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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

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: NCT03345836
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

Condition or disease Intervention/treatment Phase
Crohn's Disease Other: Matching placebo for upadacitinib Drug: upadacitinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 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 of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : February 14, 2021
Estimated Study Completion Date : February 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Arm B
Participants will receive placebo for 12 weeks.
Other: Matching placebo for upadacitinib
Tablet

Arm C
Participants will receive open-label upadacitinib dose A for 12 weeks.
Drug: upadacitinib
Tablet
Other Name: ABT-494

Experimental: Arm A
Participants will receive upadacitinib dose A for 12 weeks.
Drug: upadacitinib
Tablet
Other Name: ABT-494




Primary Outcome Measures :
  1. Proportion of participants with clinical remission [ Time Frame: Week 12 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Proportion of participants with endoscopic response [ Time Frame: Week 12 ]
    Endoscopic response is defined as decrease in SES-CD from Baseline.


Secondary Outcome Measures :
  1. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: From Week 0 to Week 12 ]
    The FACIT-F questionnaire was developed to assess fatigue.

  2. Proportion of participants with enhanced clinical response [ Time Frame: Week 2 ]
    Enhanced Clinical Response defined as decrease in average daily SF and/or decrease in average daily AP score.

  3. Proportion of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: At Week 12 ]
    IBDQ bowel symptom domain response is defined as the increase of IBDQ bowel symptom domain score >= 8

  4. Proportion of participants with hospitalizations due to CD [ Time Frame: Week 12 ]
    This is assessed during 12 week double-blind induction period by reviewing participant's hospitalization data.

  5. Proportion of participants with clinical remission [ Time Frame: Week 4 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  6. Proportion of participants with clinical remission per Crohn's Disease Activity Index (CDAI) remission in participants with a Baseline CDAI of 220 to 450 [ Time Frame: Week 12 ]
    CDAI remission is defined as CDAI < 150.

  7. Proportion of participants with endoscopic remission [ Time Frame: Week 12 ]
    Endoscopic remission is defined per SES-CD.

  8. Proportion of participants with >= 50% reduction in draining fistulas [ Time Frame: Week 12 ]
    This is assessed in participants with draining fistulas at Baseline.

  9. Change from Baseline in Crohn's Symptoms Severity Questionnaire (CSS) [ Time Frame: From Week 0 to Week 12 ]
    The CSS is a self-administered questionnaire that consists of questions about how the participants felt in regards to their Crohn's disease.

  10. Proportion of participants who discontinue corticosteroid use for Crohn's disease (CD) and achieve clinical remission [ Time Frame: Week 12 ]
    This is assessed in participants taking corticosteroids at Baseline.



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.


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

Inclusion Criteria:

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
  • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
  • Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
  • Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
  • Participant with ostomy or ileoanal pouch
  • Participant diagnosed with short gut or short bowel syndrome
  • Screening laboratory and other analyses show abnormal results.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345836


