Clinical trial NCT00306215: A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Official title: A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: double-blind
placebo-controlled
multicenter
efficacy
safety
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

* moderate to severe Crohn's Disease
* CDAI 250-450
* CRP \>7.5
* signed written informed consent

Key Exclusion Criteria:

* \> 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

Primary outcomes:
measure: 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
timeFrame: Day 57
Secondary outcomes:
measure: 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
timeFrame: Day 57
Other outcomes:
Locations:
city: Bankstown
country: Australia
facility: Bankstown - Lidcombe Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Womens Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital
state: Victoria
city: Frankston
country: Australia
facility: Bayside Gastroenterology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin
city: Linz
country: Austria
facility: A.ö. Krankenhaus der Elisabethinen Linz
city: Poelten
country: Austria
facility: Landesklinikum St. Poelten
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung
city: Wien
country: Austria
facility: Universitätsklinik für Innere Medizin III
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Campinas
country: Brazil
facility: Unigastro
city: Centro Petrópolis
country: Brazil
facility: Centro Petropolitano de Reumatologia e Fisioterapia
city: Curitiba
country: Brazil
facility: Hospital das Clínicas de Curitiba UFPR
city: Goiania
country: Brazil
facility: Instituto Goiano de Gastro
city: Goiânia
country: Brazil
facility: Hospital Geral de Goiânia
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas PUC-RS
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
city: Santo André
country: Brazil
facility: Santo André Diagnósticos e tratamentoLtda.
city: Santos
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Santos
city: Sao Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Sofia
country: Bulgaria
facility: 4 MHAT, 38 "Makedonia" 1000
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska"
city: Sofia
country: Bulgaria
facility: UMHAT Queen Joanna
city: Sofia
country: Bulgaria
facility: UMHAT" St. Ivan Rilsky"
city: Sofia
country: Bulgaria
facility: V City Hospital
city: Varna
country: Bulgaria
facility: UMHAT "St. Marina"
city: Calgary
country: Canada
facility: Health Science Centre
state: Alberta
city: Vancouver
country: Canada
facility: Lair Centre
state: British Columbia
city: Richmond Hill
country: Canada
facility: DHC Research
state: Ontario
city: Toronto
country: Canada
facility: Mt. Sinai Hospital
state: Ontario
city: Levis
country: Canada
facility: Centre Hospitalier--Hotel-Dieu de Levis
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHAUQ-Hopital St-Sacrement
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie, Edvarda Benese 1549
city: Olomouc
country: Czechia
facility: II.Interni klinika, Endoskopie
city: Prague
country: Czechia
facility: General University Hospital Prague
city: Prague
country: Czechia
facility: Medic Kral ltd.
city: Praha
country: Czechia
facility: Fakultni nemocnice
city: Praha
country: Czechia
facility: Klinika hepatogastroenterologieIKEM
city: Pribram
country: Czechia
facility: Regional Hospital Pribram
city: Tabor
country: Czechia
facility: Regional Hospital Tabor
city: České Budejovice
country: Czechia
facility: Private Gastroenterology Centre
city: Arhus C
country: Denmark
facility: Medical Department V Århus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital Gastroenterologisk department
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Medical department S Odense University hospital
city: Amiens
country: France
facility: CHU Amiens - Hôpital Nord
city: Nice
country: France
facility: Service d'Hépato-Gastroentérologie et de Nutrition Clinique
city: Pessac
country: France
facility: Hopital du Haut-Lévêque
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Toulouse
country: France
facility: Service de Gastro-Enterologie et Nutrition
city: Berlin
country: Germany
facility: Charité Campus Mitte, Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Medizinische Klinik m.S. Hepatologie, Gastroenterologie, Endokrinologie und Stoffwechsel
city: Hamburg
country: Germany
facility: Fachärztin für Innere Medizin
city: Kiel
country: Germany
facility: Klinikum der Christian-Albrechts-Universität zu Kiel
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A.ö.R
city: Münster
country: Germany
facility: Gastroenterologische Praxis am Germania-Campus
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Bekescsaba
country: Hungary
facility: Réthy Pál Kórház
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Bajcsy-Zsilinszky Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem OEC
city: Esztergom
country: Hungary
facility: Vaszary Kolos Kórház
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház
city: Miskolc
country: Hungary
facility: BAZ Megyei Kórház
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion MC
city: Haifa
country: Israel
facility: Rambam Medical Center,
city: Jerusalem
country: Israel
facility: Hadassah Ein-Karem Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
city: Trzifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Amersfoort
country: Netherlands
facility: Ringweg Randenbroek 110
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken Locatie Sophia Afd. Interne Geneeskunde
city: Bialystok
country: Poland
facility: ZOZ MSWiA Oddział Chorób Wewnętrznych
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Klinicznym, Oddzial Kliniczny Gasteroenterologii
city: Bydgoszcz
country: Poland
facility: SPZOZ Wojewodzki Szpital
city: Krakow
country: Poland
facility: Klinika Chorob Wewnetrznych I Gastroenterologii
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4
city: Opole
country: Poland
facility: SPZOZ Szpital Wojewódzki w Opolu
city: Sopot
country: Poland
facility: SOPMED Niepubliczny Zakład Opieki Zdrowotnej
city: Szczecin
country: Poland
facility: Klinika Gastroenterologii i Chorób Wewnętrznych Samodzielny Publiczny Szpital Kliniczny nr 1 im. T. Sokołowskiego Pomorskiej Akademii Medycznej ul.Unii Lubelskiej 1
city: Warsaw
country: Poland
facility: Wojskowy Insytutu Medyczny
city: Warszawa
country: Poland
facility: NZOZ Vivamed Zespół Lekarzy Specjalistów ul. Trocka 10A
city: Warszawa
country: Poland
facility: CSK MSWiA, Klinika Gastroenterologii
city: Wroclaw
country: Poland
facility: Klinika Gastroenterologii i Hepatologii, Akademii Medycznej
city: Cape Town
country: South Africa
facility: Panorama Medi Clinic
city: Cape Town
country: South Africa
facility: Louis Leipoldt Gastroenterology Centre, Louis Leipoldt Medical Centre
city: Cape Town
country: South Africa
facility: GastroEnterology Unit, Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: Quatro Clinical Trial Institute
city: Johannesburg
country: South Africa
facility: 427 Ontdekkers Road, Florida Park
city: Göteborg
country: Sweden
facility: Medicinkliniken, SU/Östra sjukhuset
city: Lund
country: Sweden
facility: Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Medicinmottagningen, Södersjukhuset
city: Stockholm
country: Sweden
facility: Sophiahemmet
city: London
country: United Kingdom
facility: Centre for Gastroenterology Royal Free Hospital
city: Oxford
country: United Kingdom
facility: Dept of Gastroenterology, John Radcliffe Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.