Trial record 4 of 31 for:
Upadacitinib
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03653026 |
|
Recruitment Status :
Recruiting
First Posted : August 31, 2018
Last Update Posted : February 5, 2019
|
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
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- No Results Posted
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- How to Read a Study Record
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of Upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis (UC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis (UC) | Drug: Upadacitinib (ABT-494) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 462 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis |
| Actual Study Start Date : | October 29, 2018 |
| Estimated Primary Completion Date : | February 23, 2022 |
| Estimated Study Completion Date : | February 23, 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
| Experimental: Upadacitinib |
Drug: Upadacitinib (ABT-494)
Upadacitinib will be orally administered |
| Experimental: Placebo |
Drug: Placebo
Placebo will be orally administered |
Primary Outcome Measures :
- Proportion of participants who achieve clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]It is defined as Stool Frequency Subscore (SFS) <=1 and not greater than baseline, Rectal Bleeding Subscore (RBS) of 0 and endoscopic subscore <=1.
Secondary Outcome Measures :
- Proportion of participants with endoscopic improvement [ Time Frame: At Week 8 ]Endoscopic improvement is defined as an endoscopic subscore <=1.
- Proportion of participants with endoscopic remission [ Time Frame: At Week 8 ]Endoscopic remission is defined as an endoscopic subscore =0.
- Proportion of participants achieving clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]Clinical response per Adapted Mayo is defined as a decrease from baseline in the Adapted Mayo score >= 2 points and >= 30% from baseline, PLUS a decrease in RBS >= 1 or an absolute RBS <= 1.
- Proportion of participants achieving clinical response per Partial Adapted Mayo score [ Time Frame: At Week 2 ]It is defined as a decrease in the partial adapted mayo score >= 1 points and >= 30% from Baseline, PLUS a decrease in RBS>=1 or an absolute RBS<=1.
- Proportion of participants who reported no bowel urgency [ Time Frame: At Week 8 ]Bowel urgency is monitored electronically via a handheld device.
- Proportion of participants who reported no abdominal pain [ Time Frame: At Week 8 ]Abdominal pain information will be collected electronically via a handheld device.
- Proportion of participants who achieved histologic improvement [ Time Frame: At Week 8 ]It is defined as decrease from Baseline in Geboes score
- Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 8 ]It is defined as the increase of IBDQ bowel symptom domain score >=6
- Proportion of participants with mucosal healing [ Time Frame: At Week 8 ]It is defined as the endoscopic and histologic remission
- Proportion of participants with UC-related hospitalizations [ Time Frame: Through Week 8 ]Participants with an US related event that results in admission to the hospital will be assessed.
- Proportion of participants with UC-related surgeries [ Time Frame: Through Week 8 ]Participants who underwent surgery related to UC will be assessed.
- Proportion of participants achieving response in IBDQ fatigue item [ Time Frame: At Week 8 ]It is defined as the increase of IBDQ fatigue item score >=1
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Ulcerative Colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
- Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
- Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
- Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
- If female, participant must meet the contraception recommendation criteria.
Exclusion Criteria:
- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Participant with disease limited to the rectum during the Screening endoscopy.
- Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
- Participant who received azathioprine or 6-mercaptipurine (6-MP) within 10 days of Baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- Screening laboratory and other analyses show any prespecified abnormal hematologic results.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653026
Contacts
| Contact: ABBVIE CALL CENTER | 847.283.8955 | abbvieclinicaltrials@abbvie.com |
Hide Study Locations
Locations
| United States, Alabama | |
| CB Flock Research Corporation /ID# 206094 | Recruiting |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Delsol Research Management, Ll /Id# 208889 | Not yet recruiting |
| Chandler, Arizona, United States, 85224 | |
| AZ Arthritis and Rheum Researc /ID# 211030 | Not yet recruiting |
| Phoenix, Arizona, United States, 85032-9306 | |
| University of Arizona /ID# 208856 | Not yet recruiting |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Citrus Valley Gastroenterology /ID# 205627 | Not yet recruiting |
| Covina, California, United States, 91722-3797 | |
| Ucsd /Id# 204919 | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| United Gastroenterologists /ID# 207867 | Not yet recruiting |
| Los Alamitos, California, United States, 90720-3309 | |
| Gastrointestinal Biosciences /ID# 205314 | Not yet recruiting |
| Los Angeles, California, United States, 90067-2001 | |
| Facey Medical Foundation /ID# 205301 | Not yet recruiting |
| Mission Hills, California, United States, 91345 | |
| United Gastroenterologists - Murrieta /ID# 205313 | Not yet recruiting |
