A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (PRECiSE 3)
July 5, 2018 updated by: UCB Pharma SA
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
596
Phase
- Phase 3
Expanded Access
Available outside the clinical trial.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia
- 11001
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Ballarat, Australia
- 11016
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Bankstown, Australia
- 11011
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Box Hill, Australia
- 11007
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Frankston, Australia
- 11013
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Fremantle, Australia
- 11010
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Garran, Australia
- 11015
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Herston, Australia
- 11017
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Lauceston, Australia
- 11014
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Melbourne, Australia
- 11003
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Melbourne, Australia
- 11004
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New Lambton, Australia
- 11005
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Newtown, Australia
- 11018
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Parkville, Australia
- 11012
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Graz, Austria
- 46005
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Linz, Austria
- 46006
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Wien, Austria
- 46002
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Minsk, Belarus
- 12001
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Minsk, Belarus
- 12003
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Vitebsk, Belarus
- 12002
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Brussels, Belgium
- 13004
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Gent, Belgium
- 13001
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Liege, Belgium
- 13002
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Sofia, Bulgaria
- 15001
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Sofia, Bulgaria
- 15002
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Halifax, Canada
- 16014
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Ottawa, Canada
- 16021
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Toronto, Canada
- 16013
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Vancouver, Canada
- 16001
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Vancouver, Canada
- 16010
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Brno, Czechia
- 18003
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Ceske Budejovice, Czechia
- 18011
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Hradek Kralove, Czechia
- 18006
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Melnik, Czechia
- 18009
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Olomouc, Czechia
- 18007
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Olomouc, Czechia
- 18008
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Pardubice, Czechia
- 18010
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Plzen - Lochotin, Czechia
- 18005
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Praha 10, Czechia
- 18012
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Praha 2, Czechia
- 18004
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Praha 4, Czechia
- 18002
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Aalborg, Denmark
- 19004
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Aarhus, Denmark
- 19002
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Copenhagen, Denmark
- 19009
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Copenhagen, Denmark
- 19008
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Glostrup, Denmark
- 19001
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Herlev, Denmark
- 19010
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Hvidovre, Denmark
- 19007
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Odense C, Denmark
- 19005
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Tallin, Estonia
- 20001
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Tartu, Estonia
- 20002
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Tbilisi, Georgia
- 48001
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Berlin, Germany
- 22002
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Berlin, Germany
- 22009
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Berlin, Germany
- 22006
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Cologne, Germany
- 22021
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Dresden, Germany
- 22026
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Göttingen, Germany
- 22013
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Hannover, Germany
- 22017
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Kiel, Germany
- 22015
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Leipzig, Germany
- 22024
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Magdeburg, Germany
- 22003
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Minden, Germany
- 22001
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Münster, Germany
- 22008
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Wilhelmshaven, Germany
- 22005
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Shatin, Hong Kong
- 23002
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Budapest, Hungary
- 24002
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Budapest, Hungary
- 24012
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Budapest, Hungary
- 24015
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Debrecen, Hungary
- 24001
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Dunaujvaros, Hungary
- 24014
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Gyor, Hungary
- 24010
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Gyula, Hungary
- 24005
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Pecs, Hungary
- 24009
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Szeged, Hungary
- 24008
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Szekszard, Hungary
- 24011
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Veszprem, Hungary
- 24007
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Beer Sheva, Israel
- 26004
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Haifa, Israel
- 26007
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Jerusalem, Israel
- 26006
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Bologna, Italy
- 27002
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Milano, Italy
- 27001
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Palermo, Italy
- 27004
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Roma, Italy
- 27007
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Roma, Italy
- 27006
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Riga, Latvia
- 28001
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Riga, Latvia
- 28003
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Kaunas, Lithuania
- 29001
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Auckland, New Zealand
- 31002
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Christchurch, New Zealand
- 31001
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Hamilton, New Zealand
- 31005
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Tauranga, New Zealand
- 31003
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Tauranga, New Zealand
- 31004
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Hamar, Norway
- 32009
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Haugesund, Norway
- 32001
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Oslo, Norway
- 32005
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Oslo, Norway
- 32008
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Tromso, Norway
- 32004
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Bialystok, Poland
- 33022
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Bydgoszcz, Poland
- 33004
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Cracow, Poland
- 33002
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Krakow, Poland
- 33010
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Lodz, Poland
- 33011
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Lodz, Poland
- 33012
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Lublin, Poland
- 33019
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Opole, Poland
- 33020
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Sopot, Poland
- 33003
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Szczecin, Poland
- 33013
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Warsaw, Poland
- 33007
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Warszawa, Poland
- 33009
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Warszawa, Poland
- 33001
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Warszawa, Poland
- 33016
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Wroclaw, Poland
- 33006
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Wroclaw, Poland
- 33021
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Lipetsk, Russian Federation
- 34017
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Moscow, Russian Federation
- 34006
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Moscow, Russian Federation
- 34015
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Nizhny Novgorod, Russian Federation
- 34016
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St. Petersburg, Russian Federation
- 34001
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St. Petersburg, Russian Federation
- 34005
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St. Petersburg, Russian Federation
- 34007
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St. Petersburg, Russian Federation
- 34013
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Volgograd, Russian Federation
- 34008
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Belgrade, Serbia
- 35001
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Belgrade, Serbia
- 35002
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Belgrade, Serbia
- 35004
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Belgrade, Serbia
- 35005
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Nis, Serbia
- 35003
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Singapore, Singapore
- 36002
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Singapore, Singapore
- 36001
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Celje, Slovenia
- 38001
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Ljubljana, Slovenia
- 38003
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Novo Mesto, Slovenia
- 38004
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Cape Town, South Africa
- 39016
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Cape Town, South Africa
- 39003
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Cape Town, South Africa
- 39017
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Durban, South Africa
- 39011
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Goodwood, South Africa
- 39012
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Johannesburg, South Africa
- 39010
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Johannesburg, South Africa
- 39002
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Johannesburg, South Africa
- 39007
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Johannesburg, South Africa
- 39013
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Midrand, South Africa
- 39008
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PORT Elisabeth, South Africa
- 39004
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Pretoria, South Africa
- 39006
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Pretoria, South Africa
- 39014
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Pretoria, South Africa
- 39019
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Barcelona, Spain
- 40009
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Stockholm, Sweden
- 41001
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Stockholm, Sweden
- 41004
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Umea, Sweden
- 41002
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Crimean Autonomy, Ukraine
- 43005
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Dniepropetrovsk, Ukraine
- 43008
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Dniepropetrovsk, Ukraine
- 43002
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Donetsk, Ukraine
- 43004
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Kharkov, Ukraine
- 43001
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Kiev, Ukraine
- 43007
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Lviv, Ukraine
- 43003
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Odessa, Ukraine
- 43006
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Alabama
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Birmingham, Alabama, United States
- 45102
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Huntsville, Alabama, United States
- 45028
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Arizona
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Tucson, Arizona, United States
- 45144
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California
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Orange, California, United States
- 45095
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San Diego, California, United States
- 45006
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San Diego, California, United States
- 45131
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Colorado
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Colorado Springs, Colorado, United States
- 45130
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Florida
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Gainesville, Florida, United States
- 45094
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Jacksonville, Florida, United States
- 45029
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Miami, Florida, United States
- 45087
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Plantation, Florida, United States
- 45085
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Georgia
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Atlanta, Georgia, United States
- 45143
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Savannah, Georgia, United States
- 45064
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Indiana
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Columbus, Indiana, United States
- 45138
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Kentucky
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Louisville, Kentucky, United States
- 45111
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Maryland
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Annapolis, Maryland, United States
- 45105
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Chevy Chase, Maryland, United States
- 45033
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Laurel, Maryland, United States
- 45013
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Minnesota
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Plymouth, Minnesota, United States
- 45057
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Missouri
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Jefferson City, Missouri, United States
- 45108
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Nebraska
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Lincoln, Nebraska, United States
- 45031
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New Jersey
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Berlin, New Jersey, United States
- 45035
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Florham Park, New Jersey, United States
- 45124
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New Brunswick, New Jersey, United States
- 45018
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New York
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Great Neck, New York, United States
- 45009
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New York, New York, United States
- 45070
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Rochester, New York, United States
- 45117
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North Carolina
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Raleigh, North Carolina, United States
- 45003
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Winston-Salem, North Carolina, United States
- 45040
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Ohio
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Cincinnati, Ohio, United States
- 45081
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Cincinnati, Ohio, United States
- 45091
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Dayton, Ohio, United States
- 45054
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Oklahoma
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Oklahoma City, Oklahoma, United States
- 45039
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Tulsa, Oklahoma, United States
- 45041
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Oregon
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Portland, Oregon, United States
- 45048
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Tennessee
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Chattanooga, Tennessee, United States
- 45084
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Germantown, Tennessee, United States
- 45113
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Nashville, Tennessee, United States
- 45119
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Nashville, Tennessee, United States
- 45071
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Texas
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Houston, Texas, United States
- 45022
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San Antonio, Texas, United States
- 45073
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Utah
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Salt Lake City, Utah, United States
- 45139
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Salt Lake City, Utah, United States
- 45020
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South Ogden, Utah, United States
- 45052
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Virginia
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Christiansburg, Virginia, United States
- 45078
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Norfolk, Virginia, United States
- 45109
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Washington
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Tacoma, Washington, United States
- 45135
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
- Subjects must be able to understand the information provided to them and give written informed consent
Exclusion Criteria:
- Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Certolizumab Pegol
400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
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Liquid for subcutaneous injection, 200 mg/ml.
400 mg at Week 2, and every 4 weeks thereafter until Week 362.
Up to 84 months of therapy in this study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
Time Frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
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Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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HBI remission is defined as total HBI score of 4 points or less.
HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being.
The first three parameters are scored for the previous day.
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032
Time Frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit
|
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points.
HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being.
The first three parameters are scored for the previous day.
|
From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit
|
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Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033
Time Frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)
|
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the Last Visit in this study.
A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
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From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)
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C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Time Frame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
Time Frame: Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
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Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lichtenstein GR, Thomsen OO, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, Sandborn WJ; Precise 3 Study Investigators. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol. 2010 Jul;8(7):600-9. doi: 10.1016/j.cgh.2010.01.014. Epub 2010 Feb 1.
- Sandborn WJ, Wolf DC, Kosutic G, Parker G, Schreiber S, Lee SD, Abraham B, Afzali A, Arsenescu RI, Gutierrez A, Spearman M, Coarse J, Feagan BG. Effects of Transient and Persistent Anti-drug Antibodies to Certolizumab Pegol: Longitudinal Data from a 7-Year Study in Crohn's Disease. Inflamm Bowel Dis. 2017 Jul;23(7):1047-1056. doi: 10.1097/MIB.0000000000001100.
- Melmed GY, McGovern D, Schreiber S, Kosutic G, Spearman M, Coarse J, Sandborn WJ. Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. Curr Med Res Opin. 2016 Dec;32(12):1937-1941. doi: 10.1080/03007995.2016.1221802. Epub 2016 Aug 22.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
August 1, 2018
Last Update Submitted That Met QC Criteria
July 5, 2018
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C87033
- 2005-002622-60 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.