severity (PGIS) category [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants by PGIS category

  36. Change from Baseline in Ulcerative Colitis Symptoms Questionnaire (UC-SQ) score [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in UC-SQ score

  37. Percentage of participants by Patient Global Impression of Change (PGIC) category [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Percentage of participants by PGIC category

  38. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Change in FACIT-F score

  39. Health care resource utilization (HCRU), including all-cause and UC-related hospitalizations and surgeries [ Time Frame: At Week 0, Week 48 and every 48 weeks thereafter through 288 weeks ]
    Health care resource utilization



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: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible

  • Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3.
  • If female, participant must meet the criteria for Contraception Recommendations.
  • Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.
  • Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
  • Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

  • For any reason participant is considered by the investigator to be an unsuitable candidate.
  • Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug.
  • Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  • Current evidence of active or untreated latent tuberculosis.
  • Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
  • Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234.
  • History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.

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): NCT03006068


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Locations
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United States, Alabama
CB Flock Research Corporation /ID# 165986
Mobile, Alabama, United States, 36608
United States, Arizona
Delsol Research Management, Ll /Id# 170130
Chandler, Arizona, United States, 85224
Arizona Arthritis & Rheumatolo /ID# 169823
Phoenix, Arizona, United States, 85032-9306
Physician's Research Group /ID# 211886
Tempe, Arizona, United States, 85284-2604
Adobe Clinical Research LLC /ID# 155249
Tucson, Arizona, United States, 85712
Banner University Medical Cent /ID# 150568
Tucson, Arizona, United States, 85724
United States, California
Citrus Valley Gastroenterology /ID# 151915
Covina, California, United States, 91722-3797
UC San Diego Health System /ID# 155187
La Jolla, California, United States, 92093
United Gastroenterologists /ID# 207467
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 157082
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 203135
Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 151213
Murrieta, California, United States, 92563
Ventura County Gastroenterology /ID# 163417
Oxnard, California, United States, 93030
San Diego Clinical Trials /ID# 212121
San Diego, California, United States, 92120
Medical Assoc Research Grp /ID# 169149
San Diego, California, United States, 92123
Univ of California San Francis /ID# 164583
San Francisco, California, United States, 94158
United States, Colorado
Delta Waves, Inc. /ID# 151727
Colorado Springs, Colorado, United States, 80918
Western States Clinical Res /ID# 158078
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Western Connecticut Medical Group /ID# 169211
Danbury, Connecticut, United States, 06810-6000
Medical Research Ctr CT /ID# 150534
Hamden, Connecticut, United States, 06518
United States, Florida
West Central Gastroenterology /ID# 155242
Clearwater, Florida, United States, 33762
Moonshine Research Center, Inc /ID# 152534
Doral, Florida, United States, 33166
Palmetto Research, LLC /ID# 151724
Hialeah, Florida, United States, 33016
Nature Coast Clinical Research /ID# 154070
Inverness, Florida, United States, 34452
Borland-Groover Clinic /ID# 170913
Jacksonville, Florida, United States, 32258
Florida Research Institute /ID# 211605
Lakewood Ranch, Florida, United States, 34211-4930
Ctr for Advanced Gastroenterol /ID# 202018
Maitland, Florida, United States, 32751-6108
Crystal Pharmacology Research /ID# 151848
Miami, Florida, United States, 33165
New Horizon Research Center /ID# 152475
Miami, Florida, United States, 33175
Coral Research Clinic /ID# 150524
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 163093
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 151725
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 200271
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 201791
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 200274
Tampa, Florida, United States, 33613-4680
United States, Georgia
Atlanta Gastroenterology Spec /ID# 150565
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern Medical /ID# 151157