| Murrieta, California, United States, 92563 | |
| UC Irvine /ID# 205315 | Not yet recruiting |
| Orange, California, United States, 92868 | |
| Ventura County Gastroenterology /ID# 205628 | Not yet recruiting |
| Oxnard, California, United States, 93030 | |
| Medical Assoc Research Grp /ID# 205626 | Recruiting |
| San Diego, California, United States, 92123 | |
| University of California, San /ID# 205070 | Not yet recruiting |
| San Francisco, California, United States, 94143-0633 | |
| United States, Colorado | |
| Delta Waves, Inc. /ID# 206170 | Not yet recruiting |
| Colorado Springs, Colorado, United States, 80918 | |
| Western States Clinical Res /ID# 206091 | Not yet recruiting |
| Wheat Ridge, Colorado, United States, 80033-2896 | |
| United States, Connecticut | |
| Western Connecticut Medical Group /ID# 208290 | Not yet recruiting |
| Danbury, Connecticut, United States, 06810-6000 | |
| United States, Florida | |
| Gastro Florida /ID# 206174 | Not yet recruiting |
| Clearwater, Florida, United States, 33756 | |
| Palmetto Research, LLC /ID# 208293 | Not yet recruiting |
| Hialeah, Florida, United States, 33016 | |
| Nature Coast Clinical Research /ID# 206087 | Recruiting |
| Inverness, Florida, United States, 34452 | |
| Borland-Groover Clinic /ID# 208128 | Not yet recruiting |
| Jacksonville, Florida, United States, 32258 | |
| Ctr for Advanced Gastroenterol /ID# 207995 | Not yet recruiting |
| Maitland, Florida, United States, 32751-6108 | |
| Coral Research Clinic /ID# 208292 | Not yet recruiting |
| Miami, Florida, United States, 33186-4643 | |
| Advanced Research Institute /ID# 206077 | Not yet recruiting |
| New Port Richey, Florida, United States, 34653 | |
| Endoscopic Research, Inc. /ID# 207360 | Not yet recruiting |
| Orlando, Florida, United States, 32803 | |
| Omega Research Consultants /ID# 206066 | Not yet recruiting |
| Orlando, Florida, United States, 32810 | |
| Clinical Research Trials of Florida, Inc. /ID# 206068 | Not yet recruiting |
| Tampa, Florida, United States, 33607 | |
| Florida Hospital Tampa /ID# 207363 | Not yet recruiting |
| Tampa, Florida, United States, 33613-4680 | |
| United States, Georgia | |
| Atlanta Gastroenterology Spec /ID# 206173 | Not yet recruiting |
| Suwanee, Georgia, United States, 30024 | |
| United States, Illinois | |
| Northwestern Medical Group - Saint Clair /ID# 206084 | Not yet recruiting |
| Chicago, Illinois, United States, 60611-5975 | |
| Rush University Medical Center /ID# 206158 | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago /ID# 206172 | Not yet recruiting |
| Chicago, Illinois, United States, 60637-1443 | |
| Carle Foundation Hospital /ID# 207397 | Not yet recruiting |
| Effingham, Illinois, United States, 62401 | |
| United States, Indiana | |
| MediSphere Medical Research Center /ID# 206073 | Not yet recruiting |
| Evansville, Indiana, United States, 47714-8011 | |
| Indianapolis Gastroenterology /ID# 206381 | Not yet recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Iowa | |
| University of Iowa Hospitals /ID# 206167 | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Tri-State Gastroenterology /ID# 206124 | Not yet recruiting |
| Crestview Hills, Kentucky, United States, 41017 | |
| United States, Louisiana | |
| Houma Digestive Health Special /ID# 206176 | Not yet recruiting |
| Houma, Louisiana, United States, 70360 | |
| Nola Research Works, LLC /ID# 206089 | Not yet recruiting |
| New Orleans, Louisiana, United States, 70115 | |
| Louisiana Research Ctr. LLC /ID# 206064 | Not yet recruiting |
| Shreveport, Louisiana, United States, 71105-6800 | |
| United States, Maryland | |
| Gastro Center of Maryland /ID# 206883 | Not yet recruiting |
| Columbia, Maryland, United States, 21045 | |
| United States, Michigan | |
| University of Michigan Hospitals /ID# 206918 | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109-5008 | |
| Huron Gastroenterology Assoc /ID# 205109 | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48197 | |
| Caro Health Plaza /ID# 208048 | Not yet recruiting |
| Caro, Michigan, United States, 48723-9686 | |
| Clin Res Inst of Michigan, LLC /ID# 207078 | Not yet recruiting |
| Chesterfield, Michigan, United States, 48047 | |
| Revival Research Institute, LLC /ID# 207282 | Not yet recruiting |
| Southfield, Michigan, United States, 48034-1659 | |
| United States, Minnesota | |
| Minneapolis VA Medical Center /ID# 206104 | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Mississippi | |
| Southern Therapy and Advanced Research (STAR) LLC /ID# 206069 | Not yet recruiting |
| Jackson, Mississippi, United States, 39216 | |
| United States, Nevada | |
| Las Vegas Medical Research /ID# 206814 | Not yet recruiting |
| Las Vegas, Nevada, United States, 89113 | |
| United States, New Jersey | |
| AGA Clinical Research Associates, LLC /ID# 206880 | Recruiting |
| Egg Harbor Township, New Jersey, United States, 08234 | |
| Atlantic Digestive Health Inst /ID# 208748 | Not yet recruiting |
| Morristown, New Jersey, United States, 07960 | |
| Rutgers Robert Wood Johnson /ID# 207382 | Not yet recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Advantage Clinical Trials /ID# 206082 | Not yet recruiting |
| Bronx, New York, United States, 10468 | |
| NY Scientific /ID# 206080 | Recruiting |
| Brooklyn, New York, United States, 11235 | |
| NYU Langone Long Island CRA /ID# 206079 | Not yet recruiting |
| Great Neck, New York, United States, 11021 | |
| DiGiovanna Institute for Medic /ID# 206885 | Not yet recruiting |
