COTTONWOOD: Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02118584
Collaborator
(none)
1,822
415
2
131
4.4
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1822 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Actual Study Start Date :
Sep 15, 2014
Anticipated Primary Completion Date :
Aug 16, 2025
Anticipated Study Completion Date :
Aug 16, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Open-label Extension

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
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.
Other Names:
  • RG7413
  • RO5490261
  • PRO145223
  • rhuMAb Beta7
  • No Intervention: Part 2: Safety Monitoring

    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).

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) - Part 1 [Baseline up to 9 years (assessed at Baseline, Week 4, 8, 12 thereafter every 12 weeks up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)]

    2. Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1 [Week 108]

    3. Percentage of Participants With Endoscopic Remission [Week 108]

    4. Percentage of Participants With Anti-therapeutic Antibodies to Etrolizumab - Part 1 [Baseline, Week 12, every 48 weeks, week 108, at early withdrawal from treatment up to 9 years after first participant enrolled or until commercial availability, whichever is earlier, or until sponsor's decision to terminate the study)]

    5. Percentage of Participants With Adverse Events - Part 1 [Baseline up to 9 years after the first participant is enrolled or until commercial availability, whichever is earlier, or until the Sponsor's decision to terminate the study]

    6. Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2 [104 weeks]

    7. Change From Baseline in pMCS at Year 9 [Baseline, Year 9]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Medical Center Birmingham Alabama United States 35294
    2 University of California San Diego Medical Center La Jolla California United States 92093-5354
    3 University of California, Irvine Medical Center Orange California United States 92868
    4 SDG Clinical Research San Diego California United States 92103
    5 University of California at San Francisco San Francisco California United States 94115
    6 Ventura Clinical Trials Ventura California United States 93003
    7 Peak Gastroenterology Associates Colorado Springs Colorado United States 80907
    8 Rocky Mountain Gastroenterology Associates Denver Colorado United States 80222
    9 Clinical Research of the Rockies Lafayette Colorado United States 80026
    10 Innovative Medical Research of South Florida, Inc. Aventura Florida United States 33180
    11 West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida United States 33762
    12 IMIC, Inc Miami Beach Florida United States 33140
    13 Regenerate Clinical Trials Miami Florida United States 33155
    14 FQL Research, LLC Miramar Florida United States 33025
    15 Gastroenterology Group of Naples Naples Florida United States 34102
    16 Internal Medicine Specialists Orlando Florida United States 32806
    17 Advanced Research Institute, Inc. Trinity Florida United States 34655
    18 Shafran Gastroenterology Center Winter Park Florida United States 32789
    19 Atlanta Gastroenterology Associates Atlanta Georgia United States 30342
    20 Gastroenterology Associates of Central Georgia Macon Georgia United States 31201
    21 Gastrointestinal Specialists of Georgia, PC Marietta Georgia United States 30060
    22 Atlanta Gastroenterology Specialists, PC Suwanee Georgia United States 30024
    23 Northwestern University Feinberg School Of Medicine Chicago Illinois United States 60611
    24 University of Chicago Medical Center; Medicine, Section of Pulmonary Chicago Illinois United States 60637
    25 Southwest Gastroenterology Oak Lawn Illinois United States 60453
    26 Aquiant Research New Albany Indiana United States 47150
    27 Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas United States 66606
    28 Gastroenterology Associates, LLC Baton Rouge Louisiana United States 70809
    29 Louisiana Research Center, LLC Shreveport Louisiana United States
    30 Massachusetts General Hospital; Crohn's & Colitis Center Boston Massachusetts United States 02114
    31 University of Michigan Ann Arbor Michigan United States 48109
    32 Henry Ford Health System Detroit Michigan United States 48202
    33 Center for Digestive Health Troy Michigan United States 48098
    34 Huron Gastroenterology Associates Ypsilanti Michigan United States 48197
    35 Regents of the University of Minnesota Minneapolis Minnesota United States 55455
    36 University of Mississippi Medical Center Jackson Mississippi United States 39216
    37 Ehrhardt Clinical Research, LLC Belton Missouri United States 64012
    38 Kansas City Research Institute, LLC Kansas City Missouri United States 64131
    39 Clinica Peruano Americana S.A. Great Neck New York United States 11021
    40 NYU Langone Medical Center IRB New York New York United States 10010
    41 Concorde Medical Group New York New York United States 10016
    42 Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) New York New York United States 10021
    43 Asheville Gastroenterology Associates, P.A. Asheville North Carolina United States 28801
    44 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    45 Kinston Medical Specialists Kinston North Carolina United States 28501
    46 Consultants for Clin. Rsrch Cincinnati Ohio United States 45219
    47 UC Health Clinical Trials Office; Division of Digestive Diseases Cincinnati Ohio United States 45267
    48 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    49 Gastroenterology Center of the Midsouth, P.C. Memphis Tennessee United States 38120
    50 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    51 Texas Digestive Disease Consultants - Dallas Dallas Texas United States 75231
    52 Wellness Clinical Research Center San Antonio Texas United States 78232
    53 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    54 Tyler Research Institute, LLC Tyler Texas United States 75701
    55 Ericksen Research and Development Clinton Utah United States 84015
    56 University of Utah School of Medicine Salt Lake City Utah United States 84132
    57 McGuire Research Institute; Gastroenterology Richmond Virginia United States 23249
    58 Washington Gastroenterology Bellevue Washington United States 98004
    59 Instituto Medico DAMIC Cordoba Argentina X5003DCE
    60 Hospital Provincial del Centenario Rosario Argentina S2002KDS
    61 Bankstown-Lidcombe Hospital Bankstown New South Wales Australia 2200
    62 Concord Repatriation General Hospital Concord New South Wales Australia 2139
    63 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    64 Mater Adult Hospital Mackay Queensland Australia 4740
    65 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    66 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    67 Flinders Medical Centre Bedford Park South Australia Australia 5042
    68 Launceston General Hospital; Gastroenterology Research Launceston Tasmania Australia 7250
    69 Monash Medical Centre Clayton Victoria Australia 3168
    70 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
    71 Footscray Hospital Footscray Victoria Australia 3011
    72 St Frances Xavier Cabrini Hospital Malvern Victoria Australia 3144
    73 Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics Parkville Victoria Australia 3050
    74 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    75 LKH - Universitätsklinikum der PMU Salzburg Salzburg Austria 5020
    76 Medizinische Universität Wien Wien Austria 1090
    77 GZA Ziekenhuizen - Campus Sint-Vincentius Antwerpen Belgium 2018
    78 Imeldaziekenhuis Bonheiden Belgium 2820
    79 CHU St Pierre (St Pierre) Brussels Belgium 1000
    80 UZ Brussel Brussel Belgium 1090
    81 Cliniques Universitaires Saint-Luc; Pharmacy Bruxelles Belgium 1200
    82 UZ Gent Gent Belgium 9000
    83 AZ Sint Elisabeth Herentals Herentals Belgium 2200
    84 UZ Leuven; Neurology Leuven Belgium 3000
    85 AZ Delta (Campus Rumbeke) Roeselare Belgium 8800
    86 Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia Salvador BA Brazil 41110-170
    87 Hospital Universitario Walter Cantidio - UFC Fortaleza CE Brazil 60430-370
    88 CCBR - Brasilia Brasilia DF Brazil 70200-730
    89 Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Goiânia GO Brazil 74535-170
    90 Hospital Felicio Rocho Belo Horizonte MG Brazil 30110-068
    91 Centro Digestivo de Curitiba Curitiba PR Brazil 80430-160
    92 Hospital Universitario Clementino Fraga Filho - UFRJ Rio de Janeiro RJ Brazil 21941-913
    93 Hospital Moinhos de Vento Porto Alegre RS Brazil 90035-001
    94 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    95 Hospital Ernesto Dornelles Porto Alegre RS Brazil 90160-092
    96 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu SP Brazil 18618-970
    97 CAEP - Centro Avancado de Estudos e Pesquisas Ltda. Campinas SP Brazil 13087-567
    98 CECIP - Centro de Estudos Clínicos do Interior Paulista Jaú SP Brazil 17210-190
    99 Pesquisare Saúde Sociedade Simples Santo Andre SP Brazil 09080-000
    100 Hospital Estadual Mario Covas Santo Andre SP Brazil 09190-610
    101 Hospital Sírio-Libanês Sao Paulo SP Brazil 01308-050
    102 Hospital do Servidor Público Estadual/HSPE-SP São Paulo SP Brazil 04039-901
    103 Medical Centre "Asklepii", OOD Dupnitsa Bulgaria 2600
    104 DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology Pleven Bulgaria 5800
    105 Medical center Medconsult Pleven OOD Pleven Bulgaria 5800
    106 MHAT - Ruse, AD Ruse Bulgaria 7002
    107 MHAT "Hadzhi Dimitar", OOD Sliven Bulgaria 8800
    108 "City Clinic UMHAC" EOOD Sofia Bulgaria 1407
    109 UMHAT "Sv. Ivan Rilski", EAD Sofia Bulgaria 1431
    110 UMHAT Tsaritsa Yoanna - ISUL, EAD Sofia Bulgaria 1527
    111 Diagnostic Consultation Center CONVEX EOOD Sofia Bulgaria 1680
    112 Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Stara Zagora Bulgaria 6000
    113 MHAT 'Sv. Marina', EAD; First Children's Clinic Varna Bulgaria 9010
    114 MC Medica Plus Veliko Tarnovo Bulgaria 5000
    115 University of Calgary Calgary Alberta Canada T2N 2T9
    116 Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology Edmonton Alberta Canada T6G 2X8
    117 Pacific Gastroenterology Associates Vancouver British Columbia Canada V6Z 2K5
    118 Queen Elizabeth II Health Sciences Centre; Gastroenterology Research Halifax Nova Scotia Canada B3H 1V7
    119 Guelph GI & Surgery Clinic Guelph Ontario Canada N1H 3R3
    120 University Hospital - London Health Sciences Centre London Ontario Canada N6A 5A5
    121 Taunton Health Centre Oshawa Ontario Canada L1H 7K4
    122 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
    123 Toronto Liver Centre Toronto Ontario Canada M6H 3M1
    124 Toronto Digestive Disease Associates Vaughan Ontario Canada L4L 4Y7
    125 Centre de santé et de services sociaux Champlain-Charles-Le Moyne Greenfield Park Quebec Canada J4V 2H1
    126 Hotel Dieu de Levis Levis Quebec Canada G6V 3Z1
    127 Hôpital Maisonneuve - Rosemont Montreal Quebec Canada H1T 2M4
    128 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8
    129 RTS - Fundación Valle de Lili Cali Colombia 0
    130 Instituto de Coloproctologia ICO S.A.S. Medellin Colombia 050025
    131 Clinical Hospital Centre Osijek Osijek Croatia 31000
    132 Clinical Hospital Sveti Duh; Department of Neurology Zagreb Croatia 10000
    133 Vojenska nemocnice Brno Brno Czechia 636 00
    134 Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika Brno Czechia 65691
    135 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    136 Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove Czechia 500 12
    137 Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum Kladno Czechia 272 59
    138 PreventaMed, s.r.o. Olomouc Czechia 779 00
    139 Mestska Nemocnice Ostrava Ostrava Czechia 728 80
    140 Pardubicka krajska nemocnice, a.s. Pardubice Czechia 532 03
    141 Nemocnice Na Bulovce Prague Czechia 180 01
    142 ISCARE a.s. Praha 7 Czechia 170 04
    143 Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni Usti Nad Labem Czechia 401 13
    144 Krajska nemocnice T. Bati, a.s. Zlin Czechia 76001
    145 Herlev og Gentofte Hospital Herlev Denmark 2730
    146 Rigshospitalet; Medicinsk gastroenterologisk klinik København Ø Denmark 2100
    147 Ålborg Universitets Hospital; Gastromedicinsk Ålborg Denmark 9000
    148 OÜ Innomedica Tallinn Estonia 10117
    149 East Tallinn Central Hospital Tallinn Estonia 10138
    150 West Tallinn Central Hospital Tallinn Estonia 10617
    151 North Estonia Medical Centre Foundation Tallinn Estonia 13419
    152 Tartu University Hospital Tartu Estonia 51014
    153 CHU Amiens - Hopital Sud Amiens France 80054
    154 CHU de Caen - Hopital Cote de Nacre Caen France 14033
    155 CHU Tours - Hôpital Trousseau Chambray les Tours France 37170
    156 Hôpital Beaujon Clichy cedex France 92110
    157 Hopital Claude Huriez - CHU Lille Lille France 59037
    158 CHU Hopital Saint Eloi Montpellier France 34295
    159 CHU Nice - Hopital de l'Archet 2 Nice France 06202
    160 Hôpital Saint-Louis Paris France 75475
    161 CHU Bordeaux - Hôpital Haut-Lévêque Pessac France 33600
    162 Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie Pierre-Benite France 69495
    163 CHU Saint Etienne - Hôpital Nord Saint Etienne France 42055
    164 Höpital Hautepierre; Pediatrie1 Strasbourg France 67098
    165 CHU de Toulouse - Hôpital Rangueil Toulouse Cedex 09 France 31059
    166 Hôpital de Brabois Adultes Vandoeuvre-les-nancy France 54511
    167 Charite Universitaetsmedizin Berlin - Campus Charite Mitte Berlin Germany 10117
    168 Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Berlin Germany 12200
    169 DRK Kliniken Berlin Westend Berlin Germany 14050
    170 Krankenhaus Waldfriede e. V. Berlin Germany 14163
    171 Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH Bochum Germany 44789
    172 Universitaetsklinikum Erlangen Erlangen Germany 91054
    173 Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt Germany 60590
    174 Universitaetsklinikum Freiburg; Urology Freiburg Germany 79106
    175 Universitaetsklinikum Halle (Saale) Halle Germany 06120
    176 Hamburgisches Forschungsinstitut fuer CED Hamburg Germany 20148
    177 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    178 Gastroenterologie Eppendorfer Baum Hamburg Germany 20249
    179 Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie Hannover Germany 30625
    180 Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena Jena Germany 07740
    181 Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24116
    182 Medizinisches Zentrum Klinikum Lueneburg Lueneburg Germany 21339
    183 Klinikum Mannheim GmbH Universitätsklinikum Mannheim Germany 68167
    184 Universitaetsklinikum Muenster Muenster Germany 48149
    185 Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt Schweinfurt Germany 97421
    186 Universitaetsklinikum Ulm Ulm Germany 89081
    187 University General Hospital of Heraklion Herakleion Greece 711 10
    188 University of Hong Kong Hong Kong Hong Kong
    189 DRC Gyogyszervizsgalo Kozpont Kft Balatonfured Hungary 8230
    190 Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza Bekescsaba Hungary 5600
    191 Semmelweis Egyetem Budapest Hungary 1083
    192 Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budapest Hungary 1125
    193 Pannónia Klinika Magánorvosi Budapest Hungary 1136
    194 Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely Budapest Hungary H-1077
    195 Endomedix Diagnosztikai Kozpont Budapest Hungary
    196 Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont Debrecen Hungary 4025
    197 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
    198 Markhot Ferenc Oktato Korhaz es Rendelointezet Eger Hungary 3300
    199 Petz Aladar Megyei Oktato Korhaz Gyor Hungary 9024
    200 Pest Megyei Flor Ferenc Korhaz Kistarcsa Hungary 2143
    201 Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Miskolc Hungary 3526
    202 Pecsi Tudomanyegyetem Pecs Hungary 7624
    203 Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes Hungary 6600
    204 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár Hungary 8000
    205 Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology Hyderabad Andhra Pradesh India 500058
    206 Nirmal Hospital Surat Gujarat India 395002
    207 K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka India 590010
    208 M. S. Ramaiah Medical College and Hospital Bengaluru Karnataka India 560054
    209 Midas institute of Gastroenterology Nagpur Maharashtra India 440012
    210 Dayanand Medical College and Hospital Ludhiana Punjab India 141001
    211 S. R. Kalla Memorial Gastro & General Hospital Jaipur Rajasthan India 302001
    212 Kasturba Medical College & Hospital Mangalore India 575001
    213 Ruby Hall Clinic Pune India 411 001
    214 King Edward Memorial Hospital Research Centre Pune India 411011
    215 Bnai Zion Medical Center; Internal Medicine Haifa Israel 3339419
    216 Shaare Zedek Medical Center Jerusalem Israel 9103102
    217 Hadassah University Hospital - Ein Kerem Jerusalem Israel 9112001
    218 Holy Family Hospital Nazareth Israel 16100
    219 Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute Petach Tiqwa Israel 49100
    220 Kaplan Medical Center Rehovot Israel 7610001
    221 Assaf Harofeh Rishon Lezion Israel 7505001
    222 Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit Tel Hashomer Israel 52621
    223 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh Bologna Emilia-Romagna Italy 40138
    224 A.O.U. Policlinico di Modena Modena Emilia-Romagna Italy 40124
    225 Azienda Ospedaliero Universitaria di Parma Parma Emilia-Romagna Italy 43126
    226 Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma Lazio Italy 00133
    227 Azienda Ospedaliera San Camillo Forlanini Roma Lazio Italy 00152
    228 Ospedale Sandro Pertini Roma Lazio Italy 00157
    229 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Lazio Italy 00168
    230 Azienda Ospedaliero Universitaria San Martino Genova Liguria Italy 16132
    231 Fondazione Poliambulanza Istituto Ospedaliero Brescia Lombardia Italy 25124
    232 Azienda Ospedaliera Fatebenefratelli e Oftalmico Milano Lombardia Italy 20121
    233 Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Milano Lombardia Italy 20162
    234 Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) Milano Lombardia Italy
    235 Ospedale di Circolo; Neuropsichiatria Infantile Rho Lombardia Italy 20017
    236 Istituto Clinico Humanitas Rozzano (MI) Lombardia Italy 20089
    237 I.R.C.C.S Policlinico San Donato San Donato Milanese (MI) Lombardia Italy 20097
    238 IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest San Giovanni Rotondo Lombardia Italy 71013
    239 Ospedale Mauriziano Umberto I Torino Piemonte Italy 10128
    240 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Sicilia Italy 90127
    241 Azienda Ospedaliera Universitaria Careggi Florence Toscana Italy 50134
    242 Azienda Ospedaliera di Padova Padova Veneto Italy 35128
    243 Dong-A University Hospital Busan Korea, Republic of 49201
    244 Pusan National University Hospital Busan Korea, Republic of 49241
    245 Kyungpook National University Medical Center Daegu Korea, Republic of 41404
    246 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    247 Kyungpook National University Hospital Daegu Korea, Republic of 41944
    248 Yeungnam Univ. Hospital Daegu Korea, Republic of 705-717
    249 Korea University Ansan Hospital Gyeonggi-do Korea, Republic of 15355
    250 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    251 CHA Bundang Medical Centre; CHA university Seongnam Korea, Republic of 13520
    252 Seoul National University Hospital Seoul Korea, Republic of 03080
    253 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    254 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    255 Samsung Medical Center Seoul Korea, Republic of 06351
    256 Asan Medical Center. Seoul Korea, Republic of 138-736
    257 Ajou University Hospital Suwon City Korea, Republic of 443-721
    258 The Catholic University of Korea St. Vincent's Hospital Suwon-si, Korea, Republic of 442-723
    259 Yonsei University Wonju Severance Christian Hospital Wonju-Si Korea, Republic of 220-701
    260 Central Outpatient Clinic Daugavpils Latvia LV-5401
    261 Pauls Stradins Clinical University Hospital Rīga Latvia LV-1002
    262 Digestive Diseases Center "Gastro" Rīga Latvia LV-1079
    263 Hospital of Lithuanian University of Health. Sciences Kaunas Clinics Kaunas Lithuania 50009
    264 Klaipeda Seamen's Hospital, Public Institution Klaipeda Lithuania 92288
    265 Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology Vilnius Lithuania LT-08661
    266 Hospital Raja Perempuan Zainab II; Department of Medicine Kota Bahru Malaysia 15586
    267 Pusat Perubatan Universiti Kebangsaan Malaysia Kuala Lumpur Malaysia 56000
    268 University Malaya Medical Center Kuala Lumpur Malaysia 59100
    269 Hospital Tengku Ampuan Afzan Pahang Malaysia 25100
    270 Centro Integral en Reumatología S.A. de C.V. (CIRSA) Guadalajara Jalisco Mexico 44160
    271 Centro Regiomontano de Estudios Clínicos Roma S.C. Monterrey Nuevo LEON Mexico 64610
    272 Phylasis Clinicas Research S de RL de CV Estado de México Mexico 54769
    273 Accelerium S. de R.L. de C.V. Monterrey Mexico 64000
    274 Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León Monterrey Mexico 64460
    275 Amsterdam UMC Location VUMC Amsterdam Netherlands 1081 HV
    276 Amsterdam UMC Location AMC Amsterdam Netherlands 1105 AZ
    277 Radboudumc NL -nijmegen Netherlands 6525 GA
    278 North Shore Hospital Auckland New Zealand 0620
    279 Middlemore Hospital Auckland New Zealand
    280 Dunedin Hospital Dunedin New Zealand
    281 Waikato Hospital Hamilton New Zealand 3248
    282 Shakespeare Specialist Group Takapuna New Zealand 0620
    283 Tauranga Hospital Tauranga New Zealand 3143
    284 Akershus universitetssykehus HF Lørenskog Norway 1478
    285 Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz Poland 85-312
    286 Centrum Medyczne LUKA MED.Joanna Łuka Chojnice Poland 89-600
    287 Centrum Medyczne Sw. Lukasza Częstochowa Poland 42-202
    288 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego Gdansk Poland 80-305
    289 Pro Familia Altera Sp z o.o. Katowice Poland 40-645
    290 Nzoz All-Medicus Katowice Poland 40-660
    291 Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM Katowice Poland 40-752
    292 NZOZ Centrum Medyczne ProMiMed Krakow Poland 31-637
    293 Centrum Opieki Zdrowotnej Orkan-Med Ksawerow Poland 95-054
    294 Indywidualna Specjalistyczna Praktyka Lekarska Lublin Poland 20-015
    295 GASTROMED Sp. z o.o. Lublin Poland 20-582
    296 Allmedica Badania Kliniczne Sp z o.o. Sp K. Nowy Targ Poland 34-400
    297 Wojewodzki Specjalistyczny Szpital w Olsztynie Olsztyn Poland 10-561
    298 SOLUMED Centrum Medyczne Poznań Poland 60-529
    299 Centrum Medyczne Medyk Rzeszow Poland 35-055
    300 Gabinet Lekarski, Bartosz Korczowski Rzeszów Poland 35-302
    301 Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia Sopot Poland 81-756
    302 Niepubliczny Zaklad Opieki Zdrowotnej SONOMED Szczecin Poland 70-351
    303 Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin Poland 71-434
    304 Centrum Zdrowia MDM Warszawa Poland 00-631
    305 Zespó Przychodni Specjalistycznych PRIMA Warszawa Poland 02-018
    306 Endoterapia PFG Sp. z o.o. Warszawa Poland 02-653
    307 Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Warszawa Poland 02-781
    308 Nzoz Vivamed Warszawa Poland 03-580
    309 LexMedica Osrodek Badan Klinicznych Wroclaw Poland 53-114
    310 EMC Instytut Medyczny S.A. Wrocław Poland 50-220
    311 PlanetMed Wrocław Poland 52-210
    312 AppleTreeClinics Sp. z o.o. Łódź Poland 90-349
    313 Hospital de Braga Braga Portugal 4710-243
    314 Hospital da Senhora da Oliveira Guimarães Guimarães Portugal 4835-044
    315 Spitalul Clinic Colentina Bucharest Romania 772202
    316 S.C MedLife S.A Bucuresti Romania 010719
    317 Centrul Medical Unirea SRL Bucuresti Romania 040055
    318 Centrul de Gastroenterologie Dr. Goldis Timisoara Romania 300002
    319 Yusupov Hospital Moskva Adygeja Russian Federation 127015
    320 Baltic Medicine St.Petersburg Leningrad Russian Federation 194356
    321 CJSC Nasledniki Moscow Moskovskaja Oblast Russian Federation 119192
    322 FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology Sankt-peterburg Sankt Petersburg Russian Federation 194044
    323 SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery Sankt-peterburg Sankt Petersburg Russian Federation 194354
    324 SBIH City Clinical Hospital #31 Sankt-peterburg Sankt Petersburg Russian Federation 197110
    325 FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy St. Petersburg Sankt Petersburg Russian Federation 193163
    326 Medical and Sanitary Division of Severstal Cherepovets Vologda Russian Federation 162600
    327 SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF Voronezh Voronez Russian Federation 394036
    328 SBEI HPE Altai StateMedicalUniversityofMoH andSD Barnaul Russian Federation 656050
    329 Irkutsk State Medical Academy of Continuing Education Irkutsk Russian Federation
    330 FSBIH Central Clinical Hospital of RAS Moscow Russian Federation 119333
    331 FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology Moscow Russian Federation 123154
    332 SBHI of NN region "RCH of NN n.a. N.A.Semashko" Nizhny Novgorod Russian Federation 603126
    333 FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS Novosibirsk Russian Federation 630117
    334 BHI of Omsk region Clinical Oncology Dispensary Omsk Russian Federation 644013
    335 SBEI of HPE "Omsk SMA" Ministry of healthcare of RF" Omsk Russian Federation 644043
    336 SEIHPE "Rostov SMU of MoH of RF" Rostov-on-Don Russian Federation 344022
    337 City Hospital #26 St Petersburg Russian Federation 196247
    338 LLC International Medical Centre "SOGAZ" St-Petersburg Russian Federation 198035
    339 Pavlov First Saint Petersburg State Medical University St. Petersburg Russian Federation 197022
    340 SPb SHI "City Hospital #9" St. Petersburg Russian Federation 197110
    341 Stavropol Regional Clinical Diagnostic Consultative Center Stavropol Russian Federation 355017
    342 FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation Stavropol Russian Federation 355018
    343 Clinical Center Zvezdara Belgrade Serbia 11000
    344 Military Medical Academy Belgrade Serbia 11040
    345 Clinical Center Zemun Belgrade Serbia 11080
    346 Clinical Center Kragujevac Kragujevac Serbia 34000
    347 General Hospital Djordje Joanovic Zrenjanin Serbia 23000
    348 Singapore General Hospital Singapore Singapore 169608
    349 Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica Slovakia 975 17
    350 Nemocnica A.Lena Humenne, n.o. Humenné Slovakia 066 01
    351 KM Management spol. s r.o. Nitra Slovakia 94901
    352 Fakultna nemocnica Nitra Nitra Slovakia 950 01
    353 Gastro I, s.r.o. Prešov Slovakia 080 01
    354 Svet zdravia a.s. Rimavská Sobota Slovakia 979 01
    355 Endomed, s.r.o. Vranov nad Topľou Slovakia 093 01
    356 Accout Center s.r.o. Šahy Slovakia 936 01
    357 Netcare Universitas Private Hospital Bloemfontein South Africa 9301
    358 Dr MJ Prins Practice Cape Town South Africa 7500
    359 Dr JP Wright Practice Cape Town South Africa 7708
    360 Emmed Research Pretoria South Africa 0002
    361 Corporacio Sanitaria Parc Tauli Sabadell Barcelona Spain 08208
    362 Fundacion Hospital de Alcorcon; Servicio de Digestivo Alcorcon Madrid Spain 28922
    363 Centro Médico Teknon Barcelona Spain
    364 Hospital Universitari de Girona Dr Josep Trueta Girona Spain 17007
    365 Hospital Universitario de la Princesa Madrid Spain 28006
    366 Hospital Universitario La Paz Madrid Spain 280146
    367 Hospital Universitario de Fuenlabrada Madrid Spain 28942
    368 Hospital Universitari i Politecnic La Fe Valencia Spain 46026
    369 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    370 Inselspital-Universitaetsspital Bern Bern Switzerland 3010
    371 Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner Bern Switzerland 3012
    372 Gazi University Medical Faculty; Gastroenterology Ankara Turkey 06500
    373 Haydarpasa Numune Training and Research Hospital; Medical Oncology Istanbul Turkey 34668
    374 Kocaeli Universitesi Tip Fakultesi; Infectious Diseases Kocaeli Turkey 41380
    375 CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC Kharkiv Kharkiv Governorate Ukraine 61037
    376 Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital Kharkiv Kharkiv Governorate Ukraine 61058
    377 Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Kyiv Kharkiv Governorate Ukraine 04107
    378 CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI Sumy Kharkiv Governorate Ukraine 40022
    379 LLC Gastroenterology Center IBD Team Zaporizhzhia Kharkiv Governorate Ukraine 69000
    380 CNE Kyiv CCH #18 Kyiv KIEV Governorate Ukraine 01030
    381 CI of Kyiv RC Kyiv Regional Clinical Hospital Kyiv KIEV Governorate Ukraine 04107
    382 Medical Center of Limited Liability Company Medical Clinic Blagomed Kyiv KIEV Governorate Ukraine 1023
    383 Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" Kyiv KIEV Governorate Ukraine 2091
    384 CI of Kyiv RC Regional Clinical Hospital #2 Kyiv KIEV Governorate Ukraine 4073
    385 Lviv Regional Clinical Hospital Lviv KIEV Governorate Ukraine 79010
    386 CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training Uzhgorod KIEV Governorate Ukraine 88009
    387 A.Novak Transcarpathian Regional Clinical Hospital Uzhgorod KIEV Governorate Ukraine 88018
    388 RCNECRCH Dept of Surgery, SHEI Ukr BSMU Chernivtsi Podolia Governorate Ukraine 58002
    389 CI City Hospital #1 Zaporizhzhia Tavria Okruha Ukraine 69104
    390 RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU Chernivtsi Ukraine 58002
    391 SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU Dnipropetrovsk Ukraine 49074
    392 GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Kharkiv Ukraine 61039
    393 CI of Healthcare Kharkiv CCH #13 Kharkiv Ukraine 61124
    394 CI Kherson Afanasii and Olha Tropiny City Clinical Hospital Kherson Ukraine 73000
    395 CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv Kyiv Ukraine 02232
    396 Odessa regional clinical Hospital Odessa Ukraine 65117
    397 M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA Poltava Ukraine 36011
    398 M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy Poltava Ukraine 36011
    399 Private Small Enterprise Medical Center Pulse Vinnytsia Ukraine 21001
    400 M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia Ukraine 21018
    401 MCIC Health Clinic BO LTD TPC Slaomed Vinnytsia Ukraine 21029
    402 Co Ltd. Diaservice Zaporizhzhia Ukraine 69035
    403 CI City Hospital #7 Zaporizhzhia Ukraine 69118
    404 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    405 University Hospital Coventry Coventry United Kingdom CV2 2DX
    406 Royal Devon and Exeter Hospital (Wonford) Exeter United Kingdom EX2 5DW
    407 St James University Hospital Leeds United Kingdom LS9 7TF
    408 The Royal London Hospital London United Kingdom E1 1FR
    409 University College London Hospital London United Kingdom NW1 - 2PG
    410 St Thomas Hospital London United Kingdom SE1 7EH
    411 King's College London London United Kingdom SE5 9NU
    412 Fairfield General Hospital Manchester United Kingdom M8 5RB
    413 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP
    414 Nottingham University Hospitals; QMC Campus Nottingham United Kingdom NG7 2UH
    415 Southampton General Hospital Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02118584
    Other Study ID Numbers:
    • GA28951
    • 2013-004435-72
    First Posted:
    Apr 21, 2014
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2022