A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
- Registration Number
- NCT00306215
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.
- Detailed Description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 436
- moderate to severe Crohn's Disease
- CDAI 250-450
- CRP >7.5
- signed written informed consent
Key
- > 100 cm of small bowel resected
- ileostomy, colostomy or rectal pouch
- diagnosis of ulcerative colitis or indeterminate colitis
- evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
- hepatitis B, C or HIV infection
- history of infection requiring IV antibiotics
- serious or GI infection in the previous 12 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 CCX282-B Blinded study arm 4 CCX282-B Blinded study arm 1 CCX282-B Blinded study arm 2 CCX282-B Blinded study arm
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (112)
The Alfred Hospital
🇦🇺Prahran, Victoria, Australia
Krankenanstalt Rudolfstiftung
🇦🇹Wien, Austria
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Centre for Gastroenterology Royal Free Hospital
🇬🇧London, United Kingdom
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
UZ Gent
🇧🇪Gent, Belgium
Centro Petropolitano de Reumatologia e Fisioterapia
🇧🇷Centro Petrópolis, Brazil
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Wojskowy Insytutu Medyczny
🇵🇱Warsaw, Poland
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Bayside Gastroenterology
🇦🇺Frankston, Victoria, Australia
Universitätsklinik für Innere Medizin
🇦🇹Innsbruck, Austria
Universitätsklinik für Innere Medizin III
🇦🇹Wien, Austria
Hospital das Clínicas de Curitiba UFPR
🇧🇷Curitiba, Brazil
Klinikum der Universität Regensburg
🇩🇪Regensburg, Germany
Bnai Zion MC
🇮🇱Haifa, Israel
Assaf Harofeh Medical Center
🇮🇱Trzifin, Israel
UMHAT "St. Marina"
🇧🇬Varna, Bulgaria
DHC Research
🇨🇦Richmond Hill, Ontario, Canada
Unigastro
🇧🇷Campinas, Brazil
Hospital Geral de Goiânia
🇧🇷Goiânia, Brazil
Santo André Diagnósticos e tratamentoLtda.
🇧🇷Santo André, Brazil
Irmandade da Santa Casa de Misericórdia de Santos
🇧🇷Santos, Brazil
4 MHAT, 38 "Makedonia" 1000
🇧🇬Sofia, Bulgaria
UMHAT Queen Joanna
🇧🇬Sofia, Bulgaria
V City Hospital
🇧🇬Sofia, Bulgaria
CHAUQ-Hopital St-Sacrement
🇨🇦Quebec, Canada
Ringweg Randenbroek 110
🇳🇱Amersfoort, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
ZOZ MSWiA Oddział Chorób Wewnętrznych
🇵🇱Bialystok, Poland
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
🇩🇪Berlin, Germany
Service de Gastro-Enterologie et Nutrition
🇫🇷Toulouse, France
A.ö. Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
Landesklinikum St. Poelten
🇦🇹Poelten, Austria
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Instituto Goiano de Gastro
🇧🇷Goiania, Brazil
Military Medical Academy
🇧🇬Sofia, Bulgaria
UMHAT "Alexandrovska"
🇧🇬Sofia, Bulgaria
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Service d'Hépato-Gastroentérologie et de Nutrition Clinique
🇫🇷Nice, France
Hôpital Charles Nicolle
🇫🇷Rouen, France
Health Science Centre
🇨🇦Calgary, Alberta, Canada
Lair Centre
🇨🇦Vancouver, British Columbia, Canada
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
🇧🇷Sao Paulo, Brazil
Hospital Israelita Albert Einstein
🇧🇷São Paulo, Brazil
UMHAT" St. Ivan Rilsky"
🇧🇬Sofia, Bulgaria
Centre Hospitalier--Hotel-Dieu de Levis
🇨🇦Levis, Quebec, Canada
Réthy Pál Kórház
🇭🇺Bekescsaba, Hungary
Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
🇭🇺Budapest, Hungary
Klinikum der Christian-Albrechts-Universität zu Kiel
🇩🇪Kiel, Germany
BAZ Megyei Kórház
🇭🇺Miskolc, Hungary
The Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
SPZOZ Szpital Wojewódzki w Opolu
🇵🇱Opole, Poland
Kaplan Medical Center
🇮🇱Rechovot, Israel
NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
🇵🇱Warszawa, Poland
Royal Brisbane and Womens Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St Vincents Hospital
🇦🇺Fitzroy, Victoria, Australia
Mt. Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Medical department S Odense University hospital
🇩🇰Odense, Denmark
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Universitetssjukhuset
🇸🇪Lund, Sweden
Bankstown - Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
Hospital São Lucas PUC-RS
🇧🇷Porto Alegre, Brazil
Hospital das Clínicas de São Paulo
🇧🇷São Paulo, Brazil
Regional Hospital Pribram
🇨🇿Pribram, Czechia
Hepato-Gastroenterologie, Edvarda Benese 1549
🇨🇿Hradec Kralove, Czechia
II.Interni klinika, Endoskopie
🇨🇿Olomouc, Czechia
General University Hospital Prague
🇨🇿Prague, Czechia
Medic Kral ltd.
🇨🇿Prague, Czechia
Fakultni nemocnice
🇨🇿Praha, Czechia
Klinika hepatogastroenterologieIKEM
🇨🇿Praha, Czechia
Regional Hospital Tabor
🇨🇿Tabor, Czechia
Private Gastroenterology Centre
🇨🇿České Budejovice, Czechia
Herlev Hospital Gastroenterologisk department
🇩🇰Herlev, Denmark
Medical Department V Århus University Hospital
🇩🇰Arhus C, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Hopital du Haut-Lévêque
🇫🇷Pessac, France
CHU Amiens - Hôpital Nord
🇫🇷Amiens, France
Charité Campus Mitte, Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Magdeburg A.ö.R
🇩🇪Magdeburg, Germany
Fachärztin für Innere Medizin
🇩🇪Hamburg, Germany
Gastroenterologische Praxis am Germania-Campus
🇩🇪Münster, Germany
Vaszary Kolos Kórház
🇭🇺Esztergom, Hungary
Debreceni Egyetem OEC
🇭🇺Debrecen, Hungary
Petz Aladár Megyei Oktató Kórház
🇭🇺Győr, Hungary
Rambam Medical Center,
🇮🇱Haifa, Israel
Soroka Medical Center
🇮🇱Beer-Sheva, Israel
Hadassah Ein-Karem Medical Center
🇮🇱Jerusalem, Israel
Meir Hospital
🇮🇱Kfar-Saba, Israel
Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
🇳🇱Zwolle, Netherlands
Samodzielny Publiczny Szpital Kliniczny Nr 4
🇵🇱Lublin, Poland
SPZOZ Wojewodzki Szpital
🇵🇱Bydgoszcz, Poland
10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
🇵🇱Bydgoszcz, Poland
SOPMED Niepubliczny Zakład Opieki Zdrowotnej
🇵🇱Sopot, Poland
Klinika Chorob Wewnetrznych I Gastroenterologii
🇵🇱Krakow, Poland
Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
🇵🇱Szczecin, Poland
CSK MSWiA, Klinika Gastroenterologii
🇵🇱Warszawa, Poland
Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
🇵🇱Wroclaw, Poland
Panorama Medi Clinic
🇿🇦Cape Town, South Africa
Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
🇿🇦Cape Town, South Africa
Quatro Clinical Trial Institute
🇿🇦Cape Town, South Africa
GastroEnterology Unit, Groote Schuur Hospital
🇿🇦Cape Town, South Africa
427 Ontdekkers Road, Florida Park
🇿🇦Johannesburg, South Africa
Medicinkliniken, SU/Östra sjukhuset
🇸🇪Göteborg, Sweden
Medicinmottagningen, Södersjukhuset
🇸🇪Stockholm, Sweden
Sophiahemmet
🇸🇪Stockholm, Sweden
Dept of Gastroenterology, John Radcliffe Hospital
🇬🇧Oxford, United Kingdom