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A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors (HICKORY)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100696
Recruitment Status : Active, not recruiting
First Posted : April 1, 2014
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Etrozulimab Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 609 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Actual Study Start Date : May 21, 2014
Estimated Primary Completion Date : April 24, 2020
Estimated Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: Etrolizumab (Open-Label Induction Phase)
Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.
Drug: Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Other Names:
  • PRO145223
  • RO5490261
  • RG7413

Experimental: Cohort 2: Etrolizumab (Double-Blind Induction Phase)
Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
Drug: Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Other Names:
  • PRO145223
  • RO5490261
  • RG7413

Placebo Comparator: Cohort 2: Placebo (Double-Blind Induction Phase)
Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
Drug: Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Experimental: Etrolizumab Responders: Etrolizumab (Maintenance Phase)
Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.
Drug: Etrozulimab
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Other Names:
  • PRO145223
  • RO5490261
  • RG7413

Placebo Comparator: Etrolizumab Responders: Placebo (Maintenance Phase)
Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.
Drug: Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.

Placebo Comparator: Placebo Responders: Placebo (Maintenance Phase)
Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.
Drug: Placebo
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.




Primary Outcome Measures :
  1. Induction Phase: Percentage of Participants with Remission at Week 14, as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 14 ]
  2. Maintenance Phase: Percentage of Participants with Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]

Secondary Outcome Measures :
  1. Induction Phase: Percentage of Participants with Clinical Remission at Week 14, as Determined by the MCS [ Time Frame: Week 14 ]
  2. Induction Phase: Percentage of Participants with Clinical Response at Week 14, as Determined by the MCS [ Time Frame: Week 14 ]
  3. Induction Phase: Percentage of Participants with Improvement from Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore [ Time Frame: Baseline and Week 14 ]
  4. Induction Phase: Percentage of Participants with Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore [ Time Frame: Week 14 ]
  5. Induction Phase: Percentage of Participants with Histologic Remission at Week 14, as Determined by the Nancy Histological Index [ Time Frame: Week 14 ]
  6. Induction Phase: Change from Baseline to Week 6 in MCS Rectal Bleed Subscore [ Time Frame: Baseline and Week 6 ]
  7. Induction Phase: Change from Baseline to Week 6 in MCS Stool Frequency Subscore [ Time Frame: Baseline and Week 6 ]
  8. Induction Phase: Change from Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire [ Time Frame: Baseline and Week 14 ]
  9. Induction Phase: Change from Baseline to Week 14 in UC Abdominal Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 14 ]
  10. Induction Phase: Change from Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline and Week 14 ]
  11. Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
  12. Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66, as Determined by the MCS [ Time Frame: Week 66 ]
  13. Maintenance Phase: Percentage of Participants with Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
  14. Maintenance Phase: Percentage of Participants with Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore [ Time Frame: Baseline and Week 66 ]
  15. Maintenance Phase: Percentage of Participants with Histologic Remission at Week 66, as Determined by the Nancy Histological Index [ Time Frame: Week 66 ]
  16. Maintenance Phase: Percentage of Participants with Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore [ Time Frame: Week 66 ]
  17. Maintenance Phase: Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Week 66 ]
  18. Maintenance Phase: Percentage of Participants with Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Week 66 ]
  19. Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 66 ]
  20. Maintenance Phase: Change From Baseline to Week 66 in UC Abdominal Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 66 ]
  21. Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ [ Time Frame: Baseline and Week 66 ]
  22. Number of Participants with at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE v4.0) [ Time Frame: From Baseline up to Week 78 ]
  23. Number of Participants with Adverse Events Leading to Study Drug Discontinuation [ Time Frame: From Baseline up to Week 78 ]
  24. Number of Participants with Serious Infection-Related Adverse Events [ Time Frame: From Baseline up to Week 78 ]
  25. Number of Participants with Infection-Related Adverse Events by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 78 ]
  26. Number of Participants with Injection-Site Reactions by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 78 ]