Chicago, Illinois, United States, 60611
Rush University Medical Center /ID# 153050
Chicago, Illinois, United States, 60612
University of Chicago /ID# 150564
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem - Evanston /ID# 150570
Evanston, Illinois, United States, 60201
Carle Foundation Hospital /ID# 151155
Urbana, Illinois, United States, 61801
United States, Indiana
MediSphere Medical Research Center /ID# 152080
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 162914
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 157059
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 167183
Topeka, Kansas, United States, 66606
United States, Kentucky
Tri-State Gastroenterology /ID# 169812
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Houma Digestive Health Special /ID# 151851
Houma, Louisiana, United States, 70360
Nola Research Works, LLC /ID# 153365
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 150526
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
University of Maryland Med Ctr /ID# 150529
Baltimore, Maryland, United States, 21201
Gastro Center of Maryland /ID# 200024
Columbia, Maryland, United States, 21045
United States, Massachusetts
Massachusetts General Hospital /ID# 165678
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Hospitals /ID# 151158
Ann Arbor, Michigan, United States, 48109
Huron Gastroenterology Assoc /ID# 152712
Ann Arbor, Michigan, United States, 48197
Clin Res Inst of Michigan, LLC /ID# 153031
Chesterfield, Michigan, United States, 48047
Revival Research Institute, LLC /ID# 207281
Southfield, Michigan, United States, 48034-1659
Center for Digestive Health /ID# 161983
Troy, Michigan, United States, 48098-6363
Gastroenterology Associates of Western Michigan, PLC /ID# 157487
Wyoming, Michigan, United States, 49519
United States, Minnesota
Minneapolis VA Medical Center /ID# 204621
Minneapolis, Minnesota, United States, 55417
Mayo Clinic - Rochester /ID# 151681
Rochester, Minnesota, United States, 55905-0001
Minnesota Gastroenterology P.A /ID# 151682
Saint Paul, Minnesota, United States, 55114
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 170713
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University-School of Medicine /ID# 150537
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Medical Research /ID# 153052
Las Vegas, Nevada, United States, 89113
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 150566
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC /ID# 153048
Egg Harbor Township, New Jersey, United States, 08234
Atlantic Digestive Health Inst /ID# 150527
Morristown, New Jersey, United States, 07960
Rutgers Robert Wood Johnson /ID# 155247
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center /ID# 150559
Bronx, New York, United States, 10461
Advantage Clinical Trials /ID# 163940
Bronx, New York, United States, 10468
NY Scientific /ID# 152708
Brooklyn, New York, United States, 11235
NYU Langone Long Island Clin. Res. Assoc. /ID# 155271
Great Neck, New York, United States, 11021
Columbia Univ Medical Center /ID# 163409
New York, New York, United States, 10032-3725
DiGiovanna Institute for Medic /ID# 201534
North Massapequa, New York, United States, 11758
Premier Medical Group /ID# 153366
Poughkeepsie, New York, United States, 12601
Gastro Group of Rochester /ID# 151080
Rochester, New York, United States, 14618-5703
Richmond University Medical Center /ID# 201860
Staten Island, New York, United States, 10310-1664
United States, North Carolina
Digestive Health Partners, P.A /ID# 167238
Asheville, North Carolina, United States, 28801
Carolinas Medical Center /ID# 157060
Charlotte, North Carolina, United States, 28203
Charlotte Gastro Hepatology /ID# 150561
Charlotte, North Carolina, United States, 28207
Clinical Trials of America /ID# 153453
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Medical Center /ID# 150528
Winston-Salem, North Carolina, United States, 27157-0001
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 170291
Fargo, North Dakota, United States, 58104
United States, Ohio
Consultants for Clinical Res /ID# 151683
Cincinnati, Ohio, United States, 45219
University of Cincinnati /ID# 164584
Cincinnati, Ohio, United States, 45267-0585
The Ohio State University - Columbus /ID# 169417
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 169697
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 200066
Dayton, Ohio, United States, 45424
Dayton Gastroenterology, Inc. /ID# 167632
Englewood, Ohio, United States, 45415
Great Lakes Gastroenterology Research LLC /ID# 201773
Mentor, Ohio, United States, 44060-6211
Ohio Clinical Research Partner /ID# 154074
Mentor, Ohio, United States, 44060
United States, Oklahoma
Digestive Disease Specialists /ID# 201057