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Alabama
Alabama Medical Group, PC /ID# 171133 Recruiting
Mobile, Alabama, United States, 36608-1787
CB Flock Research Corporation /ID# 166220 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Delsol Research Management, Ll /Id# 170179 Recruiting
Chandler, Arizona, United States, 85224
HonorHealth Research Institute - Shea /ID# 164734 Recruiting
Scottsdale, Arizona, United States, 85258
Arizona Arthritis & Rheumatolo /ID# 203891 Recruiting
Sun City, Arizona, United States, 85032
United States, California
Citrus Valley Gastroenterology /ID# 166201 Recruiting
Covina, California, United States, 91722-3797
United Gastroenterologists /ID# 207452 Recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 164887 Recruiting
Los Angeles, California, United States, 90067-2001
Facey Medical Foundation /ID# 203137 Recruiting
Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 164845 Recruiting
Murrieta, California, United States, 92563
Ucsd /Id# 164679 Recruiting
San Diego, California, United States, 92103
Medical Assoc Research Grp /ID# 169705 Recruiting
San Diego, California, United States, 92123
UCSF Center for Colitis and Crohn's Disease /ID# 202373 Recruiting
San Francisco, California, United States, 94115-3011
Univ of California San Francis /ID# 164843 Not yet recruiting
San Francisco, California, United States, 94158
Care Access Research /ID# 167766 Completed
San Pablo, California, United States, 94806
United States, Colorado
Peak Gastroenterology Associat /ID# 170181 Recruiting
Colorado Springs, Colorado, United States, 80907
Delta Waves, Inc. /ID# 164872 Recruiting
Colorado Springs, Colorado, United States, 80918
Western States Clinical Research, Inc. /ID# 164895 Recruiting
Wheat Ridge, Colorado, United States, 80033-2896
United States, Connecticut
Medical Research Ctr CT /ID# 164829 Recruiting
Hamden, Connecticut, United States, 06518
United States, Florida
Clinical Res of West FL, Inc. /ID# 205825 Recruiting
Clearwater, Florida, United States, 33765
Clinical Res of West FL, Inc. /ID# 208117 Recruiting
Clearwater, Florida, United States, 33765
Borland-Groover Clinic /ID# 203498 Recruiting
Jacksonville, Florida, United States, 32258
Ctr for Advanced Gastroenterol /ID# 165332 Recruiting
Maitland, Florida, United States, 32751-6108
Crystal Pharmacology Research /ID# 166101 Completed
Miami, Florida, United States, 33165
Coral Research Clinic /ID# 164657 Recruiting
Miami, Florida, United States, 33186-4643
Advanced Research Institute /ID# 164814 Recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 205893 Recruiting
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 203480 Recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 203484 Recruiting
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 171175 Recruiting
Tampa, Florida, United States, 33613-4680
United States, Georgia
Gastro Assoc of Central GA /ID# 165460 Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Spec /ID# 164780 Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 165320 Not yet recruiting
Chicago, Illinois, United States, 60611-2927
Rush University Medical Center /ID# 165485 Not yet recruiting
Chicago, Illinois, United States, 60612
University of Chicago /ID# 165472 Recruiting
Chicago, Illinois, United States, 60637
DuPage Medical Group /ID# 205303 Recruiting
Downers Grove, Illinois, United States, 60515-5509
United States, Indiana
MediSphere Medical Research Center /ID# 166209 Recruiting
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 164837 Recruiting
Indianapolis, Indiana, United States, 46237
Aquiant Research /ID# 205504 Not yet recruiting
New Albany, Indiana, United States, 47150-4053
United States, Iowa
University of Iowa Hospitals and Clinics /ID# 165330 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Tri-State Gastroenterology /ID# 165484 Recruiting
Crestview Hills, Kentucky, United States, 41017
University of Louisville /ID# 168536 Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville /ID# 208093 Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
CroNOLA, LLC /ID# 164722 Recruiting
Houma, Louisiana, United States, 70360
Nola Research Works, LLC /ID# 164897 Recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 164659 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
Johns Hopkins University School of Medicine /ID# 211940 Not yet recruiting
Baltimore, Maryland, United States, 21287-0010
MGG Group, Inc.Chevy Chase Clinical Research /ID# 164835 Recruiting
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland /ID# 171171 Recruiting
Columbia, Maryland, United States, 21045
United States, Massachusetts
Lahey Hospital and Medical Center /ID# 214725 Not yet recruiting
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan Hospitals /ID# 164844 Recruiting
Ann Arbor, Michigan, United States, 48109
Clin Res Inst of Michigan, LLC /ID# 170178 Recruiting
Chesterfield, Michigan, United States, 48047
Digestive Health Associates (DHA) - Farmington Hills /ID# 206099 Completed
Farmington Hills, Michigan, United States, 48334-3230
Center for Digestive Health /ID# 164733 Recruiting
Troy, Michigan, United States, 48098-6363
United States, Minnesota
Minneapolis VA Medical Center /ID# 204622 Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Mayo Clinic - Rochester /ID# 164868 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
Southern Therapy and Advanced Research (STAR) LLC /ID# 165318 Recruiting
Jackson, Mississippi, United States, 39216
United States, Nebraska
Quality Clinical Research, Inc /ID# 170177 Recruiting
Omaha, Nebraska, United States, 68114
CHI Nebraska d/b/a CHI Health /ID# 168545 Recruiting
Omaha, Nebraska, United States, 68124
United States, Nevada
Comprehensive Digestive Instit /ID# 168562 Recruiting
Las Vegas, Nevada, United States, 89113
United States, New Jersey
AGA Clinical Research Associates, LLC /ID# 164883 Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Rutgers, The State University /ID# 166092 Not yet recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Medical Center /ID# 166226 Recruiting
Bronx, New York, United States, 10461
Advantage Clinical Trials /ID# 168557 Recruiting
Bronx, New York, United States, 10468
NY Scientific /ID# 164833 Recruiting
Brooklyn, New York, United States, 11235
NYU Langone Long Island CRA /ID# 164830 Recruiting
Great Neck, New York, United States, 11021
Weill Cornell Medicine/NYP /ID# 165480 Not yet recruiting
New York, New York, United States, 10021-4872
Icahn School of Med Mt. Sinai /ID# 170172 Recruiting
New York, New York, United States, 10029
Weill Cornell Medicine /ID# 164870 Recruiting
New York, New York, United States, 10032-3725
Gastro Group of Rochester /ID# 166216 Recruiting
Rochester, New York, United States, 14618-5703
Richmond University Medical Center /ID# 201855 Recruiting
Staten Island, New York, United States, 10310-1664
United States, North Carolina
Carolinas Medical Center /ID# 164834 Recruiting
Charlotte, North Carolina, United States, 28203
PMG Research of Charlotte /ID# 171170 Recruiting
Charlotte, North Carolina, United States, 28209
Wake Research Associates, LLC /ID# 164663 Recruiting
Raleigh, North Carolina, United States, 27612
Wake Forest Baptist Medical Center /ID# 201225 Recruiting
Winston-Salem, North Carolina, United States, 27157-0001
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 170184 Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Consultants for Clinical Res /ID# 164855 Recruiting
Cincinnati, Ohio, United States, 45219
University of Cincinnati /ID# 164720 Recruiting
Cincinnati, Ohio, United States, 45267-0585
Cleveland Clinic Main Campus /ID# 208220 Not yet recruiting
Cleveland, Ohio, United States, 44195
Ohio State University/ Gastroe /ID# 170174 Recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 205618 Recruiting
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 201290 Recruiting
Dayton, Ohio, United States, 45424
Dayton Gastroenterology, Inc. /ID# 167624 Recruiting
Englewood, Ohio, United States, 45415
Great Lakes Gastroenterology Research LLC /ID# 202007 Recruiting
Mentor, Ohio, United States, 44060-6211
United States, Oklahoma
Digestive Disease Specialists /ID# 201062 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC /ID# 164737 Recruiting
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultant /ID# 166228 Recruiting
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
University of Pennsylvania /ID# 168402 Recruiting
Philadelphia, Pennsylvania, United States, 19104-5502
Thomas Jefferson University /ID# 168014 Recruiting
Philadelphia, Pennsylvania, United States, 19107-4414
United States, South Carolina
Pharmacorp Clinical Trials /ID# 164809 Recruiting
Charleston, South Carolina, United States, 29412
Gastroenterology Associates, P.A. /ID# 164880 Recruiting
Greenville, South Carolina, United States, 29615-3593
United States, South Dakota
Rapid City Medical Center /ID# 201734 Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Gastro One /ID# 164718 Recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 203612 Recruiting
Johnson City, Tennessee, United States, 37604
Quality Medical Research, PLLC /ID# 205262 Recruiting
Nashville, Tennessee, United States, 37211
Vanderbilt Univ Med Ctr /ID# 164846 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
TX Clinical Research Institute /ID# 164848 Recruiting
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 164865 Recruiting
Baytown, Texas, United States, 77521-2415
Texas Digestive Disease Consultants /ID# 209802 Recruiting
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209952 Recruiting
Cedar Park, Texas, United States, 78613-5028
DHAT Research Institute /ID# 164777 Not yet recruiting
Garland, Texas, United States, 75044-2208
CliniCore International, LLC /ID# 164662 Completed
Houston, Texas, United States, 77027-6812
Baylor College of Medicine /ID# 164847 Recruiting
Houston, Texas, United States, 77030-3411
Centex Studies, Inc. - Houston /ID# 201213 Recruiting
Houston, Texas, United States, 77058
GI Specialists of Houston /ID# 202338 Recruiting
Houston, Texas, United States, 77070-4347
Caprock Gastro Research /ID# 215437 Not yet recruiting
Lubbock, Texas, United States, 79424-3017
Clinical Associates in Researc /ID# 164863 Recruiting
San Antonio, Texas, United States, 78212
Sagact Pllc /Id# 169754 Recruiting
San Antonio, Texas, United States, 78229
Carl R. Meisner Medical Clinic /ID# 201060 Completed
Sugar Land, Texas, United States, 77478
Tyler Research Institute, LLC /ID# 168681 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 167813 Recruiting
Victoria, Texas, United States, 77904
United States, Utah
HP Clinical Research /ID# 164929 Recruiting
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 164866 Recruiting
Ogden, Utah, United States, 84403
Care Access Research /ID# 164853 Completed
Salt Lake City, Utah, United States, 84124-1377
Advanced Clinical Research (ACR) - Salt Lake City /ID# 166095 Recruiting
West Jordan, Utah, United States, 84088
United States, Washington
Washington Gastroenterology /ID# 164721 Recruiting
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 164680 Recruiting
Seattle, Washington, United States, 98101
University of Washington /ID# 164875 Not yet recruiting
Seattle, Washington, United States, 98109
The Vancouver Clinic, INC. PS /ID# 164811 Recruiting
Vancouver, Washington, United States, 98664
United States, Wisconsin
Froedtert and Medical College /ID# 202286 Recruiting
Milwaukee, Wisconsin, United States, 53226-3522
Allegiance Research Specialist /ID# 165321 Recruiting
Wauwatosa, Wisconsin, United States, 53226
American Samoa
Southern California Res. Ctr. /ID# 169654 Recruiting
Coronado, American Samoa, 92118-1408
Argentina
Hospital Italiano de Buenos Aires /ID# 215543 Not yet recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
Cardio Alem /ID# 211284 Not yet recruiting
San Isidro, Buenos Aires, Argentina, 1642
Hopital Centenario /ID# 171254 Recruiting
Rosario, Santa Fe, Argentina, 2000
Cemic /Id# 169184 Recruiting
Buenos Aires, Argentina, 1431
Gedyt /ID# 210019 Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, 1125
Hospital Privado Univesitario /ID# 169228 Recruiting
Cordoba, Argentina, 5016
Australia, New South Wales
Concord Repatriation & Gen Hos /ID# 171509 Recruiting
Concord, New South Wales, Australia, 2139
Australia, Queensland
Coral Sea Clinical Research /ID# 212987 Recruiting
North Mackay, Queensland, Australia, 4740
Mater Misericordiae /ID# 204908 Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital /ID# 171511 Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital /ID# 203734 Recruiting
Melbourne, Victoria, Australia, 3128
Australia, Western Australia
Fiona Stanley Hospital /ID# 171510 Recruiting
Murdoch, Western Australia, Australia, 6150
Austria
Krankenanstalt Rudolfstiftung /ID# 203437 Recruiting
Vienna, Wien, Austria, 1030
Medical University of Vienna /ID# 169462 Recruiting
Vienna, Wien, Austria, 1090
LKH Salzburg and Paracelsus /ID# 214467 Not yet recruiting
Salzburg, Austria, 5020
Belgium
Cliniques Universitaires Saint Luc /ID# 200297 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
AZ Sint-Lucas /ID# 200301 Recruiting
Ghent, Belgium, 9000
UZ Leuven /ID# 200298 Recruiting
Leuven, Belgium, 3000
CHU de Liege Sart Tilman /ID# 200299 Recruiting
Liege, Belgium, 4000
CHU Dinant Godinne - UCL Namur /ID# 200300 Recruiting
Yvoir, Belgium, 5530
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 208050 Not yet recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Center Tuzla /ID# 210324 Not yet recruiting
Tuzla, Tuzlanski, Bosnia and Herzegovina, 75000
Clinical Center University of Sarajevo /ID# 203885 Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda /ID# 166870 Recruiting
Goiania, Goias, Brazil, 74535-170
Hospital Nossa Senhora das Graças /ID# 166869 Recruiting
Curitiba, Parana, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre /ID# 166872 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Upeclin Fmb - Unesp /Id# 166876 Recruiting
Botucatu, Sao Paulo, Brazil, 18618-686
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 166874 Recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina do ABC /ID# 208327 Recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Kaiser Clinica e Hospital Dia /ID# 166873 Recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
Hospital Universitario Clement /ID# 210646 Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Bulgaria
UMHAT "Kaspela" EOOD /ID# 167617 Recruiting
Plovdiv, Bulgaria, 4001
II MHAT - Sofia /ID# 167618 Recruiting
Sofia, Bulgaria, 1202
MHAT Trakia /ID# 201678 Recruiting
Stara Zagora, Bulgaria, 6004
University Multiprofile Hospit /ID# 167570 Not yet recruiting
Varna, Bulgaria, 9010
Canada, Alberta
University of Calgary /ID# 166963 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 168041 Not yet recruiting
Edmonton, Alberta, Canada, T5R 1W2
Covenant Health /ID# 166966 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Fraser Clinical Trials Inc /ID# 166957 Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
GIRI Gastrointestinal Research Institute /ID# 166964 Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Nova Scotia
QEII - Victoria Building /ID# 169306 Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Scott Schulman medicine profes /ID# 169064 Recruiting
North Bay, Ontario, Canada, P1B2H3
Taunton surgical centre /ID# 168039 Recruiting
Oshawa, Ontario, Canada, L1H 7K4
The Ottawa Hospital /ID# 212413 Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Medicor Research Inc. /ID# 166967 Recruiting
Sudbury, Ontario, Canada, P3A 1W8
Toronto Digestive Disease Asso /ID# 166961 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hopital Charles-Lemoyne /ID# 166959 Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 166958 Not yet recruiting
Levis, Quebec, Canada, G6V 3Z1
Crchum /Id# 170121 Recruiting
Montreal, Quebec, Canada, H2X 0A9
Montreal General Hospital - McGill University Health Centre /ID# 170010 Recruiting
Montréal, Quebec, Canada, H3G 1A4
CRCHUS Hotel-Dieu /ID# 170935 Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Chile
Research Group Ltda /ID# 203180 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 2540364
M y F Estudios Clínicos Ltda. /ID# 169995 Recruiting
Ñuñoa, Region Metropolitana De Santiago, Chile, 7750495
Hospital Guillermo Grant Benavente de Concepción /ID# 212422 Not yet recruiting
Concepción, Chile, 4070038
CTR Estudios SpA /ID# 200650 Recruiting
Providencia, Chile, 7500571
Hospital Clinico Universidad De Los Andes /ID# 207465 Not yet recruiting
Santiago, Chile, 7501504
China, Anhui
The First Affiliated Hosp, Sun /ID# 205226 Recruiting
Guangzhou, Anhui, China, 510080
Renji Hosp, Shanghai Jiaotong /ID# 204172 Not yet recruiting
Shanghai, Anhui, China, 200127
Zhongshan Hospital Xiamen Univ /ID# 204985 Recruiting
Xiamen, Anhui, China, 361004
China, Guangdong
Nanfang Hospital of Southern Medical University /ID# 204074 Recruiting
Guangzhou, Guangdong, China, 510515
The Sixth Affiliated Hosp, Sun /ID# 204049 Recruiting
Guangzhou, Guangdong, China, 510655
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 204070 Recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hosp of Jilin Univ /ID# 206867 Recruiting
Changchun, Jilin, China, 130021
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 204072 Recruiting
Shanghai, Shanghai, China, 200025
China, Zhejiang
The Second Affiliated Hospital /ID# 204078 Recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 204068 Recruiting
Hangzhou, Zhejiang, China, 310016
China
Beijing Friendship Hospital /ID# 204536 Recruiting
Beijing, China, 100050
The Second Xiangya Hospital of Central South University /ID# 204075 Recruiting
Changsha, China, 410000
Nanjing Drum Tower Hospital /ID# 204869 Recruiting
Nanjing, Jiangsu, China, 210008
Tianjin Med Univ General Hosp /ID# 206993 Recruiting
Tianjin, China, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096 Recruiting
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 204069 Recruiting
Wuhan, China, 430030
Colombia
Hospital San Vicente de Paul /ID# 200028 Recruiting
Medellin, Antioquia, Colombia, 50034
Instituto de Coloproctologia /ID# 168416 Not yet recruiting
Antioquia, Colombia
Hospital Pablo Tobon Uribe /ID# 202405 Recruiting
Medellín, Colombia
Croatia
Poliklinika Solmed /ID# 211518 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
UHC Split /ID# 171206 Not yet recruiting
Split, Croatia, 21000
Zadar General Hospital /ID# 205534 Recruiting
Zadar, Croatia, 23000
CH Dubrava /ID# 171186 Recruiting
Zagreb, Croatia, 10000
UHC Sestre Milosrdnice /ID# 171190 Recruiting
Zagreb, Croatia, 10000
UHC Zagreb /ID# 171201 Recruiting
Zagreb, Croatia, 10000
Czechia
Nemocnice Horovice, NH Hospita /ID# 209869 Not yet recruiting
Horovice, Czechia, 268 31
Hepato-Gastroenterologie HK s.r.o. /ID# 171566 Recruiting
Hradec Kralove, Czechia, 500 12
Artroscan , s.r.o. /ID# 171592 Recruiting
Ostrava, Czechia, 722 00
Restrial /ID# 208652 Recruiting
Prague 412, Czechia, 143 00
Denmark
Nordsjallands Hospital /ID# 200613 Recruiting
Frederikssund, Hovedstaden, Denmark, 3600
Herlev Hospital /ID# 200782 Recruiting
Herlev, Hovedstaden, Denmark, 2730
Sjaellands Universitets Hospit /ID# 200783 Recruiting
Roskilde, Sjælland, Denmark, 4000
Hvidovre Hospital /ID# 200611 Recruiting
Hvidovre, Denmark, 2650
Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010 Recruiting
Alexandria, Egypt, 21131
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015 Recruiting
Alexandria, Egypt, 21131
Cairo University /ID# 209557 Not yet recruiting
Cairo, Egypt, 11559
Nat Hep & Trop Med Res Inst /ID# 170990 Recruiting
Cairo, Egypt, 11559
Ain Shams University Hospital /ID# 209565 Not yet recruiting
Cairo, Egypt, 11566
Air Force Specialized Hospital /ID# 170995 Recruiting
Cairo, Egypt
Zagazig University Hospital /ID# 209558 Not yet recruiting
EL Sharkya, Egypt
Estonia
Tartu University Hospital /ID# 203140 Recruiting
Tartu, Estonia, 51014
France
Chu de Nice-Hopital L'Archet Ii /Id# 171009 Recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
Hôpital Haut-Lévêque /ID# 207414 Not yet recruiting
Pessac CEDEX, Gironde, France, 33604
CHRU Lille - Hôpital Claude Huriez /ID# 206539 Not yet recruiting
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 170646 Recruiting
Montpellier CEDEX 5, Herault, France, 34295
Hopital Beaujon /ID# 171011 Recruiting
Clichy, Ile-de-France, France, 92110
CHU de SAINT ETIENNE - Hopital Nord /ID# 171018 Recruiting
St. Priest En Jarez, Loire, France, 42270
Centre Hospitalier Lyon Sud /ID# 171014 Recruiting
Pierre Benite CEDEX, Rhone, France, 69495
Chu Amiens Picardie - Hopital /Id# 171016 Recruiting
Amiens Cedex 01, France, 80054
Chru Trousseau /Id# 169786 Recruiting
Chambray-les-tours, France, 37170
CHU Henri Mondor /ID# 169787 Recruiting
Creteil, France, 94000
Polyclinique Grand Sud /ID# 170649 Recruiting
Nimes Cedex, France, 30932
Hopital Rangueil /ID# 169785 Recruiting
Toulouse, France, 31059
Duplicate_CHRU de NANCY /ID# 170985 Recruiting
Vandoeuvre-les-nancy Cedex, France, 54511
Germany
Universitatsklinikum Mannheim /ID# 168778 Not yet recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitaetsklinikum Erlangen /ID# 203551 Recruiting
Erlangen, Bayern, Germany, 91054
Universitaetsmedizin St. Josef Krankenhaus Werden /ID# 203571 Recruiting
Essen, Nordrhein-Westfalen, Germany, 45239
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740 Recruiting
Saarbrücken, Saarland, Germany, 66111
Univ Hosp Schleswig-Holstein /ID# 168779 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Ulm /ID# 203563 Not yet recruiting
Ulm, Thueringen, Germany, 89081
Charite; Campus Benjamin Frank /ID# 169067 Recruiting
Berlin, Germany, 12200
Gastroenterologie am Mexikoplatz /ID# 203573 Recruiting
Berlin, Germany, 14163
Agaplesion Markus Krankenhaus /ID# 168777 Recruiting
Frankfurt, Germany, 60341
Universitaetsklinikum Frankfurt /ID# 203565 Recruiting
Frankfurt, Germany, 60590
Universitaetsklinikum Halle (S /ID# 207454 Not yet recruiting
Halle, Germany, 06120
Medizinisches Versorgungszentrum Portal 10 /ID# 200213 Recruiting
Munster, Germany, 48155
Greece
Tzaneio general hospital of Piraeus /ID# 206432 Recruiting
Piraeus, Attiki, Greece, 18536
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037 Recruiting
Athens, Greece, 10676
General Hospital of Athens Ippokratio /ID# 167036 Recruiting
Athens, Greece, 11527
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103 Recruiting
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 167035 Recruiting
Heraklion, Greece, 71110
Genl Hosp Thessaloniki Hipp /ID# 208824 Not yet recruiting
Thessaloniki, Greece, 54642
Hong Kong
Queen Mary Hospital /ID# 171217 Recruiting
Hong Kong, Hong Kong, 999077
Hungary
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546 Recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Bugat Pal Korhaz /ID# 201889 Recruiting
Gyöngyös, Heves, Hungary, 3200
Obudai Egeszsegugyi Centrum Kft. /ID# 201891 Recruiting
Budapest, Hungary, 1036
MH Honvedkorhaz /ID# 201719 Recruiting
Budapest, Hungary, 1062
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720 Recruiting
Debrecen, Hungary, 4031
Mentahaz Maganorvosi Kozpont /ID# 201890 Recruiting
Szekesfehervar, Hungary, 8000
Ireland
Mercy University Hospital /ID# 206510 Not yet recruiting
Cork, Ireland, T12 WE28
Israel
Soroka Medical Center /ID# 169912 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Rabin Medical Center /ID# 202635 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 204876 Recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Hadassah Ein Kerem Medical Ctr /ID# 169927 Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Assaf Harofeh Medical Center /ID# 204870 Recruiting
Be'er Ya'akov, Israel, 70300
Kaplan Medical Center /ID# 170277 Recruiting
Rehovot, Israel, 76100
Italy
Universita di Catanzaro Magna Graecia /ID# 201920 Recruiting
Catanzaro, Calabria, Italy, 88100
AOU Policlinico S. Orsola Malpighi /ID# 168173 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 200008 Recruiting
Modena, Emilia-Romagna, Italy, 41124
Policlinico Universitario Campus Bio-Medico /ID# 168169 Recruiting
Rome, Lazio, Italy, 00128
Azienda Ospedaliera San Camillo Forlanini /ID# 168170 Recruiting
Rome, Lazio, Italy, 00152
Istituto Clinico Humanitas /ID# 168171 Recruiting
Rozzano, Milano, Italy, 20089
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 168168 Recruiting
Rome, Roma, Italy, 00168
A.O. Per L'Emergenza Cannizzaro /ID# 168176 Recruiting
Catania, Sicilia, Italy, 95126
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 168172 Recruiting
Negrar, Verona, Italy, 37024
Policlinico San Martino/Univer /ID# 168177 Recruiting
Genova, Italy, 16132
ASST Fatebenefratelli Sacco- O /ID# 168167 Recruiting
Milano, Italy, 20121
Ospedali Riuniti Villa Sofia-C /ID# 168175 Recruiting
Palermo, Italy, 90146
AOU Pisana /ID# 202420 Recruiting
Pisa, Italy, 56124
Policlinico Tor Vergata /ID# 168174 Recruiting
Rome, Italy, 00133
Japan
Aichi Medical University Hosp /ID# 165957 Recruiting
Nagakute, Aichi, Japan, 4801195
Nagoya University Hospital /ID# 165955 Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 165956 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Hirosaki National Hospital /ID# 165944 Recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Medical Center /ID# 165949 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Fukuoka University Chikushi Hospital /ID# 214403 Not yet recruiting
Chikushino, Fukuoka, Japan, 818-8502
Kurume University Hospital /ID# 166004 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
National Hospital Organization Takasaki General Medical Center /ID# 167136 Recruiting
Takasaki-shi, Gunma, Japan, 370-0829
NHO Fukuyama Medical Center /ID# 167139 Recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 167133 Recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 167137 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Aoyama Clinic /ID# 166001 Recruiting
Kobe, Hyogo, Japan, 650-0015
The Hospital of Hyogo College of Medicine /ID# 200173 Recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8501
Kanazawa University Ho /ID# 169215 Recruiting
Kanazawa, Ishikawa, Japan, 92086-41
Iwate Medical University Hospital /ID# 202407 Recruiting
Morioka-shi, Iwate, Japan, 020-8505
JP Red Cross Kyoto Daiichi Hos /ID# 165958 Recruiting
Kyoto-shi, Kyoto, Japan, 605-0981
Tohoku University Hospital /ID# 167135 Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Niigata University Medical & Dental Hospital /ID# 170044 Recruiting
Niigata-shi, Niigata, Japan, 951-8520
Ishida Clinic of IBD and Gastroenterology /ID# 167134 Recruiting
Oita-shi, Oita, Japan, 870-0823
Osaka City University Hospital /ID# 166007 Recruiting
Osaka-shi, Osaka, Japan, 545-0051
Shiga University of Medical Science Hospital /ID# 167141 Recruiting
Otsu, Shiga, Japan, 520-2192
Medical Hospital of Tokyo Medical and Dental University /ID# 165948 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokai University Hachioji Hospital /ID# 165951 Recruiting
Hachioji, Tokyo, Japan, 192-0032
Kyorin University Hospital /ID# 165950 Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Tokyo Women's Medical University Hospital /ID# 205981 Recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 200156 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Hiroshima University Hospital /ID# 166006 Recruiting