  27. Number of Participants with Hypersensitivity Reaction Events by Severity, According to NCI-CTCAE v4.0 [ Time Frame: From Baseline up to Week 78 ]
  28. Number of Participants with Malignancies [ Time Frame: From Baseline up to Week 78 ]
  29. Number of Participants with Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study [ Time Frame: Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78) ]
  30. Etrolizumab Serum Trough Concentration [ Time Frame: Pre-dose at Baseline, Weeks 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78) ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of UC established at least 3 months prior to Day 1
  • Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
  • Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
  • Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
  • Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
  • Use of highly effective contraception as defined by the protocol
  • Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
  • Prior or planned surgery for UC
  • Past or present ileostomy or colostomy
  • Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
  • Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
  • Any prior treatment with rituximab
  • Any treatment with tofacitinib during screening
  • Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
  • Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
  • Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
  • History of recurrent opportunistic infections and/or severe disseminated viral infections
  • History of organ transplant
  • Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
  • Received a live attenuated vaccine within 4 weeks prior to Day 1

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100696


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92093-5354
Gastrointestinal Bioscience
Los Angeles, California, United States, 90067
Orange County Institute of Gastroenterology & Endoscopy
Mission Viejo, California, United States, 92691
Sutter Gould Medical Foundation
Modesto, California, United States, 95355
Community Clinical Trials
Orange, California, United States, 92868
Sutter Institute for Medical Research
Roseville, California, United States, 95661
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
Precision Research Institute, LLC
San Diego, California, United States, 92114
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
University of California at San Francisco
San Francisco, California, United States, 94115
Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri
San Francisco, California, United States, 94158
Santa Monica Research Institute
Santa Monica, California, United States, 90404
ABS Health, LLC
Whittier, California, United States, 90602
United States, Colorado
Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Gastroenterology Associates
Denver, Colorado, United States, 80222
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
Lakewood, Colorado, United States, 80215
United States, Connecticut
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
United States, Florida
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States, 33180
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States, 33762
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Center for Advanced Gastroenterology
Maitland, Florida, United States, 32751
FQL Research, LLC
Miramar, Florida, United States, 33025
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Advanced Research Institute
New Port Richey, Florida, United States, 34653
Med-Care Research
North Miami Beach, Florida, United States, 33162
Center For Digestive Health
Orlando, Florida, United States, 32803
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Agile Clinical Research Trials
Atlanta, Georgia, United States, 30328
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
Carle Foundation
Urbana, Illinois, United States, 61801
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202-1798
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
United States, Massachusetts
Massachusetts General Hospital; Crohn's & Colitis Center
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Minnesota
Regents of the University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Research Institute, LLC
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
United States, New Jersey
Allied Gastrointestinal Associates, PA
Voorhees, New Jersey, United States, 08043
United States, New York
Northwell Health
Great Neck, New York, United States, 11021
Concorde Medical Group
New York, New York, United States, 10016
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States, 10016
Weill Cornell Brain & Spine Center
New York, New York, United States, 10021
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Asheville Gastroenterology Associates, P.A.; Gastroenterology
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States, 28207
Atlantic Medical Group
Kinston, North Carolina, United States, 28501
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States, 28144
United States, Ohio
Consultants for Clinical Research Inc.; Fairfield Office
Cincinnati, Ohio, United States, 45014
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
Consultants for Clinical Research Inc.; Cornell Office
Cincinnati, Ohio, United States, 45249
UC Health, LLC.