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC /ID# 150569
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultant /ID# 163096
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Northwest Gastroenterology Cli /ID# 152528
Portland, Oregon, United States, 97210
United States, Pennsylvania
Allegheny General Hospital /ID# 163828
Pittsburgh, Pennsylvania, United States, 15212
Guthrie Medical Group, PC /ID# 150533
Sayre, Pennsylvania, United States, 18840
Penn State Health Colonnade /ID# 150267
State College, Pennsylvania, United States, 16803
United States, South Carolina
Pharmacorp Clinical Trials /ID# 153363
Charleston, South Carolina, United States, 29412
Gastroenterology Associates, P.A. /ID# 150557
Greenville, South Carolina, United States, 29615-3593
United States, Tennessee
Gastro One /ID# 151154
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 203611
Johnson City, Tennessee, United States, 37604
Quality Medical Research, PLLC /ID# 203427
Nashville, Tennessee, United States, 37211
Vanderbilt Univ Med Ctr /ID# 153364
Nashville, Tennessee, United States, 37232-0011
United States, Texas
TX Clinical Research Institute /ID# 151528
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 164636
Baytown, Texas, United States, 77521-2415
Texas Digestive Disease Consultants /ID# 209806
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209949
Cedar Park, Texas, United States, 78613-5028
Baylor Scott & White Research /ID# 200771
Dallas, Texas, United States, 75246
DHAT Research Institute /ID# 151221
Garland, Texas, United States, 75044-2208
Vilo Research Group Inc /ID# 212626
Houston, Texas, United States, 77017-2337
CliniCore International, LLC /ID# 152078
Houston, Texas, United States, 77027-6812
Baylor College of Medicine /ID# 150538
Houston, Texas, United States, 77030-3411
Houston Methodist Hospital /ID# 207660
Houston, Texas, United States, 77030
Centex Studies, Inc. - Houston /ID# 201217
Houston, Texas, United States, 77058
GI Specialists of Houston /ID# 202337
Houston, Texas, United States, 77070-4347
Clinical Associates in Researc /ID# 167954
San Antonio, Texas, United States, 78212
Sagact Pllc /Id# 169397
San Antonio, Texas, United States, 78229
Carl R. Meisner Medical Clinic /ID# 171270
Sugar Land, Texas, United States, 77478
Baylor Scott & White Health /ID# 204777
Temple, Texas, United States, 76508
Tyler Research Institute, LLC /ID# 169147
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 167764
Victoria, Texas, United States, 77904
United States, Utah
HP Clinical Research /ID# 163941
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 162640
Ogden, Utah, United States, 84403
Utah Gastroenterology /ID# 163097
Salt Lake City, Utah, United States, 84124
Advanced Clinical Research (ACR) - Salt Lake City /ID# 163180
West Jordan, Utah, United States, 84088
United States, Virginia
Ctr for Gastrointestinal Healt /ID# 153369
Franklin, Virginia, United States, 23851
United States, Washington
Washington Gastroenterology /ID# 163630
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 153030
Seattle, Washington, United States, 98101
The Polyclinic /ID# 165117
Seattle, Washington, United States, 98122-4201
The Vancouver Clinic, INC. PS /ID# 162334
Vancouver, Washington, United States, 98664
United States, Wisconsin
Aurora Medical Center - Grafto /ID# 151726
Grafton, Wisconsin, United States, 53024
WI Center for Advanced Res /ID# 151845
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin /ID# 151850
Milwaukee, Wisconsin, United States, 53226-3522
Argentina
Cardio Alem /ID# 211281
San Isidro, Buenos Aires, Argentina, 1642
Mautalen Salud e Investigacion /ID# 171174
Buenos Aires, Argentina, 1128
Hospital Britanico de Bs As /ID# 209496
Caba, Argentina, 1280
Gedyt /ID# 210016
Ciudad Autonoma Buenos Aires, Argentina, 1125
Hospital Privado Univesitario /ID# 164186
Cordoba, Argentina, 5016
Damic /Id# 152548
Cordoba, Argentina, X5003
Instituto Medico CER /ID# 152343
Quilmes, Argentina, 1878
Sanatorio 9 de Julio S.A. /ID# 150215
San Miguel de Tucuman, Argentina, 4000
Australia, Queensland
Mater Misericordiae /ID# 212686
South Brisbane, Queensland, Australia, 4101
Griffith University /ID# 211954
Southport, Queensland, Australia, 4222
Australia, Victoria
Monash Health /ID# 150218
Clayton, Victoria, Australia, 3168
St. Vincents Hosp Melbourne /ID# 152503
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
Fiona Stanley Hospital /ID# 211641
Murdoch, Western Australia, Australia, 6150
Austria
Krankenanstalt Rudolfstiftung /ID# 162867
Vienna, Wien, Austria, 1030
Medizinische Universität Wien /ID# 150616
Vienna, Wien, Austria, 1090
Ordensklinikum Linz GmbH, Elisabethinen /ID# 150462
Linz, Austria, 4020
LKH Salzburg and Paracelsus /ID# 150463
Salzburg, Austria, 5020
Wilhelminenspital der Stadt Wien /ID# 150615
Wien, Austria, 1160
Belarus
Vitebsk Regional Advanced Clin /ID# 169592
Vitebsk, Belarus, 210001
Belgium
UZ Leuven /ID# 150468
Leuven, Belgium, 3000
AZ-Delta /ID# 150467
Roeselare, Belgium, 8800
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 150223
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 150712
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Center Tuzla /ID# 150224
Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
University Clinical Hospital Mostar /ID# 150711
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo /ID# 150222
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda /ID# 153744
Goiania, Goias, Brazil, 74535-170
Hospital Nossa Senhora das Graças /ID# 152488
Curitiba, Parana, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre /ID# 153745
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Upeclin Fmb - Unesp /Id# 152493
Botucatu, Sao Paulo, Brazil, 18618-686
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 152492
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina do ABC /ID# 152489
Santo André, Sao Paulo, Brazil, 09060-870
Kaiser Clinica e Hospital Dia /ID# 152491
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
Hospital Universitario Clement /ID# 152495
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
University of Calgary /ID# 151818
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 211169
Edmonton, Alberta, Canada, T5R 1W2
Zeidler Ledcor Centre /ID# 151824
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 158931
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Okanagan Clinical Trials /ID# 153179
Kelowna, British Columbia, Canada, V1Y 1Z9
Percuro Clinical Research, Ltd /ID# 150479
Victoria, British Columbia, Canada, V8V 3M9
Canada, Ontario
McMaster University Med Cent /ID# 150477
Hamilton, Ontario, Canada, L8S 4K1
The Ottawa Hospital /ID# 151817
Ottawa, Ontario, Canada, K1H 8L6
Medicor Research Inc. /ID# 151825
Sudbury, Ontario, Canada, P3A 1W8
Toronto Digestive Disease Asso /ID# 150475
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CISSS de la Monteregie /ID# 159271
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 150473
Levis, Quebec, Canada, G6V 3Z1
Recherche GCP Research /ID# 151819
Montreal, Quebec, Canada, H1M 1B1
Crchum /Id# 167170
Montreal, Quebec, Canada, H2X 0A9
Montreal General Hospital - McGill University Health Centre /ID# 170013
Montréal, Quebec, Canada, H3G 1A4
CRCHUS Hotel-Dieu /ID# 150478
Sherbrooke, Quebec, Canada, J1G 2E8
Chile
Research Group Ltda /ID# 203177
Santiago, Region Metropolitana De Santiago, Chile, 2540364
M y F Estudios Clínicos Ltda. /ID# 200112
Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495
Centro de Investigaciones Clínicas Viña del Mar /ID# 150226
Viña del Mar, Valparaíso, Chile, 2540488
Hospital Clínico Regional Dr. Guillermo Grant Benavente /ID# 212425
Concepción, Chile, 4070038
CTR Estudios SpA /ID# 200111
Providencia, Chile, 7500571
Hospital Clinico Universidad De Los Andes /ID# 207427
Santiago, Chile, 7501504
Clinica Las Condes /ID# 153756
Santiago, Chile
China, Anhui
The First Affiliated Hosp, Sun /ID# 150517
Guangzhou, Anhui, China, 510080
Shanghai Tenth People's Hosp /ID# 150522
Shanghai, Anhui, China, 200072
Renji Hosp, Shanghai Jiaotong /ID# 165826
Shanghai, Anhui, China, 200127
China, Chongqing
Daping Hospital, Research Institute of Surgery Third Military Medical University /ID# 165747
Chongqing, Chongqing, China, 400042
China, Guangdong
The Sixth Affiliated Hosp, Sun /ID# 150518
Guangzhou, Guangdong, China, 510655
China, Hubei
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167089
Wuhan, Hubei, China, 430022
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 212185
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hosp of Jilin Univ /ID# 210087
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 150523
Shanghai, Shanghai, China, 200025
China, Zhejiang
The second affiliated hospital of Zhejiang University school of medicine /ID# 165813
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 150516
Hangzhou, Zhejiang, China, 310016
China
Xiangya Hosp Central South Uni /ID# 167230
Changsha, China, 410008
West China Hospital, Sichuan University /ID# 167041
Chengdu, China, 610041
Shengjing Hospital of China Medical University /ID# 166921
Shenyang, China, 110004
Tianjin Med Univ General Hosp /ID# 170605
Tianjin, China, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167079
Wuhan, China, 430022
Colombia
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 152811
Bogota, Cundinamarca, Colombia, 11411
Hospital Univ San Ignacio /ID# 152679
Bogota, Colombia, 110231
Instituto de Coloproctologia /ID# 152815
Medellin, Colombia, 050024
Hospital Universitario de San /ID# 155388
Medellin, Colombia
Hospital Pablo Tobon Uribe /ID# 159096
Medellín, Colombia
Inst Med Alta Tec Onc (IMAT) /ID# 207052
Montería, Colombia, 230002
Croatia
Klinicka bolnica Dubrava Zagreb /ID# 150228
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 150262
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 150715
Zagreb, Grad Zagreb, Croatia, 10000
Poliklinika Solmed /ID# 211567
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 150229
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Rijeka /ID# 150714
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Zadar General Hospital /ID# 150261
Zadar, Croatia, 23000
Czechia
CTCenter MaVe, s.r.o. /ID# 150903
Olomouc, Olomoucky Kraj, Czechia, 779 00
Axon Clinical, s.r.o. /ID# 152477
Praha, Praha 5, Czechia, 150 00
Hepato-Gastroenterologie HK s.r.o. /ID# 150946
Hradec Kralove, Czechia, 500 12
Artroscan s.r.o. /ID# 150502
Ostrava, Czechia, 722 00
ISCARE I.V.F. a.s. /ID# 209279
Prague, Czechia, 170 00
Estonia
East Tallinn Central Hospital /ID# 150488
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 150490
Tallinn, Estonia, 10617
North Estonian Medical Centre /ID# 160871
Tallinn, Estonia, 13419
Tartu University Hospital /ID# 150489
Tartu, Estonia, 51014
Finland
Tampere University Hospital /ID# 150376
Tampere, Pirkanmaa, Finland, 33520
Helsinki Univ Central Hospital /ID# 154283
Helsinki, Finland, 00290
Keski-Suomen Keskussairaala /ID# 155665
Jyvaskyla, Finland, 40620
Laakarikeskus Ikioma /ID# 150377
Mikkeli, Finland, 50100
Tyks /Id# 169895
Turku, Finland, 20521
France
Centre Hospitalier Lyon Sud /ID# 152540
Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
CHU Hopital Nord /ID# 165773
Marseille, Bouches-du-Rhone, France, 13915
CHRU Lille - Hôpital Claude Huriez /ID# 152609
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 200088
Montpellier CEDEX 5, Herault, France, 34295
Hopital Beaujon /ID# 211420
Clichy, Ile-de-France, France, 92110
CHU NANCY - Hôpital Brabois Adultes /ID# 150392
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
CHU Amiens Picardie /ID# 163458
Amiens CEDEX 1, Somme, France, 80054
CHD Vendee /ID# 165749
La Roche Sur Yon, France, 85000
Hopital de L'archet 2 /ID# 152608
Nice, France, 06202
Hopital Saint Antoine /ID# 200089
Paris, France, 75012
Hopital Nord /ID# 165756
Saint Priest En Jarez, France, 42270
Germany
Universitatsklinikum Mannheim /ID# 150405
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitatsklinikum Munster /ID# 150402
Munster, Niedersachsen, Germany, 48149
Univ Hosp Schleswig-Holstein /ID# 161871
Kiel, Schleswig-Holstein, Germany, 24105
Praxis am Bayerischen Platz /ID# 151697
Berlin, Germany, 10825
Agaplesion Markus Krankenhaus /ID# 161870
Frankfurt, Germany, 60341
Medizinisches Versorgungszentrum Portal 10 /ID# 207136
Munster, Germany, 48155
Universitatsklinikum Tubingen /ID# 151698
Tuebingen, Germany, 72076
Gastro Data Wiesbaden /ID# 150404
Wiesbaden, Germany, 65189
Greece
General Hospital of Athens Laiko /ID# 208672
Athens, Attiki, Greece, 115 27
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150406
Athens, Greece, 10676
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202101
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 150236
Heraklion, Greece, 71110
University General Hospital of Ioannina /ID# 164247
Ioannina, Greece, 45500
"Theageneio" Anticancer Hospital /ID# 164187
Thessaloniki, Greece, 54639
Genl Hosp Thessaloniki Hipp /ID# 209522
Thessaloniki, Greece, 54642
Hungary
Markusovszky Egyetemi Oktatókórház /ID# 150410
Szombathely, Vas, Hungary, 9700
Bekes Megyei Kozponti Korhaz /ID# 151601
Bekescsaba, Hungary, 5600
Semmelweis Egyetem /ID# 150409
Budapest, Hungary, 1085
Meditres Kft. /ID# 151597
Kecskemet, Hungary, 6000
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151599
Sopron, Hungary, 9400
Mentahaz Maganorvosi Kozpont /ID# 206977
Szekesfehervar, Hungary, 8000
Ireland
Mercy University Hospital /ID# 153794
Cork, Ireland, T12 WE28
Trinity College Dublin - St. J /ID# 150413
Dublin, Ireland, 8580
St Vincent's University Hosp /ID# 150411
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 150414
Dublin, Ireland, D09 XR63
Galway University Hospital /ID# 150412
Galway, Ireland, H91 YR71
Israel
Hadassah Ein Kerem Medical Ctr /ID# 165119
Jerusalem, Yerushalayim, Israel, 91120
Soroka Medical Ctr /ID# 156562
Be'er Sheva, Israel, 84101
Rambam Health Care Campus /ID# 150416
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 163139
Jerusalem, Israel, 91031
Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 150424
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliera San Camillo Forlanini /ID# 151362
Rome, Lazio, Italy, 00152
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150421
Milan, Lombardia, Italy, 20122
Istituto Clinico Humanitas /ID# 151363
Rozzano, Milano, Italy, 20089
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150263
Palermo, Sicilia, Italy, 90146
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 201726
Negrar, Verona, Italy, 37024
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150605
Milano, Italy, 20121
Policlinico Tor Vergata /ID# 150425
Rome, Italy, 00133
Complesso integrato Columbus /ID# 150420
Rome, Italy, 00168
Japan
Aichi Medical University Hosp /ID# 151994
Nagakute, Aichi, Japan, 4801195
Nagoya University Hospital /ID# 152728
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 151949
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 152761
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Medical Center /ID# 151935
Sakura-shi, Chiba, Japan, 285-8741
Juntendo University Urayasu Hospital /ID# 208783
Urayasu Shi, Chiba, Japan, 279-0021
Kyushu University Hospital /ID# 152525
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 151977
Kurume-shi, Fukuoka, Japan, 830-0011
Ogaki Municipal Hospital /ID# 208226
Ogaki-shi, Gifu, Japan, 503-8502
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210711
Shiga, Higashiohmi-shi, Japan, 527-8505
NHO Fukuyama Medical Center /ID# 206294
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 170281
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151705
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 206493
Sapporo-shi, Hokkaido, Japan, 060-8543
Sapporo Tokushukai Hospital /ID# 209449
Sapporo, Hokkaido, Japan, 004-0041
Aoyama Clinic /ID# 152048
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 152433
Nishinomiya-shi, Hyogo, Japan, 663-8501
Kanazawa University Ho /ID# 207810
Kanazawa, Ishikawa, Japan, 92086-41
Iwate Medical University Hospital /ID# 203412
Morioka-shi, Iwate, Japan, 020-8505
Idzuro Imamura Hospital /ID# 207640
Kagoshima, Kagishimashi, Japan, 8920824
Yokohama City Univ Med Center /ID# 169900
Yokohama-shi, Kanagawa, Japan, 232-0024
JP Red Cross Kyoto Daiichi Hos /ID# 152358
Kyoto-shi, Kyoto, Japan, 605-0981
Mie University Hospital /ID# 207253
Tsu-shi, Mie, Japan, 514-8507
National Hospital Organization Sendai Medical Center /ID# 209529
Sendai-shi, Miyagi, Japan, 983-0045
Ishida Clinic of IBD and Gastroenterology /ID# 210118
Oita-shi, Oita, Japan, 870-0823
Kinshukai Infusion Clinic /ID# 207866
Osaka-shi, Osaka, Japan, 530-0011
Japanese Red Cross Osaka Hospi /ID# 209477
Osaka-shi, Osaka, Japan, 543-8555
Osaka City University Hospital /ID# 152681
Osaka-shi, Osaka, Japan, 545-0051
Saitama Medical Center, Saitama Medical University /ID# 152019
Kawagoe-shi, Saitama, Japan, 350-8550
Tokito Clinic /ID# 152676
Saitama-shi, Saitama, Japan, 336-0963
Kyoto University Hospital /ID# 211808
Kyoto, Sakyo-ku, Japan, 606-8507
Hamamatsu University Hospital /ID# 205709
Higashi-ku, Shizuoka, Japan, 431-3192
Medical Hospital of Tokyo Medical and Dental University /ID# 152017
Bunkyo-ku, Tokyo, Japan, 113-8519
St.Luke's International Hospital /ID# 208075
Chuo-ku, Tokyo, Japan, 104-8560
Tokai University Hachioji Hospital /ID# 152584
Hachioji, Tokyo, Japan, 192-0032
Teikyo University Hospital /ID# 209865
Itabashi-ku, Tokyo, Japan, 173-8605
Kitasato Univ Kitasato Inst Ho /ID# 152687
Minato-ku, Tokyo, Japan, 108-8642
Kyorin University Hospital /ID# 153195
Mitaka-shi, Tokyo, Japan, 181-8611
Tokyo Women's Medical University Hospital /ID# 205978
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 171468
Yamagata-shi, Yamagata, Japan, 990-9585
Yamanashi Prefectural Ctr Hosp /ID# 151909
Kofu-shi, Yamanashi, Japan, 400-8506
Fukui Prefectural Hospital /ID# 210450
Fukui, Japan, 910-0846
Saiseikai Fukuoka General Hosp /ID# 209481
Fukuoka, Japan, 810-0001
Hiroshima University Hospital /ID# 151952
Hiroshima, Japan, 734-8551
National Hospital Organization Mito Medical Center /ID# 152626
Ibaraki, Japan, 3113193
Shimane University School of Medicine /ID# 208906
Izumo, Japan, 693-0021
Sameshima Hospital /ID# 206673
Kagoshima, Japan
Tsujinaka Hospital Kashiwanoha /ID# 209572
Kashiwa, Japan
St. Marianna Univ Hospital /ID# 209452
Kawasaki, Japan, 216-8511
Kitakyushu Municipal Med Ctr /ID# 152589
Kitakyushu, Japan, 802-0077
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157820
Kurashiki, Japan, 710-0142
Saiseikai Niigata Daini Hosp /ID# 209923
Niigata, Japan, 950-1104
Obihiro-Kosei General Hospital /ID# 210425
Obihiro, Japan, 080-0016
NHO Nagasaki Medical Center /ID# 210821
Omura-shi, Japan, 856-8562
Kitano Hospital /ID# 210396
Osaka, Japan, 530-8480
Sapporo Higashi Tokushukai /ID# 208495
Sapporo, Japan, 065-0033
NHO Shizuoka Medical Center /ID# 163571
Shizuoka, Japan
Center hospital of the National Center for Global Health and Medicine /ID# 209533
Tokyo, Japan, 162-8655
Toyohashi Municipal Hospital /ID# 171470
Toyohashi, Japan, 441-8570
Ieda Hospital /ID# 157782
Toyota-shi, Japan, 470-1219
Kenseikai Dongo Hospital /ID# 208102
Yamato Takada, Japan, 635-0022
Showa Univ Fujigaoka Hosp /ID# 208223
Yokohama-shi, Japan, 227-0043
Korea, Republic of
Dong-A University Hospital /ID# 161568
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 161569
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 150432
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
St. Vincent's Hospital /ID# 150434
Suwon, Gyeonggido, Korea, Republic of, 16247
Kangbuk Samsung Hospital /ID# 150435
Seoul, Jongno-Gu, Korea, Republic of, 03181
Severance Hospital /ID# 161566
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 150433
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Hanyang University Guri Hosp /ID# 150431
Guri-si, Korea, Republic of, 471-701
CHA Bundang Medical Center /ID# 161567
Seongnam, Korea, Republic of, 463-712
Asan Medical Center /ID# 159155
Seoul, Korea, Republic of, 05505
Latvia
Riga East Clinical Univ Hosp /ID# 150436
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 153183
Riga, Latvia, LV-1002
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 150439
Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 163719
Klaipeda, Lithuania, 92288
Klaipeda Seamens Hospital /ID# 163501
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 164172
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Sultanah Bahiyah /ID# 152310
Alor Setar, Kedah, Malaysia, 05460
Hospital Ampang /ID# 152311
Ampang, Selangor, Malaysia, 68000
UKM Medical Centre /ID# 152313
Kuala Lumpur, Selangor, Malaysia, 56000
Uni Malaya MC /ID# 150440
Kuala Lumpur, Malaysia, 59100
Mexico
Morales Vargas Centro de Investigación S.C /ID# 211327
León de los Aldama, Guanajuato, Mexico, 37000
Issste /Id# 150239
Guadalajara, Jalisco, Mexico, 44600
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 202334
Guadalajara, Jalisco, Mexico, 44650
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150265
Monterrey, Nuevo Leon, Mexico, 64610
Netherlands
Radboud Universitair Medisch Centrum /ID# 151701
Nijmegen, Gelderland, Netherlands, 6525 GA
Academisch Medisch Centrum /ID# 150617
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Leids Universitair Medisch Centrum /ID# 152625
Leiden, Netherlands, 2333 ZA
Erasmus Medisch Centrum /ID# 150619
Rotterdam, Netherlands, 3015 CE
Universitair Medisch Centrum Utrecht /ID# 152776
Utrecht, Netherlands, 3584 CX
Norway
Akershus Universitetssykehus_MAIN /ID# 150622
Lorenskog, Akershus, Norway, 1478
Universitetssykehuset Nord-Norge /ID# 152836
Tromsø, Troms, Norway, 9019
Poland
Zespol Przychodni Prima /Id# 150627
Warsaw, Mazowieckie, Poland, 02-018
Centrum Zdrowia MDM /ID# 150626
Warszawa, Mazowieckie, Poland, 00-635
Endoterapia PFG Sp. z.o.o. /ID# 150624
Warszawa, Mazowieckie, Poland, 02-653
Endoskopia Sp. z o.o. /ID# 152940
Sopot, Zachodniopomorskie, Poland, 81-756
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 151616
Guimarães, Braga, Portugal, 4835-044
Centro Hosp de Lisboa Central /ID# 151620
Lisbon, Lisboa, Portugal, 1169-050
Hospital Garcia de Orta, E.P.E /ID# 151622
Almada, Setubal, Portugal, 2805-267
CCA Braga - Hospital de Braga /ID# 151617
Braga, Portugal, 4710-243
Centro Hospitalar Lisboa Norte, EPE /ID# 151615
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE /ID# 151619
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 152336
Santa Maria Da Feira, Portugal, 4520-211
Unidade Local De Saude Do Alto Minho /ID# 151618
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 150629
San Juan, Puerto Rico, 00935
Romania
Clinic Fundeni Institute /ID# 150630
Bucharest, Bucuresti, Romania, 022328
Clinic Fundeni Institute /ID# 161604
Bucharest, Bucuresti, Romania, 022328
Cabinet Particular Policlinic Algomed /ID# 150631
Timisoara, Romania, 300002
Russian Federation
Immanuel Kant Baltic Federal University /ID# 202129
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
NW State Medical Univ na Mechn /ID# 169332
St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
Perm Clinical Center of FMBA /ID# 150634
Perm, Permskiy Kray, Russian Federation, 614109
LLC Medical Company Hepatolog /ID# 200208
Samara, Samarskaya Oblast, Russian Federation, 443063
LLC Uromed /ID# 200728
Smolensk, Smolenskaya Oblast, Russian Federation, 214031
LLC Novaya Klinika /ID# 208106
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Kazan State Medical University /ID# 166040
Kazan, Tatarstan, Respublika, Russian Federation, 420012
City Clinical Hospital 24 /ID# 150638
Moscow, Russian Federation, 127015
P.A. Bayandin Murmansk Regiona /ID# 165916
Murmansk, Russian Federation, 183047
Republican Clin Hos n.a. Baran /ID# 206508
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 208968
Pushkin, Russian Federation, 196603
Stavropol State Medical Univ /ID# 150635
Stavropol, Russian Federation, 355017
Serbia
Clinical Center Serbia /ID# 150642
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 150641
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 150643
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 150640
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 151902
NIS, Nisavski Okrug, Serbia, 18000
Clinical Center Kragujevac /ID# 150644
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 150759
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital /ID# 150583
Singapore, Singapore, 119074
Gleneagles Medical Centre /ID# 206020
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 150646
Singapore, Singapore, 308433
Slovakia
Medak s.r.o., gastroenterologi /ID# 150550
Bratislava, Bratislavsky Kraj, Slovakia, 851 01
FN s poliklinikou F.D. Rooseve /ID# 150869
Banska Bystrica, Slovakia, 97517
Slovak Research Center Team Me /ID# 150240
Ilava, Slovakia, 019 01
B and B MED s.r.o. /ID# 150584
Kosice, Slovakia, 040 01
Fakultna nemocnica s poliklini /ID# 211371
Nove Zamky, Slovakia, 94002
Gastro I.S.R.O. /ID# 150585
Presov, Slovakia, 08001
South Africa
Clinresco Centres /ID# 163625
Johannesburg, Gauteng, South Africa, 1619
Chris Hani Baragwanath Hosp /ID# 157730
Johannesburg, Gauteng, South Africa, 1864
Wits Clinical Research Site /ID# 150586
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 162203
Cape Town, Milnerton, South Africa, 7441
Kingsbury Hospital /ID# 150587
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg /ID# 155145
Cape Town, Western Cape, South Africa, 7800
MD Search /ID# 157524
Boksburg North, South Africa, 1460
Spain
Comple Hospi Univ de Santiago /ID# 171492
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitario y Politecnico La Fe /ID# 150591
Valencia, Valenciana, Spain, 46026
Comple Hosp Univ de A Coruna /ID# 203912
A Coruna, Spain, 15006
Hospital Clinic de Barcelona /ID# 150598
Barcelona, Spain, 08036
Hospital Reina Sofia de Cordob /ID# 154031
Cordoba, Spain, 14004
Hospital Univ Dr. Negrin /ID# 203965
Las Palmas de Gran Canaria, Spain, 35010
Hospital Univ Ramon y Cajal /ID# 171491
Madrid, Spain, 28034
Complejo Asistencial de Salama /ID# 150590
Salamanca, Spain, 37007
Sweden
Sahlgrenska University Hosp /ID# 152326
Goteborg, Sweden, 413 45
Switzerland
Kantonsspital St. Gallen /ID# 152601
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 161732
Basel, Switzerland, 4031
Inselspital, Universitaetsklinik /ID# 152602
Bern, Switzerland, 3010
University Hospital Zurich /ID# 152603
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 150600
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 151751
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 150604
Taipei City, Taipei, Taiwan, 100
Kaohsiung Medical University /ID# 150606
Kaohsiung, Taiwan, 80708
Chung Shan Medical University /ID# 150603
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp /ID# 151750
Taipei City, Taiwan, 11217
Turkey
Erciyes University Medical Fac /ID# 150495
Melikgazi, Kayseri, Turkey, 38030
Gazi Universitesi Tip Fakultes /ID# 150493
Ankara, Turkey, 06500
Istanbul Universitesi Cerrahpa /ID# 150491
Cerrahpasa, Turkey, 34098
Umraniye Training and Res Hosp /ID# 163136
Istanbul, Turkey, 34764
Mersin University Medical /ID# 163135
Mersin, Turkey, 33343
Ukraine
Regional Clinical Hospital - Center for Emergency Medical Care and Disaster Med /ID# 206941
Kharkiv, Kharkivska Oblast, Ukraine, 61204
Kyiv Municipal Clinical Hospital #18 /ID# 150505
Kiev, Kyiv, Ukraine, 03134
Medical Center of the "Health /ID# 162501
Vinnytsya, Vinnytska Oblast, Ukraine, 21009
Municipal Institution City Hospital #7 /ID# 212965
Zaporizhzhia, Zaporizka Oblast, Ukraine, 69118
Regional Clin Hosp Mechnykov /ID# 207731
Dnipropetrovsk, Ukraine, 49005
Lviv Regional Clinical Hospita /ID# 150508
Lviv, Ukraine, 79010
Odessa Regional Clinical Hosp /ID# 162502
Odesa, Ukraine, 65025
Public Nonprofit Enterprise Regional Oncology Center of Regional Coun /ID# 211962
Kirovohrad, Кропивницький, Ukraine, 25011
United Kingdom
RD&E Hospital /ID# 150510
Exeter, Devon, United Kingdom, EX2 5DW
Queen Elizabeth University Hos /ID# 163788
Glasgow, Glasgow City, United Kingdom, G51 4TF
The Royal London Hospital /ID# 150515
London, London, City Of, United Kingdom, E1 1BB
Basingstoke & North Hampshire /ID# 150511
Basingstoke, United Kingdom, RG24 9NA
Royal United Hospitals Bath /ID# 154211
Bath, United Kingdom, BA1 3NG
Univ Hospitals Birmingham NHS Foundation trust /ID# 150513
Birmingham, United Kingdom, B15 2TG
St. George's Healthcare NHS /ID# 208376
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: NCT03006068     History of Changes
Other Study ID Numbers: M14-533
2016-000674-38 ( EudraCT Number )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 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:
Ulcerative Colitis (UC)
Upadacitinib (ABT-494)
Long Term Extension (LTE)
Safety
Efficacy
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