NCT02118584

Brief Summary

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,822

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_3

Geographic Reach
40 countries

388 active sites

Status
terminated

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 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

September 15, 2014

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 23, 2024

Completed
Last Updated

October 23, 2024

Status Verified

September 1, 2024

Enrollment Period

9.1 years

First QC Date

April 16, 2014

Results QC Date

September 30, 2024

Last Update Submit

September 30, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS)

    The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off.

    Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks

  • Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)

    The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off.

    At OLE Week 108

  • Part 1: Percentage of Participants With Endoscopic Remission

    The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off.

    At OLE Week 108

  • Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0]

    An AE is any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0

    An AE is any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Serious Infection Related AES

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0

    AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Malignancies

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0

    AE=untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.

    From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

  • Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period

    From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks

Study Arms (2)

Part 1: Open-label Extension

EXPERIMENTAL

Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).

Drug: Etrolizumab

Part 2: Safety Monitoring

NO INTERVENTION

All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).

Interventions

Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.

Also known as: RG7413, RO5490261, PRO145223, rhuMAb Beta7
Part 1: Open-label Extension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1 (Open-label Extension)
  • \- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
  • Part 2 (Safety Monitoring)
  • Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
  • Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
  • Participants who transfer from Part 1 (OLE)
  • Completion of the 12-week safety follow-up prior to entering.

You may not qualify if:

  • Part 1 (Open-label Extension)
  • Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
  • Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
  • Any new, significant, uncontrolled condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (411)

University of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Location

University of California San Diego Medical Center

La Jolla, California, 92093-5354, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

SDG Clinical Research

San Diego, California, 92103, United States

Location

University of California at San Francisco

San Francisco, California, 94115, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Clinical Research of the Rockies

Lafayette, Colorado, 80026, United States

Location

Rocky Mountain Gastroenterology Associates

Wheat Ridge, Colorado, 80033, United States

Location

Innovative Medical Research of South Florida, Inc.

Aventura, Florida, 33180, United States

Location

West Central Gastroenterology d/b/a Gastro Florida

Clearwater, Florida, 33756, United States

Location

Regenerate Clinical Trials

Miami, Florida, 33155, United States

Location

IMIC, Inc

Miami Beach, Florida, 33140, United States

Location

FQL Research, LLC

Miramar, Florida, 33025, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, 30024, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center; Medicine, Section of Pulmonary

Chicago, Illinois, 60637, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

Aquiant Research

New Albany, Indiana, 47150, United States

Location

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606, United States

Location

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Location

Massachusetts General Hospital; Crohn's & Colitis Center

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Ehrhardt Clinical Research, LLC

Belton, Missouri, 64012, United States

Location

Kansas City Research Institute, LLC

Kansas City, Missouri, 64131, United States

Location

Clinica Peruano Americana S.A.

Great Neck, New York, 11021, United States

Location

NYU Langone Medical Center

New York, New York, 10016-9451, United States

Location

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

New York, New York, 10021, United States

Location

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Consultants for Clin. Rsrch

Cincinnati, Ohio, 45219, United States

Location

UC Health Clinical Trials Office; Division of Digestive Diseases

Cincinnati, Ohio, 45267, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Gastroenterology Center of the Midsouth, P.C.

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 75231, United States

Location

Wellness Clinical Research Center

San Antonio, Texas, 78232, United States

Location

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, 76092, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

Ericksen Research and Development

Clinton, Utah, 84015, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

McGuire Research Institute; Gastroenterology

Richmond, Virginia, 23249, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004, United States

Location

Instituto Medico DAMIC

Córdoba, X5003DCE, Argentina

Location

Hospital Provincial del Centenario

Rosario, S2002KDS, Argentina

Location

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, 2200, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Adult Hospital

Mackay, Queensland, 4740, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Launceston General Hospital; Gastroenterology Research

Launceston, Tasmania, 7250, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

St Frances Xavier Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

Parkville, Victoria, 3050, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

GZA Ziekenhuizen - Campus Sint-Vincentius

Antwerp, 2018, Belgium

Location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

CHU St Pierre (St Pierre)

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc; Pharmacy

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Sint Elisabeth Herentals

Herentals, 2200, Belgium

Location

UZ Leuven; Neurology

Leuven, 3000, Belgium

Location

AZ Delta (Campus Rumbeke)

Roeselare, 8800, Belgium

Location

Hospital Universitario Walter Cantidio - UFC

Fortaleza, Ceará, 60430-370, Brazil

Location

Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia

Salvador, Estado de Bahia, 41110-170, Brazil

Location

CCBR - Brasilia

Brasília, Federal District, 70200-730, Brazil

Location

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

Goiânia, Goiás, 74535-170, Brazil

Location

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, 30110-068, Brazil

Location

Centro Digestivo de Curitiba

Curitiba, Paraná, 80430-160, Brazil

Location

Hospital Universitario Clementino Fraga Filho - UFRJ

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-092, Brazil

Location

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, 18618-970, Brazil

Location

CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, 13087-567, Brazil

Location

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, 17210-190, Brazil

Location

Pesquisare Saúde Sociedade Simples

Santo André, São Paulo, 09080-000, Brazil

Location

Hospital Estadual Mario Covas

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Hospital Sírio-Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Hospital do Servidor Público Estadual/HSPE-SP

São Paulo, São Paulo, 04039-901, Brazil

Location

Medical Centre "Asklepii", OOD

Dupnitsa, 2600, Bulgaria

Location

DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology

Pleven, 5800, Bulgaria

Location

Medical center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

Location

MHAT - Ruse, AD

Rousse, 7002, Bulgaria

Location

MHAT "Hadzhi Dimitar", OOD

Sliven, 8800, Bulgaria

Location

"City Clinic UMHAC" EOOD

Sofia, 1407, Bulgaria

Location

UMHAT "Sv. Ivan Rilski", EAD

Sofia, 1431, Bulgaria

Location

UMHAT Tsaritsa Yoanna - ISUL, EAD

Sofia, 1527, Bulgaria

Location

Diagnostic Consultation Center CONVEX EOOD

Sofia, 1680, Bulgaria

Location

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, 6000, Bulgaria

Location

MHAT 'Sv. Marina', EAD; First Children's Clinic

Varna, 9010, Bulgaria

Location

MC Medica Plus

Veliko Tarnovo, 5000, Bulgaria

Location

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

Edmonton, Alberta, T6G 2X8, Canada

Location

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Guelph GI & Surgery Clinic

Guelph, Ontario, N1H 3R3, Canada

Location

University Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Taunton Health Centre

Oshawa, Ontario, L1H 7K4, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Toronto Digestive Disease Associates

Vaughan, Ontario, L4L 4Y7, Canada

Location

Centre de santé et de services sociaux Champlain-Charles-Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hotel Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

RTS - Fundación Valle de Lili

Cali, 0, Colombia

Location

Instituto de Coloproctologia ICO S.A.S.

Medellín, 050025, Colombia

Location

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

Clinical Hospital Sveti Duh; Department of Neurology

Zagreb, 10000, Croatia

Location

Vojenska nemocnice Brno

Brno, 636 00, Czechia

Location

Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

Brno, 65691, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

Kladno, 272 59, Czechia

Location

PreventaMed, s.r.o.

Olomouc, 779 00, Czechia

Location

Mestska Nemocnice Ostrava

Ostrava, 728 80, Czechia

Location

Pardubicka krajska nemocnice a.s.

Pardubice, 532 03, Czechia

Location

ISCARE a.s.

Prague, 170 04, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 01, Czechia

Location

Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

Ústí nad Labem, 401 13, Czechia

Location

Krajska nemocnice T. Bati, a.s.

Zlín, 76001, Czechia

Location

Ålborg Universitets Hospital; Gastromedicinsk

Aalborg, 9000, Denmark

Location

Herlev og Gentofte Hospital

Hellerup, 2900, Denmark

Location

Rigshospitalet; Afdeling for Tarmsvigt og Leversygdomme

København Ø, 2100, Denmark

Location

OÜ Innomedica

Tallinn, 10117, Estonia

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

CHU Amiens - Hopital Sud

Amiens, 80054, France

Location

CHU de Caen Hopital Cote de Nacre

Caen, 14033, France

Location

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Hopital Claude Huriez - CHU Lille

Lille, 59037, France

Location

CHU Hopital Saint Eloi

Montpellier, 34295, France

Location

CHU Nice - Hopital de l'Archet 2

Nice, 06202, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, 33600, France

Location

Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

Pierre-Bénite, 69495, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

Location

Höpital Hautepierre; Pediatrie1

Strasbourg, 67098, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

Krankenhaus Waldfriede e. V.

Berlin, 14163, Germany

Location

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

Bochum, 44789, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, 60590, Germany

Location

Universitaetsklinikum Freiburg; Urology

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Hamburgisches Forschungsinstitut fuer CED

Hamburg, 20148, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Gastroenterologie Eppendorfer Baum

Hamburg, 20249, Germany

Location

Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Hanover, 30625, Germany

Location

Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

Jena, 07740, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24116, Germany

Location

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, 68167, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt

Schweinfurt, 97421, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

University General Hospital of Heraklion

Heraklio, 711 10, Greece

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230, Hungary

Location

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, 5600, Hungary

Location

Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

Budapest, 1088, Hungary

Location

Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

Budapest, 1125, Hungary

Location

Pannónia Klinika Magánorvosi

Budapest, 1136, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, H-1077, Hungary

Location

Endomedix Diagnosztikai Kozpont

Budapest, Hungary

Location

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, 4025, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Markhot Ferenc Oktato Korhaz es Rendelointezet

Eger, 3300, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 7624, Hungary

Location

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, 6600, Hungary

Location

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Location

Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology

Hyderabad, Andhra Pradesh, 500058, India

Location

Nirmal Hospital

Surat, Gujarat, 395002, India

Location

K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

M. S. Ramaiah Medical College and Hospital

Bengaluru, Karnataka, 560054, India

Location

Kasturba Medical College & Hospital

Manglore, Karnataka, 575001, India

Location

Midas institute of Gastroenterology

Nagpur, Maharashtra, 440012, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Dayanand Medical College and Hospital

Ludhiana, Punjab, 141001, India

Location

S. R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302001, India

Location

King Edward Memorial Hospital Research Centre

Pune, 411011, India

Location

Bnai Zion Medical Center; Internal Medicine

Haifa, 3339419, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Holy Family Hospital

Nazareth, 1641101, Israel

Location

Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute

Petach Tiqwa, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Assaf Harofeh

Rishon LeZiyyon, 7505001, Israel

Location

Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

Tel Litwinsky, 52621, Israel

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

Bologna, Emilia-Romagna, 40138, Italy

Location

A.O.U. Policlinico di Modena

Modena, Emilia-Romagna, 40124, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Ospedale Sandro Pertini

Rome, Lazio, 00157, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 151, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy, 25124, Italy

Location

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, Lombardy, 20121, Italy

Location

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Lombardy, 20162, Italy

Location

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, Lombardy, Italy

Location

Ospedale di Circolo; Neuropsichiatria Infantile

Rho, Lombardy, 20017, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

Location

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy, 20097, Italy

Location

IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

San Giovanni Rotondo, Lombardy, 71013, Italy

Location

Ospedale Mauriziano Umberto I

Turin, Piedmont, 10128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, 90127, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Azienda Ospedaliera di Padova

Padua, Veneto, 35128, Italy

Location

Central Outpatient Clinic

Daugavpils, LV-5401, Latvia

Location

Pauls Stradins Clinical University Hospital

R?ga, LV-1002, Latvia

Location

Digestive Diseases Center "Gastro"

R?ga, LV-1079, Latvia

Location

Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Klaipeda Seamen's Hospital, Public Institution

Klaipėda, 92288, Lithuania

Location

Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

Vilnius, LT-08661, Lithuania

Location

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, FED. Territory of Kuala Lumpur, 56000, Malaysia

Location

University Malaya Medical Center

Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Raja Perempuan Zainab II; Department of Medicine

Kota Bharu, 15586, Malaysia

Location

Centro Integral en Reumatología S.A. de C.V. (CIRSA)

Guadalajara, Jalisco, 44160, Mexico

Location

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

Location

Centro Regiomontano de Estudios Clínicos Roma S.C.

Monterrey, Nuevo León, 64610, Mexico

Location

Phylasis Clinicas Research S de RL de CV

Cuautitlán Izcalli, 54769, Mexico

Location

Amsterdam UMC Location VUMC

Amsterdam, 1081 HV, Netherlands

Location

Amsterdam UMC Location AMC

Amsterdam, 1105 AZ, Netherlands

Location

Radboudumc

NL -nijmegen, 6525 GA, Netherlands

Location

North Shore Hospital

Auckland, 0620, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Waikato Hospital

Hamilton, 3248, New Zealand

Location

Shakespeare Specialist Group

Takapuna, 0620, New Zealand

Location

Tauranga Hospital

Tauranga, 3143, New Zealand

Location

Akershus universitetssykehus HF

Lørenskog, 1478, Norway

Location

AppleTreeClinics Sp. z o.o.

?ód?, 90-349, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-312, Poland

Location

Centrum Medyczne Lukamed Joanna Luka

Chojnice, 89-600, Poland

Location

Centrum Medyczne Sw. Lukasza

Cz?stochowa, 42-202, Poland

Location

7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

Gdansk, 80-305, Poland

Location

Pro Familia Altera Sp z o.o.

Katowice, 40-645, Poland

Location

Nzoz All-Medicus

Katowice, 40-660, Poland

Location

Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM

Katowice, 40-752, Poland

Location

NZOZ Centrum Medyczne ProMiMed

Krakow, 31-637, Poland

Location

Centrum Opieki Zdrowotnej Orkan-Med

Ksawerów, 95-054, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Lublin, 20-015, Poland

Location

GASTROMED Sp. z o.o.

Lublin, 20-582, Poland

Location

Allmedica Badania Kliniczne Sp z o.o. Sp K.

Nowy Targ, 34-400, Poland

Location

Wojewodzki Specjalistyczny Szpital w Olsztynie

Olsztyn, 10-561, Poland

Location

SOLUMED Centrum Medyczne

Późna, 60-529, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Location

Gabinet Lekarski, Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

Sopot, 81-756, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

Szczecin, 70-351, Poland

Location

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-189, Poland

Location

Zespó Przychodni Specjalistycznych PRIMA

Warsaw, 02-018, Poland

Location

Endoterapia PFG Sp. z o.o.

Warsaw, 02-653, Poland

Location

Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Nzoz Vivamed

Warsaw, 03-580, Poland

Location

Przychodnia EuroMediCare

Wroc?aw, 50-220, Poland

Location

PlanetMed

Wroc?aw, 52-210, Poland

Location

LexMedica Osrodek Badan Klinicznych

Wroclaw, 53-114, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital da Senhora da Oliveira Guimarães

Guimarães, 4835-044, Portugal

Location

S.C MedLife S.A

Bucharest, 010719, Romania

Location

Centrul Medical Unirea SRL

Bucharest, 040055, Romania

Location

Spitalul Clinic Colentina

Bucharest, 772202, Romania

Location

Centrul de Gastroenterologie Dr. Goldis

Timișoara, 300002, Romania

Location

Yusupov Hospital

Moskva, Adygeya Republic, 127015, Russia

Location

SBEI HPE Altai StateMedicalUniversityofMoH andSD

Barnaul, Altayskiy Kray, 656050, Russia

Location

FSBIH Central Clinical Hospital of RAS

Moscow, Moscow Oblast, 119333, Russia

Location

FSBI ?State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

Moscow, Moscow Oblast, 123154, Russia

Location

SBHI of NN region ?RCH of NN n.a. N.A.Semashko?

Nizhny Novgorod, Niznij Novgorod, 603126, Russia

Location

SEIHPE "Rostov SMU of MoH of RF"

Rostov-on-Don, Rostov Oblast, 344022, Russia

Location

FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy

Saint Petersburg, Sankt-Peterburg, 193163, Russia

Location

FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology

Saint Petersburg, Sankt-Peterburg, 194044, Russia

Location

SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

Saint Petersburg, Sankt-Peterburg, 194354, Russia

Location

Baltic Medicine

Saint Petersburg, Sankt-Peterburg, 194356, Russia

Location

City Hospital #26

Saint Petersburg, Sankt-Peterburg, 196247, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

SBIH City Clinical Hospital #31

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

SPb SHI "City Hospital #9"

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

LLC International Medical Centre ?SOGAZ?

Saint Petersburg, Sankt-Peterburg, 198035, Russia

Location

Medical and Sanitary Division of Severstal

Cherepovets, Vologda Oblast, 162600, Russia

Location

SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF

Voronezh, Voronez, 394036, Russia

Location

Irkutsk State Medical Academy of Continuing Education

Irkutsk, 664079, Russia

Location

FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

Novosibirsk, 630117, Russia

Location

BHI of Omsk region Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

Omsk, 644043, Russia

Location

Stavropol Regional Clinical Diagnostic Consultative Center

Stavropol, 355017, Russia

Location

FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation

Stavropol, 355018, Russia

Location

Clinical Center Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11040, Serbia

Location

Clinical Center Zemun

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital Djordje Joanovic

Zrenjanin, 23000, Serbia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, 974 01, Slovakia

Location

Nemocnica A.Lena Humenne, n.o.

Humenné, 066 01, Slovakia

Location

Endomed, s.r.o.

Košice, 040 01, Slovakia

Location

KM Management spol. s r.o.

Nitra, 94901, Slovakia

Location

Gastro I, s.r.o.

Prešov, 080 01, Slovakia

Location

Svet zdravia a.s.

Rimavská Sobota, 979 01, Slovakia

Location

Accout Center s.r.o.

Šahy, 936 01, Slovakia

Location

Netcare Universitas Private Hospital

Bloemfontein, 9301, South Africa

Location

Dr MJ Prins Practice

Cape Town, 7500, South Africa

Location

Dr JP Wright Practice

Cape Town, 7708, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Yeungnam Univ. Hospital

Daegu, 705-717, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

CHA Bundang Medical Centre; CHA university

Seongnam, 13520, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Asan Medical Center.

Seoul, 5505, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, 442-723, South Korea

Location

Ajou University Hospital

Suwon, 443-721, South Korea

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Fundacion Hospital de Alcorcon; Servicio de Digestivo

Alcorcón, Madrid, 28922, Spain

Location

Centro Médico Teknon

Barcelona, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, 28942, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Inselspital-Universitaetsspital Bern

Bern, 3010, Switzerland

Location

Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

Bern, 3012, Switzerland

Location

Gazi University Medical Faculty; Gastroenterology

Ankara, 06500, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital; Medical Oncology

Istanbul, 34668, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

Kocaeli, 41380, Turkey (Türkiye)

Location

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

Kharkiv, Kharkiv Governorate, 61037, Ukraine

Location

Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, Kharkiv Governorate, 61058, Ukraine

Location

Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, Kharkiv Governorate, 04107, Ukraine

Location

CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI

Sumy, Kharkiv Governorate, 40022, Ukraine

Location

LLC Gastroenterology Center IBD Team

Zaporizhzhia, Kharkiv Governorate, 69000, Ukraine

Location

CNE Kyiv CCH #18

Kyiv, KIEV Governorate, 01030, Ukraine

Location

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, KIEV Governorate, 04107, Ukraine

Location

Medical Center of Limited Liability Company Medical Clinic Blagomed

Kyiv, KIEV Governorate, 1023, Ukraine

Location

Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

Kyiv, KIEV Governorate, 2091, Ukraine

Location

CI of Kyiv RC Regional Clinical Hospital #2

Kyiv, KIEV Governorate, 4073, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, KIEV Governorate, 79010, Ukraine

Location

CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training

Uzhhorod, KIEV Governorate, 88009, Ukraine

Location

A.Novak Transcarpathian Regional Clinical Hospital

Uzhhorod, KIEV Governorate, 88018, Ukraine

Location

RCNECRCH Dept of Surgery, SHEI Ukr BSMU

Chernivtsi, Podolia Governorate, 58002, Ukraine

Location

CI City Hospital #1

Zaporizhzhia, Tavria Okruha, 69104, Ukraine

Location

RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

Chernivtsi, 58002, Ukraine

Location

SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU

Dnipropetrovsk, 49074, Ukraine

Location

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

Kharkiv, 61039, Ukraine

Location

CI of Healthcare Kharkiv CCH #13

Kharkiv, 61124, Ukraine

Location

CI Kherson Afanasii and Olha Tropiny City Clinical Hospital

Kherson, 73000, Ukraine

Location

CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

Kyiv, 02232, Ukraine

Location

Odessa regional clinical Hospital

Odesa, 65117, Ukraine

Location

M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA

Poltava, 36011, Ukraine

Location

M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

Poltava, 36011, Ukraine

Location

Private Small Enterprise Medical Center Pulse

Vinnytsia, 21001, Ukraine

Location

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

Vinnytsia, 21018, Ukraine

Location

MCIC Health Clinic BO LTD TPC Slaomed

Vinnytsia, 21029, Ukraine

Location

Co Ltd. Diaservice

Zaporizhzhia, 69035, Ukraine

Location

CI City Hospital #7

Zaporizhzhia, 69118, Ukraine

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospital Coventry

Coventry, CV2 2DX, United Kingdom

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

The Royal London Hospital

London, E1 1FR, United Kingdom

Location

University College London Hospital

London, N7 9NH, United Kingdom

Location

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

King's College London

London, SE5 9NU, United Kingdom

Location

Fairfield General Hospital

Manchester, M8 5RB, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham University Hospitals; QMC Campus

Nottingham, NG7 2UH, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

etrolizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

September 15, 2014

Primary Completion

October 5, 2023

Study Completion

October 5, 2023

Last Updated

October 23, 2024

Results First Posted

October 23, 2024

Record last verified: 2024-09

Locations