Cincinnati, Ohio, United States, 45267
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73012
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
St Lukes Health Network
Bethlehem, Pennsylvania, United States, 18015
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Pioneer Research Solutions
Houston, Texas, United States, 077099
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Utah
Ericksen Research and Development
Clinton, Utah, United States, 84015
Advanced Research Institute
Ogden, Utah, United States, 84405
University of Utah School of Medicine; Psychiatry
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia; Gastroenterology and Hepatology
Charlottesville, Virginia, United States, 22908
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, United States, 23502
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States, 23249
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
University of Washington / Harborview Medical Center; University of Washington
Seattle, Washington, United States, 98104
The Vancouver Clinic; Internal Medicine
Vancouver, Washington, United States, 98664-4896
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226-3596
Argentina
Hospital Privado de Comunidad; Cardiology
Mar Del Plata, Argentina, B7602CBM
Hospital Provincial del Centenario
Rosario, Argentina, 2000
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Argentina, 2000
Australia, New South Wales
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Footscray Hospital; Gastroenterology
Footscray, Victoria, Australia, 3011
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia, 3144
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Klinikum Klagenfurt am Wörtersee; Acute geriatric care
Klagenfurt, Austria, 9020
KH der Barmherzigen Brüder Linz
Linz, Austria, 4040
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria, 5020
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
GZA Ziekenhuizen - Campus Sint-Vincentius
Antwerpen, Belgium, 2018
Imeldaziekenhuis
Bonheiden, Belgium, 2820
CHU St Pierre (St Pierre)
Brussels, Belgium, 1000
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
AZ Sint Elisabeth Herentals
Herentals, Belgium, 2200
UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy
Leuven, Belgium, 3000
CHU Sart-Tilman
Liège, Belgium, 4000
AZ Delta (Stedelijk Ziekenhuis)
Roeselare, Belgium, 8800
Brazil
CCBR - Brasilia
Brasilia, DF, Brazil, 70200-730
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, GO, Brazil, 74535-170
Eurolatino Pesquisas Médicas Ltda.
Uberlandia, MG, Brazil, 38411-186
Centro Digestivo de Curitiba
Curitiba, PR, Brazil, 80430-160
Hospital Universitário Clementino Fraga Filho - UFRJ
Rio de Janeiro, RJ, Brazil, 21941-913
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
Rio de Janeiro, RJ, Brazil, 22271-100
Hospital Moinhos de Vento; Instituto de Educação e Pesquisa
Porto Alegre, RO, Brazil, 90560-030
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Hospital Ernesto Dornelles
Porto Alegre, RS, Brazil, 90160-092
Clinica de Neoplasias Litoral
Itajai, SC, Brazil, 88301-220
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, SP, Brazil, 18618-970
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, SP, Brazil, 13087-567
Centro Multidisciplinar de Estudos Clínicos - CEMEC
Santo Andre, SP, Brazil, 09190-510
UNIFESP Universidade Federal de Sao Paulo
Sao Paulo, SP, Brazil, 04024-002
Canada, Alberta
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre - University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Winnipeg Regional Health Authority; Neurosurgery Department
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Pharmaceutical Integrated Research Corporation
Bridgewater, Nova Scotia, Canada, B4V 3N2
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Toronto Digestive Disease Associates
Downsview, Ontario, Canada, M3N 2V7
Guelph GI & Surgery Clinic
Guelph, Ontario, Canada, N1H 3R3
LHSC - University Hospital
London, Ontario, Canada, N6A 5A5
London Health Sciences Centre · Victoria Hospital; Research Pharmacy
London, Ontario, Canada, N6A 5W9
Taunton Surgical Centre
Oshawa, Ontario, Canada, L1H 7K4
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Canada, Quebec
Hotel Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital; Endoscopy Department
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czechia
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, Czechia, 625 00
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Fakultni nemocnice Olomouc
Olomouc, Czechia, 775 20
Pardubicka krajska nemocnice, a.s.
Pardubice, Czechia, 532 03
Nemocnice Na Bulovce
Prague, Czechia, 180 01
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Klinicke centrum ISCARE Lighthouse
Praha 7, Czechia, 170 04
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Usti Nad Labem, Czechia, 401 13
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Rigshospitalet; Medicinsk gastroenterologisk klinik
København Ø, Denmark, 2100
Sygehus Sønderjylland Åbenrå
Åbenrå, Denmark, 6200
Ålborg Universitets Hospital; Gastromedicinsk
Ålborg, Denmark, 9000
France
CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
Amiens Cedex01, France, 80054
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex, France, 25030
Hôpital Beaujon
Clichy cedex, France, 92110
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin Bicêtre cedex, France, 94275
Hopital Claude Huriez - CHU Lille
Lille, France, 59037
Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology
Marseille cedex 20, France, 13915
CHU Nice - Hopital de l'Archet 2
Nice, France, 06202
Hôpital Saint-Louis
Paris, France, 75475
Hôpital Saint-Antoine
Paris, France, 75571
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
Pessac, France, 33604
CHU Saint Etienne - Hôpital Nord
Saint Etienne, France, 42055
Hopital Hautepierre - CHU Strasbourg
Strasbourg, France, 67098
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 09, France, 31059
Hôpital de Brabois Adultes
Vandoeuvre-les-nancy, France, 54511
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany, 10117
Charite - Campus Virchow-Klinikum; Cardiology
Berlin, Germany, 13353
DRK Kliniken Berlin Westend
Berlin, Germany, 14050
Krankenhaus Waldfriede e. V.
Berlin, Germany, 14163
Staedisches Klinikum Brandenburg
Brandenburg an der Havel, Germany, 14770
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Kliniken Essen-Mitte
Essen, Germany, 45136
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany, 60590
Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
Freiburg, Germany, 79106
Krankenhaus Martha-Maria Halle-Doelau
Halle (Saale), Germany, 06120
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Hamburgisches Forschungsinstitut fuer CED
Hamburg, Germany, 20148
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Gastroenterologie
Hamburg, Germany, 20249
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter
Heidelberg, Germany, 69121
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena
Jena, Germany, 07740
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24116
Universitätsklinikum Koeln
Koeln, Germany, 50937
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, Germany, 39120
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, Germany, 68167
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Gastro Campus Research; Praxis am Germania Campus
Muenster, Germany, 48159
Praxis Dr. med. Volker Aldinger UG
Neustadt, Germany, 67433
Gemeinschaftspraxis Mohl, Juenglin, Hasenstein
Saarbrücken, Germany, 66111
Gastroenterologische Gemeinschaftspraxis Stade
Stade, Germany, 21682
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Greece
University General Hospital of Alexandroupolis; Vascular Surgery
Alexandroupolis, Greece, 681 00
University General Hospital of Alexandroupolis
Alexandroupolis, Greece, 68100
General Hospital of Athens "Evangelismos"
Athens, Greece, 10676
District General Hospital of Athens Laiko; 1st Internal Medicine Clinic
Athens, Greece, 115 27
General Hospital of Nea Ionia "Kostantopoulio"
Athens, Greece, 142 33
University General Hospital of Heraklion
Herakleion, Greece, 711 10
University General Hospital of Ioannina
Ioannina, Greece, 455 00
Interbalkan Hospital
Pilaia Thessalonikis, Greece, 5700
Anticancer Hospital of Thessaliniki " Theagenio"
Thessaloniki, Greece, 54007
Hungary
Dr Rethy Pal Korhaz-Rendelointezet; III. Belgyogyaszat-Hepatologia
Bekescsaba, Hungary, 5600
Szent Margit Hospital; Dept. of Oncology
Budapest, Hungary, 1032
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft
Budapest, Hungary, 1033
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary, 1036
Semmelweis Egyetem
Budapest, Hungary, 1083
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum
Budapest, Hungary, 1135
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, Hungary, H-1077
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft
Debrecen, Hungary, 4025
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, Hungary, 3300
Bugat Pal Korhaz-Rendelointezet
Gyongyos, Hungary, 3200
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary, 9024
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, Hungary, 5703
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Hungary, 2084
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, Hungary, 3526
Karolina Korhaz
Mosonmagyaróvár, Hungary, 9200
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
Szeged, Hungary, 6720
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary, 8000
Israel
Assaf Harofeh Medical Center
Beer Yaacov, Israel, 6093000
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Rambam Health Care Campus
Haifa, Israel, 3109600
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Rabin Medical Center-Beilinson Campus
Petach Tikva, Israel, 4941492
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Kaplan Medical Center
Rehovot, Israel, 7661041
Tel Aviv Sourasky Medical Ctr; Gastroenterology Department
Tel Aviv, Israel, 6423900
Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Emilia-Romagna, Italy, 40138
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy, 40124
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Lazio, Italy, 00133
Azienda Ospedaliera San Camillo Forlanini
Roma, Lazio, Italy, 00151
Complesso Integrato Columbus
Roma, Lazio, Italy, 00168
Azienda Ospedaliero Universitaria San Martino
Genova, Liguria, Italy, 16132
ASST FATEBENEFRATELLI SACCO (Sacco)
Milano, Lombardia, Italy, 20157
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardia, Italy, 27100
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardia, Italy, 20017
Istituto Clinico Humanitas
Rozzano (MI), Lombardia, Italy, 20089
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardia, Italy, 20097
Nefrologia; Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, Sicilia, Italy, 98125
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana, Italy, 50141
Azienda Ospedaliera Di Padova
Padova, Veneto, Italy, 35128
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of, 49201
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Kyungpook National University Hospital; Opthalmology
Daegu, Korea, Republic of, 700-721
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Korea University Ansan Hospital
Gyeonggi-do, Korea, Republic of, 15355
CHA Bundang Medical Centre; CHA university
Seongnam, Korea, Republic of, 13520
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center.
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 6351
The Catholic University of Korea St. Vincent's Hospital
Suwon-si,, Korea, Republic of, 442-723
Lithuania
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Vilnius University Hospital Santariskiu Clinic Public Insti
Vilnius, Lithuania, 08661
Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo LEON, Mexico, 64610
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, Mexico, 62290
Nucleo Victoria de Investigacion Clinica S.C.
Durango, Mexico, 34000
Centro de Investigacion Farmacologica del Bajio, S.C.
Leon, Mexico, 37520
Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
Mexico, Distrito Federal, Mexico, 14000
Accelerium S. de R.L. de C.V.
Monterrey, Mexico, 64000
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey, Mexico, 64460
Centro de Investigacion Torre Medica Sanatorio Toluca
Toluca de Lerdo, Mexico, 50120
Netherlands
Amsterdam UMC Location VUMC
Amsterdam, Netherlands, 1081 HV
Onze Lieve Vrouwe Gasthuis, locatie Oost
Amsterdam, Netherlands, 1091 AC
Academisch Medisch Centrum; Pharmacy Trial Department
Amsterdam, Netherlands, 1105 AZ
Rijnstate; Internal Medicine Department
Arnhem, Netherlands, 6815 AD
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Radboudumc
NL -nijmegen, Netherlands, 6525 GA
Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Poland, 85-312
Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ
Elblag, Poland, 82-300
Nzoz All-Medicus
Katowice, Poland, 40-660
Centrum Medyczne Medyk
Rzeszow, Poland, 35-055
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, Poland, 35-302
Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia
Sopot, Poland, 81-756
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, Poland, 70-351
Centrum Zdrowia Matki, Dziecka i Mlodziezy - przychodnia
Warszawa, Poland, 00-632
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa, Poland, 02-507
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa, Poland, 02-781
Nzoz Vivamed
Warszawa, Poland, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, Poland, 53-114
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, Poland, 53-333
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, Poland, 54-144
Romania
Spitalul Clinic Colentina
Bucharest, Romania, 772202
SC Euroclinic Hospital SA
Bucuresti, Romania, 014461
Centrul de Gastroenterologie Dr. Goldis
Timisoara, Romania, 300002
Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, LA Coruña, Spain, 15405
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcon, Madrid, Spain, 28922
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clínic i Provincial; Servicio de Farmacia
Barcelona, Spain, 08036
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Universitario La Paz
Madrid, Spain, 280146
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Switzerland
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, Switzerland, 3004
Spital Netz Bern AG- Spital Tiefenau
Bern, Switzerland, 3004
Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
Bern, Switzerland, 3010
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Universitaetsspital Zuerich
Zürich, Switzerland, 8091
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom, EX2 5DW
The Royal London Hospital
London, United Kingdom, E1 1BB
University College London Hospital
London, United Kingdom, NW1 - 2PG
Royal Free Hospital
London, United Kingdom, NW3 2QS
St Thomas Hospital
London, United Kingdom, SE1 7EH
King's College London
London, United Kingdom, SE5 9NU
Fairfield General Hospital
Manchester, United Kingdom, M8 5RB
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Nottingham University Hospitals; QMC Campus
Nottingham, United Kingdom, NG7 2UH
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5AN
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02100696     History of Changes
Other Study ID Numbers: GA28950
2013-004278-88 ( EudraCT Number )
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
rhuMAb Beta7
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs