A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
FORTIFY
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
2 other identifiers
interventional
1,336
43 countries
466
Brief Summary
The study consists of 4 sub-studies, as follows:
- Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
- Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
- Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
- Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
- OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2018
Longer than P75 for phase_3
466 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 14, 2025
August 1, 2025
8.1 years
April 4, 2017
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.
Week 52
Sub-Study 1: Percentage of Participants With Endoscopic Response
Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Week 52
Sub-Study 3: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Up to Week 220
Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration
Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.
Up to Week 16
Sub-Study 4: Percentage of Participants who had no Potential Hazards
Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.
Up to Week 16
Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16
SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.
Up to Week 16
Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.
Up to Week 16
Secondary Outcomes (12)
Sub-Study 1: Percentage of Participants With Clinical Remission
Week 52
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
Week 52
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Week 52
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Week 52
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Week 52
- +7 more secondary outcomes
Other Outcomes (3)
Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Week 52
Sub-Study 2: Percentage of Participants With Endoscopic Response
Week 52
Sub-Study 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Up to Week 52
Study Arms (8)
Double-blind Placebo for Risankizumab (Sub-Study 1)
PLACEBO COMPARATORParticipants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Double-blind Risankizumab Dose 1 (Sub-Study 1)
EXPERIMENTALParticipants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Double-blind Risankizumab Dose 2 (Sub-Study 1)
EXPERIMENTALParticipants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Maintenance Risankizumab Dose 1 (Sub-Study 2)
EXPERIMENTALParticipants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Maintenance Risankizumab Dose 2 (Sub-Study 2)
EXPERIMENTALParticipants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Open-label Risankizumab (Sub-Study 3)
EXPERIMENTALParticipants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Risankizumab On-Body Injector and Open Label (Sub-Study 4)
EXPERIMENTALParticipants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
CTE: Open Label Continuous Treatment Extension
EXPERIMENTALParticipants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Interventions
Placebo for Risankizumab SC Subcutaneous (SC) Injection
Risankizumab IV Intravenous (IV) infusion
Placebo for Risankizumab IV Intravenous (IV) infusion
Risankizumab SC Subcutaneous (SC) injection
Subcutaneous (SC) injection; on-body injector (OBI)
Eligibility Criteria
You may qualify if:
- Participants who have entered and completed Study M16-006 or Study M15-991 or other AbbVie risankizumab Crohn's disease study.
- Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
- Sub-Study 4:
- Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
- Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).
You may not qualify if:
- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study that in the Investigator's judgment makes the participant unsuitable for this study.
- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or another AbbVie risankizumab Crohn's disease study.
- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (496)
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884
Mesa, Arizona, 85206, United States
Phoenix VA Health Care System /ID# 162264
Phoenix, Arizona, 85012, United States
Banner - University Medical Center Tucson /ID# 158502
Tucson, Arizona, 85719, United States
Atria Clinical Research /ID# 164505
Little Rock, Arkansas, 72209-7040, United States
Southern California Res. Ctr. /ID# 211991
Coronado, California, 92118-1408, United States
Duplicate_Newport Huntington Medical Group /ID# 213035
Huntington Beach, California, 92648, United States
UC San Diego Health Systems /ID# 155555
La Jolla, California, 92093, United States
United Medical Doctors /ID# 207888
Los Alamitos, California, 90720-3309, United States
TLC Clinical Research Inc /ID# 212719
Los Angeles, California, 90048, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
Los Angeles, California, 90067-2001, United States
United Medical Doctors - Murrieta /ID# 158300
Murrieta, California, 92563, United States
University of California San Francisco - Mission Bay /ID# 157127
San Francisco, California, 94158, United States
Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839
West Hollywood, California, 90048, United States
Peak Gastroenterology Associates, PC /ID# 165843
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Pediatric Gastroenterology /ID# 207170
Lone Tree, Colorado, 80124-6798, United States
Duplicate_Western Connecticut Medical Group /ID# 165879
Danbury, Connecticut, 06810, United States
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262
Brandon, Florida, 33510-3107, United States
South Lake Pain Institute, Inc /ID# 162808
Clermont, Florida, 34711, United States
Omega Research Maitland, LLC /ID# 171082
DeBary, Florida, 32713-2260, United States
Universal Axon Clinical Research /ID# 165428
Doral, Florida, 33166, United States
Nature Coast Clinical Research - Inverness /ID# 159408
Inverness, Florida, 34452-4717, United States
SIH Research Mumtaz, Inc /ID# 163083
Kissimmee, Florida, 34741-4161, United States
Alliance Medical Research /ID# 163837
Lighthouse PT, Florida, 33064, United States
Cfagi Llc /Id# 202479
Maitland, Florida, 32751-6108, United States
Sylvester Comprehensive Cancer Center /ID# 155007
Miami, Florida, 33136-1002, United States
Coral Research Clinic /ID# 158456
Miami, Florida, 33186-4643, United States
South Florida Research Ph I-IV, Inc. /ID# 161832
Miami, Florida, 33193, United States
Gastroenterology Group Naples /ID# 165204
Naples, Florida, 34102, United States
Advanced Research Institute, Inc /ID# 161966
New Port Richey, Florida, 34653, United States
Endoscopic Research, Inc. /ID# 205906
Orlando, Florida, 32803, United States
IMIC Inc. Medical Research /ID# 154942
Palmetto Bay, Florida, 33157, United States
Duplicate_Clinical Research of West Florida, Inc /ID# 208125
Tampa, Florida, 33606-1246, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 205865
Tampa, Florida, 33606, United States
Atlanta Gastro Assoc /ID# 154724
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 154850
Macon, Georgia, 31201, United States
Duplicate_Northwestern University /ID# 158261
Chicago, Illinois, 60611-2927, United States
The University of Chicago Medical Center /ID# 157124
Chicago, Illinois, 60637-1443, United States
NorthShore University-Endeavor Health Evanston Hospital /ID# 158265
Evanston, Illinois, 60201, United States
Southwest Gastroenterology /ID# 164781
Oak Lawn, Illinois, 60453, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 154722
Topeka, Kansas, 66606, United States
Duplicate_University of Kentucky Chandler Medical Center /ID# 157120
Lexington, Kentucky, 40536, United States
University of Louisville Hospital /ID# 210525
Louisville, Kentucky, 40202, United States
GI Alliance /ID# 161963
Baton Rouge, Louisiana, 70809, United States
Houma Digestive Health Special /ID# 158264
Houma, Louisiana, 70360, United States
Delricht Research /ID# 206644
New Orleans, Louisiana, 70115, United States
Nola Research Works, LLC /ID# 161317
New Orleans, Louisiana, 70115, United States
Louisiana Research Center, LLC /ID# 162237
Shreveport, Louisiana, 71105-6800, United States
Metropolitan Gastroenterology Group - Chevy Chase /ID# 154832
Chevy Chase, Maryland, 20815, United States
Gastro Center of Maryland /ID# 165001
Columbia, Maryland, 21045, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126
Ann Arbor, Michigan, 48109, United States
Clin Res Inst of Michigan, LLC /ID# 169179
Chesterfield, Michigan, 48047, United States
Center for Digestive Health /ID# 154683
Troy, Michigan, 48098-6363, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313
Wyoming, Michigan, 49519, United States
Mayo Clinic - Rochester /ID# 163086
Rochester, Minnesota, 55905-0001, United States
St. Louis University /ID# 161883
St Louis, Missouri, 63104, United States
University of Nebraska Medical Center /ID# 210058
Omaha, Nebraska, 68198-2000, United States
Vector Clinical Trials /ID# 160170
Las Vegas, Nevada, 89128-0435, United States
Revival Research Institute, Inc /ID# 210985
Las Vegas, Nevada, 89128-3157, United States
NY Scientific /ID# 158294
Brooklyn, New York, 11235, United States
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447
Burnt Hills, New York, 12027, United States
Intercity Advanced Gastroentertology Center /ID# 215205
Fresh Meadows, New York, 11366, United States
Duplicate_Northwell Health Division of Gastroenterology at Great Neck /ID# 168738
Great Neck, New York, 11021-5206, United States
NYU Langone Long Island Clinical Research Associates /ID# 154829
Lake Success, New York, 11042, United States
Digestive Disease Care /ID# 211777
New Hyde Park, New York, 11040, United States
NYU Langone Medical Center /ID# 160169
New York, New York, 10016-6402, United States
Weill Cornell Medicine /ID# 165878
New York, New York, 10022, United States
Icahn School of Medicine at Mount Sinai /ID# 165612
New York, New York, 10029, United States
Columbia Univ Medical Center /ID# 161899
New York, New York, 10032-3725, United States
Lenox Hill Hospital /ID# 168467
New York, New York, 10075, United States
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 171126
North Massapequa, New York, 11758, United States
Univ NC Chapel Hill /ID# 154833
Chapel Hill, North Carolina, 27514-4220, United States
Atrium Health Carolinas Medical Center /ID# 158428
Charlotte, North Carolina, 28203, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873
Raleigh, North Carolina, 27612, United States
Plains Clinical Research Center, LLC /ID# 169718
Fargo, North Dakota, 58104-5925, United States
Tri-State Endoscopy Center /ID# 154927
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Main Campus /ID# 209226
Cleveland, Ohio, 44195, United States
The Ohio State University /ID# 164708
Columbus, Ohio, 43210, United States
Optimed Research, Ltd. /ID# 167887
Columbus, Ohio, 43235, United States
Hometown Urgent Care and Resea /ID# 170464
Dayton, Ohio, 45424, United States
Great Lakes Gastroenterology Research, LLC /ID# 201770
Mentor, Ohio, 44060-6211, United States
Hightower Clinical /ID# 211993
Oklahoma City, Oklahoma, 73102, United States
Digestive Disease Specialists /ID# 170775
Oklahoma City, Oklahoma, 73112, United States
Adult Gastroenterology Associates - Gen 1 Research /ID# 208864
Tulsa, Oklahoma, 74136-7823, United States
Children's Hospital of Pittsburgh of UPMC /ID# 212544
Pittsburgh, Pennsylvania, 15224-1334, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 208297
Wyomissing, Pennsylvania, 19610, United States
Medical University of South Carolina /ID# 212858
Charleston, South Carolina, 29425, United States
Gastroenterology Associates, P.A. of Greenville /ID# 154904
Greenville, South Carolina, 29607, United States
Rapid City Medical Center - GI Research /ID# 163838
Rapid City, South Dakota, 57701, United States
Gastro One /ID# 154726
Cordova, Tennessee, 38018, United States
East Tennessee Research Institute /ID# 168739
Johnson City, Tennessee, 37604, United States
Clinical Neuroscience Solutions - Memphis /ID# 164180
Memphis, Tennessee, 38119, United States
Vanderbilt University Medical Center /ID# 157121
Nashville, Tennessee, 37232-0011, United States
TX Clinical Research Institute /ID# 159404
Arlington, Texas, 76012, United States
Inquest Clinical Research /ID# 165694
Baytown, Texas, 77521-2415, United States
Texas Digestive Disease Consultants /ID# 209946
Cedar Park, Texas, 78613-5028, United States
GI Alliance /ID# 209797
Cedar Park, Texas, 78613, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406
Dallas, Texas, 75246, United States
Duplicate_DHAT Research Institute /ID# 158208
Garland, Texas, 75044-2208, United States
Vilo Research Group Inc /ID# 207655
Houston, Texas, 77017-2337, United States
Baylor College of Medicine /ID# 158203
Houston, Texas, 77030, United States
Centex Studies, Inc. - Houston /ID# 201219
Houston, Texas, 77058, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 161323
San Antonio, Texas, 78212, United States
Southern Star Research Institute, LLC /ID# 168773
San Antonio, Texas, 78229-5390, United States
Baylor Scott & White Center for Diagnostic Medicine /ID# 204131
Temple, Texas, 76508, United States
Tyler Research Institute, LLC /ID# 166797
Tyler, Texas, 75701, United States
Gastro Health & Nutrition - Victoria /ID# 164290
Victoria, Texas, 77904, United States
Advanced Research Institute /ID# 154907
Ogden, Utah, 84405, United States
Velocity Clinical Research - Salt Lake City /ID# 161778
West Jordan, Utah, 84088, United States
Richmond VA Medical Center /ID# 159988
Richmond, Virginia, 23249, United States
Duplicate_Virginia Mason Medical Center /ID# 155556
Seattle, Washington, 98101, United States
West Virginia University Hospitals /ID# 167941
Morgantown, West Virginia, 26506, United States
Cemic /Id# 168078
Ciudad Autonoma Buenos Aires, Buenos Aires, 1431, Argentina
Hospital Britanico de Buenos Aires /ID# 168077
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280, Argentina
Hospital Provincial del Centenario /ID# 170886
Rosario, Santa Fe Province, 2000, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 168076
Córdoba, 5016, Argentina
Mater Misericordiae Limited /ID# 167220
South Brisbane, Queensland, 4101, Australia
Griffith University /ID# 212635
Southport, Queensland, 4222, Australia
Lyell McEwin Hospital /ID# 212215
Elizabeth Vale, South Australia, 5112, Australia
Emeritus Research /ID# 213512
Camberwell, Victoria, 3124, Australia
Universitaetsklinikum St. Poelten /ID# 166424
Sankt Pölten, Lower Austria, 3100, Austria
Medizinische Universitaet Graz /ID# 158140
Graz, Styria, 8010, Austria
Krankenhaus der Barmherzigen Brueder Wien /ID# 212060
Vienna, Vienna, 1020, Austria
Medizinische Universitaet Wien /ID# 158141
Vienna, Vienna, 1090, Austria
Grodno city clinical hospital #2 /ID# 205113
Hrodna, Grodnenskaya, 230011, Belarus
Gomel Regional Clinical Hospital /ID# 205112
Homyel, 246029, Belarus
Vitebsk Regional Advanced Clin /ID# 206778
Vitebsk, 210001, Belarus
Imelda Ziekenhuis /ID# 157403
Bonheiden, Antwerpen, 2820, Belgium
AZ Sint-Maarten /ID# 212876
Mechelen, Antwerpen, 2800, Belgium
ZAS Palfijn /ID# 212877
Merksem, Antwerpen, 2170, Belgium
Universite Libre de Bruxelles - Hopital Erasme /ID# 157408
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 157406
Brussels, Brussels Capital, 1200, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 157404
Liège, Liege, 4000, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 157412
Yvoir, Namur, 5530, Belgium
UZ Gent /ID# 157405
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 157407
Leuven, Vlaams-Brabant, 3000, Belgium
AZ-Delta /ID# 157402
Roeselare, West-Vlaanderen, 8800, Belgium
AZ Maria Middelares /ID# 213532
Ghent, 9000, Belgium
AZ Groeninge /ID# 211513
Kortrijk, 8500, Belgium
CHU de Liege /ID# 157409
Liège, 4000, Belgium
Klinicki centar Banja Luka /ID# 164513
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 165139
Sarajevo, 71000, Bosnia and Herzegovina
UMHAT Dr Georgi Stranski EAD /ID# 203976
Pleven, 5800, Bulgaria
Umbal Kaspela /ID# 165700
Plovdiv, 4001, Bulgaria
2nd Mhat /ID# 165702
Sofia, 1202, Bulgaria
Tokuda Hospital Sofia /ID# 165701
Sofia, 1407, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 204815
Sofia, 1431, Bulgaria
Duplicate_UMHAT Tsaritsa Joanna - ISUL /ID# 211242
Sofia, 1527, Bulgaria
MHAT Trakia /ID# 201668
Stara Zagora, 6004, Bulgaria
University of Calgary /ID# 157155
Calgary, Alberta, T2N 4Z6, Canada
Allen Whey Khye Lim Professional Corporation /ID# 169763
Edmonton, Alberta, T5R 1W2, Canada
University of Alberta Hospital /ID# 157099
Edmonton, Alberta, T6G 2B7, Canada
Covenant Health /ID# 161632
Edmonton, Alberta, T6K 4B2, Canada
Fraser Clinical Trials Inc /ID# 159055
New Westminster, British Columbia, V3L 3W4, Canada
Giri Gi Research Institute - Vancouver /ID# 157096
Vancouver, British Columbia, V5Z 2K5, Canada
Percuro Clinical Research, Ltd /ID# 161631
Victoria, British Columbia, V8V 3M9, Canada
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 157088
Halifax, Nova Scotia, B3H 2Y9, Canada
IWK Health Center /ID# 165905
Halifax, Nova Scotia, B3K 6R8, Canada
Medicor Research Inc /ID# 157150
Greater Sudbury, Ontario, P3A 1W8, Canada
Duplicate_Hamilton Health Sciences -McMaster University Medical Centre /ID# 157184
Hamilton, Ontario, L8S 4K1, Canada
London Health Sciences Center- University Hospital /ID# 157161
London, Ontario, N6A 5W9, Canada
Scott Shulman Medicine Professional Corporation /ID# 165906
North Bay, Ontario, P1B 2H3, Canada
Mount Sinai Hospital /ID# 169764
Toronto, Ontario, M5G 1X5, Canada
Toronto Digestive Disease Associates /ID# 157158
Vaughan, Ontario, L4L 4Y7, Canada
Hotel Dieu de Levis /ID# 214377
Lévis, Quebec, G6V 3Z1, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056
Montreal, Quebec, H1T 2M4, Canada
Montreal General Hospital- McGill University Health Center /ID# 157085
Montreal, Quebec, H3G 1A4, Canada
CISSS de la Monteregie Centre - Hopital Charles Le Moyne /ID# 161630
Greenfield Park, J4V 2H1, Canada
Hospital Guillermo Grant Benavente de Concepción /ID# 210760
Concepción, Bio-Bio, 4070038, Chile
Hospital Las Higueras /ID# 167092
Talcahuano, Bio-Bio, 1740000, Chile
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122
Santiago, Region Metropolitana Santiago, 8350488, Chile
Complejo Asistencial Dr. Sotero del Rio /ID# 169384
Santiago, Santiago Metropolitan, 8207257, Chile
Guangdong Provincial People's Hospital /ID# 212949
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 210784
Guangzhou, Guangdong, 510655, China
The Second Hospital of Hebei Medical University /ID# 212738
Shijiazhuang, Hebei, 050000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST /ID# 210858
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University /ID# 214874
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University /ID# 211700
Changsha, Hunan, 410011, China
The First Affiliated Hospital of Nanchang University /ID# 211036
Nanchang, Jiangxi, 330006, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840
Shanghai, Shanghai Municipality, 200065, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705
Shanghai, Shanghai Municipality, 200127, China
Shanghai East Hospital /ID# 212684
Shanghai, Shanghai Municipality, 200136, China
West China Hospital, Sichuan University /ID# 210890
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital /ID# 210926
Tianjin, Tianjin Municipality, 300052, China
The second affiliated hospital of Zhejiang University school of medicine /ID# 210724
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625
Hangzhou, Zhejiang, 310020, China
Jinhua Municipal Central Hospital /ID# 215628
Jinhua, Zhejiang, 321000, China
Instituto de Coloproctologia /ID# 158743
Medellín, Antioquia, 050024, Colombia
Hospital Pablo Tobón Uribe /ID# 158730
Medellín, Antioquia, 050034, Colombia
Hospital Universitario San Vic /ID# 171486
Medellín, Antioquia, 50010, Colombia
Hospital Univ San Ignacio /ID# 158734
Bogota, Cundinamarca, 110231, Colombia
Klinicka bolnica Dubrava Zagreb /ID# 157560
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 157728
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 157561
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Borzan d.o.o. /ID# 157559
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 157562
Split, Split-Dalmatia County, 21000, Croatia
Zadar General Hospital /ID# 157563
Zadar, 23000, Croatia
Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465
Prague, Praha 4, 140 00, Czechia
Iscare Klinické Centrum /ID# 225794
Prague, Praha 9, 190 00, Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 163225
Hradec Králové, 500 12, Czechia
Nemocnice Pardubickeho kraje, a.s. /ID# 163226
Pardubice, 530 03, Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306
Prague, 118 33, Czechia
Axon Clinical, s.r.o. /ID# 163223
Prague, 140 00, Czechia
Fakultni Thomayerova nemocnice /ID# 162941
Prague, 140 59, Czechia
ResTrial s.r.o. /ID# 211078
Prague, 143 00, Czechia
Nemocnice Horovice - NH Hospital a.s /ID# 211077
Prague, 155 00, Czechia
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530
Hvidovre, Capital Region, 2650, Denmark
Aarhus Universitetshospital - Skejby /ID# 155664
Aarhus, Central Jutland, 8200, Denmark
Roskilde Sygehus /ID# 155532
Roskilde, Region Sjælland, 4000, Denmark
Sygehusenheden Nyborg - OUH /ID# 161525
Nyborg, Region Syddanmark, 5800, Denmark
Odense University Hospital /ID# 155531
Odense, Region Syddanmark, 5000, Denmark
Alexandria University /ID# 157187
Alexandria, Alexandria Governorate, 21131, Egypt
Alexandria University /ID# 164540
Alexandria, Alexandria Governorate, 21131, Egypt
Zagazig University Hospitals /ID# 164539
Al Sharqia, 44519, Egypt
Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175
Cairo, 11559, Egypt
National Hepatology and Tropical Medicine Research Institute /ID# 157874
Cairo, 11559, Egypt
Duplicate_Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506
Cairo, 11566, Egypt
North Estonia Medical Centre /ID# 164326
Mustamäe, Harju, 13419, Estonia
West Tallinn Central Hospital /ID# 157075
Tallinn, Harju, 10617, Estonia
East Tallinn Central Hospital /ID# 157074
Tallinn, 10138, Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 162557
Nice, Alpes-Maritimes, 06202, France
Centre Hospitalier Universitaire de Bordeaux /ID# 162558
Pessac, Gironde, 33604, France
CHU Montpellier - Hopital Saint Eloi /ID# 215147
Montpellier, Herault, 34295, France
Duplicate_CHU Grenoble - Hopital Michallon /ID# 212834
La Tronche, Isere, 38700, France
CHRU Nancy - Hopitaux de Brabois /ID# 162561
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
CHRU Lille - Hopital Claude Huriez /ID# 162559
Lille, Nord, 59037, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 162562
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
HCL - Hopital Lyon Sud /ID# 162560
Pierre-Bénite, Rhone, 69495, France
CHU Amiens-Picardie Site Sud /ID# 165058
Amiens, Somme, 80054, France
CHRU Pontchaillou /ID# 213209
Rennes, 35033, France
Hopital Beaujon /ID# 166284
Clichy, Île-de-France Region, 92110, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249858
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Universitaetsklinikum Freiburg /ID# 162030
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Praxis fuer Gastroenterologie /ID# 166150
Heidelberg, Baden-Wurttemberg, 69121, Germany
Universitatsklinikum Mannheim /ID# 162031
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Ulm /ID# 164990
Ulm, Baden-Wurttemberg, 89081, Germany
Medizinisches Versorgunszentrum Dachau /ID# 211555
Dachau, Bavaria, 85221, Germany
Universitaetsklinikum Erlangen /ID# 159343
Erlangen, Bavaria, 91054, Germany
Duplicate_Agaplesion Markus Krankenhaus /ID# 159345
Frankfurt am Main, Hesse, 60431, Germany
Universitaetsklinikum Frankfurt /ID# 212979
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover /ID# 162032
Hanover, Lower Saxony, 30625, Germany
Klinikum Lueneburg /ID# 163678
Lüneburg, Lower Saxony, 21339, Germany
Universitaetsklinikum Koeln /ID# 164989
Cologne, North Rhine-Westphalia, 50937, Germany
Evangelisches Krankenhaus Kalk /ID# 212726
Cologne, North Rhine-Westphalia, 51103, Germany
Praxiszentrum fuer Gastroenterologie /ID# 211966
Grevenbroich, North Rhine-Westphalia, 41515, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029
Minden, North Rhine-Westphalia, 32423, Germany
Universitaetsklinikum Muenster /ID# 159344
Münster, North Rhine-Westphalia, 48149, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528
Saarbrücken, Saarland, 66111, Germany
Eugastro /ID# 212078
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Jena /ID# 159351
Jena, Thuringia, 07747, Germany
Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220
Berlin, 10117, Germany
Duplicate_Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894
Berlin, 10117, Germany
Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974
Berlin, 10787, Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350
Berlin, 10825, Germany
DRK Kliniken Berlin Westend /ID# 166151
Berlin, 14050, Germany
Krankenhaus Waldfriede /ID# 212727
Berlin-Zehlendorf, 14163, Germany
Stadtisches Klinikum Braunschweig /ID# 163680
Braunschweig, 38126, Germany
Universitaetsklinikum Magdeburg /ID# 211843
Magdeburg, 39120, Germany
Universitaetsklinikum Regensburg /ID# 163813
Regensburg, 93042, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914
Athens, Attica, 11527, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 157424
Nikaia, Attica, 18454, Greece
Tzaneio general hospital of Piraeus /ID# 206443
Piraeus, Attica, 18536, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 157422
Heraklion, Crete, 71500, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423
Athens, 10676, Greece
University General Hospital of Ioannina /ID# 157420
Ioannina, 45500, Greece
Theageneio Anticancer Hospital /ID# 163897
Thessaloniki, 54639, Greece
Queen Mary Hospital /ID# 163923
Hong Kong, 999077, Hong Kong
Tuen Mun Hospital /ID# 163905
Hong Kong, Hong Kong
Duplicate_Beaumont Hospital /ID# 157543
Beaumont, Dublin, D09 XR63, Ireland
St Vincent's University Hospital /ID# 157540
Elm Park, Dublin, D04 T6F4, Ireland
University Hospital Galway /ID# 157541
Galway, H91 YR71, Ireland
Shaare Zedek Medical Center /ID# 163541
Jerusalem, Jerusalem, 91031, Israel
Shaare Zedek Medical Center /ID# 171068
Jerusalem, Jerusalem, 91031, Israel
Hadassah Medical Center-Hebrew University /ID# 165914
Jerusalem, Jerusalem, 91120, Israel
The Edith Wolfson Medical Center /ID# 217331
Ashkelon, Southern District, 5822000, Israel
Soroka University Medical Center /ID# 157794
Beersheba, Southern District, 8443901, Israel
The Chaim Sheba Medical Center /ID# 157793
Ramat Gan, Tel Aviv, 5265601, Israel
The Chaim Sheba Medical Center /ID# 171069
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 157792
Tel Aviv, Tel Aviv, 6423906, Israel
Duplicate_Rambam Medical Center /ID# 171067
Haifa, 3109601, Israel
Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436
Torrette, Ancona, 60123, Italy
Duplicate_Ospedale Policlinico San Martino /ID# 162439
Genoa, Genova, 16132, Italy
IRCCS Istituto Clinico Humanitas /ID# 155642
Rozzano, Lombardy, 20089, Italy
ASST Fatebenefratelli Sacco /ID# 155639
Milan, Milano, 20157, Italy
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227
Rho, Milano, 20017, Italy
Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438
Rome, Roma, 00128, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158022
Rome, Roma, 00133, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 155644
Rome, Roma, 00149, Italy
Duplicate_Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912
Rome, Roma, 00161, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640
Rome, Roma, 00168, Italy
Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992
Florence, Tuscany, 50139, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299
Negrar, Verona, 37024, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 155643
Bologna, 40138, Italy
Ospedale Cannizzaro /ID# 161300
Catania, 95126, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 212016
Catanzaro, 88100, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 155641
Milan, 20122, Italy
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028
Modena, 41124, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 155645
Palermo, 90146, Italy
Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031
Pavia, 27100, Italy
Aichi Medical University Hospital /ID# 160097
Nagakute, Aichi-ken, 480-1195, Japan
Daido Clinic - Nagoya /ID# 211476
Nagoya, Aichi-ken, 457-8511, Japan
Nagoya University Hospital /ID# 160116
Nagoya, Aichi-ken, 466-8560, Japan
Nagoya City University Hospital /ID# 160100
Nagoya, Aichi-ken, 467-8602, Japan
Duplicate_Fujita Health University Hospital /ID# 163234
Toyoake-shi, Aichi-ken, 470-1192, Japan
Tokatsu Tsujinaka Hospital /ID# 163352
Abiko-shi, Chiba, 270-1168, Japan
Duplicate_Chiba University Hospital /ID# 217533
Chiba, Chiba, 260-8677, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 213848
Kashiwa-shi, Chiba, 277-0871, Japan
The Jikei University Kashiwa Hospital /ID# 200030
Kashiwa-shi, Chiba, 277-8567, Japan
Toho University Sakura Medical Center /ID# 160099
Sakura-shi, Chiba, 285-8741, Japan
Fukuoka University Hospital /ID# 217793
Fukuoka, Fukuoka, 814-0180, Japan
Kurume University Hospital /ID# 160106
Kurume-shi, Fukuoka, 830-0011, Japan
National Hospital Organization Fukuyama Medical Center /ID# 163577
Fukuyama-shi, Hiroshima, 720-8520, Japan
Hiroshima University Hospital /ID# 160109
Hiroshima, Hiroshima, 734-8551, Japan
Duplicate_Asahikawa Medical University Hospital /ID# 162848
Asahikawa-shi, Hokkaido, 078-8510, Japan
Sapporo Tokushukai Hospital /ID# 213492
Sapporo, Hokkaido, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096
Sapporo, Hokkaido, 060-0033, Japan
Sapporo Medical University Hospital /ID# 163056
Sapporo, Hokkaido, 060-8543, Japan
Nishinomiya Municipal Central Hospital /ID# 210103
Nishinomiya-shi, Hyōgo, 663-8014, Japan
Hyogo Medical University Hospital /ID# 160107
Nishinomiya-shi, Hyōgo, 663-8501, Japan
NHO Mito Medical Center /ID# 160092
Higashiibaraki-gun, Ibaraki, 311-3193, Japan
Kanazawa University Hospital /ID# 202258
Kanazawa, Ishikawa-ken, 920-8641, Japan
Gokeikai Ofuna Chuo Hospital /ID# 171066
Kamakura-shi, Kanagawa, 247-0056, Japan
Kitasato University Hospital /ID# 171065
Sagamihara-shi, Kanagawa, 252-0375, Japan
Duplicate_Yokohama Municipal Citizen's Hospital /ID# 207161
Yokohama, Kanagawa, 221-0855, Japan
Duplicate_Yokohama City University Medical Center /ID# 163907
Yokohama, Kanagawa, 232-0024, Japan
Mie University Hospital /ID# 203640
Tsu, Mie-ken, 514-8507, Japan
Yokkaichi Hazu Medical Center /ID# 163764
Yokkaichi-shi, Mie-ken, 510-0016, Japan
Tohoku University Hospital /ID# 162847
Sendai, Miyagi, 9808574, Japan
Tohoku Rosai Hospital /ID# 163229
Sendai, Miyagi, 981-8563, Japan
Osaka Metropolitan University Hospital /ID# 160117
Osaka, Osaka, 545-8586, Japan
Saitama Medical Center /ID# 160093
Kawagoe, Saitama, 350-8550, Japan
Tokitokai Tokito clinic /ID# 160110
Saitama-shi, Saitama, 336-0963, Japan
Shiga University of Medical Science Hospital /ID# 164025
Ōtsu, Shiga, 520-2192, Japan
Hamamatsu University Hospital /ID# 205690
Hamamatsu, Shizuoka, 431-3192, Japan
NHO Shizuoka Medical Center /ID# 163057
Sunto-gun, Shizuoka, 411-8611, Japan
Institute of Science Tokyo Hospital /ID# 160095
Bunkyo-ku, Tokyo, 113-8519, Japan
Tokai University Hachioji Hospital /ID# 160098
Hachioji-shi, Tokyo, 192-0032, Japan
The Jikei University Hospital /ID# 163209
Minato-ku, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital /ID# 160105
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital /ID# 160114
Mitaka-shi, Tokyo, 181-8611, Japan
Tokyo Women's Medical University Hospital /ID# 205974
Shinjuku-ku, Tokyo, 162-8666, Japan
Wakayama Medical University Hospital /ID# 202561
Wakayama, Wakayama, 641-8510, Japan
Yamagata University Hospital /ID# 200159
Yamagata, Yamagata, 990-9585, Japan
Yamanashi Prefectural Central Hospital /ID# 160094
Kofu, Yamanashi, 400-8506, Japan
VCA Polyclinic Aura /ID# 159611
Riga, 1035, Latvia
Pauls Stradins Clinical University Hospital /ID# 159612
Riga, LV-1002, Latvia
Duplicate_Digestive Disease Center Gastro /ID# 163107
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583
Kaunas, 50161, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 162514
Vilnius, 08661, Lithuania
Universiti Sains Malaysia /ID# 160666
Kelantan, Kelantan, 16150, Malaysia
Queen Elizabeth Hospital /ID# 160664
Division Pantai Barat Utara, Sabah, 88200, Malaysia
Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363
Kuala Lumpur, Selangor, 56000, Malaysia
Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734
Zapopan, Jalisco, 45070, Mexico
JM Research SC /ID# 170729
Cuernavaca, Morelos, 62290, Mexico
Unidad de Atencion Medica e Investigacion en Salud /ID# 170732
Mérida, Yucatán, 97000, Mexico
Health Pharma Professional Research S.A de C.V /ID# 170730
Del. Benito Juárez, 03810, Mexico
Elisabeth Tweesteden Ziekenhuis /ID# 163632
Tilburg, North Brabant, 5022 GC, Netherlands
Amsterdam UMC, locatie AMC /ID# 157956
Amsterdam, North Holland, 1105 AZ, Netherlands
Aotearoa Clinical Trials /ID# 167226
Papatoetoe, Auckland, 2025, New Zealand
Christchurch Hospital. /ID# 167224
Christchurch, Canterbury, 8011, New Zealand
Dunedin Hospital /ID# 167227
Otago, Otago, 9016, New Zealand
Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225
Wellington, 6021, New Zealand
Duplicate_Vestre viken - Baerum Sykehus /ID# 212996
Gjettum, Akershus, 1346, Norway
Akershus Universitetssykehus /ID# 169379
Nordbyhagen, Akershus, 1474, Norway
Helse More og Romsdal HF, Alesund sjukehus /ID# 212810
Ålesund, Møre og Romsdal, 6017, Norway
Sykehuset Levanger Helse NT /ID# 201669
Levanger, Nord-Trondelag, 7601, Norway
Solumed Centrum Medyczne /ID# 163569
Poznan, Greater Poland Voivodeship, 60-529, Poland
Gastromed Sp. z o.o /ID# 212476
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Duplicate_Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocl /ID# 212601
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Planetmed Sp. z o.o. /ID# 202799
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940
Lublin, Lublin Voivodeship, 20-049, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie /ID# 210941
Lublin, Lublin Voivodeship, 20-954, Poland
Centrum Zdrowia MDM /ID# 163570
Warsaw, Masovian Voivodeship, 00-189, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 163582
Warsaw, Masovian Voivodeship, 02-507, Poland
Vivamed Sp. z o.o. /ID# 202800
Warsaw, Masovian Voivodeship, 03-580, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580
Warsaw, Masovian Voivodeship, 04-730, Poland
Centrum Medycznym Medyk /ID# 212891
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Centrum Medyczne Lukamed Sp. z o.o. /ID# 212478
Chojnice, Pomeranian Voivodeship, 89-600, Poland
H-T Centrum Medyczne Endoterapia /ID# 212475
Tychy, Silesian Voivodeship, 43-100, Poland
Wojewódzki Szpital Specjalistyczny W Olsztynie /ID# 212474
Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477
Lodz, Łódź Voivodeship, 90-153, Poland
Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737
Guimarães, Braga District, 4835-044, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752
Portimão, Faro District, 8500-338, Portugal
Centro Hospitalar de Entre Douro e Vouga /ID# 160672
Santa Maria DA Feira, Porto District, 4520-211, Portugal
Duplicate_Hospital Garcia de Orta, EPE /ID# 160745
Almada, Setúbal District, 2805-267, Portugal
Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713
Faro, 8000-386, Portugal
Centro Hospitalar de Lisboa Central /ID# 160673
Lisbon, 1169-050, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751
Lisbon, 1349-019, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 160692
Lisbon, 1649-035, Portugal
Hospital de Loures, E.P.E /ID# 207759
Loures, 2674-514, Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 160693
Porto, 4200-319, Portugal
Centro Hosp de Tondela-Viseu /ID# 160699
Viseu, 3504-509, Portugal
Fundeni Clinical Institute /ID# 170899
Bucharest, 022328, Romania
Tvm Med Serv Srl /Id# 170902
Cluj-Napoca, 400132, Romania
Cabinet Particular Policlinic Algomed /ID# 170900
Timișoara, 300002, Romania
Duplicate_Centrul Medical Tuculanu SRL /ID# 170903
Timișoara, 300168, Romania
Kuzbass Regional Clinical Hospital /ID# 200962
Kemerovo, Kemerovo Oblast, 650099, Russia
Novosibirski Gastrocenter /ID# 217552
Novosibirsk, Novosibirsk Oblast, 630007, Russia
Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439
Perm, Permskiy Kray, 614990, Russia
Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978
Saint Petersburg, Sankt-Peterburg, 194100, Russia
Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970
Stavropol, Stavropol Kray, 355012, Russia
Tver Regional Clinical Hospital /ID# 206858
Tver', Tver Oblast, 170036, Russia
Regional Clinical Hospital #1 /ID# 200973
Tyumen, Tyumen Oblast, 625023, Russia
Alliance Biomedical Ural Group /ID# 200972
Izhevsk, Udmurtiya Republic, 426061, Russia
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808
Moscow, 123423, Russia
City Clinical Hospital No. 31 /ID# 208872
Saint Petersburg, 197110, Russia
Ulyanovsk Regional Clinical Hospital /ID# 200964
Ulyanovsk, 432017, Russia
Clinical Hosp Center Zvezdara /ID# 157052
Belgrade, Beograd, 11000, Serbia
Military Medical Academy /ID# 157053
Belgrade, Beograd, 11000, Serbia
University Children's Hospital 'Tirsova' /ID# 211482
Belgrade, Beograd, 11000, Serbia
University Clinical Center Serbia /ID# 157047
Belgrade, Beograd, 11000, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799
Belgrade, Beograd, 11040, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 157050
Belgrade, Beograd, 11080, Serbia
General Hospital Leskovac /ID# 209575
Leskovac, Jablanicki Okrug, 16000, Serbia
Duplicate_University Clinical Center Kragujevac /ID# 157049
Kragujevac, Sumadijski Okrug, 34000, Serbia
University Clinical Center Vojvodina /ID# 157046
Novi Sad, 21000, Serbia
Mount Elizabeth Hospital /ID# 205741
Singapore, Central Singapore, 228510, Singapore
National University Hospital /ID# 160667
Singapore, 119074, Singapore
Singapore General Hospital /ID# 160668
Singapore, 169608, Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468
Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia
KM Management, spol. s.r.o. /ID# 206764
Nitra, Nitra Region, 949 01, Slovakia
Gastro I., s.r.o. /ID# 156469
Prešov, Presov, 080 01, Slovakia
Clinresco Centers /ID# 163865
Johannesburg, Gauteng, 1619, South Africa
Wits Clinical Research /ID# 158114
Johannesburg, Gauteng, 1864, South Africa
Private Practice Dr MN Rajabally /ID# 163112
Cape Town, Western Cape, 7800, South Africa
Spoke Research Inc /ID# 158116
CAPE TOWN Milnerton, Western Cape, 7441, South Africa
Inje University Haeundae Hospital /ID# 202518
Busan, Busan Gwang Yeogsi, 48108, South Korea
Dong-A University Medical Center /ID# 158699
Busan, Busan Gwang Yeogsi, 49201, South Korea
Pusan National University Hospital /ID# 158695
Busan, Busan Gwang Yeogsi, 49241, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 213554
Daejeon, Daejeon Gwang Yeogsi, 34943, South Korea
Hanyang University Guri Hospital /ID# 158690
Guri-si, Gyeonggido, 11923, South Korea
Duplicate_CHA University Bundang Medical Center /ID# 158698
Seongnam-si, Gyeonggido, 13496, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 158693
Suwon, Gyeonggido, 16247, South Korea
Kangbuk Samsung Hospital /ID# 158694
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Asan Medical Center /ID# 158696
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 158692
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Yeungnam University Medical Center /ID# 158691
Daegu, 42415, South Korea
Yonsei University Health System Severance Hospital /ID# 158689
Seoul, 03722, South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553
Ferrol, A Coruna, 15405, Spain
Hospital Universitari de Bellvitge /ID# 208207
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 157573
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Basurto /ID# 205190
Bilbao, Vizcaya, 48013, Spain
Hospital Clinic de Barcelona /ID# 157552
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Maranon /ID# 161145
Madrid, 28007, Spain
Hospital Universitario La Paz /ID# 159235
Madrid, 28046, Spain
Hospital Universitario de Salamanca /ID# 157558
Salamanca, 37711, Spain
Hospital Universitario Virgen Macarena /ID# 159967
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia /ID# 209700
Valencia, 46010, Spain
Hospital Universitario y Politecnico La Fe /ID# 157556
Valencia, 46026, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 212525
Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet /ID# 157557
Zaragoza, 50009, Spain
Skane University hospital /ID# 211745
Malmo, Skåne County, 214 28, Sweden
Karolinska University Hospital Solna /ID# 212025
Solna, Stockholm County, 171 64, Sweden
GHP Stockholm Gastro Center /ID# 211748
Stockholm, Stockholm County, 114 28, Sweden
Medicinkliniken, Gastroenheten /ID# 163744
Stockholm, Stockholm County, 116 28, Sweden
Danderyd Hospital /ID# 202138
Stockholm, Stockholm County, 182 88, Sweden
Duplicate_Sahlgrenska University Hospital /ID# 163792
Gothenburg, Västra Götaland County, 413 45, Sweden
Duplicate_Sahlgrenska University Hospital /ID# 163797
Gothenburg, Västra Götaland County, 413 46, Sweden
University Hospital Basel /ID# 164554
Basel Town, Canton of Basel-City, 4031, Switzerland
University Hospital Zurich /ID# 163536
Zurich, Canton of Zurich, 8006, Switzerland
Inselspital, Universitaetsspital Bern /ID# 163535
Bern, 3010, Switzerland
National Taiwan University Hospital /ID# 162190
Taipei City, Taipei, 100, Taiwan
China Medical University Hospital /ID# 160141
Taichung, 40447, Taiwan
Taichung Veterans General Hospital /ID# 160140
Taichung, 40705, Taiwan
National Cheng Kung University Hospital /ID# 160142
Tainan, 704, Taiwan
Taipei Veterans General Hosp /ID# 212712
Taipei, 11217, Taiwan
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658
Lviv, Lviv Oblast, 79000, Ukraine
MNE Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216474
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
University Hospital of M.I. Pyrogov VNMU /ID# 212000
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
ME Volyn Regional Clinical Hospital of Volyn Regional Council /ID# 206789
Lutsk, Volyn Oblast, 43005, Ukraine
Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960
Uzhhorod, Zakarpattia Oblast, 88018, Ukraine
Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657
Kharkiv, 61037, Ukraine
Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399
Kherson, 73000, Ukraine
Kyiv City Clinical Hospital No.18 /ID# 162531
Kyiv, 01030, Ukraine
Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 211998
Kyiv, 02091, Ukraine
Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659
Kyiv, 02232, Ukraine
Medical Center of LLC Medbud-Clinic /ID# 216998
Kyiv, 03037, Ukraine
Kyiv Railway Clinical Hosp No.2 /ID# 217366
Kyiv, 03049, Ukraine
Addenbrooke's Hospital /ID# 158034
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 157544
Exeter, Devon, EX2 5DW, United Kingdom
Hull University Teaching Hospitals NHS Trust /ID# 158761
Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom
Western General Hospital - NHS Lothian /ID# 207448
Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom
Gartnavel General Hospital /ID# 202568
Glasgow, Glasgow City, G12 0YN, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 163713
London, Greater London, E1 2ES, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 157546
London, Greater London, SE1 9RT, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 158036
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936
Chertsey, Surrey, KT16 0PZ, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 157550
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Barnsley Hospital NHS Foundation Trust /ID# 202773
Barnsley, S75 2EP, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 157545
Birmingham, B15 2TH, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust /ID# 209570
Huddersfield, HX3 0PW, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 158760
London, SE5 9RS, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708
Newcastle upon Tyne, NE3 3HD, United Kingdom
Northern Care Alliance NHS Group /ID# 207766
Salford, M6 8HD, United Kingdom
Related Publications (8)
Panaccione R, Ferrante M, Dotan I, Panes J, Hisamatsu T, Bossuyt P, Danese S, Song A, Kalabic J, Joshi N, Zambrano J, Zhang Y, Duan WR, Kligys K, Dubinsky MC, Lindsay JO, Vermeire S, Siegmund B, Irving PM, D'Haens G. Extended Risankizumab Treatment in Patients With Crohn's Disease Who Did Not Achieve Clinical Response to Induction Treatment. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2012-2022.e6. doi: 10.1016/j.cgh.2024.12.023. Epub 2025 Feb 3.
PMID: 39909280DERIVEDFeagan BG, Colombel JF, Panaccione R, Schreiber S, Ferrante M, Kamikozuru K, Ma C, Lee WJ, Griffith J, Joshi N, Kligys K, Kalabic J, Xuan S, Dubinsky M. Early Endoscopic Outcomes After Risankizumab Are Associated With Fewer Hospitalizations and Surgeries in Crohn's Disease. Gastro Hep Adv. 2024 Sep 5;4(1):100544. doi: 10.1016/j.gastha.2024.08.022. eCollection 2025.
PMID: 39802486DERIVEDAtreya R, Ferrante M, Panaccione R, Feagan B, Shchukina O, Jairath V, Rieder F, Hisamatsu T, Siegmund B, Kligys K, Song A, Zambrano J, Mallick M, Zhang Y, Armuzzi A, D'Haens G. Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies. J Crohns Colitis. 2025 Apr 4;19(4):jjae164. doi: 10.1093/ecco-jcc/jjae164.
PMID: 39485390DERIVEDPeyrin-Biroulet L, Colombel JF, Louis E, Ferrante M, Motoya S, Panaccione R, Torres J, Ungaro RC, Kligys K, Kalabic J, Zambrano J, Zhang Y, D'Haens G. Shorter Crohn's Disease Duration Is Associated With Better Clinical and Endoscopic Outcomes With Risankizumab in Phase 3 Studies. Gastro Hep Adv. 2024 Mar 7;3(4):539-550. doi: 10.1016/j.gastha.2024.02.008. eCollection 2024.
PMID: 39131711DERIVEDFerrante M, Irving PM, Abreu MT, Axler J, Gao X, Cao Q, Fujii T, Rausch A, Torres J, Neimark E, Song A, Wallace K, Kligys K, Berg S, Liao X, Zhou Q, Kalabic J, Feagan B, Panaccione R. Maintenance Risankizumab Sustains Induction Response in Patients with Crohn's Disease in a Randomized Phase 3 Trial. J Crohns Colitis. 2024 Mar 1;18(3):416-423. doi: 10.1093/ecco-jcc/jjad168.
PMID: 37797293DERIVEDDubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
PMID: 37368103DERIVEDLoftus EV Jr, Griffith J, Neimark E, Song A, Wallace K, Nannapaneni S, Zhou J, Byrne R, Kligys K, Pang Y, Liao X, Kalabic J, Dubinsky M. Efficacy, Safety, Patient Experience, and Tolerability of Risankizumab Administered by On-Body Injector for Moderate to Severe Crohn's Disease. Adv Ther. 2023 May;40(5):2311-2325. doi: 10.1007/s12325-023-02477-2. Epub 2023 Mar 14.
PMID: 36917429DERIVEDFerrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.
PMID: 35644155DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 7, 2017
Study Start
April 9, 2018
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.