JUNIPER: Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02403323
Collaborator
(none)
900
292
2
131.4
3.1
0
Study Details
Study Description
Brief Summary
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
900 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Actual Study Start Date
:
Jun 8, 2015
Anticipated Primary Completion Date
:
May 21, 2026
Anticipated Study Completion Date
:
May 21, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Etrolizumab Open-Label Extension Participants will receive open-label treatment with etrolizumab once every 4 weeks until commercial availability in their country or sponsor's decision to terminate the study, whichever is earlier (up to approximately 10 years after the first patient is enrolled). |
Drug: Etrolizumab
105 mg etrolizumab subcutaneous administration once every 4 weeks
Other Names:
|
| No Intervention: Part 2: Safety Monitoring Participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events. |
Outcome Measures
Primary Outcome Measures
- Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time [Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Number of Participants with Clinical Remission Over Time [Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earlier (up to approximately 10 years)]
Clinical remission is defined by a loose/soft stool frequency (SF) mean daily score ≤3 and an abdominal pain mean daily score ≤1 with no worsening in either subscore compared to baseline, averaged over 7 days prior to visit.
- Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108 [Week 108 (or at early withdrawal, if prior to Week 108)]
- Part 1: Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0 [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Number of Infection-Related Adverse Events per Patient-Year [From Week 0 until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0 [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants who Develop Malignancies [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Number of Malignancies per Patient-Year [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0 [From Week 0 until completion of safety follow-up, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)]
- Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [Weeks 0 and 12, and every 48 weeks thereafter until study completion or early withdrawal (up to approximately 10 years)]
- Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML) [From end of safety follow-up until completion of 92-week safety monitoring in Part 2 (up to 92 weeks)]
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:
- Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
-
Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
-
Patients who transfer from Part 1
-
Completion of the 12-week safety follow-up period prior to entering
Exclusion Criteria:
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Valley Gastroenterology Consultants | Arcadia | California | United States | 91006 |
| 2 | University of California San Diego Medical Center | La Jolla | California | United States | 92093-5354 |
| 3 | VA Long Beach Healthcare System | Long Beach | California | United States | 90822 |
| 4 | Digestive Care Associates, A Medical Corporation | San Carlos | California | United States | 94070 |
| 5 | SDG Clinical Research | San Diego | California | United States | 92103 |
| 6 | Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri | San Francisco | California | United States | 94158 |
| 7 | Peak Gastroenterology Associates | Colorado Springs | Colorado | United States | 80907 |
| 8 | Innovative Medical Research of South Florida | Aventura | Florida | United States | 33180 |
| 9 | West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | United States | 33762 |
| 10 | University of Florida College of Medicine | Gainesville | Florida | United States | 32610 |
| 11 | Borland-Groover Clinic | Jacksonville | Florida | United States | 32256 |
| 12 | IMIC, Inc | Miami Beach | Florida | United States | 33140 |
| 13 | FQL Research, LLC | Miramar | Florida | United States | 33025 |
| 14 | Shafran Gastroenterology Center | Winter Park | Florida | United States | 32789 |
| 15 | Emory University Hospital | Atlanta | Georgia | United States | 30308 |
| 16 | Atlanta Gastroenterology Associates | Atlanta | Georgia | United States | 30342 |
| 17 | Columbus Regional Research Institute | Columbus | Georgia | United States | 31904 |
| 18 | Atlanta Center for Gastroenterology, PC | Decatur | Georgia | United States | 30033 |
| 19 | Gastroenterology Associates of Central Georgia | Macon | Georgia | United States | 31201 |
| 20 | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States | 30060 |
| 21 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
| 22 | Northwestern Uni-Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 23 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
| 24 | Southwest Gastroenterology | Oak Lawn | Illinois | United States | 60453 |
| 25 | Carle Foundation Hospital | Urbana | Illinois | United States | 61801-2500 |
| 26 | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | United States | 66606 |
| 27 | Gastroenterology Associates, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 28 | Louisiana Research Center, LLC | Shreveport | Louisiana | United States | |
| 29 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 30 | Gastroenterology Associates of Western Michigan, P.L.C. | Grand Rapids | Michigan | United States | 49506 |
| 31 | Center for Digestive Health | Troy | Michigan | United States | 48098 |
| 32 | Henry Ford Health System | West Bloomfield | Michigan | United States | 48322 |
| 33 | Mayo Clinic - Rochester | Rochester | Minnesota | United States | 55905 |
| 34 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 35 | Ehrhardt Clinical Research, LLC | Belton | Missouri | United States | 64012 |
| 36 | Concorde Medical Group | New York | New York | United States | 10016 |
| 37 | Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | United States | 10021 |
| 38 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 39 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 40 | Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | United States | 28207 |
| 41 | Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston | Kinston | North Carolina | United States | 28501 |
| 42 | Consultants for Clinical Research Inc. | Cincinnati | Ohio | United States | 45219 |
| 43 | Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | United States | 44060 |
| 44 | Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | United States | 73112 |
| 45 | Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | United States | 17110 |
| 46 | Innovative Clinical Research | Greenville | South Carolina | United States | 29604 |
| 47 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 48 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 49 | Texas Digestive Disease Consultants - Dallas | Dallas | Texas | United States | 75231 |
| 50 | University of Texas Southwestern Medical Center; Internal Medicne | Dallas | Texas | United States | 75390-9151 |
| 51 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 52 | Methodist Hospital Research Institute | Houston | Texas | United States | 77030 |
| 53 | Wellness Clinical Research Center | San Antonio | Texas | United States | 78232 |
| 54 | Texas Digestive Disease Consultants - Southlake | Southlake | Texas | United States | 76092 |
| 55 | Digestive Health Specialists of Tyler | Tyler | Texas | United States | 75701 |
| 56 | Ericksen Research and Development | Clinton | Utah | United States | 84015 |
| 57 | University of Utah School of Medicine | Salt Lake City | Utah | United States | 84132 |
| 58 | McGuire Research Institute; Gastroenterology | Richmond | Virginia | United States | 23249 |
| 59 | Digestive Disease Institute; Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 60 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
| 61 | Hospital Italiano | Caba | Argentina | C1199ABB | |
| 62 | The Canberra Hospital | Garran | Australian Capital Territory | Australia | 2065 |
| 63 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
| 64 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
| 65 | University of the Sunshine Coast | Sippy Downs | Queensland | Australia | 4556 |
| 66 | Mater Adult Hospital | South Brisbane | Queensland | Australia | 4101 |
| 67 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 68 | Flinders Medical Centre | Bedford Park | South Australia | Australia | 5042 |
| 69 | St Vincent's Hospital Melbourne | Fitzroy | Victoria | Australia | 3065 |
| 70 | Footscray Hospital | Footscray | Victoria | Australia | 3011 |
| 71 | St Frances Xavier Cabrini Hospital | Malvern | Victoria | Australia | 3144 |
| 72 | Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics | Parkville | Victoria | Australia | 3050 |
| 73 | The Alfred Hospital | Prahan | Victoria | Australia | 3181 |
| 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 | UZ Brussel | Brussel | Belgium | 1090 | |
| 78 | CHU St Pierre (César de Paepe) X | Bruxelles | Belgium | 1000 | |
| 79 | ULB Hopital Erasme; Service de Néphrologie | Bruxelles | Belgium | 1070 | |
| 80 | UZ Antwerpen | Edegem | Belgium | 2650 | |
| 81 | AZ Maria Middelares | Gent | Belgium | 9000 | |
| 82 | Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiânia | GO | Brazil | 74535-170 |
| 83 | Hospital Felicio Rocho | Belo Horizonte | MG | Brazil | 30110-068 |
| 84 | Centro Digestivo de Curitiba | Curitiba | PR | Brazil | 80430-160 |
| 85 | Hospital Universitario Clementino Fraga Filho - UFRJ | Rio de Janeiro | RJ | Brazil | 21941-913 |
| 86 | Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A | Rio de Janeiro | RJ | Brazil | 22271-100 |
| 87 | Hospital Sao Vicente de Paulo | Passo Fundo | RS | Brazil | 99010-090 |
| 88 | Hospital das Clinicas - UFRGS | Porto Alegre | RS | Brazil | 90035-903 |
| 89 | Hospital Ernesto Dornelles | Porto Alegre | RS | Brazil | 90160-092 |
| 90 | UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu | SP | Brazil | 18618-970 |
| 91 | Pesquisare Saúde Sociedade Simples | Santo Andre | SP | Brazil | 09080-000 |
| 92 | Praxis Pesquisa Médica | Santo Andre | SP | Brazil | 09090-790 |
| 93 | Hospital Estadual Mario Covas | Santo Andre | SP | Brazil | 09190-610 |
| 94 | Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto | SP | Brazil | 15090-000 |
| 95 | Hospital Sírio-Libanês | Sao Paulo | SP | Brazil | 01308-050 |
| 96 | Universidade Federal de Sao Paulo - UNIFES | Sao Paulo | SP | Brazil | 04026-000 |
| 97 | Hospital do Servidor Público Estadual/HSPE-SP | São Paulo | SP | Brazil | 04039-901 |
| 98 | "City Clinic UMHAC" EOOD | Sofia | Bulgaria | 1407 | |
| 99 | UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria | 1431 | |
| 100 | University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
| 101 | Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology | Edmonton | Alberta | Canada | T6G 2X8 |
| 102 | (G.I.R.I.) GI Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 103 | Winnipeg Regional Health Authority; Neurosurgery Department | Winnipeg | Manitoba | Canada | R3A 1R9 |
| 104 | Queen Elizabeth II Health Sciences Centre; Gastroenterology Research | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 105 | University Hospital - London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 106 | Taunton Health Centre | Oshawa | Ontario | Canada | L1H 7K4 |
| 107 | The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit | Ottawa | Ontario | Canada | K1H 1A2 |
| 108 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 109 | Toronto Digestive Disease Associates | Vaughan | Ontario | Canada | L4L 4Y7 |
| 110 | Hôpital Maisonneuve - Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 111 | McGill University Health Centre - Glen Site | Montreal | Quebec | Canada | H4A 3J1 |
| 112 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W8 |
| 113 | Clinical Hospital Centre Osijek | Osijek | Croatia | 31000 | |
| 114 | General Hospital Pula | Pula | Croatia | 52000 | |
| 115 | Clinical Hospital Center Sestre Milosrdnice | Zagreb | Croatia | 10000 | |
| 116 | Vojenska nemocnice Brno | Brno | Czechia | 636 00 | |
| 117 | Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika | Brno | Czechia | 65691 | |
| 118 | Nemocnice Ceske Budejovice a.s. | Ceske Budejovice | Czechia | 370 01 | |
| 119 | Gastroenterologie s.r.o. | Hradec Kralove | Czechia | 500 02 | |
| 120 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
| 121 | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | Czechia | 500 12 | |
| 122 | PreventaMed, s.r.o. | Olomouc | Czechia | 779 00 | |
| 123 | Fakultni nemocnice Ostrava | Ostrava - Poruba | Czechia | 708 52 | |
| 124 | ISCARE a.s. | Praha 7 | Czechia | 170 04 | |
| 125 | Fakultni nemocnice Kralovske Vinohrady | Praha | Czechia | 110 34 | |
| 126 | West Tallinn Central Hospital | Tallinn | Estonia | 10617 | |
| 127 | North Estonia Medical Centre Foundation | Tallinn | Estonia | 13419 | |
| 128 | Tartu University Hospital | Tartu | Estonia | 51014 | |
| 129 | CHU Amiens - Hopital Sud | Amiens | France | 80054 | |
| 130 | CHU de Caen - Hopital Cote de Nacre | Caen | France | 14033 | |
| 131 | Hôpital Beaujon | Clichy cedex | France | 92110 | |
| 132 | Hopital Claude Huriez - CHU Lille | Lille | France | 59037 | |
| 133 | CHU NANTES - Hôtel Dieu; Pharmacy | Nantes | France | 44093 | |
| 134 | CHU Nice - Hopital de l'Archet 2 | Nice | France | 06202 | |
| 135 | Hôpital Saint-Louis | Paris | France | 75475 | |
| 136 | Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN | Pessac | France | 33604 | |
| 137 | Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie | Pierre-Benite | France | 69495 | |
| 138 | CHU du Reims - Hopital Robert Debré | Reims | France | 51092 | |
| 139 | CHU Saint Etienne - Hôpital Nord | Saint Etienne | France | 42055 | |
| 140 | Höpital Hautepierre; Pediatrie1 | Strasbourg | France | 67098 | |
| 141 | Hôpital de Brabois Adultes | Vandoeuvre-les-nancy | France | 54511 | |
| 142 | Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie | Berlin | Germany | 13353 | |
| 143 | Charité Campus Virchow-Klinikum; Department of Cardiology | Berlin | Germany | 13353 | |
| 144 | Krankenhaus Waldfriede e. V. | Berlin | Germany | 14163 | |
| 145 | Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH | Bochum | Germany | 44789 | |
| 146 | Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | Germany | 60590 | |
| 147 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 148 | Klinikum Mannheim GmbH Universitätsklinikum | Mannheim | Germany | 68167 | |
| 149 | Gemeinschaftspraxis | Offenburg | Germany | 77652 | |
| 150 | Universitaetsklinikum Ulm | Ulm | Germany | 89081 | |
| 151 | Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza | Bekescsaba | Hungary | 5600 | |
| 152 | Obudai Egeszsegugyi Centrum Kft. | Budapest | Hungary | 1036 | |
| 153 | Semmelweis Egyetem | Budapest | Hungary | 1083 | |
| 154 | Szt Janos Korhaz es EbudaiEgyesitettKorhazak | Budapest | Hungary | 1125 | |
| 155 | Pannonia Maganorvosi Centrum | Budapest | Hungary | 1135 | |
| 156 | Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika | Debrecen | Hungary | 4012 | |
| 157 | Petz Aladar Megyei Oktato Korhaz | Gyor | Hungary | 9024 | |
| 158 | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | Hungary | 2143 | |
| 159 | Haemek Medical Center | Afula | Israel | 18101 | |
| 160 | Soroka University Medical Centre | Beer Sheva | Israel | 8410101 | |
| 161 | Wolfson Medical Center | Holon | Israel | 5822012 | |
| 162 | Shaare Zedek Medical Center | Jerusalem | Israel | 9103102 | |
| 163 | Holy Family Hospital | Nazareth | Israel | 16100 | |
| 164 | Rabin Medical Center-Beilinson Campus | Petach Tikva | Israel | 4941492 | |
| 165 | Tel Aviv Sourasky Medical Center; Pharmacy | Tel Aviv | Israel | 6423906 | |
| 166 | A.O.U. Policlinico di Modena | Modena | Emilia-Romagna | Italy | 40124 |
| 167 | Azienda Ospedaliera San Camillo Forlanini | Roma | Lazio | Italy | 00152 |
| 168 | Policlinico Universitario Agostino Gemelli; Farmacia | Roma | Lazio | Italy | 00168 |
| 169 | Asst Fatebenefratelli Sacco (Fatebenefratelli) | Milano | Lombardia | Italy | 20121 |
| 170 | Istituto Clinico Humanitas | Rozzano (MI) | Lombardia | Italy | 20089 |
| 171 | I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI) | Lombardia | Italy | 20097 |
| 172 | Azienda Ospedaliera Universitaria Careggi | Florence | Toscana | Italy | 50134 |
| 173 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
| 174 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 175 | Yeungnam Univ. Hospital | Daegu | Korea, Republic of | 705-717 | |
| 176 | Korea University Ansan Hospital | Gyeonggi-do | Korea, Republic of | 15355 | |
| 177 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
| 178 | CHA Bundang Medical Centre; CHA university | Seongnam | Korea, Republic of | 13520 | |
| 179 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 180 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 181 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 182 | Yonsei University Wonju Severance Christian Hospital | Wonju-Si | Korea, Republic of | 220-701 | |
| 183 | Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy | Riga | Latvia | LV-1005 | |
| 184 | Pauls Stradins Clinical University Hospital | Rīga | Latvia | LV-1002 | |
| 185 | Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas | Lithuania | 50009 | |
| 186 | Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology | Vilnius | Lithuania | 08661 | |
| 187 | Clinical Research Institute | Tlalnepantla de Baz | Mexico CITY (federal District) | Mexico | 54055 |
| 188 | Medical Care & Research SA de CV | Mérida | Yucatan | Mexico | 97070 |
| 189 | Amsterdam UMC, Locatie VUMC; Gastroenterology | Amsterdam | Netherlands | 1081 HV | |
| 190 | Amsterdam UMC Location AMC | Amsterdam | Netherlands | 1105 AZ | |
| 191 | Leids Universitair Medisch Centrum; Cardiology | Leiden | Netherlands | 2333 ZA | |
| 192 | Maastricht University Medical Center | Maastricht | Netherlands | 6229 HX | |
| 193 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3000 CA | |
| 194 | Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | Netherlands | 6162 BG | |
| 195 | ETZ TweeSteden | Tilburg | Netherlands | 5042AD | |
| 196 | North Shore Hospital | Auckland | New Zealand | 0620 | |
| 197 | Christchurch Hospital NZ | Christchurch | New Zealand | 8011 | |
| 198 | Dunedin Public Hospital | Dunedin | New Zealand | 9016 | |
| 199 | Waikato Hospital | Hamilton | New Zealand | 3248 | |
| 200 | Hutt Hospital | Lower Hutt | New Zealand | 5010 | |
| 201 | Shakespeare Specialist Group | Takapuna | New Zealand | 0620 | |
| 202 | Tauranga Hospital | Tauranga | New Zealand | 3143 | |
| 203 | SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego | Białystok | Poland | 15-275 | |
| 204 | Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | Poland | 85-312 | |
| 205 | Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ | Elblag | Poland | 82-300 | |
| 206 | ETG Kielce | Kielce | Poland | 25-355 | |
| 207 | Centrum Opieki Zdrowotnej Orkan-Med | Ksawerow | Poland | 95-054 | |
| 208 | Indywidualna Specjalistyczna Praktyka Lekarska | Lublin | Poland | 20-015 | |
| 209 | Allmedica Badania Kliniczne Sp z o.o. Sp K. | Nowy Targ | Poland | 34-400 | |
| 210 | Centrum Medyczne "MEDYK" | Rzeszow | Poland | 35-055 | |
| 211 | Gabinet Lekarski, Bartosz Korczowski | Rzeszów | Poland | 35-302 | |
| 212 | Niepubliczny Zaklad Opieki Zdrowotnej SONOMED | Szczecin | Poland | 70-351 | |
| 213 | Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 214 | Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj | Toruń | Poland | 87-100 | |
| 215 | Centrum Zdrowia MDM | Warszawa | Poland | 00-631 | |
| 216 | Zespó Przychodni Specjalistycznych PRIMA | Warszawa | Poland | 02-018 | |
| 217 | LexMedica Osrodek Badan Klinicznych | Wroclaw | Poland | 53-114 | |
| 218 | EMC Instytut Medyczny S.A. | Wrocław | Poland | 50-220 | |
| 219 | PlanetMed sp. z o.o. | Wrocław | Poland | 52-210 | |
| 220 | S.C MedLife S.A | Bucuresti | Romania | 010719 | |
| 221 | Spitalul Clinic Colentina | Sector 2 | Romania | 020125 | |
| 222 | Centrul de Gastroenterologie Dr. Goldis | Timisoara | Romania | 300002 | |
| 223 | LLC "Novosibirsk GastroCenter" | Novosibirsk | Altaj | Russian Federation | 630007 |
| 224 | Baltic Medicine | St.Petersburg | Leningrad | Russian Federation | 194356 |
| 225 | North-Western Medical University n.a. I.I. Mechnikov; Rheumatology | Sankt-peterburg | Sankt Petersburg | Russian Federation | 191015 |
| 226 | SBIH City Clinical Hospital #31 | Sankt-peterburg | Sankt Petersburg | Russian Federation | 197110 |
| 227 | SBEI HPE Altai StateMedicalUniversityofMoH andSD | Barnaul | Russian Federation | 656050 | |
| 228 | Irkutsk State Medical Academy of Continuing Education | Irkutsk | Russian Federation | ||
| 229 | LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology | Moscow | Russian Federation | 125015 | |
| 230 | SBEIHPE Novosibirsk State Medical University | Novosibirsk | Russian Federation | 630091 | |
| 231 | BHI of Omsk region Clinical Oncology Dispensary | Omsk | Russian Federation | 644013 | |
| 232 | Evromedservis LCC | Pushkin | Russian Federation | 196603 | |
| 233 | SEIHPE "Rostov SMU of MoH of RF" | Rostov-on-Don | Russian Federation | 344022 | |
| 234 | Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department | Saint-Petersburg | Russian Federation | 191015 | |
| 235 | Pavlov First Saint Petersburg State Medical University | St. Petersburg | Russian Federation | 197022 | |
| 236 | Clinical Center Zvezdara | Belgrade | Serbia | 11000 | |
| 237 | Military Medical Academy | Belgrade | Serbia | 11040 | |
| 238 | General Hospital Djordje Joanovic | Zrenjanin | Serbia | 23000 | |
| 239 | KM Management spol. s r.o. | Nitra | Slovakia | 94901 | |
| 240 | Endomed, s.r.o. | Vranov nad Topľou | Slovakia | 093 01 | |
| 241 | Accout Center s.r.o. | Šahy | Slovakia | 936 01 | |
| 242 | Dr D Epstein Practice | Cape Town | South Africa | 7405 | |
| 243 | Emmed Research | Pretoria | South Africa | 0002 | |
| 244 | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 245 | Hospital Clínic i Provincial; Servicio de Farmacia | Barcelona | Spain | 08036 | |
| 246 | Hospital Reina Sofia; Medical Oncology | Cordoba | Spain | 14004 | |
| 247 | Hospital Juan Ramón Jiménez | Huelva | Spain | 21005 | |
| 248 | Hospital Universitario de la Princesa | Madrid | Spain | 28006 | |
| 249 | Hospital Universitario La Paz | Madrid | Spain | 280146 | |
| 250 | Hospital Universitario de Fuenlabrada | Madrid | Spain | 28942 | |
| 251 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 252 | Hospital Universitario Virgen del Rocio | Sevilla | Spain | 41013 | |
| 253 | Hospital Universitari i Politecnic La Fe | Valencia | Spain | 46026 | |
| 254 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
| 255 | Inselspital-Universitaetsspital Bern | Bern | Switzerland | 3010 | |
| 256 | Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner | Bern | Switzerland | 3012 | |
| 257 | Universitätsspital Zürich | Zürich | Switzerland | 8091 | |
| 258 | Hacettepe University Medical Faculty; Gastroenterology | Ankara | Turkey | 06100 | |
| 259 | Gazi University Medical Faculty | Ankara | Turkey | 06500 | |
| 260 | Acibadem Fulya Hospital; Neurology | Istanbul | Turkey | 34349 | |
| 261 | Haydarpasa Numune Training and Research Hospital; Gastroenterology | Istanbul | Turkey | 34668 | |
| 262 | Ege University Medical Faculty | Izmir | Turkey | 35100 | |
| 263 | Medeniyet University Goztepe Training and Research Hospital. | Kadiköy | Turkey | 34722 | |
| 264 | Kocaeli Universitesi Tip Fakultesi; Infectious Diseases | Kocaeli | Turkey | 41380 | |
| 265 | Acibadem Kozyatagi Hospital; Gastroenterology | Kozyataği | Turkey | 34742 | |
| 266 | CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | Kharkiv Governorate | Ukraine | 61037 |
| 267 | CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine | Kharkiv | Kharkiv Governorate | Ukraine | 61204 |
| 268 | LLC Gastroenterology Center IBD Team | Zaporizhzhia | Kharkiv Governorate | Ukraine | 69000 |
| 269 | Medical Center of Limited Liability Company Medical Clinic Blagomed | Kyiv | KIEV Governorate | Ukraine | 1023 |
| 270 | Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+" | Kyiv | KIEV Governorate | Ukraine | 2091 |
| 271 | CI of Kyiv RC Regional Clinical Hospital #2 | Kyiv | KIEV Governorate | Ukraine | 4073 |
| 272 | Lviv Regional Clinical Hospital | Lviv | KIEV Governorate | Ukraine | 79010 |
| 273 | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | Kuban People's Republica | Ukraine | 76000 |
| 274 | RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU | Chernivtsi | Ukraine | 58002 | |
| 275 | CHI Kharkiv City Clinical Hospital #13 | Kharkiv | Ukraine | 61124 | |
| 276 | Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2 | Odesa | Ukraine | 65059 | |
| 277 | Private Small Enterprise Medical Center Pulse | Vinnytsia | Ukraine | 21001 | |
| 278 | M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | Ukraine | 21018 | |
| 279 | MCIC MC LLC Health Clinic | Vinnytsia | Ukraine | 21029 | |
| 280 | Royal Victoria Hospital | Belfast | United Kingdom | BT12 6BA | |
| 281 | University Hospital Coventry | Coventry | United Kingdom | CV2 2DX | |
| 282 | Royal Devon and Exeter Hospital (Wonford) | Exeter | United Kingdom | EX2 5DW | |
| 283 | Queen Elizabeth Hospital | Kings Lynn | United Kingdom | PE30 4ET | |
| 284 | St James University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 285 | Royal Liverpool University Hospital | Liverpool | United Kingdom | L7 8XP | |
| 286 | Whipps Cross Hospital | London | United Kingdom | E11 1NR | |
| 287 | University College London Hospital | London | United Kingdom | NW1 - 2PG | |
| 288 | Fairfield General Hospital | Manchester | United Kingdom | M8 5RB | |
| 289 | Royal Victoria Infirmary; Stroke unit | Newcastle Upon Tyne | United Kingdom | NE1 4LP | |
| 290 | Nottingham University Hospitals Queen's Medical Centre | Nottingham | United Kingdom | NG7 2UH | |
| 291 | Royal Berkshire Hospital | Reading | United Kingdom | RG1 5AN | |
| 292 | 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:
NCT02403323
Other Study ID Numbers:
- GA29145
- 2014-003855-76
First Posted:
Mar 31, 2015
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022