Hiroshima, Japan, 734-8551
Sameshima Hospital /ID# 206674 Recruiting
Kagoshima, Japan
Nara Medical Univ Hospital /ID# 169216 Recruiting
Kashihara, Japan, 634-0813
Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002 Recruiting
Kurashiki, Japan, 710-0142
The Jikei University Hospital /ID# 167142 Recruiting
Minato-ku, Japan, 105-8471
Kyoto University Hospital /ID# 169888 Recruiting
Sakyo-ku, Japan, 606-8507
NHO Shizuoka Medical Center /ID# 167138 Recruiting
Shimizu-sho, Japan
Toyohashi Municipal Hospital /ID# 200174 Recruiting
Toyohashi, Japan, 441-8570
Wakayama Medical University /ID# 169481 Recruiting
Wakayama, Japan, 641-8510
JP Red Cross Wakayama Med Ctr /ID# 200638 Recruiting
Wakayama, Japan
Kenseikai Dongo Hospital /ID# 208103 Recruiting
Yamatotakada, Japan, 635-0022
Yokkaichi Hazu Medical Center /ID# 167191 Recruiting
Yokkaichi-shi, Japan, 510-0016
Korea, Republic of
Dong-A University Hospital /ID# 167582 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 167580 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Kyungpook National Univ Hosp /ID# 207015 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
CHA Bundang Medical center, CHA University /ID# 167583 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kangbuk Samsung Hospital /ID# 167577 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Yonsei University Health System, Severance Hospital /ID# 167581 Recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 167579 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Haeundae Paik Hospital /ID# 202629 Recruiting
Busan, Korea, Republic of, 48108
Hanyang University Guri Hosp /ID# 167578 Recruiting
Guri-si, Korea, Republic of, 471-701
Chung-Ang University Hostipal /ID# 207017 Recruiting
Seoul, Korea, Republic of, 06973
Latvia
Riga East Clinical Univ Hosp /ID# 169496 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 169493 Recruiting
Riga, Latvia, LV-1002
Digestive Diseases Ctr Gastro /ID# 169517 Recruiting
Riga, Latvia, LV-1006
Lithuania
Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 207263 Recruiting
Kaunas, Lithuania, 50161
Vilnius University Hospital /ID# 203285 Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Sultanah Bahiyah /ID# 202627 Recruiting
Alor Setar, Kedah, Malaysia, 05460
UKM Medical Centre /ID# 170778 Recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Mexico
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143 Recruiting
Victoria de Durango, Durango, Mexico, 34000
Morales Vargas Centro de Investigación S.C /ID# 203495 Recruiting
León de los Aldama, Guanajuato, Mexico, 37000
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779 Recruiting
Guadalajara, Jalisco, Mexico, 44650
Netherlands
Radboud Universitair Medisch Centrum /ID# 166925 Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Academisch Medisch Centrum /ID# 166924 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Medisch Spectrum Twente /ID# 170297 Recruiting
Enschede, Netherlands, 7511 JX
Atrium-Orbis Zuyderland Medisch Centrum /ID# 169698 Recruiting
Heerlen, Netherlands, 6419 PC
Poland
Vistamed /ID# 208570 Recruiting
Wrocław, Dolnoslaskie, Poland, 53-149
Malopolskie Centrum Kliniczne /ID# 202166 Recruiting
Cracow, Malopolskie, Poland, 30-149
Centrum Zdrowia MDM /ID# 200486 Recruiting
Warsaw, Mazowieckie, Poland, 00-635
Endoterapia PFG Sp. z.o.o. /ID# 200488 Recruiting
Warszawa, Mazowieckie, Poland, 02-653
Portugal
Hospital Egas Moniz /ID# 170249 Not yet recruiting
Lisbon, Porto, Portugal, 1349-019
HGO - Hospital Garcia de Orta /ID# 170234 Recruiting
Almada, Portugal, 2805-267
Centro Hospitalar e Universitário de Coimbra, EPE /ID# 170240 Not yet recruiting
Coimbra, Portugal, 3000-075
HSOG - Hospital Senhora da Oli /ID# 170225 Recruiting
Guimaraes, Portugal, 4835-044
Centro Hospitalar de Sao Joao /ID# 170231 Recruiting
Porto, Portugal, 4200-319
Unidade Local De Saude Do Alto Minho /ID# 200606 Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Mindful Medical Research /ID# 203357 Recruiting
San Juan, Puerto Rico, 00918-3756
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 166770 Recruiting
San Juan, Puerto Rico, 00935
Romania
Institutul Clinic Fundeni /ID# 167826 Not yet recruiting
Sector 2, Bucuresti, Romania, 22328
Clinica GASTRO MED SRL /ID# 206367 Not yet recruiting
Cluj-Napoca, Cluj, Romania, 400380
Cabinet Particular Policlinic Algomed /ID# 167827 Not yet recruiting
Timisoara, Romania, 300002
Centrul Medical Tuculanu SRL /ID# 167829 Not yet recruiting
Timisoara, Romania, 300168
Russian Federation
Immanuel Kant Baltic Federal University /ID# 202128 Recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
Perm Clinical Center of FMBA /ID# 202988 Recruiting
Perm, Permskiy Kray, Russian Federation, 614109
Private institution Center of educational and clinical gastroenterology, hepatol /ID# 202995 Recruiting
Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
Kazan State Medical University /ID# 169574 Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Llc Olla-Med /Id# 208721 Recruiting
Moscow, Russian Federation, 105554
P.A. Bayandin Murmansk Regiona /ID# 169575 Recruiting
Murmansk, Russian Federation, 183047
LLC Medical center Zdorovaya s /ID# 209233 Recruiting
Novosibirsk, Russian Federation, 630099
Republican Clin Hos n.a. Baran /ID# 206487 Recruiting
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 206609 Recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 206615 Recruiting
Pyatigorsk, Russian Federation, 357532
Serbia
Clinical Center Serbia /ID# 168220 Recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 168221 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 168784 Recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 168799 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center Kragujevac /ID# 205858 Recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 168222 Recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
Gleneagles Medical Centre /ID# 206530 Recruiting
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 203159 Recruiting
Singapore, Singapore, 308433
Slovakia
FNsP F.D.Roosevelta Banska Bys /ID# 169952 Recruiting
Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17
KM Management s.r.o. /ID# 170199 Recruiting
Nitra, Slovakia, 949 01
Slovenia
Univ Medical Ctr Ljubljana /ID# 211042 Recruiting
Ljubljana, Slovenia, 1000
South Africa
Farmovs (Pty) Ltd /Id# 207536 Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Lenasia Clinical Trial Centre /ID# 205144 Recruiting
Johannesburg, Gauteng, South Africa, 1820
Wits Clinical Research Site /ID# 170851 Recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Constantiaberg /ID# 169852 Recruiting
Cape Town, Western Cape, South Africa, 7800
Dr JP Wright /ID# 170885 Recruiting
Cape Town, South Africa, 7708
Spain
H. Un. Marques de Valdecilla /ID# 202039 Recruiting
Santander, Cantabria, Spain, 39008
Hospital Universitario y Politecnico La Fe /ID# 201988 Recruiting
Valencia, Valenciana, Spain, 46026
Comple Hosp Univ de A Coruna /ID# 203908 Recruiting
A Coruna, Spain, 15006
Hospital Clinic de Barcelona /ID# 171242 Recruiting
Barcelona, Spain, 08028
Vall d'Hebron University Hospi /ID# 171237 Recruiting
Barcelona, Spain, 08035
Hosp Univ Girona Josep Trueta /ID# 202040 Recruiting
Girona, Spain, 17007
Hospital Juan Ramon Jimenez /ID# 171243 Recruiting
Huelva, Spain, 21005
Hospital Univ Dr. Negrin /ID# 171238 Recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Universitario La Paz /ID# 171241 Recruiting
Madrid, Spain, 28046
Hospital Univ. Son Espases /ID# 201997 Recruiting
Palma de Mallorca, Spain, 07120
Complejo Hospitalario de Navar /ID# 202038 Recruiting
Pamplona, Spain, 31008
Hospital Universitario Virgen Macarena /ID# 171240 Recruiting
Sevilla, Spain, 41009
Sweden
Alingsås lasarett /ID# 170838 Recruiting
Alingsås, Vastra Gotalands Lan, Sweden, 441 33
Södra Älvsborgs sjukhus /ID# 202889 Recruiting
Borås, Vastra Gotalands Lan, Sweden, 501 82
Sahlgrenska US Gbg /ID# 169031 Completed
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
Hallands sjukhus Halmstad /ID# 170840 Recruiting
Halmstad, Sweden, 302 33
Switzerland
Inselspital, Universitaetsklinik /ID# 171006 Recruiting
Bern, Switzerland, 3010
Universitatsspital Zurich /ID# 170999 Recruiting
Zurich, Switzerland, CH-8091
Taiwan
National Taiwan University Hos /ID# 169789 Recruiting
Taipei, Taiwan, 10041
Chang Gung Memorial Hospital /ID# 169788 Recruiting
Taoyuan, Taiwan, 33305
Turkey
Acıbadem Kozyatagı Hospital /ID# 209405 Recruiting
Kadiköy, Istanbul, Turkey, 34742
Erciyes University Medical Fac /ID# 171321 Recruiting
Melikgazi, Kayseri, Turkey, 38030
Ankara Univ Medical Faculty /ID# 206412 Recruiting
Ankara, Turkey, 6100
Inonu Universitesi Turgut Ozal /ID# 201267 Recruiting
Battalgazi/malatya, Turkey, 44280
Mustafa Kemal University Medic /ID# 171318 Recruiting
Hatay, Turkey, 31001
Istanbul University Cerrahpasa Medical Faculty /ID# 200280 Recruiting
Istanbul, Turkey, 34098
Marmara University Medical Fac /ID# 171316 Recruiting
Istanbul, Turkey, 34899
Sisli Etfal Train & Res Hosp /ID# 171317 Recruiting
Sisli, Turkey, 34371
Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 207870 Not yet recruiting
Kiev, Kyiv, Ukraine, 03134
United Kingdom
South Eastern Health and Social Care Trust /ID# 205322 Recruiting
Belfast, Antrim, United Kingdom, BT16 1RH
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388 Recruiting
Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
Royal United Hospitals Bath /ID# 169084 Recruiting
Bath, United Kingdom, BA1 3NG
Queen Elizabeth Hospital - BIRMINGHAM /ID# 169080 Recruiting
Birmingham, United Kingdom, B15 2TH
Russells Hall Hospital, Dudley /ID# 169079 Recruiting
Dudley, United Kingdom, DY1 2HQ
London North West Healthcare N /ID# 169078 Not yet recruiting
Harrow, United Kingdom, HA1 3UJ
King's College Hospital NHS /ID# 169082 Recruiting
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS /ID# 205551 Recruiting
London, United Kingdom, SW17 0QT
The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 169085 Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
St. Helens and Knowsley Teach /ID# 209085 Recruiting
Prescot, United Kingdom, L35 5DR
Stockport NHS foundation trust /ID# 208718 Recruiting
Stockport, United Kingdom, SK2 7JE
Taunton and Somerset NHS Found /ID# 209664 Not yet recruiting
Tauntojn, United Kingdom, TA1 5DN
New Cross Hospital, Royal Wolv /ID# 171387 Not yet recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03345836     History of Changes
Other Study ID Numbers: M14-431
2017-001226-18 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 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

Layout table for additional information
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
Crohn's Disease
Efficacy
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents