Trial record 10 of 31 for:    Upadacitinib

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. Identifier: NCT03345836
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 855 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 : January 9, 2020
Estimated Study Completion Date : March 17, 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

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

Experimental: Arm A
Participants will receive upadacitinib dose A for 12 weeks.
Drug: upadacitinib
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.

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

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 identifier (NCT number): NCT03345836

Contact: ABBVIE CALL CENTER 847.283.8955

  Hide Study Locations
United States, Alabama
Alabama Medical Group,PC /ID# 171133 Recruiting
Mobile, Alabama, United States, 36608
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 Not yet recruiting
Scottsdale, Arizona, United States, 85258
Arizona Arthritis & Rheumatolo /ID# 203891 Not yet recruiting
Sun City, Arizona, United States, 85032
United States, California
Citrus Valley Gastroenterology /ID# 166201 Recruiting
Covina, California, United States, 91722-3797
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Gastrointestinal Biosciences /ID# 164887 Recruiting
Los Angeles, California, United States, 90067-2001
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Mission Hills, California, United States, 91345
United Gastroenterologists - Murrieta /ID# 164845 Recruiting
Murrieta, California, United States, 92563
Ucsd /Id# 164679 Not yet 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 Not yet recruiting
San Francisco, California, United States, 94115-3011
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San Francisco, California, United States, 94158
Care Access Research /ID# 167766 Not yet recruiting
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 Not yet recruiting
Clearwater, Florida, United States, 33765
Borland-Groover Clinic /ID# 203498 Not yet recruiting
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New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 205893 Not yet recruiting
Orlando, Florida, United States, 32803
Omega Research Consultants /ID# 203480 Not yet recruiting
Orlando, Florida, United States, 32810
Clinical Research Trials of Florida, Inc. /ID# 203484 Not yet recruiting
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 171175 Recruiting
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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 Not yet recruiting
Downers Grove, Illinois, United States, 60515-5509
United States, Indiana
MediSphere Medical Research Center /ID# 166209 Not yet recruiting
Evansville, Indiana, United States, 47714-8011
Indianapolis Gastroenterology /ID# 164837 Not yet recruiting
Indianapolis, Indiana, United States, 46237
Aquiant Research /ID# 205504 Not yet recruiting
New Albany, Indiana, United States, 47150-4053
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University of Iowa Hospitals /ID# 165330 Not yet recruiting
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Tri-State Gastroenterology /ID# 165484 Recruiting
Crestview Hills, Kentucky, United States, 41017
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CroNOLA, LLC /ID# 164722 Recruiting
Houma, Louisiana, United States, 70360
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New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 164659 Recruiting
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MGG Group, Inc.Chevy Chase Clinical Research /ID# 164835 Recruiting
Chevy Chase, Maryland, United States, 20815
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Southern Therapy and Advanced Research (STAR) LLC /ID# 165318 Not yet recruiting
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Quality Clinical Research, Inc /ID# 170177 Recruiting
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Las Vegas, Nevada, United States, 89113
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AGA Clinical Research Associates, LLC /ID# 164883 Recruiting
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
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Plains Clinical Research Center, LLC /ID# 170184 Recruiting
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Nashville, Tennessee, United States, 37232-0011
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TX Clinical Research Institute /ID# 164848 Recruiting
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Inquest Clinical Research /ID# 164865 Recruiting
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United States, Washington
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American Samoa
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Bosnia and Herzegovina
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Canada, British Columbia
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China, Guangdong
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Prague 412, Czechia, 143 00
Bispebjerg Hospital /ID# 208941 Not yet recruiting
Copenhagen NV, Hovedstaden, Denmark, 2400
Nordsjallands Hospital /ID# 200613 Not yet recruiting
Frederikssund, Hovedstaden, Denmark, 3600
Herlev Hospital /ID# 200782 Recruiting
Herlev, Hovedstaden, Denmark, 2730
Sjaellands Universitets Hospit /ID# 200783 Not yet recruiting
Roskilde, Sjælland, Denmark, 4000
Hvidovre Hospital /ID# 200611 Not yet recruiting
Hvidovre, Denmark, 2650
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010 Not yet recruiting
Alexandria, Egypt, 21131
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015 Not yet recruiting
Alexandria, Egypt, 21131
Nat Hep & Trop Med Res Inst /ID# 170990 Not yet recruiting
Cairo, Egypt, 1141
Cairo University /ID# 209557 Not yet recruiting
Cairo, Egypt, 11559
Ain Shams University Hospital /ID# 209565 Not yet recruiting
Cairo, Egypt, 11566
Air Force Specialized Hospital /ID# 170995 Not yet recruiting
Cairo, Egypt
Zagazig University Hospital /ID# 209558 Not yet recruiting
EL Sharkya, Egypt
Tartu University Hospital /ID# 203140 Recruiting
Tartu, Estonia, 51014
Chu de Nice-Hopital L'Archet Ii /Id# 171009 Not yet 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 Not yet 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 Not yet 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 Not yet recruiting
Amiens Cedex 01, France, 80054
Chru Trousseau /Id# 169786 Recruiting
Chambray-les-tours, France, 37170
CHU Henri Mondor /ID# 169787 Not yet recruiting
Creteil, France, 94000
Polyclinique Grand Sud /ID# 170649 Recruiting
Nimes Cedex, France, 30932
Hopital Rangueil /ID# 169785 Not yet recruiting
Toulouse, France, 31059
Duplicate_CHRU de NANCY /ID# 170985 Not yet recruiting
Vandoeuvre-les-nancy Cedex, France, 54511
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 Not yet recruiting
Essen, Nordrhein-Westfalen, Germany, 45239
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740 Not yet recruiting
Saarbrücken, Saarland, Germany, 66111
Univ Hosp Schleswig-Holstein /ID# 168779 Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Ulm /ID# 203563 Not yet recruiting
Ulm, Thueringen, Germany, 89081
Charite; Campus Benjamin Frank /ID# 169067 Not yet recruiting
Berlin, Germany, 12200
Gastroenterologie am Mexikoplatz /ID# 203573 Not yet recruiting
Berlin, Germany, 14163
Agaplesion Markus Krankenhaus /ID# 168777 Not yet recruiting
Frankfurt, Germany, 60341
Universitaetsklinikum Frankfur /ID# 203565 Not yet recruiting
Frankfurt, Germany, 60590
Universitaetsklinikum Halle (S /ID# 207454 Not yet recruiting
Halle, Germany, 06120
Medizinisches Versorgungszentrum Portal 10 /ID# 200213 Not yet recruiting
Munster, Germany, 48155
Tzaneio general hospital of Piraeus /ID# 206432 Not yet recruiting
Piraeus, Attiki, Greece, 18536
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037 Not yet recruiting
Athens, Greece, 10676
General Hospital of Athens "Ippokratio" /ID# 167036 Not yet recruiting
Athens, Greece, 11527
General Hospital of Chest Diseases of Athens "SOTIRIA" /ID# 202103 Not yet recruiting
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 167035 Not yet recruiting
Heraklion, Greece, 71110
Genl Hosp Thessaloniki Hipp /ID# 208824 Not yet recruiting
Thessaloniki, Greece, 54642
Hong Kong
Queen Mary Hospital /ID# 171217 Not yet recruiting
Hong Kong, Hong Kong, 999077
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546 Recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Bugat Pal Korhaz /ID# 201889 Not yet recruiting
Gyöngyös, Heves, Hungary, 3200
Obudai Egeszsegugyi Centrum Kft. /ID# 201891 Not yet recruiting
Budapest, Hungary, 1036
MH Honvedkorhaz /ID# 201719 Recruiting
Budapest, Hungary, 1062
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720 Not yet recruiting
Debrecen, Hungary, 4031
Mentahaz Maganorvosi Kozpont /ID# 201890 Not yet recruiting
Szekesfehervar, Hungary, 8000
Mercy University Hospital /ID# 206510 Not yet recruiting
Cork, Ireland, T12 WE28
Soroka Medical Center /ID# 169912 Not yet recruiting
Be'er Sheva, HaDarom, Israel, 84101
Rabin Medical Center /ID# 202635 Not yet recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 204876 Not yet recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Hadassah Ein Kerem Medical Ctr /ID# 169927 Not yet recruiting
Jerusalem, Yerushalayim, Israel, 91120
Assaf Harofeh Medical Center /ID# 204870 Not yet recruiting
Be'er Ya'akov, Israel, 70300
Kaplan Medical Center /ID# 170277 Recruiting
Rehovot, Israel, 76100
Università di Catanzaro "Magna Graecia" /ID# 201920 Not yet 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 Not yet recruiting
Modena, Emilia-Romagna, Italy, 41124
Policlinico Universitario Campus Bio-Medico /ID# 168169 Not yet recruiting
Rome, Lazio, Italy, 00128
Azienda Ospedaliera San Camillo Forlanini /ID# 168170 Not yet recruiting
Rome, Lazio, Italy, 00152
Istituto Clinico Humanitas /ID# 168171 Not yet recruiting
Rozzano, Milano, Italy, 20089
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 168168 Not yet recruiting
Rome, Roma, Italy, 00168
A.O. Per L'Emergenza Cannizzaro /ID# 168176 Not yet recruiting
Catania, Sicilia, Italy, 95126
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 168172 Not yet recruiting
Negrar, Verona, Italy, 37024
Policlinico San Martino/Univer /ID# 168177 Not yet recruiting
Genova, Italy, 16132
ASST Fatebenefratelli Sacco- O /ID# 168167 Not yet recruiting
Milano, Italy, 20121
Ospedali Riuniti Villa Sofia-C /ID# 168175 Not yet recruiting
Palermo, Italy, 90146
AOU Pisana /ID# 202420 Not yet recruiting
Pisa, Italy, 56124
Policlinico Tor Vergata /ID# 168174 Not yet recruiting
Rome, Italy, 00133
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 Not yet recruiting
Hirosaki-shi, Aomori, Japan, 036-8545
Toho University Sakura Medical Center /ID# 165949 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Kurume University Hospital /ID# 166004 Not yet recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
National Hospital Organization Takasaki General Medical Center /ID# 167136 Not yet recruiting
Takasaki-shi, Gunma, Japan, 370-0829
NHO Fukuyama Medical Center /ID# 167139 Not yet recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 167133 Not yet recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943 Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 167137 Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Aoyama Clinic /ID# 166001 Not yet 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 Not yet 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 Not yet recruiting
Oita-shi, Oita, Japan, 870-0823
Osaka City University Hospital /ID# 166007 Not yet recruiting
Osaka-shi, Osaka, Japan, 545-0051
Shiga Univ Med Science Hosp /ID# 167141 Not yet 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 Not yet 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 Not yet recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Yamagata University Hospital /ID# 200156 Not yet 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 Not yet recruiting
Kashihara, Japan, 634-0813
The Jikei University Hospital /ID# 167142 Recruiting
Minato-ku, Japan, 105-8471
Kyoto University Hospital /ID# 169888 Not yet recruiting
Sakyo-ku, Japan, 606-8507
NHO Shizuoka Medical Center /ID# 167138 Not yet recruiting
Shimizu-sho, Japan
Toyohashi Municipal Hospital /ID# 200174 Not yet recruiting
Toyohashi, Japan, 441-8570
Wakayama Medical University /ID# 169481 Not yet recruiting
Wakayama, Japan, 641-8510
JP Red Cross Wakayama Med Ctr /ID# 200638 Not yet recruiting
Wakayama, Japan
Kenseikai Dongo Hospital /ID# 208103 Not yet 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 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 167580 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Kyungpook National Univ Hosp /ID# 207015 Not yet recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
CHA Bundang Medical center, CHA University /ID# 167583 Not yet recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kangbuk Samsung Hospital /ID# 167577 Not yet recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Yonsei University Health System, Severance Hospital /ID# 167581 Not yet 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 Not yet recruiting
Guri-si, Korea, Republic of, 471-701
Chung-Ang University Med. Ctr. /ID# 207017 Not yet recruiting
Seoul, Korea, Republic of, 156-755
Riga East Clinical Univ Hosp /ID# 169496 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 169493 Not yet recruiting
Riga, Latvia, LV-1002
Digestive Diseases Ctr Gastro /ID# 169517 Not yet recruiting
Riga, Latvia, LV-1006
Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 207263 Not yet recruiting
Kaunas, Lithuania, 50161
Vilnius University Hospital /ID# 203285 Recruiting
Vilnius, Lithuania, LT-08661
Hospital Sultanah Bahiyah /ID# 202627 Not yet recruiting
Alor Setar, Kedah, Malaysia, 05460
UKM Medical Centre /ID# 170778 Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143 Not yet recruiting
Victoria de Durango, Durango, Mexico, 34000
Morales Vargas Centro de Investigación S.C /ID# 203495 Not yet recruiting
León de los Aldama, Guanajuato, Mexico, 37000
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44650
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 Not yet recruiting
Enschede, Netherlands, 7511 JX
Zuyderland Medisch Centrum /ID# 169698 Not yet recruiting
Heerlen, Netherlands, 6419 PC
Vistamed /ID# 208570 Not yet recruiting
Wrocław, Dolnoslaskie, Poland, 53-149
Malopolskie Centrum Kliniczne /ID# 202166 Not yet recruiting
Cracow, Malopolskie, Poland, 30-149
Centrum Zdrowia MDM /ID# 200486 Recruiting
Warszawa, Mazowieckie, Poland, 00-635
Endoterapia PFG Sp. z.o.o. /ID# 200488 Not yet recruiting
Warszawa, Mazowieckie, Poland, 02-653
Hospital Egas Moniz /ID# 170249 Not yet recruiting
Lisbon, Porto, Portugal, 1349-019
HGO - Hospital Garcia de Orta /ID# 170234 Not yet recruiting
Almada, Portugal, 2805-267
CHUC- Centro Hospitalar e Univ /ID# 170240 Not yet recruiting
Coimbra, Portugal, 3000-075
HSOG - Hospital Senhora da Oli /ID# 170225 Not yet recruiting
Guimaraes, Portugal, 4835-044
Centro Hospitalar de Sao Joao /ID# 170231 Not yet recruiting
Porto, Portugal, 4200-319
Unidade Local De Saude Do Alto Minho /ID# 200606 Not yet recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Mindful Medical Research /ID# 203357 Not yet recruiting
San Juan, Puerto Rico, 00918-3756
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 166770 Not yet recruiting
San Juan, Puerto Rico, 00935
Clinic Fundeni Institute /ID# 167826 Not yet recruiting
Bucharest, Bucuresti, Romania, 022328
Clinic Fundeni Institute /ID# 167828 Not yet recruiting
Bucharest, Bucuresti, Romania, 022328
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 Not yet recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
Perm Clinical Center of FMBA /ID# 202988 Not yet recruiting
Perm, Permskiy Kray, Russian Federation, 614109
Private institution Center of educational and clinical gastroenterology, hepatol /ID# 202995 Not yet recruiting
Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
Kazan State Medical University /ID# 169574 Not yet recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Llc Olla-Med /Id# 208721 Not yet recruiting
Moscow, Russian Federation, 105554
P.A. Bayandin Murmansk Regiona /ID# 169575 Not yet recruiting
Murmansk, Russian Federation, 183047
LLC Medical center Zdorovaya s /ID# 209233 Not yet recruiting
Novosibirsk, Russian Federation, 630099
Republican Clin Hos n.a. Baran /ID# 206487 Not yet recruiting
Petrozavodsk, Russian Federation, 185019
PMI Euromedservice /ID# 206609 Not yet recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 206615 Not yet recruiting
Pyatigorsk, Russian Federation, 357532
Clinical Center Serbia /ID# 168220 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 168221 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 168784 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 168799 Not yet recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center Kragujevac /ID# 205858 Not yet recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 168222 Not yet recruiting
Novi Sad, Vojvodina, Serbia, 21000
Gleneagles Medical Centre /ID# 206530 Not yet recruiting
Singapore, Singapore, 258499
Tan Tock Seng Hospital /ID# 203159 Not yet recruiting
Singapore, Singapore, 308433
FNsP F.D.Roosevelta Banska Bys /ID# 169952 Recruiting
Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17
KM Management s.r.o. /ID# 170199 Not yet recruiting
Nitra, Slovakia, 949 01
Univ Medical Ctr Ljubljana /ID# 211042 Not yet recruiting
Ljubljana, Slovenia, 1000
South Africa
FARMOVS Integrated Research Solutions /ID# 207536 Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Lenasia Clinical Trial Centre /ID# 205144 Not yet recruiting
Johannesburg, Gauteng, South Africa, 1820
Wits Clinical Research Site /ID# 170851 Not yet 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
H. Un. Marques de Valdecilla /ID# 202039 Recruiting
Santander, Cantabria, Spain, 39008
Hospital Universitario y Politecnico La Fe /ID# 201988 Not yet recruiting
Valencia, Valenciana, Spain, 46026
Comple Hosp Univ de A Coruna /ID# 203908 Not yet recruiting
A Coruna, Spain, 15006
Hospital Clinic de Barcelona /ID# 171242 Recruiting
Barcelona, Spain, 08028
Vall d'Hebron University Hospi /ID# 171237 Not yet recruiting
Barcelona, Spain, 08035
Hosp Univ Girona Josep Trueta /ID# 202040 Not yet recruiting
Girona, Spain, 17007
Hospital Juan Ramon Jimenez /ID# 171243 Not yet recruiting
Huelva, Spain, 21005
Hospital Univ Dr. Negrin /ID# 171238 Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35010
Hospital Universitario La Paz /ID# 171241 Recruiting
Madrid, Spain, 28046
Hospital Univ. Son Espases /ID# 201997 Not yet recruiting
Palma de Mallorca, Spain, 07120
Complejo Hospitalario de Navar /ID# 202038 Not yet recruiting
Pamplona, Spain, 31008
Hospital Universitario Virgen Macarena /ID# 171240 Not yet recruiting
Sevilla, Spain, 41009
Alingsås lasarett /ID# 170838 Recruiting
Alingsås, Vastra Gotalands Lan, Sweden, 441 33
Södra Älvsborgs sjukhus /ID# 202889 Not yet recruiting
Borås, Vastra Gotalands Lan, Sweden, 504 55
Sahlgrenska US Gbg /ID# 169031 Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
Hallands sjukhus Halmstad /ID# 170840 Not yet recruiting
Halmstad, Sweden, 302 33
Inselspital, Universitaetsklin /ID# 171006 Not yet recruiting
Bern, Switzerland, 3010
Universitatsspital Zurich /ID# 170999 Recruiting
Zurich, Switzerland, CH-8091
National Taiwan University Hos /ID# 169789 Recruiting
Taipei, Taiwan, 10041
Chang Gung Memorial Hospital /ID# 169788 Recruiting
Taoyuan, Taiwan, 33305
Erciyes University Medical Fac /ID# 171321 Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Ankara Univ Medical Faculty /ID# 206412 Not yet recruiting
Ankara, Turkey, 6100
Inonu Universitesi Turgut Ozal /ID# 201267 Not yet recruiting
Battalgazi/malatya, Turkey, 44280
Mustafa Kemal University Medic /ID# 171318 Not yet recruiting
Hatay, Turkey, 31001
Istanbul University Cerrahpasa Medical Faculty /ID# 200280 Not yet recruiting
Istanbul, Turkey, 34098
Marmara University Medical Fac /ID# 171316 Not yet recruiting
Istanbul, Turkey, 34899
Sisli Etfal Train & Res Hosp /ID# 171317 Not yet recruiting
Sisli, Turkey, 34371
Medical Centre of OK!Clinic of International Institute of Clinical Trials /ID# 205479 Not yet recruiting
Kiev, Kyivska Oblast, Ukraine, 02091
Medical Centre CARDIOCOM /ID# 200265 Not yet recruiting
Kozyn, Kyivska Oblast, Ukraine, 08711
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 Not yet recruiting
Belfast, Antrim, United Kingdom, BT16 1RH
Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388 Not yet recruiting
Warrington, Cheshire West And Chester, United Kingdom, WA5 1QG
Kingston Hosp NHS Foundation /ID# 200648 Not yet recruiting
Kingston upon Thames, England, United Kingdom, KT2 7QB
Royal United Hospitals Bath /ID# 169084 Recruiting
Bath, United Kingdom, BA1 3NG
Queen Elizabeth Hospital - BIRMINGHAM /ID# 169080 Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Russells Hall Hospital, Dudley /ID# 169079 Not yet recruiting
Dudley, United Kingdom, DY1 2HQ
London North West Healthcare N /ID# 169078 Not yet recruiting
Harrow, United Kingdom, HA1 3UJ
Guy's and St Thomas NHS Founda /ID# 169081 Not yet recruiting
London, United Kingdom, SE1 7EH
King's College Hospital NHS /ID# 169082 Not yet recruiting
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS /ID# 205551 Recruiting
London, United Kingdom, SW17 0QT
Royal Victoria Infirmary, Newc /ID# 169085 Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
St. Helens and Knowsley Teach /ID# 209085 Not yet recruiting
Prescot, United Kingdom, L35 5DR
Stockport NHS foundation trust /ID# 208718 Not yet 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
Walverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie 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: February 12, 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.

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:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases