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Trial record 1 of 2 for:    ga28950
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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 : Completed
First Posted : April 1, 2014
Last Update Posted : May 8, 2020
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
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 16, 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


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
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
Precision Research Institute, LLC
San Diego, California, United States, 92114
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Colorado
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, Florida
FQL Research, LLC
Miramar, Florida, United States, 33025
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
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
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
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, Missouri
Kansas City Research Institute, LLC
Kansas City, Missouri, United States, 64131
United States, New York
Northwell Health
Great Neck, New York, United States, 11021
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
UC Health, LLC.
Cincinnati, Ohio, United States, 45267
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
United States, Tennessee
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
United States, Utah
Ericksen Research and Development
Clinton, Utah, United States, 84015
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, United States, 23502
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States, 23249
United States, Washington
Washington Gastroenterology
Bellevue, Washington, United States, 98004
Argentina
Hospital Provincial del Centenario
Rosario, Argentina, 2000
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
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria, 5020
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
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; Neurology
Leuven, Belgium, 3000
CHU de Liège; Tour de Pathologie
Liège, Belgium, 4000
AZ Delta (Stedelijk Ziekenhuis)
Roeselare, Belgium, 8800
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, GO, Brazil, 74535-170
Hospital Felicio Rocho
Belo Horizonte, MG, Brazil, 30110-068
Centro Digestivo de Curitiba
Curitiba, PR, Brazil, 80430-160
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, RJ, Brazil, 21941-913
Hospital Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
Hospital de Clínicas de Porto Alegre X
Porto Alegre, RS, Brazil
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
Hospital Estadual Mario Covas
Santo Andre, SP, Brazil, 09190-610
Canada, Alberta
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Nova Scotia
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
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
Czechia
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, Czechia, 625 00
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Pardubicka krajska nemocnice, a.s.
Pardubice, Czechia, 532 03
Nemocnice Na Bulovce
Prague, Czechia, 180 01
ISCARE a.s.
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
Rigshospitalet; Medicinsk gastroenterologisk klinik
København Ø, Denmark, 2100
Ålborg Universitets Hospital; Gastromedicinsk
Ålborg, Denmark, 9000
France
CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
Amiens Cedex01, France, 80054
Hôpital Beaujon
Clichy cedex, France, 92110
Hôpital Broca
Le Kremlin Bicétre 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
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
Berlin, Germany, 13353
DRK Kliniken Berlin Westend
Berlin, Germany, 14050
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Kliniken Essen-Mitte
Essen, Germany, 45136
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany, 60590
Universitaetsklinikum Freiburg
Freiburg, Germany, 79106
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Hamburgisches Forschungsinstitut fuer CED
Hamburg, Germany, 20148
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Gastroenterologie Eppendorfer Baum
Hamburg, Germany, 20249
Medizinische Hochschule Hannover; Gastroenterologie, Hepatologie und Endokrinologie
Hannover, Germany, 30625
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24116
Universitätsklinikum Koeln
Koeln, Germany, 50937
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, Germany, 68167
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Greece
Anticancer Hospital of Thessaliniki " Theagenio"
Thessaloniki, Greece, 54007
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Bekescsaba, Hungary, 5600
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary, 1036
Semmelweis Egyetem
Budapest, Hungary, 1083
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum
Budapest, Hungary, 1135
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, Hungary, H-1077
Debreceni Egyetem
Debrecen, Hungary, 4032
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, Hungary, 3300
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary, 9024
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Hungary, 2143
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, Hungary, 3526
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary, 8000
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah University Hospital - Ein Kerem; Neurosurgery
Jerusalem, Israel, 9112001
Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute
Petach Tiqwa, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 7610001
Assaf Harofeh
Rishon Lezion, Israel, 75141
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio, Italy, 00168
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milano, Lombardia, Italy
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
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana, Italy, 50141
Azienda Ospedaliera Di Padova
Padova, Veneto, Italy, 35128
Korea, Republic of
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
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Asan Medical Center.
Seoul, Korea, Republic of, 138-736
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
Netherlands
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, Netherlands, 1081 HV
Amsterdam UMC Location AMC
Amsterdam, Netherlands, 1105 AZ
Rijnstate; Internal Medicine Department
Arnhem, Netherlands, 6815 AD
Radboudumc
NL -nijmegen, Netherlands, 6525 GA
Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Poland, 85-312
Nzoz All-Medicus
Katowice, Poland, 40-660
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
Zespó Przychodni Specjalistycznych PRIMA
Warszawa, Poland, 02-018
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa, Poland, 02-781
Nzoz Vivamed
Warszawa, Poland, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, Poland, 53-114
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, Poland, 54-144
PlanetMed
Wrocław, Poland, 52-210
Romania
SC Euroclinic Hospital SA
Bucuresti, Romania, 014461
Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcon, Madrid, Spain, 28922
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Switzerland
Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
Bern, Switzerland, 3010
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, Switzerland, 3012
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
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
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02100696    
Other Study ID Numbers: GA28950
2013-004278-88 ( EudraCT Number )
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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