Clinical trial NCT00160524: 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]
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Certolizumab Pegol
Cimzia
CDP870
CZP
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 \[NCT00152425\]).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
timeFrame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
measure: Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
timeFrame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
Secondary outcomes:
measure: Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
timeFrame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
measure: 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
timeFrame: 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
measure: Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
timeFrame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
measure: 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
timeFrame: 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)
measure: C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
timeFrame: Study Completion Visit (Week 364) / (Early) Withdrawal Visit
measure: Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
timeFrame: Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 45102
state: Alabama
city: Huntsville
country: United States
facility: 45028
state: Alabama
city: Tucson
country: United States
facility: 45144
state: Arizona
city: Orange
country: United States
facility: 45095
state: California
city: San Diego
country: United States
facility: 45006
state: California
city: San Diego
country: United States
facility: 45131
state: California
city: Colorado Springs
country: United States
facility: 45130
state: Colorado
city: Gainesville
country: United States
facility: 45094
state: Florida
city: Jacksonville
country: United States
facility: 45029
state: Florida
city: Miami
country: United States
facility: 45087
state: Florida
city: Plantation
country: United States
facility: 45085
state: Florida
city: Atlanta
country: United States
facility: 45143
state: Georgia
city: Savannah
country: United States
facility: 45064
state: Georgia
city: Columbus
country: United States
facility: 45138
state: Indiana
city: Louisville
country: United States
facility: 45111
state: Kentucky
city: Annapolis
country: United States
facility: 45105
state: Maryland
city: Chevy Chase
country: United States
facility: 45033
state: Maryland
city: Laurel
country: United States
facility: 45013
state: Maryland
city: Plymouth
country: United States
facility: 45057
state: Minnesota
city: Jefferson City
country: United States
facility: 45108
state: Missouri
city: Lincoln
country: United States
facility: 45031
state: Nebraska
city: Berlin
country: United States
facility: 45035
state: New Jersey
city: Florham Park
country: United States
facility: 45124
state: New Jersey
city: New Brunswick
country: United States
facility: 45018
state: New Jersey
city: Great Neck
country: United States
facility: 45009
state: New York
city: New York
country: United States
facility: 45070
state: New York
city: Rochester
country: United States
facility: 45117
state: New York
city: Raleigh
country: United States
facility: 45003
state: North Carolina
city: Winston-Salem
country: United States
facility: 45040
state: North Carolina
city: Cincinnati
country: United States
facility: 45081
state: Ohio
city: Cincinnati
country: United States
facility: 45091
state: Ohio
city: Dayton
country: United States
facility: 45054
state: Ohio
city: Oklahoma City
country: United States
facility: 45039
state: Oklahoma
city: Tulsa
country: United States
facility: 45041
state: Oklahoma
city: Portland
country: United States
facility: 45048
state: Oregon
city: Chattanooga
country: United States
facility: 45084
state: Tennessee
city: Germantown
country: United States
facility: 45113
state: Tennessee
city: Nashville
country: United States
facility: 45071
state: Tennessee
city: Nashville
country: United States
facility: 45119
state: Tennessee
city: Houston
country: United States
facility: 45022
state: Texas
city: San Antonio
country: United States
facility: 45073
state: Texas
city: Salt Lake City
country: United States
facility: 45020
state: Utah
city: Salt Lake City
country: United States
facility: 45139
state: Utah
city: South Ogden
country: United States
facility: 45052
state: Utah
city: Christiansburg
country: United States
facility: 45078
state: Virginia
city: Norfolk
country: United States
facility: 45109
state: Virginia
city: Tacoma
country: United States
facility: 45135
state: Washington
city: Adelaide
country: Australia
facility: 11001
city: Ballarat
country: Australia
facility: 11016
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country: Australia
facility: 11011
city: Box Hill
country: Australia
facility: 11007
city: Frankston
country: Australia
facility: 11013
city: Fremantle
country: Australia
facility: 11010
city: Garran
country: Australia
facility: 11015
city: Herston
country: Australia
facility: 11017
city: Lauceston
country: Australia
facility: 11014
city: Melbourne
country: Australia
facility: 11003
city: Melbourne
country: Australia
facility: 11004
city: New Lambton
country: Australia
facility: 11005
city: Newtown
country: Australia
facility: 11018
city: Parkville
country: Australia
facility: 11012
city: Graz
country: Austria
facility: 46005
city: Linz
country: Austria
facility: 46006
city: Wien
country: Austria
facility: 46002
city: Minsk
country: Belarus
facility: 12001
city: Minsk
country: Belarus
facility: 12003
city: Vitebsk
country: Belarus
facility: 12002
city: Brussels
country: Belgium
facility: 13004
city: Gent
country: Belgium
facility: 13001
city: Liege
country: Belgium
facility: 13002
city: Sofia
country: Bulgaria
facility: 15001
city: Sofia
country: Bulgaria
facility: 15002
city: Halifax
country: Canada
facility: 16014
city: Ottawa
country: Canada
facility: 16021
city: Toronto
country: Canada
facility: 16013
city: Vancouver
country: Canada
facility: 16001
city: Vancouver
country: Canada
facility: 16010
city: Brno
country: Czechia
facility: 18003
city: Ceske Budejovice
country: Czechia
facility: 18011
city: Hradek Kralove
country: Czechia
facility: 18006
city: Melnik
country: Czechia
facility: 18009
city: Olomouc
country: Czechia
facility: 18007
city: Olomouc
country: Czechia
facility: 18008
city: Pardubice
country: Czechia
facility: 18010
city: Plzen - Lochotin
country: Czechia
facility: 18005
city: Praha 10
country: Czechia
facility: 18012
city: Praha 2
country: Czechia
facility: 18004
city: Praha 4
country: Czechia
facility: 18002
city: Aalborg
country: Denmark
facility: 19004
city: Aarhus
country: Denmark
facility: 19002
city: Copenhagen
country: Denmark
facility: 19008
city: Copenhagen
country: Denmark
facility: 19009
city: Glostrup
country: Denmark
facility: 19001
city: Herlev
country: Denmark
facility: 19010
city: Hvidovre
country: Denmark
facility: 19007
city: Odense C
country: Denmark
facility: 19005
city: Tallin
country: Estonia
facility: 20001
city: Tartu
country: Estonia
facility: 20002
city: Tbilisi
country: Georgia
facility: 48001
city: Berlin
country: Germany
facility: 22002
city: Berlin
country: Germany
facility: 22006
city: Berlin
country: Germany
facility: 22009
city: Cologne
country: Germany
facility: 22021
city: Dresden
country: Germany
facility: 22026
city: Göttingen
country: Germany
facility: 22013
city: Hannover
country: Germany
facility: 22017
city: Kiel
country: Germany
facility: 22015
city: Leipzig
country: Germany
facility: 22024
city: Magdeburg
country: Germany
facility: 22003
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country: Germany
facility: 22001
city: Münster
country: Germany
facility: 22008
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country: Germany
facility: 22005
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country: Hong Kong
facility: 23002
city: Budapest
country: Hungary
facility: 24002
city: Budapest
country: Hungary
facility: 24012
city: Budapest
country: Hungary
facility: 24015
city: Debrecen
country: Hungary
facility: 24001
city: Dunaujvaros
country: Hungary
facility: 24014
city: Gyor
country: Hungary
facility: 24010
city: Gyula
country: Hungary
facility: 24005
city: Pecs
country: Hungary
facility: 24009
city: Szeged
country: Hungary
facility: 24008
city: Szekszard
country: Hungary
facility: 24011
city: Veszprem
country: Hungary
facility: 24007
city: Beer Sheva
country: Israel
facility: 26004
city: Haifa
country: Israel
facility: 26007
city: Jerusalem
country: Israel
facility: 26006
city: Bologna
country: Italy
facility: 27002
city: Milano
country: Italy
facility: 27001
city: Palermo
country: Italy
facility: 27004
city: Roma
country: Italy
facility: 27006
city: Roma
country: Italy
facility: 27007
city: Riga
country: Latvia
facility: 28001
city: Riga
country: Latvia
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city: Kaunas
country: Lithuania
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city: Auckland
country: New Zealand
facility: 31002
city: Christchurch
country: New Zealand
facility: 31001
city: Hamilton
country: New Zealand
facility: 31005
city: Tauranga
country: New Zealand
facility: 31003
city: Tauranga
country: New Zealand
facility: 31004
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country: Norway
facility: 32009
city: Haugesund
country: Norway
facility: 32001
city: Oslo
country: Norway
facility: 32005
city: Oslo
country: Norway
facility: 32008
city: Tromso
country: Norway
facility: 32004
city: Bialystok
country: Poland
facility: 33022
city: Bydgoszcz
country: Poland
facility: 33004
city: Cracow
country: Poland
facility: 33002
city: Krakow
country: Poland
facility: 33010
city: Lodz
country: Poland
facility: 33011
city: Lodz
country: Poland
facility: 33012
city: Lublin
country: Poland
facility: 33019
city: Opole
country: Poland
facility: 33020
city: Sopot
country: Poland
facility: 33003
city: Szczecin
country: Poland
facility: 33013
city: Warsaw
country: Poland
facility: 33007
city: Warszawa
country: Poland
facility: 33001
city: Warszawa
country: Poland
facility: 33009
city: Warszawa
country: Poland
facility: 33016
city: Wroclaw
country: Poland
facility: 33006
city: Wroclaw
country: Poland
facility: 33021
city: Lipetsk
country: Russian Federation
facility: 34017
city: Moscow
country: Russian Federation
facility: 34006
city: Moscow
country: Russian Federation
facility: 34015
city: Nizhny Novgorod
country: Russian Federation
facility: 34016
city: St. Petersburg
country: Russian Federation
facility: 34001
city: St. Petersburg
country: Russian Federation
facility: 34005
city: St. Petersburg
country: Russian Federation
facility: 34007
city: St. Petersburg
country: Russian Federation
facility: 34013
city: Volgograd
country: Russian Federation
facility: 34008
city: Belgrade
country: Serbia
facility: 35001
city: Belgrade
country: Serbia
facility: 35002
city: Belgrade
country: Serbia
facility: 35004
city: Belgrade
country: Serbia
facility: 35005
city: Nis
country: Serbia
facility: 35003
city: Singapore
country: Singapore
facility: 36001
city: Singapore
country: Singapore
facility: 36002
city: Celje
country: Slovenia
facility: 38001
city: Ljubljana
country: Slovenia
facility: 38003
city: Novo Mesto
country: Slovenia
facility: 38004
city: Cape Town
country: South Africa
facility: 39003
city: Cape Town
country: South Africa
facility: 39016
city: Cape Town
country: South Africa
facility: 39017
city: Durban
country: South Africa
facility: 39011
city: Goodwood
country: South Africa
facility: 39012
city: Johannesburg
country: South Africa
facility: 39002
city: Johannesburg
country: South Africa
facility: 39007
city: Johannesburg
country: South Africa
facility: 39010
city: Johannesburg
country: South Africa
facility: 39013
city: Midrand
country: South Africa
facility: 39008
city: PORT Elisabeth
country: South Africa
facility: 39004
city: Pretoria
country: South Africa
facility: 39006
city: Pretoria
country: South Africa
facility: 39014
city: Pretoria
country: South Africa
facility: 39019
city: Barcelona
country: Spain
facility: 40009
city: Stockholm
country: Sweden
facility: 41001
city: Stockholm
country: Sweden
facility: 41004
city: Umea
country: Sweden
facility: 41002
city: Crimean Autonomy
country: Ukraine
facility: 43005
city: Dniepropetrovsk
country: Ukraine
facility: 43002
city: Dniepropetrovsk
country: Ukraine
facility: 43008
city: Donetsk
country: Ukraine
facility: 43004
city: Kharkov
country: Ukraine
facility: 43001
city: Kiev
country: Ukraine
facility: 43007
city: Lviv
country: Ukraine
facility: 43003
city: Odessa
country: Ukraine
facility: 43006
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.