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The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Blinded study arm |
|
| 2 | Experimental | Blinded study arm |
|
| 3 | Experimental | Blinded study arm |
|
| 4 | Experimental | Blinded study arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCX282-B | Drug | CCX282-B or placebo capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57 | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57 | Day 57 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bankstown - Lidcombe Hospital | Bankstown | New South Wales | 2200 | Australia | ||
| Royal Brisbane and Womens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23527300 | Derived | Keshav S, Vanasek T, Niv Y, Petryka R, Howaldt S, Bafutto M, Racz I, Hetzel D, Nielsen OH, Vermeire S, Reinisch W, Karlen P, Schreiber S, Schall TJ, Bekker P; Prospective Randomized Oral-Therapy Evaluation in Crohn's Disease Trial-1 PROTECT-1 Study Group. A randomized controlled trial of the efficacy and safety of CCX282-B, an orally-administered blocker of chemokine receptor CCR9, for patients with Crohn's disease. PLoS One. 2013;8(3):e60094. doi: 10.1371/journal.pone.0060094. Epub 2013 Mar 20. |
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| Herston |
| Queensland |
| 4029 |
| Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Launceston General Hospital | Launceston | Tasmania | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| St Vincents Hospital | Fitzroy | Victoria | Australia |
| Bayside Gastroenterology | Frankston | Victoria | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| The Alfred Hospital | Prahran | Victoria | 3181 | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| Universitätsklinik für Innere Medizin | Innsbruck | Austria |
| A.ö. Krankenhaus der Elisabethinen Linz | Linz | Austria |
| Landesklinikum St. Poelten | Pölten | Austria |
| Krankenanstalt Rudolfstiftung | Vienna | Austria |
| Universitätsklinik für Innere Medizin III | Vienna | Austria |
| UZ Gent | Ghent | Belgium |
| UZ Gasthuisberg | Leuven | Belgium |
| Unigastro | Campinas | 13070-040 | Brazil |
| Centro Petropolitano de Reumatologia e Fisioterapia | Centro Petrópolis | 25620-040 | Brazil |
| Hospital das Clínicas de Curitiba UFPR | Curitiba | 80060-900 | Brazil |
| Hospital Geral de Goiânia | Goiânia | 74043-110 | Brazil |
| Instituto Goiano de Gastro | Goiânia | 74535-170 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | 90035-003 | Brazil |
| Hospital São Lucas PUC-RS | Porto Alegre | 90610-000 | Brazil |
| Hospital Universitário Clementino Fraga Filho | Rio de Janeiro | 21941-590 | Brazil |
| Santo André Diagnósticos e tratamentoLtda. | Santo André | 09090-780 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Santos | Santos | 11075-900 | Brazil |
| Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | 01221-020 | Brazil |
| Hospital das Clínicas de São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | 05651-901 | Brazil |
| 4 MHAT, 38 "Makedonia" 1000 | Sofia | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| UMHAT "Alexandrovska" | Sofia | Bulgaria |
| UMHAT Queen Joanna | Sofia | Bulgaria |
| UMHAT" St. Ivan Rilsky" | Sofia | Bulgaria |
| V City Hospital | Sofia | Bulgaria |
| UMHAT "St. Marina" | Varna | Bulgaria |
| Health Science Centre | Calgary | Alberta | T2N 4N1 | Canada |
| Lair Centre | Vancouver | British Columbia | V5Z 1H1 | Canada |
| DHC Research | Richmond Hill | Ontario | Canada |
| Mt. Sinai Hospital | Toronto | Ontario | Canada |
| Centre Hospitalier--Hotel-Dieu de Levis | Lévis | Quebec | G6V 3Z1 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| Jewish General Hospital | Montreal | Quebec | Canada |
| CHAUQ-Hopital St-Sacrement | Québec | Quebec | Canada |
| Private Gastroenterology Centre | České Budejovice | Czechia |
| Hepato-Gastroenterologie, Edvarda Benese 1549 | Hradec Králové | 500 12 | Czechia |
| II.Interni klinika, Endoskopie | Olomouc | 775 20 | Czechia |
| Fakultni nemocnice | Prague | 100 10 | Czechia |
| Klinika hepatogastroenterologieIKEM | Prague | 140 21 | Czechia |
| General University Hospital Prague | Prague | Czechia |
| Medic Kral ltd. | Prague | Czechia |
| Regional Hospital Pribram | Příbram | Czechia |
| Regional Hospital Tabor | Tábor | Czechia |
| Medical Department V Århus University Hospital | Arhus C | 8000 | Denmark |
| Herlev Hospital Gastroenterologisk department | Herlev | 2730 | Denmark |
| Hvidovre Hospital | Hvidovre | Denmark |
| Medical department S Odense University hospital | Odense | 5000 | Denmark |
| CHU Amiens - Hôpital Nord | Amiens | France |
| Service d'Hépato-Gastroentérologie et de Nutrition Clinique | Nice | France |
| Hopital du Haut-Lévêque | Pessac | France |
| Hôpital Charles Nicolle | Rouen | France |
| Service de Gastro-Enterologie et Nutrition | Toulouse | France |
| Charité Campus Mitte, Universitätsmedizin Berlin | Berlin | Germany |
| Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel | Berlin | Germany |
| Fachärztin für Innere Medizin | Hamburg | Germany |
| Klinikum der Christian-Albrechts-Universität zu Kiel | Kiel | Germany |
| Universitätsklinikum Magdeburg A.ö.R | Magdeburg | Germany |
| Gastroenterologische Praxis am Germania-Campus | Münster | Germany |
| Klinikum der Universität Regensburg | Regensburg | Germany |
| Réthy Pál Kórház | Békéscsaba | Hungary |
| Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház | Budapest | Hungary |
| Debreceni Egyetem OEC | Debrecen | Hungary |
| Vaszary Kolos Kórház | Esztergom | Hungary |
| Petz Aladár Megyei Oktató Kórház | Győr | Hungary |
| BAZ Megyei Kórház | Miskolc | Hungary |
| Soroka Medical Center | Beersheba | Israel |
| Bnai Zion MC | Haifa | 31048 | Israel |
| Rambam Medical Center, | Haifa | Israel |
| Hadassah Ein-Karem Medical Center | Jerusalem | 91120 | Israel |
| Meir Hospital | Kfar Saba | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| The Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Assaf Harofeh Medical Center | Trzifin | Israel |
| Ringweg Randenbroek 110 | Amersfoort | Netherlands |
| Ikazia Ziekenhuis | Rotterdam | 3083AN | Netherlands |
| Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde | Zwolle | 8025 AB | Netherlands |
| ZOZ MSWiA Oddział Chorób Wewnętrznych | Bialystok | Poland |
| 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii | Bydgoszcz | Poland |
| SPZOZ Wojewodzki Szpital | Bydgoszcz | Poland |
| Klinika Chorob Wewnetrznych I Gastroenterologii | Krakow | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 | Lublin | Poland |
| SPZOZ Szpital Wojewódzki w Opolu | Opole | Poland |
| SOPMED Niepubliczny Zakład Opieki Zdrowotnej | Sopot | Poland |
| Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1 | Szczecin | 71-252 | Poland |
| NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A | Warsaw | 03-563 | Poland |
| CSK MSWiA, Klinika Gastroenterologii | Warsaw | Poland |
| Wojskowy Insytutu Medyczny | Warsaw | Poland |
| Klinika Gastroenterologii i Hepatologii, Akademii Medycznej | Wroclaw | Poland |
| Panorama Medi Clinic | Cape Town | 7500 | South Africa |
| Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre | Cape Town | 7530 | South Africa |
| GastroEnterology Unit, Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| Quatro Clinical Trial Institute | Cape Town | South Africa |
| 427 Ontdekkers Road, Florida Park | Johannesburg | South Africa |
| Medicinkliniken, SU/Östra sjukhuset | Gothenburg | Sweden |
| Universitetssjukhuset | Lund | Sweden |
| Medicinmottagningen, Södersjukhuset | Stockholm | Sweden |
| Sophiahemmet | Stockholm | Sweden |
| Centre for Gastroenterology Royal Free Hospital | London | NW3 2PF | United Kingdom |
| Dept of Gastroenterology, John Radcliffe Hospital | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C583420 | CCX282-B |
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