Ulcerative Colitis (UC)Phase 3U-ACTIVATENCT03006068
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)
A Phase 3 study testing Upadacitinib (ABT-494) in people with Ulcerative Colitis (UC), run by AbbVie at 492 sites in 46 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Upadacitinib (ABT-494)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 950 participants
- Where
- 492 sitesin 46 countries
- Study dates
- 31 Jan 2017to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.
- If female, participant must meet the contraception criteria.
- 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.
Who cannot join
- 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.
- Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE) during the preceding studies, that in the investigator's judgment makes the participant unsuitable for this study.
- 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 tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol.
- 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.
Trial locations and contacts
492 sites in 46 countries.
492 sites in 46 countries
United States147 sites
Duplicate_University of New Mexico Department of Internal Medicine /ID# 214399
Albuquerque, New Mexico, 87131
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151158
Ann Arbor, Michigan, 48109
Huron Gastroenterology Assoc /ID# 152712
Ann Arbor, Michigan, 48197
TX Clinical Research Institute /ID# 151528
Arlington, Texas, 76012
Digestive Health Partners - Biltmore Office /ID# 167238
Asheville, North Carolina, 28801
University of Maryland, Baltimore /ID# 150529
Baltimore, Maryland, 21201
Inquest Clinical Research /ID# 164636
Baytown, Texas, 77521-2415
Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 163630
Bellevue, Washington, 98004
Massachusetts General Hospital /ID# 165678
Boston, Massachusetts, 02114
HP Clinical Research /ID# 163941
Bountiful, Utah, 84010
NY Scientific /ID# 152708
Brooklyn, New York, 11235
Texas Digestive Disease Consultants /ID# 209949
Cedar Park, Texas, 78613-5028
GI Alliance /ID# 209806
Cedar Park, Texas, 78613
Delsol Research Management, Ll /Id# 170130
Chandler, Arizona, 85224
Pharmacorp Clinical Trials /ID# 153363
Charleston, South Carolina, 29412
Atrium Health Carolinas Medical Center /ID# 157060
Charlotte, North Carolina, 28203
Charlotte Gastroenterology and Hepatology, PLLC /ID# 150561
Charlotte, North Carolina, 28207
Clin Res Inst of Michigan, LLC /ID# 153031
Chesterfield, Michigan, 48047
Clin Res Inst of Michigan, LLC /ID# 161983
Chesterfield, Michigan, 48047
Next Innovative Clinical Research - Chicago /ID# 217323
Chicago, Illinois, 60605-2168
Duplicate_The University of Chicago DCAM /ID# 150564
Chicago, Illinois, 60637
Gastro Health Research /ID# 151683
Cincinnati, Ohio, 45219
University Of Cincinnati Medical Center /ID# 164584
Cincinnati, Ohio, 45219
West Central Gastroenterology /ID# 155242
Clearwater, Florida, 33762
Delta Waves, Inc. /ID# 151727
Colorado Springs, Colorado, 80918
Gastro Center of Maryland /ID# 200024
Columbia, Maryland, 21045
The Ohio State University /ID# 169417
Columbus, Ohio, 43210
Optimed Research, Ltd. /ID# 169697
Columbus, Ohio, 43235
Gastro One /ID# 151154
Cordova, Tennessee, 38018
Citrus Valley Gastroenterology /ID# 151915
Covina, California, 91722-3797
Tri-State Gastroenterology /ID# 169812
Crestview Hills, Kentucky, 41017
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200771
Dallas, Texas, 75246
Duplicate_Western Connecticut Medical Group /ID# 169211
Danbury, Connecticut, 06810
Hometown Urgent Care and Resea /ID# 200066
Dayton, Ohio, 45424
Moonshine Research Center, Inc /ID# 152534
Doral, Florida, 33166
Universal Axon Clinical Research /ID# 213463
Doral, Florida, 33166
Cooper Gastroenterology at Fire Road /ID# 153048
Egg Harbor, New Jersey, 08234
Dayton Gastroenterology, Inc. /ID# 167632
Englewood, Ohio, 45415
Duplicate_NorthShore University HealthSystem /ID# 150570
Evanston, Illinois, 60201
MediSphere Medical Research Center /ID# 152080
Evansville, Indiana, 47714-8011
Plains Clinical Research Center, LLC /ID# 170291
Fargo, North Dakota, 58104-5925
Ctr for Gastrointestinal Healt /ID# 153369
Franklin, Virginia, 23851
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 151221
Garland, Texas, 75044
Aurora Medical Center - Grafto /ID# 151726
Grafton, Wisconsin, 53024
Duplicate_NYU Langone Long Island Clinical Research Association /ID# 155271
Great Neck, New York, 11021
Atlantic Gastroenterology Clinical Research /ID# 151901
Greenville, North Carolina, 27834
Gastroenterology Associates, P.A. of Greenville /ID# 150557
Greenville, South Carolina, 29607
Gastroenterology Center of Connecticut /ID# 150534
Hamden, Connecticut, 06518
Palmetto Research, LLC /ID# 151724
Hialeah, Florida, 33016
Northwest Health Care Associates /ID# 151591
Hoffman Estates, Illinois, 60169
Houma Digestive Health Special /ID# 151851
Houma, Louisiana, 70360
Vilo Research Group Inc /ID# 212626
Houston, Texas, 77017-2337
CliniCore International, LLC /ID# 152078
Houston, Texas, 77027-6812
Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 150538
Houston, Texas, 77030-3411
Centex Studies, Inc. - Houston /ID# 201217
Houston, Texas, 77058
GI Specialists of Houston /ID# 202337
Houston, Texas, 77070-4347
Newport Huntington Medical Group /ID# 217006
Huntington Beach, California, 92648-5994
Indianapolis Gastroenterology /ID# 162914
Indianapolis, Indiana, 46237
Nature Coast Clinical Research - Inverness /ID# 154070
Inverness, Florida, 34452-4717
University of Iowa Hospitals and Clinics /ID# 157059
Iowa City, Iowa, 52242
University of Mississippi Medical Center /ID# 213140
Jackson, Mississippi, 39216-4500
Southern Therapy and Advanced Research (STAR) LLC /ID# 170713
Jackson, Mississippi, 39216
Encore Borland-Groover Clinical Research /Id# 170913
Jacksonville, Florida, 32256
Duplicate_East Tennessee Research Institute /ID# 203611
Johnson City, Tennessee, 37604
SIH Research Mumtaz, Inc /ID# 163199
Kissimmee, Florida, 34741-4161
UC San Diego Health System /ID# 155187
La Jolla, California, 92037
Vector Clinical Trials /ID# 153052
Las Vegas, Nevada, 89128
Dartmouth-Hitchcock Medical Center /ID# 150566
Lebanon, New Hampshire, 03756
South Denver Gastroenterology /ID# 151224
Lone Tree, Colorado, 80124
United Medical Doctors /ID# 207467
Los Alamitos, California, 90720-3309
TLC Clinical Research Inc /ID# 216830
Los Angeles, California, 90048
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157082
Los Angeles, California, 90067-2001
Duplicate_Caprock Gastro Research, LLC /ID# 215116
Lubbock, Texas, 79424-3017
Gastroenterology Associates of Central Georgia, LLC /ID# 165783
Macon, Georgia, 31201
Cfagi Llc /Id# 202018
Maitland, Florida, 32751-6108
Great Lakes Gastroenterology Research, LLC /ID# 201773
Mentor, Ohio, 44060-6211
Ohio Clinical Research Partner /ID# 154074
Mentor, Ohio, 44060
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886
Mesa, Arizona, 85206
Duplicate_University of Miami /ID# 215443
Miami, Florida, 33136
Advanced Pharma CR, LLC /ID# 151723
Miami, Florida, 33147
New Horizon Research Center /ID# 152475
Miami, Florida, 33165-3372
Crystal Pharmacology Research /ID# 151848
Miami, Florida, 33165
Coral Research Clinic /ID# 150524
Miami, Florida, 33186-4643
Wisconsin Center for Advanced Research /ID# 151845
Milwaukee, Wisconsin, 53215
Duplicate_Medical College of Wisconsin /ID# 151850
Milwaukee, Wisconsin, 53226-3522
Facey Medical Foundation /ID# 203135
Mission Hills, California, 91345
East View Medical Research, LLC /ID# 171184
Mobile, Alabama, 36606
CB Flock Research Corporation /ID# 165986
Mobile, Alabama, 36608
Atlantic Digestive Health Inst /ID# 150527
Morristown, New Jersey, 07960
United Medical Doctors - Murrieta /ID# 151213
Murrieta, California, 92563
Quality Medical Research /ID# 203427
Nashville, Tennessee, 37211
Vanderbilt University Medical Center /ID# 153364
Nashville, Tennessee, 37232-0011
Rutgers Robert Wood Johnson /ID# 155247
New Brunswick, New Jersey, 08901
Nola Research Works, LLC /ID# 153365
New Orleans, Louisiana, 70115
Advanced Research Institute, Inc /ID# 163093
New Port Richey, Florida, 34653
Columbia Univ Medical Center /ID# 163409
New York, New York, 10032-3725
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 201534
North Massapequa, New York, 11758
Advanced Research Institute /ID# 162640
Ogden, Utah, 84405
Hightower Clinical /ID# 216338
Oklahoma City, Oklahoma, 73102
Digestive Disease Specialists /ID# 201057
Oklahoma City, Oklahoma, 73112
Endoscopic Research, Inc. /ID# 151725
Orlando, Florida, 32803
Omega Research Group /ID# 200271
Orlando, Florida, 32808
Ventura County Gastroenterology Medical Group /ID# 163417
Oxnard, California, 93030-0190
Northwest Gastroenterology Clinic /ID# 152528
Portland, Oregon, 97210
Premier Medical Group - GI Division /ID# 153366
Poughkeepsie, New York, 12601
Inland Empire Clinical Trials, LLC /ID# 216163
Rialto, California, 92377
Infinite Clinical Trials /ID# 215342
Riverdale, Georgia, 30274
Mayo Clinic - Rochester /ID# 151681
Rochester, Minnesota, 55905-0001
Gastoenterology Group of Rochester /ID# 151080
Rochester, New York, 14618-5703
Minnesota Gastroenterology PA /ID# 151682
Saint Paul, Minnesota, 55114
Utah Gastroenternology - St. Mark's Office /ID# 163097
Salt Lake City, Utah, 84124
Clinical Associates in Research Therapeutics of America, LLC /ID# 167954
San Antonio, Texas, 78212
Southern Star Research Institute, LLC /ID# 169397
San Antonio, Texas, 78229-5390
San Diego Clinical Trials /ID# 212121
San Diego, California, 92120
Medical Assoc Research Grp /ID# 169149
San Diego, California, 92123
Univ of California San Francis /ID# 164583
San Francisco, California, 94158
Guthrie Medical Group, PC /ID# 150533
Sayre, Pennsylvania, 18840
Virginia Mason Hospital & Medical Center /ID# 153030
Seattle, Washington, 98101
The Polyclinic /ID# 165117
Seattle, Washington, 98122-4201
Louisiana Research Center, LLC /ID# 150526
Shreveport, Louisiana, 71105-6800
Revival Research Institute, LLC /ID# 207281
Southfield, Michigan, 48034-1659
Washington University-School of Medicine /ID# 150537
St Louis, Missouri, 63110
Penn State Health Colonnade /ID# 150267
State College, Pennsylvania, 16803-2309
Richmond University Medical Center /ID# 201860
Staten Island, New York, 10310-1664
Carl R. Meisner Medical Clinic /ID# 171270
Sugar Land, Texas, 77478
Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823
Sun City, Arizona, 85306
Atlanta Gastroenterology Spec /ID# 150565
Suwanee, Georgia, 30024
Clinical Research Trials of Florida, Inc. /ID# 201791
Tampa, Florida, 33607
Duplicate_University of South Florida /ID# 214494
Tampa, Florida, 33612
Duplicate_AdventHealth Tampa /ID# 200274
Tampa, Florida, 33613-4680
Baylor Scott & White Center for Diagnostic Medicine /ID# 204777
Temple, Texas, 76508
Montefiore Medical Center - Moses Campus /ID# 150559
The Bronx, New York, 10467
Advantage Clinical Trials /ID# 163940
The Bronx, New York, 10468
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 167183
Topeka, Kansas, 66606
Adobe Clinical Research LLC /ID# 155249
Tucson, Arizona, 85712
Duplicate_University of Arizona /ID# 150568
Tucson, Arizona, 85724
Options Health Research, LLC /ID# 150569
Tulsa, Oklahoma, 74104
Healthcare Research Consultant /ID# 163096
Tulsa, Oklahoma, 74135
Tyler Research Institute, LLC /ID# 169147
Tyler, Texas, 75701
Carle Foundation Hospital /ID# 151155
Urbana, Illinois, 61801
The Vancouver Clinic, INC. PS /ID# 162334
Vancouver, Washington, 98664
Gastro Health & Nutrition - Victoria /ID# 167764
Victoria, Texas, 77904
Duplicate_Velocity Clinical Research - Salt Lake City /ID# 163180
West Jordan, Utah, 84088
Western States Clinical Res /ID# 158078
Wheat Ridge, Colorado, 80033-2896
Clinical Trials of America /ID# 153453
Winston-Salem, North Carolina, 27103
Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 150528
Winston-Salem, North Carolina, 27157-0001
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157487
Wyoming, Michigan, 49519
Japan74 sites
Tokatsu Tsujinaka Hospital /ID# 214964
Abiko-shi, Chiba, 270-1168
Duplicate_Asahikawa Medical University Hospital /ID# 170281
Asahikawa-shi, Hokkaido, 078-8510
Institute of Science Tokyo Hospital /ID# 152017
Bunkyo-ku, Tokyo, 113-8519
Fukuoka University Chikushi Hospital /ID# 152627
Chikushino-shi, Fukuoka, 818-8502
St. Lukes International Hospital /ID# 208075
Chuo-ku, Tokyo, 104-8560
Fukui Prefectural Hospital /ID# 210450
Fukui-shi, Fukui, 910-8526
Saiseikai Fukuoka Genaral Hospital /ID# 209481
Fukuoka, Fukuoka, 810-0001
Kyushu University Hospital /ID# 152525
Fukuoka, Fukuoka, 812-8582
National Hospital Organization Fukuyama Medical Center /ID# 206294
Fukuyama-shi, Hiroshima, 720-8520
Tokai University Hachioji Hospital /ID# 152584
Hachioji-shi, Tokyo, 192-0032
Hamamatsu University Hospital /ID# 205709
Hamamatsu, Shizuoka, 431-3192
Duplicate_National Hospital Organization Mito Medical Center /ID# 152626
Higashi Ibaraki-gun, Ibaraki, 311-3193
National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210711
Higashi-ohmi-shi, Shiga, 527-8505
National Hospital Organization Hirosaki General Medical Center /ID# 152761
Hirosaki-shi, Aomori, 036-8545
Hiroshima University Hospital /ID# 151952
Hiroshima, Hiroshima, 734-8551
Shimane University Hospital /ID# 208906
Izumo-shi, Shimane, 693-8501
Imamura General Hospital /ID# 227138
Kagoshima, Kagoshima-ken, 890-0064
Idzuro Imamura Hospital /ID# 207640
Kagoshima, Kagoshima-ken, 892-0824
Sameshima Hospital /ID# 206673
Kagoshima, Kagoshima-ken, 892-0846
Kagoshima IBD Gastroenterology Clinic /ID# 245222
Kagoshima, Kagoshima-ken, 8920804
Kanazawa University Hospital /ID# 207810
Kanazawa, Ishikawa-ken, 920-8641
Tsujinaka Hospital - Kashiwanoha /ID# 209572
Kashiwa-shi, Chiba, 277-0871
Saitama Medical Center /ID# 152019
Kawagoe, Saitama, 350-8550
St Marianna University School Of Medicine /ID# 209452
Kawasaki-shi, Kanagawa, 216-8511
Duplicate_Kitakyushu Municipal Medical Center /ID# 152589
Kitakyushu, Fukuoka, 8020077
Aoyama Clinic /ID# 152048
Kobe, Hyōgo, 650-0015
Yamanashi Prefectural Central Hospital /ID# 151909
Kofu, Yamanashi, 400-8506
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157820
Kurashiki-shi, Okayama-ken, 710-0142
Kurume University Hospital /ID# 151977
Kurume-shi, Fukuoka, 830-0011
Japanese Red Cross Kyoto Daiichi Hosital /ID# 152358
Kyoto, Kyoto, 605-0981
Kyoto University Hospital /ID# 211808
Kyoto, Kyoto, 606-8507
Kitasato University Kitasato Institute Hospital /ID# 152687
Minato-ku, Tokyo, 108-8642
Kyorin University Hospital /ID# 153195
Mitaka-shi, Tokyo, 181-8611
Iwate Medical University Uchimaru Medical Center /ID# 203412
Morioka, Iwate, 020-8505
Aichi Medical University Hospital /ID# 151994
Nagakute, Aichi-ken, 480-1195
Nagoya University Hospital /ID# 152728
Nagoya, Aichi-ken, 466-8560
Nagoya City University Hospital /ID# 151949
Nagoya, Aichi-ken, 467-8602
Saiseikai Niigata Hospital /ID# 209923
Niigata, Niigata, 950-1104
Duplicate_Niigata University Medical & Dental Hospital /ID# 218050
Niigata, Niigata, 951-8520
Duplicate_Hyogo Medical University Hospital /ID# 152433
Nishinomiya-shi, Hyōgo, 663-8501
Obihiro kosei Hospital /ID# 210425
Obihiro-shi, Hokkaido, 080-0024
Ogaki Municipal Hospital /ID# 208226
Ogaki-shi, Gifu, 503-8502
Ishida Clinic of IBD and Gastroenterology /ID# 210118
Ōita, Oita Prefecture, 870-0823
Duplicate_Okayama University Hospital /ID# 217924
Okayama, Okayama-ken, 700-8558
NHO Nagasaki Medical Center /ID# 210821
Omura-shi, Nagasaki, 856-8562
Kinshukai Infusion Clinic /ID# 207866
Osaka, Osaka, 530-0011
Kitano Hospital, Tazuke Kofukai Medical Research Institute /ID# 210396
Osaka, Osaka, 530-8480
Osaka City General Hospital /ID# 152703
Osaka, Osaka, 534-0021
Osaka Red Cross Hospital /ID# 209477
Osaka, Osaka, 543-8555
Osaka Metropolitan University Hospital /ID# 152681
Osaka, Osaka, 545-8586
Duplicate_Saga University Hospital /ID# 209272
Saga, Saga-ken, 849-8501
Tokitokai Tokito clinic /ID# 152676
Saitama-shi, Saitama, 336-0963
Toho University Sakura Medical Center /ID# 151935
Sakura-shi, Chiba, 285-8741
Sapporo Tokushukai Hospital /ID# 209449
Sapporo, Hokkaido, 004-0041
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151705
Sapporo, Hokkaido, 060-0033
Sapporo Medical University Hospital /ID# 206493
Sapporo, Hokkaido, 060-8543
Sapporo Higashi Tokushukai Hospital /ID# 208495
Sapporo, Hokkaido, 065-0033
National Hospital Organization Sendai Medical Center /ID# 209529
Sendai, Miyagi, 983-8520
Duplicate_Center hospital of the National Center for Global Health and Medicine /ID# 209533
Shinjuku-ku, Tokyo, 162-8655
Duplicate_Tokyo Women's Medical University Hospital /ID# 205978
Shinjuku-ku, Tokyo, 162-8666
Tokuyama Central Hospital /ID# 216995
Shunan-shi, Yamaguchi, 745-8522
NHO Shizuoka Medical Center /ID# 163571
Sunto-gun, Shizuoka, 411-8611
Shoyukai Fujita Gastroenterological Hospital /ID# 216494
Takatsuki-shi, Osaka, 569-0086
Teikyo University Hospital /ID# 209865
Tokyo, 173-8605
Toyohashi Municipal Hospital /ID# 171470
Toyohashi, Aichi-ken, 441-8570
Toyonaka Municipal Hospital /ID# 217083
Toyonaka-shi, Osaka, 560-0055
Ieda Hospital /ID# 157782
Toyota-shi, Aichi-ken, 470-1219
Mie University Hospital /ID# 207253
Tsu, Mie-ken, 514-8507
Juntendo University Urayasu Hospital /ID# 208783
Urayasu-shi, Chiba, 279-0021
Yamagata University Hospital /ID# 171468
Yamagata, Yamagata, 990-9585
Kenseikai Dongo Hospital /ID# 208102
Yamatotakada-shi, Nara, 635-0022
Yokkaichi Hazu Medical Center /ID# 214349
Yokkaichi-shi, Mie-ken, 510-0016
SHOWA Medical University Fujigaoka Hospital /ID# 208223
Yokohama, Kanagawa, 227-8501
Yokohama City University Medical Center /ID# 169900
Yokohama, Kanagawa, 232-0024
Canada16 sites
University of Calgary /ID# 151818
Calgary, Alberta, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 211169
Edmonton, Alberta, T5R 1W2
University of Alberta Hospital /ID# 151824
Edmonton, Alberta, T6G 2B7
Covenant Health /ID# 158931
Edmonton, Alberta, T6K 4B2
Medicor Research Inc /ID# 151825
Greater Sudbury, Ontario, P3A 1W8
CISSS de la Monteregie /ID# 159271
Greenfield Park, Quebec, J4V 2H1
Duplicate_Hamilton Health Sciences -McMaster University Medical Centre /ID# 150477
Hamilton, Ontario, L8S 4K1
OCT Research ULC /ID# 153179
Kelowna, British Columbia, V1Y 1Z9
Duplicate_CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150473
Lévis, Quebec, G6V 3Z1
Recherche GCP Research /ID# 151819
Montreal, Quebec, H1M 1B1
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167170
Montreal, Quebec, H2X 0A9
Montreal General Hospital - McGill University Health Centre /ID# 170013
Montreal, Quebec, H3G 1A4
Ottawa Hospital Research Institute /ID# 151817
Ottawa, Ontario, K1H 8L6
CIUSSS de l'Estrie - CHUS /ID# 150478
Sherbrooke, Quebec, J1G 2E8
Toronto Digestive Disease Associates /ID# 150475
Vaughan, Ontario, L4L 4Y7
Percuro Clinical Research, Ltd /ID# 150479
Victoria, British Columbia, V8V 3M9
China16 sites
The First Hospital of Jilin University /ID# 210087
Changchun, Jilin, 130021
Duplicate_Xiangya Hospital Central South University /ID# 167230
Changsha, Hunan, 410008
West China Hospital, Sichuan University /ID# 167041
Chengdu, Sichuan, 610041
The First Affiliated Hospital, Sun Yat-sen University /ID# 150517
Guangzhou, Guangdong, 510080
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 150518
Guangzhou, Guangdong, 510655
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 165813
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150516
Hangzhou, Zhejiang, 310018
The First Affiliated Hospital of Nanchang University /ID# 212185
Nanchang, Jiangxi, 330006
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150523
Shanghai, Shanghai Municipality, 200065
Shanghai Tenth People's Hospital /ID# 150522
Shanghai, Shanghai Municipality, 200072
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165826
Shanghai, Shanghai Municipality, 200127
Shengjing Hospital of China Medical University /ID# 166921
Shenyang, Liaoning, 110022
Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216407
Shiyan, Hubei, 442700
Tianjin Medical University General Hospital /ID# 170605
Tianjin, Tianjin Municipality, 300052
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167089
Wuhan, Hubei, 430022
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167079
Wuhan, Hubei, 430022
Germany10 sites
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 151697
Berlin, 10825
Duplicate_Agaplesion Markus Krankenhaus /ID# 161870
Frankfurt am Main, Hesse, 60431
Gastroenterologische Gemeinschaftspraxis Herne /ID# 214575
Herne, North Rhine-Westphalia, 44623
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161871
Kiel, Schleswig-Holstein, 24105
Universitatsklinikum Mannheim /ID# 150405
Mannheim, Baden-Wurttemberg, 68167
Duplicate_Universitaetsklinikum Muenster /ID# 150402
Munster, Lower Saxony, 48149
Medizinisches Versorgungszentrum Portal 10 /ID# 207136
Münster, 48155
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215812
Saarbrücken, Saarland, 66111
Universitaetsklinikum Tuebingen /ID# 151698
Tübingen, Baden-Wurttemberg, 72076
Praxis medicum /ID# 150404
Wiesbaden, 65189
Italy10 sites
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 150424
Bologna, Emilia-Romagna, 40138
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150605
Milan, Milano, 20122
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150421
Milan, 20122
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201726
Negrar, Verona, 37024
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 150263
Palermo, 90146
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216673
Rho, Milano, 20017
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 150425
Rome, Roma, 00133
Duplicate_Azienda Ospedaliera San Camillo Forlanini /ID# 151362
Rome, Roma, 00152
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150420
Rome, Roma, 00168
IRCCS Istituto Clinico Humanitas /ID# 151363
Rozzano, Lombardy, 20089
Russia10 sites
Immanuel Kant Baltic Federal University /ID# 202129
Kaliningrad, Kaliningrad Oblast, 236016
Kazan State Medical University /ID# 166040
Kazan', Tatarstan, Respublika, 420012
Olla-Med Clinic /ID# 215334
Moscow, 105554
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150634
Perm, Permskiy Kray, 614109
Republican hospital named after V.A. Baranov /ID# 206508
Petrozavodsk, Murmansk Oblast, 185019
Euromedservice /ID# 208968
Pushkin, 196603
LLC Novaya Klinika /ID# 208106
Pyatigorsk, Stavropol Kray, 357500
NW State Medical Univ na Mechn /ID# 169332
Saint Petersburg, Leningradskaya Oblast', 191015
Medical Company Hepatology /ID# 200208
Samara, Samara Oblast, 443011
Duplicate_Stavropol State Medical Univ /ID# 150635
Stavropol, 355017
South Korea10 sites
Dong-A University Medical Center /ID# 161568
Busan, Busan Gwang Yeogsi, 49201
Pusan National University Hospital /ID# 161569
Busan, Busan Gwang Yeogsi, 49241
Yeungnam University Medical Center /ID# 150432
Daegu, 42415
Duplicate_Hanyang University Gurihospital /ID# 150431
Guri-si, Gyeonggido, 11923
Duplicate_CHA University Bundang Medical Center /ID# 161567
Seongnam, Gyeonggido, 13496
Kangbuk Samsung Hospital /ID# 150435
Seoul, Seoul Teugbyeolsi, 03181
Asan Medical Center /ID# 159155
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 150433
Seoul, Seoul Teugbyeolsi, 06351
Yonsei University Health System Severance Hospital /ID# 161566
Seoul, 03722
The Catholic University Of Korea St. Vincent's Hospital /ID# 150434
Suwon, Gyeonggido, 16247
Spain10 sites
Complejo Hospitalario Universitario A Coruña /ID# 203912
A Coruña, A Coruna, 15006
Hospital Clinic de Barcelona /ID# 150598
Barcelona, 08036
Duplicate_Hospital Universitario Reina Sofia /ID# 154031
Córdoba, 14004
Hospital Universitario Dr. Negrin /ID# 203965
Las Palmas de Gran Canaria, Las Palmas, 35019
Hospital Universitario Ramon y Cajal /ID# 171491
Madrid, 28034
Hospital Universitario La Paz /ID# 214541
Madrid, 28046
Hospital Universitario de Salamanca /ID# 150590
Salamanca, 37711
Hospital Universitario Marques de Valdecilla /ID# 216621
Santander, Cantabria, 39008
Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 171492
Santiago de Compostela, A Coruna, 15706
Hospital Universitario y Politecnico La Fe /ID# 150591
Valencia, 46026
Ukraine10 sites
Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207731
Dnipro, 49005
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206941
Kharkiv, Kharkiv Oblast, 61058
PE PMC Acinus, Medical and Diagnostic Center /ID# 217219
Kropyvnytskyi, 25006
Kyiv City Clinical Hospital No.18 /ID# 150505
Kyiv, 01030
Medical Center of LLC "Medical Center "Consilium Medical" /ID# 217448
Kyiv, 04050
CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217374
Kyiv, 04073
Lviv Regional Clinical Hospital /ID# 150508
Lviv, Lviv Oblast, 79010
Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 162502
Odesa, Odesa Oblast, 65025
Medical Center of the “Health /ID# 162501
Vinnytsia, Vinnytsia Oblast, 21009
MNE Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216302
Vinnytsia, Vinnytsia Oblast, 21018
Croatia8 sites
Duplicate_Poliklinika Solmed /ID# 211567
Grad Zagreb, City of Zagreb, 10000
Duplicate_Klinicki bolnicki centar Osijek /ID# 150229
Osijek, County of Osijek-Baranja, 31000
Klinicki bolnicki centar Rijeka /ID# 150714
Rijeka, Primorje-Gorski Kotar County, 51000
Klinicki Bolnicki Centar (KBC) Split /ID# 213989
Split, Split-Dalmatia County, 21000
Zadar General Hospital /ID# 150261
Zadar, 23000
Klinicka bolnica Dubrava Zagreb /ID# 150228
Zagreb, City of Zagreb, 10000
Klinicki bolnicki centar Zagreb /ID# 150262
Zagreb, City of Zagreb, 10000
Klinicki bolnicki centar Zagreb /ID# 150715
Zagreb, City of Zagreb, 10000
Portugal8 sites
Duplicate_Hospital Garcia de Orta, EPE /ID# 151622
Almada, Setúbal District, 2805-267
2CA-Braga, Hospital de Braga /ID# 151617
Braga, 4710-243
Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151616
Guimarães, Braga District, 4835-044
Duplicate_Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Cap /ID# 151620
Lisbon, 1169-050
Unidade Local de Saude de Santa Maria, EPE /ID# 151615
Lisbon, 1649-035
Unidade Local de Saude Sao Joao, EPE /ID# 151619
Porto, 4200-319
Centro Hospitalar de Entre Douro e Vouga /ID# 152336
Santa Maria DA Feira, Porto District, 4520-211
Unidade Local de Saude do Alto Minho, EPE /ID# 151618
Viana do Castelo, 4904-858
Serbia8 sites
Clinical Hosp Center Zvezdara /ID# 150641
Belgrade, Beograd, 11000
Military Medical Academy /ID# 150643
Belgrade, Beograd, 11000
University Clinical Center Serbia /ID# 150642
Belgrade, Beograd, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 150640
Belgrade, Beograd, 11080
University Clinical Center Kragujevac /ID# 150644
Kragujevac, Sumadijski Okrug, 34000
General Hospital Leskovac /ID# 217882
Leskovac, Jablanicki Okrug, 16000
Duplicate_University Clinical Center of Nis /ID# 151902
Niš, Nisavski Okrug, 18000
University Clinical Center Vojvodina /ID# 150759
Novi Sad, 21000
South Africa8 sites
MD Search /ID# 157524
Boksburg North, Gauteng, 1460
Kingsbury Hospital /ID# 150587
Cape Town, Western Cape, 7708
Private Practice Dr MN Rajabally /ID# 155145
Cape Town, Western Cape, 7800
Spoke Research Inc /ID# 162203
CAPE TOWN Milnerton, Western Cape, 7441
Clinresco Centers /ID# 163625
Johannesburg, Gauteng, 1619
Lenasia Clinical Trial Centre /ID# 214361
Johannesburg, Gauteng, 1820
Wits Clinical Research /ID# 150586
Johannesburg, Gauteng, 1864
Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 157730
Johannesburg, Gauteng, 2193
United Kingdom8 sites
Hampshire Hospitals NHS Foundation Trust /ID# 150511
Basingstoke, Essex, RG24 9NA
Duplicate_Royal United Hospitals Bath /ID# 154211
Bath, Bath And North East Somerset, BA1 3NG
University Hospitals Birmingham NHS Foundation Trust /ID# 150513
Birmingham, B15 2TH
Royal Devon & Exeter Hospital /ID# 150510
Exeter, Devon, EX2 5DW
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 163788
Glasgow, Lanarkshire, G51 4TF
Calderdale and Huddersfield NHS Foundation Trust /ID# 217659
Huddersfield, HX3 0PW
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 150515
London, Greater London, E1 2ES
Duplicate_St George's University Hospitals NHS Foundation Trust /ID# 208376
London, Greater London, SW17 0QT
Brazil7 sites
Upeclin Fmb - Unesp /Id# 152493
Botucatu, São Paulo, 18618-686
Hospital Nossa Senhora das Graças /ID# 152488
Curitiba, Paraná, 80810-040
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153744
Goiânia, Goiás, 74535-170
Hospital de Clinicas de Porto Alegre /ID# 153745
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 152492
Ribeirão Preto, São Paulo, 14049-900
Faculdade de Medicina do ABC /ID# 152489
Santo André, La Spezia, 09060-870
Kaiser Clinica e Hospital Dia /ID# 152491
São José do Rio Preto, São Paulo, 15015-110
Czechia7 sites
Hepato-Gastroenterologie HK, s.r.o. /ID# 150946
Hradec Králové, 500 12
CTCenter MaVe s.r.o. /ID# 150903
Olomouc, 779 00
ARTROSCAN s.r.o. /ID# 150502
Ostrava, 722 00
Nemocnice Pardubickeho kraje, a.s. /ID# 213541
Pardubice, 530 03
Iscare Klinické Centrum /ID# 209279
Prague, Praha 9, 190 00
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216224
Prague, 118 33
Axon Clinical, s.r.o. /ID# 152477
Prague, 140 00
Greece7 sites
General Hospital of Athens Laiko /ID# 208672
Athens, Attica, 11527
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202101
Athens, Attica, 11527
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150406
Athens, 10676
University General Hospital of Heraklion PA.G.N.I /ID# 150236
Heraklion, Crete, 71500
University General Hospital of Ioannina /ID# 164247
Ioannina, 45500
Theageneio Anticancer Hospital /ID# 164187
Thessaloniki, 54639
General Hospital of Thessaloniki Hippokrateio /ID# 209522
Thessaloniki, 54642
Poland7 sites
Endoskopia Sp. z o.o. /ID# 152940
Sopot, Pomeranian Voivodeship, 81-756
Gastromed Sp. z o.o /ID# 216198
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Centrum Zdrowia MDM /ID# 150626
Warsaw, Masovian Voivodeship, 00-189
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 150627
Warsaw, Masovian Voivodeship, 02-507
Centrum Medyczne Reuma Park /ID# 150624
Warsaw, Masovian Voivodeship, 02-665
Vivamed Sp. z o.o. /ID# 216743
Warsaw, Masovian Voivodeship, 03-580
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215733
Warsaw, Masovian Voivodeship, 04-730
Argentina6 sites
Hospital Britanico de Buenos Aires /ID# 209496
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280
Gedyt /ID# 210016
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115
Mautalen Salud e Investigacion /ID# 171174
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1128
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 164186
Córdoba, 5016
Cardio Alem /ID# 211281
San Isidro, Buenos Aires, 1642
Sanatorio 9 de Julio /ID# 150215
San Miguel de Tucumán, Tucumán Province, 4000
Australia6 sites
Monash Health - Monash Medical Centre /ID# 150218
Clayton, Victoria, 3168
St Vincent's Hospital Melbourne /ID# 152503
Fitzroy Melbourne, Victoria, 3065
Macquarie University Hospital /ID# 211953
Macquarie University, New South Wales, 2109
Fiona Stanley Hospital /ID# 211641
Murdoch, Western Australia, 6150
Mater Misericordiae Limited /ID# 212686
South Brisbane, Queensland, 4101
Griffith University /ID# 211954
Southport, Queensland, 4222
Chile6 sites
Hospital Guillermo Grant Benavente de Concepción /ID# 212425
Concepción, Biobio, 4070038
CTR Estudios Clinicos /ID# 200111
Providencia, Region Metropolitana Santiago, 7500571
M y F Estudios Clínicos /ID# 200112
Santiago, Region Metropolitana Santiago, 7750495
Research Group /ID# 203177
Santiago, Santiago Metropolitan, 2540364
Hospital Clinico Universidad De Los Andes /ID# 207427
Santiago, 7501504
Centro de Investigaciones Clínicas Viña del Mar /ID# 150226
Viña del Mar, Valparaiso, 2540488
France6 sites
Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 165749
La Roche-sur-Yon, Vendee, 85925
CHRU Lille - Hopital Claude Huriez /ID# 152609
Lille, Nord, 59037
CHU Montpellier - Hopital Saint Eloi /ID# 200088
Montpellier, Herault, 34295
Chu de Nice-Hopital Larchet Ii /Id# 152608
Nice, Alpes-Maritimes, 06202
HCL - Hopital Lyon Sud /ID# 152540
Pierre-Bénite, Rhone, 69495
CHU de Saint-Etienne, Hopital Nord /ID# 165756
Saint-Etienne, 42270
Hungary6 sites
Bekes Megyei Kozponti Korhaz /ID# 151601
Békéscsaba, 5600
Semmelweis Egyetem /ID# 150409
Budapest, 1085
Meditres Kft. /ID# 151597
Kecskemét, Bács-Kiskun county, 6000
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151599
Sopron, 9400
Mentahaz Maganorvosi Kozpont /ID# 206977
Székesfehérvár, 8000
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 150410
Szombathely, Vas County, 9700
Slovakia6 sites
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150869
Banská Bystrica, Banská Bystrica Region, 975 17
Medak s.r.o. /ID# 150550
Bratislava, 851 01
Slovak Research Center Team Me /ID# 150240
Ilava, 019 01
B+B MED, s.r.o. /ID# 150584
Košice, Košice Region, 040 01
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211371
Nové Zámky, Nitra Region, 940 34
Gastro I., s.r.o. /ID# 150585
Prešov, Presov, 080 01
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150606
Kaohsiung City, 807
Duplicate_Chung Shan Medical University Hospital /ID# 150603
Taichung, 40201
China Medical University Hospital /ID# 150600
Taichung, 40447
National Cheng Kung University Hospital /ID# 151751
Tainan, 704
Taipei Veterans General Hosp /ID# 151750
Taipei, 11217
National Taiwan University Hospital /ID# 150604
Taipei City, Taipei, 100
Turkey (Türkiye)6 sites
Istanbul University Cerrahpasa Faculty of Medicine /ID# 150491
Cerrahpaşa, 34098
Umraniye Training and Res Hosp /ID# 163136
Istanbul, 34764
Marmara University Medical Fac /ID# 214573
Istanbul, 34899
Duplicate_Erciyes University Medical Fac /ID# 150495
Melikgazi, Kayseri, 38030
Mersin University Medical /ID# 163135
Mersin, 33343
Gazi Universitesi Tip Fakultes /ID# 150493
Yenimahalle, Ankara, 06560
Bosnia and Herzegovina5 sites
Duplicate_University Clinical Centre of the Republic of Srpska /ID# 150223
Banja Luka, Republika Srpska, 78000
Duplicate_University Clinical Centre of the Republic of Srpska /ID# 150712
Banja Luka, Republika Srpska, 78000
University Clinical Hospital Mostar /ID# 150711
Mostar, 88000
Clinical Center University of Sarajevo /ID# 150222
Sarajevo, 71000
University Clinical Center Tuzla /ID# 150224
Tuzla, Tuzlanski, 75000
Finland5 sites
Duplicate_Helsinki Univ Central Hospital /ID# 154283
Helsinki, 00290
Keski-Suomen Sairaala Nova /ID# 155665
Jyväskylä, 40620
Laakarikeskus Ikioma /ID# 150377
Mikkeli, 50100
Tampereen yliopistollinen sairaala /ID# 150376
Tampere, Pirkanmaa, 33520
Turku University Hospital /ID# 169895
Turku, Southwest Finland, 20520
Ireland5 sites
Mercy University Hospital /ID# 153794
Cork, T12 WE28
St James Hospital /ID# 150413
Dublin, Dublin, D08 NHY1
Beaumont Hospital /ID# 150414
Dublin, D09 XR63
St Vincents University Hospital /ID# 150411
Elm Park, Dublin, D04 T6F4
University Hospital Galway /ID# 150412
Galway, H91 YR71
Netherlands5 sites
Amsterdam UMC, locatie AMC /ID# 150617
Amsterdam, North Holland, 1105 AZ
Leids Universitair Medisch Centrum /ID# 152625
Leiden, South Holland, 2333 ZA
Radboud Universitair Medisch Centrum /ID# 151701
Nijmegen, Gelderland, 6525 GA
Duplicate_Erasmus Medisch Centrum /ID# 150619
Rotterdam, South Holland, 3015 GD
Universitair Medisch Centrum Utrecht /ID# 152776
Utrecht, 3584 CX
Austria4 sites
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150462
Linz, Upper Austria, 4010
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 150463
Salzburg, 5020
Klinik Landstrasse /ID# 162867
Vienna, State of Vienna, 1030
Medizinische Universitaet Wien /ID# 150616
Vienna, State of Vienna, 1090
Estonia4 sites
North Estonia Medical Centre /ID# 160871
Mustamäe, Harju, 13419
West Tallinn Central Hospital /ID# 150490
Tallinn, Harju, 10617
East Tallinn Central Hospital - Magdaleena Unit /ID# 150488
Tallinn, Harju, 11312
Tartu University Hospital /ID# 150489
Tartu, 50406
Israel4 sites
Soroka University Medical Center /ID# 156562
Beersheba, Southern District, 8410101
Rambam Health Care Campus /ID# 150416
Haifa, 3109601
Shaare Zedek Medical Center /ID# 163139
Jerusalem, Jerusalem, 91031
Hadassah Medical Center-Hebrew University /ID# 165119
Jerusalem, Jerusalem, 91120
Lithuania4 sites
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150439
Kaunas, 50161
Klaipeda university hospital /ID# 163501
Klaipėda, 92288
Klaipeda University Hospital /ID# 163719
Klaipėda, 92288
Duplicate_Vilnius University Hospital /ID# 164172
Vilnius, LT-08661
Malaysia4 sites
Hospital Sultanah Bahiyah /ID# 152310
Alor Star, Kedah, 05460
Hospital Ampang /ID# 152311
Ampang, Selangor, 68000
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 152313
Kuala Lumpur, Selangor, 56000
Uni Malaya MC /ID# 150440
Kuala Lumpur, 59100
Switzerland4 sites
University Hospital Basel /ID# 161732
Basel Town, Canton of Basel-City, 4031
Inselspital, Universitaetsspital Bern /ID# 152602
Bern, 3010
Kantonsspital St. Gallen /ID# 152601
Sankt Gallen, Canton of St. Gallen, 9007
University Hospital Zurich /ID# 152603
Zurich, Canton of Zurich, 8091
Belgium3 sites
AZ Maria Middelares /ID# 150466
Ghent, 9000
Universitair Ziekenhuis Leuven /ID# 150468
Leuven, Vlaams-Brabant, 3000
AZ-Delta /ID# 150467
Roeselare, West-Vlaanderen, 8800
Colombia3 sites
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 152811
Bogota DC, Cundinamarca, 111221
Hospital Universitario de San /ID# 155388
Medellín, Antioquia
Imat Oncomedica /ID# 207052
Montería, Departamento de Córdoba, 230018
Mexico3 sites
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 202334
Guadalajara, Jalisco, 44650
Morales Vargas Centro de Investigacion S.C. /ID# 211327
León, Guanajuato, 37000
Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150265
Monterrey, Nuevo León, 64610
Singapore3 sites
National University Hospital /ID# 150583
Singapore, 119074
Gleneagles Medical Centre /ID# 206020
Singapore, 258499
Tan Tock Seng Hospital /ID# 150646
Singapore, 308433
Latvia2 sites
VCA Polyclinic Aura /ID# 150436
Riga, 1035
Pauls Stradins Clinical University Hospital /ID# 153183
Riga, LV-1002
Norway2 sites
Akershus Universitetssykehus_MAIN /ID# 150622
Lorenskog, Akershus, 1478
Universitetssykehuset I Nord-Norge /ID# 152836
Tromsø, Troms, 9019
Puerto Rico1 site
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150629
San Juan, 00935
Sweden1 site
Duplicate_Sahlgrenska University Hospital /ID# 152326
Gothenburg, Västra Götaland County, 413 45
About this study
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
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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Upadacitinib (ABT-494), Placebo
- Keywords
- Ulcerative Colitis (UC), Upadacitinib (ABT-494), Long Term Extension (LTE), Safety, Efficacy, RINVOQ
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib (ABT-494)Drug
Also called RINVOQ
Upadacitinib (ABT-494) will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Upadacitinib (ABT-494) Dose A | Experimental | The participants in this arm will receive Upadacitinib (ABT-494) dose A. Receives: Drug: Upadacitinib (ABT-494) |
| Participants receiving Upadacitinib (ABT-494) Dose B | Experimental | The participants in this arm will receive Upadacitinib (ABT-494) dose B. Receives: Drug: Upadacitinib (ABT-494) |
| Participants receiving Upadacitinib (ABT-494) Dose A or Dose B | Experimental | The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B. Receives: Drug: Upadacitinib (ABT-494) |
| Participants receiving Placebo | Experimental | The participants in this arm will receive placebo until study is unblinded. Receives: Drug: Placebo |
| Participants receiving Upadacitinib (ABT-494) Dose C | Experimental | The participants in this arm will receive Upadacitinib (ABT-494) dose C. Receives: Drug: Upadacitinib (ABT-494) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Treatment-Emergent Adverse Events
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.
Measured: Up to 288 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006068
- Sponsor's protocol ID
- M14-533
- Other IDs
- 2023-505699-31-00, 2023
- Acronym
- U-ACTIVATE
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2016
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Publications
Panaccione R, Panes J, Peyrin-Biroulet L, Colombel JF, Lindsay JO, Baert F, Atreya R, Vermeire S, Fujii T, Dubcenco E, Klaff J, Duncan B, Suravaram S, Fish I, Lacerda AP, Vladea R, Ford S, Shah S, Anyanwu SI, Rubin DT. Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies. Clin Gastroenterol Hepatol. 2026 Feb 27:S1542-3565(26)00145-X. doi: 10.1016/j.cgh.2026.02.018. Online ahead of print.
PubMed 41763462Panaccione R, Vermeire S, Danese S, Higgins PDR, Lichtenstein GR, Nakase H, Glover S, Colombel JF, Eccleston J, Kujawski M, Remple V, Yao X, Geng Z, Palac H, Sharma D, Suravaram S, Schreiber S. Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):507-519. doi: 10.1016/S2468-1253(25)00017-2.
PubMed 40347957
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03006068
- Acronym / sponsor ID
- U-ACTIVATE / M14-533
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis (UC), Upadacitinib (ABT-494), Long Term Extension (LTE), Safety, Efficacy, RINVOQ
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Upadacitinib (ABT-494) Dose A | Experimental | Drug: Upadacitinib (ABT-494)The participants in this arm will receive Upadacitinib (ABT-494) dose A. |
| Participants receiving Upadacitinib (ABT-494) Dose B | Experimental | Drug: Upadacitinib (ABT-494)The participants in this arm will receive Upadacitinib (ABT-494) dose B. |
| Participants receiving Upadacitinib (ABT-494) Dose A or Dose B | Experimental | Drug: Upadacitinib (ABT-494)The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B. |
| Participants receiving Placebo | Experimental | Drug: PlaceboThe participants in this arm will receive placebo until study is unblinded. |
| Participants receiving Upadacitinib (ABT-494) Dose C | Experimental | Drug: Upadacitinib (ABT-494)The participants in this arm will receive Upadacitinib (ABT-494) dose C. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.
- If female, participant must meet the contraception criteria.
- 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).
Key exclusion criteria (8 listed)
- 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.
- Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE) during the preceding studies, that in the investigator's judgment makes the participant unsuitable for this study.
- 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 tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upadacitinib (ABT-494)Also: RINVOQUpadacitinib (ABT-494) will be administered orally. | Drug | Participants receiving Upadacitinib (ABT-494) Dose A, Participants receiving Upadacitinib (ABT-494) Dose A or Dose B, Participants receiving Upadacitinib (ABT-494) Dose B, Participants receiving Upadacitinib (ABT-494) Dose C |
| PlaceboPlacebo will be administered orally. | Drug | Participants receiving Placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 41763462Panaccione R, Panes J, Peyrin-Biroulet L, Colombel JF, Lindsay JO, Baert F, Atreya R, Vermeire S, Fujii T, Dubcenco E, Klaff J, Duncan B, Suravaram S, Fish I, Lacerda AP, Vladea R, Ford S, Shah S, Anyanwu SI, Rubin DT. Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies. Clin Gastroenterol Hepatol. 2026 Feb 27:S1542-3565(26)00145-X. doi: 10.1016/j.cgh.2026.02.018. Online ahead of print.
- Derived from this study: PubMed 40347957Panaccione R, Vermeire S, Danese S, Higgins PDR, Lichtenstein GR, Nakase H, Glover S, Colombel JF, Eccleston J, Kujawski M, Remple V, Yao X, Geng Z, Palac H, Sharma D, Suravaram S, Schreiber S. Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):507-519. doi: 10.1016/S2468-1253(25)00017-2.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
492 sites in 46 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Upadacitinib (ABT-494) in people with Ulcerative Colitis (UC), run by AbbVie at 492 sites in 46 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 492 sites in United States, Japan, Canada, China, Germany and 41 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Treatment-Emergent Adverse Events (time frame: Up to 288 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.