| North Massapequa, New York, United States, 11758 | |
| Premier Medical Group /ID# 206097 | Not yet recruiting |
| Poughkeepsie, New York, United States, 12601 | |
| Gastro Group of Rochester /ID# 206881 | Not yet recruiting |
| Rochester, New York, United States, 14618-5703 | |
| United States, North Carolina | |
| Digestive Health Partners, P.A /ID# 206842 | Not yet recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Carolinas Medical Center /ID# 206085 | Not yet recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Wake Forest Baptist Medical Center /ID# 206067 | Not yet recruiting |
| Winston-Salem, North Carolina, United States, 27157-0001 | |
| United States, North Dakota | |
| Plains Clinical Research Center, LLC /ID# 205111 | Not yet recruiting |
| Fargo, North Dakota, United States, 58104 | |
| United States, Ohio | |
| University of Cincinnati /ID# 205633 | Not yet recruiting |
| Cincinnati, Ohio, United States, 45267-0585 | |
| The Ohio State University - Columbus /ID# 205637 | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Optimed Research, Ltd. /ID# 205638 | Not yet recruiting |
| Columbus, Ohio, United States, 43235 | |
| Hometown Urgent Care and Resea /ID# 205630 | Not yet recruiting |
| Dayton, Ohio, United States, 45424 | |
| Dayton Gastroenterology, Inc. /ID# 205639 | Not yet recruiting |
| Englewood, Ohio, United States, 45415 | |
| Great Lakes Gastroenterology Research LLC /ID# 205631 | Recruiting |
| Mentor, Ohio, United States, 44060-6211 | |
| United States, Oklahoma | |
| Digestive Disease Specialists /ID# 206076 | Not yet recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Options Health Research, LLC /ID# 206707 | Not yet recruiting |
| Tulsa, Oklahoma, United States, 74104 | |
| Healthcare Research Consultant /ID# 206706 | Not yet recruiting |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Pennsylvania | |
| Guthrie Medical Group, PC /ID# 206078 | Not yet recruiting |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, South Carolina | |
| Pharmacorp Clinical Trials /ID# 206074 | Not yet recruiting |
| Charleston, South Carolina, United States, 29412 | |
| Greenville Endoscopy Center /ID# 206098 | Not yet recruiting |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Gastro One /ID# 206178 | Not yet recruiting |
| Germantown, Tennessee, United States, 38138 | |
| East Tennessee Research Instit /ID# 206169 | Not yet recruiting |
| Johnson City, Tennessee, United States, 37604 | |
| Quality Medical Research, PLLC /ID# 206088 | Not yet recruiting |
| Nashville, Tennessee, United States, 37211 | |
| United States, Texas | |
| TX Clinical Research Institute /ID# 206718 | Not yet recruiting |
| Arlington, Texas, United States, 76012 | |
| Inquest Clinical Research /ID# 206132 | Not yet recruiting |
| Baytown, Texas, United States, 77521 | |
| Texas Digestive Disease Consultants /ID# 209805 | Not yet recruiting |
| Cedar Park, Texas, United States, 78613-5028 | |
| Texas Digestive Disease Consultants /ID# 209948 | Not yet recruiting |
| Cedar Park, Texas, United States, 78613-5028 | |
| Baylor Scott & White Research /ID# 207484 | Not yet recruiting |
| Dallas, Texas, United States, 75246 | |
| DHAT Research Institute /ID# 206716 | Not yet recruiting |
| Garland, Texas, United States, 75044-2208 | |
| CliniCore International, LLC /ID# 206065 | Not yet recruiting |
| Houston, Texas, United States, 77027-6812 | |
| Baylor College of Medicine /ID# 206717 | Not yet recruiting |
| Houston, Texas, United States, 77030-3411 | |
| Houston Methodist Hospital /ID# 207659 | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Centex Studies, Inc. - Houston /ID# 206168 | Not yet recruiting |
| Houston, Texas, United States, 77058 | |
| GI Specialists of Houston /ID# 206090 | Not yet recruiting |
| Houston, Texas, United States, 77070-4347 | |
| Clinical Associates in Researc /ID# 206710 | Not yet recruiting |
| San Antonio, Texas, United States, 78212 | |
| Sagact Pllc /Id# 205379 | Not yet recruiting |
| San Antonio, Texas, United States, 78229 | |
| Baylor Scott & White Health /ID# 206096 | Not yet recruiting |
| Temple, Texas, United States, 76508 | |
| Tyler Research Institue /ID# 206075 | Recruiting |
| Tyler, Texas, United States, 75701 | |
| Victoria gastroenterology /ID# 205378 | Not yet recruiting |
| Victoria, Texas, United States, 77904 | |
| United States, Utah | |
| HP Clinical Research /ID# 208890 | Not yet recruiting |
| Bountiful, Utah, United States, 84010 | |
| Advanced Research Institute /ID# 206133 | Not yet recruiting |
| Ogden, Utah, United States, 84403 | |
| United States, Virginia | |
| Ctr for Gastrointestinal Healt /ID# 208475 | Not yet recruiting |
| Franklin, Virginia, United States, 23851 | |
| United States, Washington | |
| Washington Gastroenterology /ID# 206177 | Not yet recruiting |
| Bellevue, Washington, United States, 98004 | |
| Virginia Mason Medical Center /ID# 206070 | Not yet recruiting |
| Seattle, Washington, United States, 98101 | |
| United States, Wisconsin | |
| WI Center for Advanced Res /ID# 206917 | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Froedtert and Medical College /ID# 206945 | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226-3522 | |
| Argentina | |
| Mautalen Salud e Investigacion /ID# 206033 | Not yet recruiting |
| Buenos Aires, Argentina, 1128 | |
| Hospital Britanico de Bs As /ID# 209497 | Not yet recruiting |
| Caba, Argentina, 1280 | |
| Instituto Medico DAMIC /ID# 206470 | Not yet recruiting |
| Cordoba, Argentina, X5003DCE | |
| Hospital Privado Univesitario /ID# 206030 | Not yet recruiting |
| Cordoba, Argentina, X5016 | |
| Instituto Medico CER /ID# 206032 | Not yet recruiting |
| Quilmes, Argentina, 1878 | |
| Sanatorio 9 de Julio S.A. /ID# 206469 | Not yet recruiting |
| San Miguel de Tucuman, Argentina, 4000 | |
| Australia, Victoria | |
| St. Vincents Hosp Melbourne /ID# 205758 | Not yet recruiting |
| Fitzroy, Victoria, Australia, 3065 | |
| Monash Medical Centre /ID# 206486 | Not yet recruiting |
| Melbourne, Victoria, Australia, 3168 | |
| Austria | |
| Krankenanstalt Rudolfstiftung /ID# 205764 | Not yet recruiting |
| Vienna, Wien, Austria, 1030 | |
| Medical University of Vienna /ID# 205763 | Not yet recruiting |
| Vienna, Wien, Austria, 1090 | |
| Belarus | |
| Vitebsk Regional Advanced Clin /ID# 208321 | Not yet recruiting |
| Vitebsk, Belarus, 210001 | |
| Belgium | |
| UZ Leuven /ID# 205988 | Not yet recruiting |
| Leuven, Belgium, 3000 | |
| AZ-Delta /ID# 205989 | Not yet recruiting |
| Roeselare, Belgium, 8800 | |
| Bosnia and Herzegovina | |
| University Clinical Centre of the Republic of Srpska /ID# 208053 | Not yet recruiting |
| Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000 | |
| University Clinical Centre of the Republic of Srpska /ID# 208055 | Not yet recruiting |
| Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000 | |
| University Clinical Center Tuzla /ID# 208057 | Not yet recruiting |
| Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000 | |
| University Clinical Hospital Mostar /ID# 208054 | Not yet recruiting |
| Mostar, Bosnia and Herzegovina, 88000 | |
| Clinical Center University of Sarajevo /ID# 208058 | Not yet recruiting |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Brazil | |
| Instituto Goiano de Gastroenterologia /ID# 206983 | Not yet recruiting |
| Goiânia, Goias, Brazil, 74535-170 | |
| Hospital Nossa Senhora das Graças /ID# 206981 | Not yet recruiting |
| Curitiba, Parana, Brazil, 80810-040 | |
| Hospital de Clinicas de Porto Alegre /ID# 206985 | Not yet recruiting |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903 | |
| Upeclin Fmb - Unesp /Id# 206986 | Not yet recruiting |
| Botucatu, Sao Paulo, Brazil, 18618-686 | |
| Faculdade de Medicina do ABC /ID# 206984 | Not yet recruiting |
| Santo André, Sao Paulo, Brazil, 09060-870 | |
| Kaiser Clinica e Hospital Dia /ID# 206982 | Not yet recruiting |
| Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110 | |
| Canada, Alberta | |
| University of Calgary /ID# 205755 | Not yet recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Zeidler Ledcor Centre /ID# 207383 | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 2X8 | |
| Covenant Health /ID# 205500 | Not yet recruiting |
| Edmonton, Alberta, Canada, T6L 6K3 | |
| Canada, British Columbia | |
| Percuro Clinical Research, Ltd /ID# 205501 | Not yet recruiting |
| Victoria, British Columbia, Canada, V8V 3M9 | |
| Canada, Ontario | |
| Toronto Digestive Disease Asso /ID# 205498 | Not yet recruiting |
| Vaughan, Ontario, Canada, L4L 4Y7 | |
| Canada, Quebec | |
| Crchum /Id# 207387 | Not yet recruiting |
| Montreal, Quebec, Canada, H2X 0A9 | |
| CRCHUS Hotel-Dieu /ID# 205499 | Not yet recruiting |
| Sherbrooke, Quebec, Canada, J1G 2E8 | |
| Chile | |
| Research Group Ltda /ID# 208037 | Not yet recruiting |
| Santiago, Region Metropolitana De Santiago, Chile, 2540364 | |
| Hospital Clinico Universidad /ID# 209979 | Not yet recruiting |
| Santiago, Region Metropolitana De Santiago, Chile, 8380456 | |
| M y F Estudios Clínicos Ltda. /ID# 208035 | Not yet recruiting |
| Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495 | |
| Centro de Investigaciones Clínicas Viña del Mar /ID# 208038 | Not yet recruiting |
| Viña del Mar, Valparaíso, Chile, 2540488 | |
| CTR Estudios SpA /ID# 208036 | Not yet recruiting |
| Providencia, Chile, 7500571 | |
| Hospital Clinico Universidad De Los Andes /ID# 207426 | Not yet recruiting |
| Santiago, Chile, 7501504 | |
| China, Anhui | |
| The First Affiliated Hosp, Sun /ID# 205267 | Not yet recruiting |
| Guangzhou, Anhui, China, 510080 | |
| The Sixth Affiliated Hosp, Sun /ID# 205268 | Not yet recruiting |
| Guangzhou, Anhui, China, 510655 | |
| Shanghai Tenth People's Hosp /ID# 211033 | Not yet recruiting |
| Shanghai, Anhui, China, 200072 | |
| Renji Hosp, Shanghai Jiaotong /ID# 205269 | Not yet recruiting |
| Shanghai, Anhui, China, 200127 | |
| China, Jilin | |
| The First Hosp of Jilin Univ /ID# 210088 | Not yet recruiting |
| Changchun, Jilin, China, 130021 | |
| China, Shanghai | |
| Ruijin Hospital, Shanghai Jiaotong /ID# 205333 | Not yet recruiting |
| Shanghai, Shanghai, China, 200025 | |
| China, Zhejiang | |
| The second affiliated hospital of Zhejiang University school of medicine /ID# 205271 | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310009 | |
| Sir Run Run Shaw Hospital /ID# 205270 | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310016 | |
| China | |
| Xiangya Hosp Central South Uni /ID# 205245 | Not yet recruiting |
| Changsha, China, 410008 | |
| West China Hospital, Sichuan University /ID# 205332 | Not yet recruiting |
| Chengdu, China, 610041 | |
| Shengjing Hospital of China Medical University /ID# 205244 | Not yet recruiting |
| Shenyang, China, 110004 | |
| Tianjin Med Univ General Hosp /ID# 205246 | Not yet recruiting |
| Tianjin, China, 300052 | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266 | Not yet recruiting |
| Wuhan, China, 430022 | |
| Tongji Hosp Tongji Med College /ID# 205265 | Not yet recruiting |
| Wuhan, China, 430030 | |
| Colombia | |
| Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 208886 | Not yet recruiting |
| Bogota DC, Cundinamarca, Colombia, 11411 | |
| Instituto de Coloproctologia /ID# 208885 | Not yet recruiting |
| Antioquia, Colombia | |
| Hospital Univ San Ignacio /ID# 209160 | Not yet recruiting |
| Bogota, Colombia, 110231 | |
| Hospital Universitario San Vic /ID# 208888 | Not yet recruiting |
| Medellin, Colombia, 50010 | |
| Inst Med Alta Tec Onc (IMAT) /ID# 208887 | Not yet recruiting |
| Montería, Colombia, 230002 | |
| Croatia | |
| Klinicka bolnica Dubrava Zagreb /ID# 208460 | Not yet recruiting |
| Zagreb, Grad Zagreb, Croatia, 10000 | |
| Klinicki bolnicki centar Zagreb /ID# 207904 | Not yet recruiting |
| Zagreb, Grad Zagreb, Croatia, 10000 | |
| Klinicki bolnicki centar Zagreb /ID# 207906 | Not yet recruiting |
| Zagreb, Grad Zagreb, Croatia, 10000 | |
| Klinicki bolnicki centar Osijek /ID# 207903 | Not yet recruiting |
| Osijek, Osjecko-baranjska Zupanija, Croatia, 31000 | |
| Klinicki bolnicki centar Rijeka /ID# 208650 | Not yet recruiting |
| Rijeka, Primorsko-goranska Zupanija, Croatia, 51000 | |
| Zadar General Hospital /ID# 207905 | Not yet recruiting |
| Zadar, Croatia, 23000 | |
| Czechia | |
| CTCenter MaVe, s.r.o. /ID# 205671 | Not yet recruiting |
| Olomouc, Olomoucky Kraj, Czechia, 779 00 | |
| Axon Clinical, s.r.o. /ID# 205670 | Not yet recruiting |
| Praha, Praha 5, Czechia, 150 00 | |
| Hepato-Gastroenterologie HK s.r.o. /ID# 205672 | Not yet recruiting |
| Hradec Kralove, Czechia, 500 12 | |
| Artroscan s.r.o. /ID# 205668 | Not yet recruiting |
| Ostrava, Czechia, 722 00 | |
| ISCARE I.V.F. a.s. /ID# 209240 | Not yet recruiting |
| Prague, Czechia, 170 00 | |
| Estonia | |
| East Tallinn Central Hospital /ID# 207564 | Not yet recruiting |
| Tallinn, Estonia, 10138 | |
| West Tallinn Central Hospital /ID# 207356 | Not yet recruiting |
| Tallinn, Estonia, 10617 | |
| North Estonian Medical Centre /ID# 207357 | Not yet recruiting |
| Tallinn, Estonia, 13419 | |
| Finland | |
| Tampere University Hospital /ID# 206161 | Not yet recruiting |
| Tampere, Pirkanmaa, Finland, 33520 | |
| Keski-Suomen Keskussairaala /ID# 206159 | Not yet recruiting |
| Jyvaskyla, Finland, 40620 | |
| Laakarikeskus Ikioma /ID# 205814 | Not yet recruiting |
| Mikkeli, Finland, 50100 | |
| Tyks /Id# 205813 | Not yet recruiting |
| Turku, Finland, 20521 | |
| France | |
| Chu de Nice-Hopital L'Archet Ii /Id# 209118 | Not yet recruiting |
| Nice CEDEX 3, Alpes-Maritimes, France, 06202 | |
| CHRU Lille - Hôpital Claude Huriez /ID# 209125 | Not yet recruiting |
| Lille CEDEX, Hauts-de-France, France, 59045 | |
| CHU de SAINT ETIENNE - Hopital Nord /ID# 209123 | Not yet recruiting |
| St. Priest En Jarez, Loire, France, 42270 | |
| CHU NANCY - Hôpital Brabois Adultes /ID# 209120 | Not yet recruiting |
| Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511 | |
| Centre Hospitalier Lyon Sud /ID# 209121 | Not yet recruiting |
| Pierre Benite CEDEX, Rhone, France, 69495 | |
| CHD Vendee /ID# 209122 | Not yet recruiting |
| La Roche Sur Yon, France, 85000 | |
| CHU de Montpellier - Hôpital S /ID# 209127 | Not yet recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Germany | |
| Universitatsklinikum Mannheim /ID# 206811 | Not yet recruiting |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| Gastroenterologie am Bayerisch /ID# 206733 | Not yet recruiting |
| Berlin, Germany, 10825 | |
| Agaplesion Markus Krankenhaus /ID# 206731 | Not yet recruiting |
| Frankfurt, Germany, 60341 | |
| Univ Hosp Schleswig-Holstein /ID# 206791 | Not yet recruiting |
| Kiel, Germany, 24105 | |
| Medizinisches Versorgungszentrum Portal 10 /ID# 207137 | Not yet recruiting |
| Munster, Germany, 48155 | |
| Universitatsklinikum Tubingen /ID# 206737 | Not yet recruiting |
| Tuebingen, Germany, 72076 | |
| Greece | |
| General Hospital of Athens Laiko /ID# 208671 | Not yet recruiting |
| Athens, Attiki, Greece, 115 27 | |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332 | Not yet recruiting |
| Athens, Greece, 10676 | |
| University General Hospital of Heraklion "PA.G.N.I" /ID# 207061 | Not yet recruiting |
| Heraklion, Greece, 71110 | |
| "Theageneio" Anticancer Hospital /ID# 206331 | Not yet recruiting |
| Thessaloniki, Greece, 54639 | |
| Genl Hosp Thessaloniki Hipp /ID# 208822 | Not yet recruiting |
| Thessaloniki, Greece, 54642 | |
| Hungary | |
| Markusovszky Egyetemi Oktatókórház /ID# 205881 | Not yet recruiting |
| Szombathely, Vas, Hungary, 9700 | |
| Bekes Megyei Kozponti Korhaz /ID# 205885 | Not yet recruiting |
| Bekescsaba, Hungary, 5600 | |
| Semmelweis Egyetem /ID# 205883 | Not yet recruiting |
| Budapest, Hungary, 1085 | |
| Meditres Kft. /ID# 205886 | Not yet recruiting |
| Kecskemet, Hungary, 6000 | |
| Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992 | Not yet recruiting |
| Sopron, Hungary, 9400 | |
| Mentahaz Maganorvosi Kozpont /ID# 205882 | Not yet recruiting |
| Szekesfehervar, Hungary, 8000 | |
| Ireland | |
| St. James's Hospital /ID# 209649 | Not yet recruiting |
| Dublin 8, Dublin, Ireland, D08 E9P6 | |
| Mercy University Hospital /ID# 206580 | Not yet recruiting |
| Cork, Ireland, T12 WE28 | |
| St Vincent's University Hosp /ID# 209210 | Not yet recruiting |
| Dublin, Ireland, D04 T6F4 | |
| Beaumont Hospital /ID# 206509 | Not yet recruiting |
| Dublin, Ireland, D09 XR63 | |
| Israel | |
| Rambam Health Care Campus /ID# 206362 | Not yet recruiting |
| Haifa, Israel, 3109601 | |
| Shaare Zedek Medical Center /ID# 206365 | Not yet recruiting |
| Jerusalem, Israel, 91031 | |
| Italy | |
| A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351 | Not yet recruiting |
| Bologna, Emilia-Romagna, Italy, 40138 | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 206349 | Not yet recruiting |
| Milan, Lombardia, Italy, 20122 | |
| Istituto Clinico Humanitas /ID# 206346 | Not yet recruiting |
| Rozzano, Milano, Italy, 20089 | |
| Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 206347 | Not yet recruiting |
| Rome, Roma, Italy, 00168 | |
| A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350 | Not yet recruiting |
| Palermo, Sicilia, Italy, 90146 | |
| Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 206354 | Not yet recruiting |
| Negrar, Verona, Italy, 37024 | |
| ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 206348 | Not yet recruiting |
| Milano, Italy, 20121 | |
| Japan | |
| Nagoya University Hospital /ID# 206355 | Not yet recruiting |
| Nagoya-shi, Aichi, Japan, 466-8560 | |
| Nagoya City University Hospital /ID# 206058 | Not yet recruiting |
| Nagoya-shi, Aichi, Japan, 467-8602 | |
| Hirosaki National Hospital /ID# 206387 | Not yet recruiting |
| Hirosaki-shi, Aomori, Japan, 036-8545 | |
| Toho University Sakura Medical Center /ID# 207705 | Not yet recruiting |
| Sakura-shi, Chiba, Japan, 285-8741 | |
| Juntendo University Urayasu Hospital /ID# 208784 | Not yet recruiting |
| Urayasu Shi, Chiba, Japan, 279-0021 | |
| Kurume University Hospital /ID# 206385 | Not yet recruiting |
| Kurume-shi, Fukuoka, Japan, 830-0011 | |
| Ogaki Municipal Hospital /ID# 208227 | Not yet recruiting |
| Ogaki-shi, Gifu, Japan, 503-8502 | |
| NHO Fukuyama Medical Center /ID# 206295 | Not yet recruiting |
| Fukuyama-shi, Hiroshima, Japan, 720-8520 | |
| Asahikawa Medical University Hospital /ID# 206404 | Not yet recruiting |
| Asahikawa-shi, Hokkaido, Japan, 078-8510 | |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059 | Not yet recruiting |
| Sapporo-shi, Hokkaido, Japan, 060-0033 | |
| Sapporo Medical Univ Hosp /ID# 206314 | Not yet recruiting |
| Sapporo-shi, Hokkaido, Japan, 060-8543 | |
| Sapporo Tokushukai Hospital /ID# 209448 | Not yet recruiting |
| Sapporo, Hokkaido, Japan, 004-0041 | |
| Aoyama Clinic /ID# 206452 | Not yet recruiting |
| Kobe, Hyogo, Japan, 650-0015 | |
| The Hospital of Hyogo College of Medicine /ID# 206455 | Not yet recruiting |
| Nishinomiya-shi, Hyogo, Japan, 663-8501 | |
| Kanazawa University Ho /ID# 206316 | Not yet recruiting |
| Kanazawa, Ishikawa, Japan, 92086-41 | |
| Iwate Medical University Hospital /ID# 207051 | Not yet recruiting |
| Morioka-shi, Iwate, Japan, 020-8505 | |
| Idzuro Imamura Hospital /ID# 207639 | Not yet recruiting |
| Kagishimashi, Kagoshima, Japan, 8920824 | |
| Mie University Hospital /ID# 206803 | Not yet recruiting |
| Tsu-shi, Mie, Japan, 514-8507 | |
| National Hospital Organization Sendai Medical Center /ID# 209528 | Not yet recruiting |
| Sendai-shi, Miyagi, Japan, 983-0045 | |
| Ishida Clinic of IBD and Gastroenterology /ID# 210119 | Not yet recruiting |
| Oita-shi, Oita, Japan, 870-0823 | |
| Japanese Red Cross Osaka Hospi /ID# 209478 | Not yet recruiting |
| Osaka-shi, Osaka, Japan, 543-8555 | |
| Osaka City University Hospital /ID# 206457 | Not yet recruiting |
| Osaka-shi, Osaka, Japan, 545-0051 | |
| Saitama Medical Center, Saitama Medical University /ID# 206393 | Not yet recruiting |
| Kawagoe-shi, Saitama, Japan, 350-8550 | |
| Tokito Clinic /ID# 206313 | Recruiting |
| Saitama-shi, Saitama, Japan, 336-0963 | |
| Hamamatsu University Hospital /ID# 206459 | Not yet recruiting |
| Higashi-ku, Shizuoka, Japan, 431-3192 | |
| Medical Hospital of Tokyo Medical and Dental University /ID# 206453 | Not yet recruiting |
| Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| St.Luke's International Hospital /ID# 208076 | Not yet recruiting |
| Chuo-ku, Tokyo, Japan, 104-8560 | |
| Tokai University Hachioji Hospital /ID# 208903 | Not yet recruiting |
| Hachioji, Tokyo, Japan, 192-0032 | |
| Teikyo University Hospital /ID# 209866 | Not yet recruiting |
| Itabashi-ku, Tokyo, Japan, 173-8605 | |
| Kyorin University Hospital /ID# 206356 | Not yet recruiting |
| Mitaka-shi, Tokyo, Japan, 181-8611 | |
| Tokyo Women's Medical University Hospital /ID# 206460 | Not yet recruiting |
| Shinjuku-ku, Tokyo, Japan, 162-8666 | |
| Yamagata University Hospital /ID# 206465 | Recruiting |
| Yamagata-shi, Yamagata, Japan, 990-9585 | |
| Fukui Prefectural Hospital /ID# 210449 | Not yet recruiting |
| Fukui, Japan, 910-0846 | |
| Saiseikai Fukuoka General Hosp /ID# 209482 | Not yet recruiting |
| Fukuoka, Japan, 810-0001 | |
| NHO Higashi-Ohmi Gen Med Ctr /ID# 210710 | Not yet recruiting |
| Higashiomi, Japan | |
| Hiroshima University Hospital /ID# 206464 | Not yet recruiting |
| Hiroshima, Japan, 734-8551 | |
| Shimane University School of Medicine /ID# 208905 | Not yet recruiting |
| Izumo, Japan, 693-0021 | |
| Sameshima Hospital /ID# 207935 | Not yet recruiting |
| Kagoshima, Japan | |
| Tsujinaka Hospital Kashiwanoha /ID# 209573 | Not yet recruiting |
| Kashiwa, Japan | |
| St. Marianna Univ Hospital /ID# 209451 | Not yet recruiting |
| Kawasaki, Japan, 216-8511 | |
| Chikuba Hospital /ID# 206646 | Not yet recruiting |
| Kurashiki, Japan, 710-0142 | |
| Saiseikai Niigata Daini Hosp /ID# 209921 | Not yet recruiting |
| Niigata, Japan, 950-1104 | |
| Obihiro-Kosei General Hospital /ID# 210424 | Not yet recruiting |
| Obihiro, Japan, 080-0016 | |
| NHO Nagasaki Medical Center /ID# 210822 | Not yet recruiting |
| Omura-shi, Japan, 856-8562 | |
| Kitano Hospital /ID# 210397 | Not yet recruiting |
| Osaka, Japan, 530-8480 | |
| Kinshukai Infusion Clinic /ID# 207865 | Not yet recruiting |
| Osaka, Japan | |
| Kyoto University Hospital /ID# 206500 | Not yet recruiting |
| Sakyo-ku, Japan, 606-8507 | |
| Sapporo Higashi Tokushukai /ID# 208494 | Not yet recruiting |
| Sapporo, Japan, 065-0033 | |
| NHO Shizuoka Medical Center /ID# 208785 | Not yet recruiting |
| Shimizu-sho, Japan | |
| Center hospital of the National Center for Global Health and Medicine /ID# 209532 | Not yet recruiting |
| Tokyo, Japan, 162-8655 | |
| Toyohashi Municipal Hospital /ID# 207625 | Not yet recruiting |
| Toyohashi, Japan, 441-8570 | |
| Ieda Hospital /ID# 207479 | Not yet recruiting |
| Toyota-shi, Japan, 470-1219 | |
| Kenseikai Dongo Hospital /ID# 208101 | Not yet recruiting |
| Yamatotakada, Japan, 635-0022 | |
| Showa Univ Fujigaoka Hosp /ID# 208224 | Not yet recruiting |
| Yokohama-shi, Japan, 227-0043 | |
| Korea, Republic of | |
| Dong-A University Hospital /ID# 206955 | Not yet recruiting |
| Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201 | |
| Pusan National University Hosp /ID# 206956 | Not yet recruiting |
| Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739 | |
| Yeungnam University Med Ctr /ID# 206959 | Not yet recruiting |
| Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415 | |
| Kangbuk Samsung Hospital /ID# 206960 | Not yet recruiting |
| Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181 | |
| CHA Bundang Medical Center /ID# 207432 | Not yet recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496 | |
| Severance Hospital /ID# 206958 | Not yet recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Latvia | |
| Riga East Clinical Univ Hosp /ID# 206828 | Not yet recruiting |
| Riga, Latvia, 1038 | |
| P. Stradins Clinical Univ Hosp /ID# 206827 | Not yet recruiting |
| Riga, Latvia, LV-1002 | |
| Lithuania | |
| Hosp Lithuanian Univ Health Sc /ID# 209052 | Not yet recruiting |
| Kovno, Kaunas, Lithuania, 50009 | |
| Klaipeda University Hospital /ID# 208790 | Not yet recruiting |
| Klaipeda, Lithuania, 92288 | |
| Klaipeda Seamens Hospital /ID# 208791 | Not yet recruiting |
| Klaipeda, Lithuania, LT-92288 | |
| Vilnius University Hospital /ID# 209051 | Not yet recruiting |
| Vilnius, Lithuania, LT-08661 | |
| Malaysia | |
| UKM Medical Centre /ID# 207662 | Not yet recruiting |
| Kuala Lumpur, Selangor, Malaysia, 56000 | |
| Uni Malaya MC /ID# 208936 | Not yet recruiting |
| Kuala Lumpur, Malaysia, 59100 | |
| Mexico | |
| Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067 | Not yet recruiting |
| Monterrey, Nuevo Leon, Mexico, 64610 | |
| CIRO - CLIN de Reum y Obesidad /ID# 208068 | Not yet recruiting |
| Guadalajara Jalisco, Mexico, CP 44650 | |
| Issste /Id# 208066 | Not yet recruiting |
| Guadalajara, Jalisco, Mexico, 44600 | |
| Netherlands | |
| Erasmus Medisch Centrum /ID# 205280 | Not yet recruiting |
| Rotterdam, Netherlands, 3015 CE | |
| Norway | |
| Akershus Universitetssykehus_MAIN /ID# 205293 | Not yet recruiting |
| Lorenskog, Akershus, Norway, 1478 | |
| Universitetssykehuset Nord-Norge /ID# 205691 | Not yet recruiting |
| Tromsø, Troms, Norway, 9019 | |
| Poland | |
| Centrum Zdrowia MDM /ID# 205874 | Not yet recruiting |
| Warszawa, Mazowieckie, Poland, 00-635 | |
| Portugal | |
| Hospital Senhora da Oliveira de Guimarães, EPE /ID# 205554 | Not yet recruiting |
| Guimarães, Braga, Portugal, 4835-044 | |
| Hospital Garcia de Orta, E.P.E /ID# 206143 | Not yet recruiting |
| Almada, Setubal, Portugal, 2805-267 | |
| Hospital de Braga /ID# 206144 | Not yet recruiting |
| Braga, Portugal, 4710-423 | |
| Centro Hospitalar Lisboa Norte, EPE /ID# 206117 | Not yet recruiting |
| Lisboa, Portugal, 1649-035 | |
| Hospital Santo Antonio dos Cap /ID# 206145 | Not yet recruiting |
| Lisbon, Portugal, 1150-069 | |
| Centro Hospitalar de Sao Joao /ID# 206142 | Not yet recruiting |
| Porto, Portugal, 4200-319 | |
| Centro Hospitalar de Entre o D /ID# 205563 | Not yet recruiting |
| Santa Maria Da Feira, Portugal, 4520-211 | |
| Unidade Local De Saude Do Alto Minho /ID# 205556 | Not yet recruiting |
| Viana Do Castelo, Portugal, 4901-858 | |
| Romania | |
| Institutul Clinic Fundeni /ID# 206011 | Not yet recruiting |
| Bucharest, Romania, 22328 | |
| Institutul Clinic Fundeni /ID# 206012 | Not yet recruiting |
| Bucharest, Romania, 22328 | |
| Cabinet Particular Policlinic Algomed /ID# 206010 | Not yet recruiting |
| Timisoara, Romania, 300002 | |
| Russian Federation | |
| Immanuel Kant Baltic Federal University /ID# 208264 | Not yet recruiting |
| Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016 | |
| NW State Medical Univ na Mechn /ID# 208258 | Not yet recruiting |
| St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015 | |
| LLC Medical Company Hepatolog /ID# 208261 | Not yet recruiting |
| Samara, Samarskaya Oblast, Russian Federation, 443063 | |
| LLC Uromed /ID# 208257 | Not yet recruiting |
| Smolensk, Smolenskaya Oblast, Russian Federation, 214031 | |
| Kazan State Medical University /ID# 208256 | Not yet recruiting |
| Kazan, Tatarstan, Respublika, Russian Federation, 420012 | |
| P.A. Bayandin Murmansk Regiona /ID# 208259 | Not yet recruiting |
| Murmansk, Russian Federation, 183047 | |
| Republican Clin Hos n.a. Baran /ID# 206507 | Not yet recruiting |
| Petrozavodsk, Russian Federation, 185019 | |
| PMI Euromedservice /ID# 208265 | Not yet recruiting |
| Pushkin, Russian Federation, 196603 | |
| LLC Novaya Clinica /ID# 208260 | Not yet recruiting |
| Pyatigorsk, Russian Federation, 357532 | |
| Serbia | |
| Clinical Center Serbia /ID# 205256 | Not yet recruiting |
| Belgrade, Beograd, Serbia, 11000 | |
| Clinical Hosp Center Zvezdara /ID# 205258 | Not yet recruiting |
| Belgrade, Beograd, Serbia, 11000 | |
| Military Medical Academy /ID# 205257 | Not yet recruiting |
| Belgrade, Beograd, Serbia, 11000 | |
| Clin Hosp Ctr Bezanijska Kosa /ID# 206413 | Not yet recruiting |
| Belgrade, Beograd, Serbia, 11080 | |
| Clinical Center of Nis /ID# 206411 | Not yet recruiting |
| NIS, Nisavski Okrug, Serbia, 18000 | |
| Clinical Center Kragujevac /ID# 206410 | Not yet recruiting |
| Kragujevac, Sumadijski Okrug, Serbia, 34000 | |
| Clinical Center Vojvodina /ID# 205259 | Not yet recruiting |
| Novi Sad, Vojvodina, Serbia, 21000 | |
| Singapore | |
| National University Hospital /ID# 209099 | Not yet recruiting |
| Singapore, Singapore, 119074 | |
| Gleneagles Medical Centre /ID# 206954 | Not yet recruiting |
| Singapore, Singapore, 258499 | |
| Tan Tock Seng Hospital /ID# 207663 | Not yet recruiting |
| Singapore, Singapore, 308433 | |
| Slovakia | |
| Medak s.r.o., gastroenterologi /ID# 205191 | Not yet recruiting |
| Bratislava, Bratislavsky Kraj, Slovakia, 851 01 | |
| FN s poliklinikou F.D. Rooseve /ID# 205147 | Not yet recruiting |
| Banska Bystrica, Slovakia, 97517 | |
| B and B MED s.r.o. /ID# 205213 | Not yet recruiting |
| Kosice, Slovakia, 040 01 | |
| Gastro I.S.R.O. /ID# 205148 | Not yet recruiting |
| Presov, Slovakia, 08001 | |
| South Africa | |
| Clinresco Centres /ID# 208083 | Not yet recruiting |
| Johannesburg, Gauteng, South Africa, 1619 | |
| Chris Hani Baragwanath Hosp /ID# 208082 | Not yet recruiting |
| Johannesburg, Gauteng, South Africa, 1864 | |
| Wits Clinical Research Site /ID# 208949 | Not yet recruiting |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Mediclinic Milnerton /ID# 207979 | Not yet recruiting |
| CAPE TOWN,Milnerton, Western Cape, South Africa, 7441 | |
| Kingsbury Hospital /ID# 205281 | Not yet recruiting |
| Cape Town, Western Cape, South Africa, 7708 | |
| Spain | |
| Comple Hospi Univ de Santiago /ID# 204411 | Not yet recruiting |
| Santiago de Compostela, A Coruna, Spain, 15706 | |
| Comple Hosp Univ de A Coruna /ID# 206907 | Not yet recruiting |
| A Coruna, Spain, 15006 | |
| Hospital Clinico y Provincial Barcelona /ID# 206906 | Not yet recruiting |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Reina S /ID# 204412 | Not yet recruiting |
| Cordoba, Spain, 14004 | |
| Hospital Univ Dr. Negrin /ID# 206905 | Not yet recruiting |
| Las Palmas de Gran Canaria, Spain, 35010 | |
| Hospital Univ Ramon y Cajal /ID# 204410 | Not yet recruiting |
| Madrid, Spain, 28034 | |
| Complejo Asistencial de Salama /ID# 205013 | Not yet recruiting |
| Salamanca, Spain, 37007 | |
| Hospital Universitario La Fe /ID# 206904 | Not yet recruiting |
| Valencia, Spain, 46026 | |
| Sweden | |
| Sahlgrenska US Gbg /ID# 205294 | Not yet recruiting |
| Göteborg, Vastra Gotalands Lan, Sweden, 413 46 | |
| Taiwan | |
| China Medical University Hosp /ID# 207845 | Not yet recruiting |
| Taichung City, Taichung, Taiwan, 40447 | |
| National Taiwan University Hospital /ID# 207847 | Not yet recruiting |
| Taipei City, Taipei, Taiwan, 100 | |
| Kaohsiung Medical University /ID# 207848 | Not yet recruiting |
| Kaohsiung, Taiwan, 80708 | |
| Taipei Veterans General Hosp /ID# 207849 | Not yet recruiting |
| Taipei City, Taiwan, 11217 | |
| Turkey | |
| Erciyes University Medical Fac /ID# 207506 | Not yet recruiting |
| Melikgazi, Kayseri, Turkey, 38030 | |
| Gazi University Med. Faculty /ID# 208040 | Not yet recruiting |
| Ankara GAZI, Turkey, 06500 | |
| Istanbul University Cerrahpasa Medical Faculty /ID# 207507 | Not yet recruiting |
| Istanbul, Turkey, 34098 | |
| Umraniye Training and Res Hosp /ID# 208206 | Not yet recruiting |
| Istanbul, Turkey, 34764 | |
| Mersin University Medical /ID# 208039 | Not yet recruiting |
| Mersin, Turkey, 33343 | |
| Ukraine | |
| Regional Clinical Hospital - Center for Emergency Medical Care and Disaster Med /ID# 206939 | Not yet recruiting |
| Kharkiv, Kharkivska Oblast, Ukraine, 61204 | |
| Medical Center of the "Health /ID# 206743 | Not yet recruiting |
| Vinnytsya, Vinnytska Oblast, Ukraine, 21009 | |
| Regional Clin Hosp Mechnykov /ID# 207725 | Not yet recruiting |
| Dnipropetrovsk, Ukraine, 49005 | |
| United Kingdom | |
| RD&E Hospital /ID# 206750 | Not yet recruiting |
| Exeter, Devon, United Kingdom, EX2 5DW | |
| Basingstoke & North Hampshire /ID# 207985 | Not yet recruiting |
| Basingstoke, United Kingdom, RG24 9NA | |
| Royal United Hospitals Bath /ID# 207095 | Not yet recruiting |
| Bath, United Kingdom, BA1 3NG | |
| Univ Hospitals Birmingham NHS Foundation trust /ID# 206536 | Not yet recruiting |
| Birmingham, United Kingdom, B15 2TG | |
| Queen Elizabeth University Hos /ID# 205154 | Not yet recruiting |
| Glasgow, United Kingdom, G514TF | |
| St. George's Healthcare NHS /ID# 208375 | Not yet recruiting |
| London, United Kingdom, SW17 0QT | |
| Barts and the London NHS Trust /ID# 205153 | Not yet recruiting |
| Whitechapel, United Kingdom, E1 1 BB | |
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03653026 History of Changes |
| Other Study ID Numbers: |
M14-675 2016-000642-62 ( EudraCT Number ) |
| First Posted: | August 31, 2018 Key Record Dates |
| Last Update Posted: | February 5, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
| URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by AbbVie:
|
Upadacitinib ABT-494 Ulcerative Colitis |
Additional relevant MeSH terms:
|
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |