COTTONWOOD: Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
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
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:
|
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
- 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)]
- Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS) - Part 1 [Week 108]
- Percentage of Participants With Endoscopic Remission [Week 108]
- 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)]
- 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]
- Percentage of Participants With Progressive Multifocal Leukoencephalopathy (PML) - Part 2 [104 weeks]
- Change From Baseline in pMCS at Year 9 [Baseline, Year 9]
Eligibility Criteria
Criteria
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
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Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
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Any new, significant, uncontrolled condition
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- GA28951
- 2013-004435-72