Clinical trial NCT00160706: A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
Official title: A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 310
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Brief summary: A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.


Eligibility criteria: Inclusion Criteria:

* Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 \[NCT00152490\] or the Week 6 randomization in CDP870-032 \[NCT00152425\] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):

  1. At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 032 \[NCT00152425\] responders) OR
  2. Higher than Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870-032 \[NCT00152425\] responders) with an absolute score of at least 350 points
* 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 upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)
timeFrame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
measure: Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)
timeFrame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
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 362) / (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 Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
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 CDP870-034
timeFrame: From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
measure: Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
timeFrame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
measure: Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034
timeFrame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
measure: C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
timeFrame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
measure: Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
timeFrame: Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 45102
state: Alabama
city: Huntsville
country: United States
facility: 45028
state: Alabama
city: Little Rock
country: United States
facility: 45044
state: Arkansas
city: Orange
country: United States
facility: 45095
state: California
city: San Francisco
country: United States
facility: 45101
state: California
city: Colorado Springs
country: United States
facility: 45130
state: Colorado
city: Gainesville
country: United States
facility: 45094
state: Florida
city: Hialeah
country: United States
facility: 45005
state: Florida
city: Miami
country: United States
facility: 45087
state: Florida
city: North Miami Beach
country: United States
facility: 45004
state: Florida
city: Chicago
country: United States
facility: 45016
state: Illinois
city: Indianapolis
country: United States
facility: 45037
state: Indiana
city: Lexington
country: United States
facility: 45019
state: Kentucky
city: Chevy Chase
country: United States
facility: 45033
state: Maryland
city: Laurel
country: United States
facility: 45013
state: Maryland
city: Rochester
country: United States
facility: 45083
state: Minnesota
city: Jefferson City
country: United States
facility: 45108
state: Missouri
city: Berlin
country: United States
facility: 45035
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: Greenville
country: United States
facility: 45145
state: North Carolina
city: High Point
country: United States
facility: 45067
state: North Carolina
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: Mayfield Heights
country: United States
facility: 45025
state: Ohio
city: Oklahoma City
country: United States
facility: 45039
state: Oklahoma
city: Tulsa
country: United States
facility: 45041
state: Oklahoma
city: Hershey
country: United States
facility: 45093
state: Pennsylvania
city: Germantown
country: United States
facility: 45113
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: 45139
state: Utah
city: South Ogden
country: United States
facility: 45052
state: Utah
city: Charlottesville
country: United States
facility: 45134
state: Virginia
city: Christiansburg
country: United States
facility: 45078
state: Virginia
city: Norfolk
country: United States
facility: 45109
state: Virginia
city: Seattle
country: United States
facility: 45141
state: Washington
city: Bankstown
country: Australia
facility: 11011
state: New South Wales
city: New Lambton
country: Australia
facility: 11005
state: New South Wales
city: Herston
country: Australia
facility: 11017
state: Queensland
city: South Brisbane
country: Australia
facility: 11006
state: Queensland
city: Lauceston
country: Australia
facility: 11014
state: Tasmania
city: Ballarat
country: Australia
facility: 11016
state: Victoria
city: Box Hill
country: Australia
facility: 11007
state: Victoria
city: Fitzroy
country: Australia
facility: 11002
state: Victoria
city: Frankston
country: Australia
facility: 11013
state: Victoria
city: Parkville
country: Australia
facility: 11012
state: Victoria
city: Adelaide
country: Australia
facility: 11009
city: Fremantle
country: Australia
facility: 11010
city: Garran
country: Australia
facility: 11015
city: Newtown
country: Australia
facility: 11018
city: Linz
country: Austria
facility: 46006
city: Salzburg
country: Austria
facility: 46003
city: Wien
country: Austria
facility: 46002
city: Minsk
country: Belarus
facility: 12001
city: Brussels
country: Belgium
facility: 13004
city: Gent
country: Belgium
facility: 13001
city: Leuven
country: Belgium
facility: 13003
city: Sofia
country: Bulgaria
facility: 15001
city: Winnipeg
country: Canada
facility: 16005
state: Manitoba
city: Halifax
country: Canada
facility: 16014
state: Nova Scotia
city: Toronto
country: Canada
facility: 16013
state: Ontario
city: Montreal
country: Canada
facility: 16008
state: Quebec
city: Hradek Kralove
country: Czechia
facility: 18006
city: Ostrava
country: Czechia
facility: 18001
city: Praha 2
country: Czechia
facility: 18004
city: Praha 4
country: Czechia
facility: 18002
city: Aalborg
country: Denmark
facility: 19004
city: Copenhagen
country: Denmark
facility: 19009
city: Herlev
country: Denmark
facility: 19010
city: Hvidovre
country: Denmark
facility: 19007
city: Vejle
country: Denmark
facility: 19003
city: Tallin
country: Estonia
facility: 20001
city: Tartu
country: Estonia
facility: 20002
city: Berlin
country: Germany
facility: 22002
city: Berlin
country: Germany
facility: 22009
city: Celle
country: Germany
facility: 22004
city: Frankfurt
country: Germany
facility: 22019
city: Göttingen
country: Germany
facility: 22013
city: Hannover
country: Germany
facility: 22017
city: Kiel
country: Germany
facility: 22015
city: Leipzig
country: Germany
facility: 22016
city: Minden
country: Germany
facility: 22001
city: Munich
country: Germany
facility: 22012
city: Münster
country: Germany
facility: 22008
city: Budapest
country: Hungary
facility: 24002
city: Pecs
country: Hungary
facility: 24009
city: Szekszard
country: Hungary
facility: 24011
city: Beer Sheva
country: Israel
facility: 26004
city: Haifa
country: Israel
facility: 26007
city: Petha Tikva
country: Israel
facility: 26005
city: Milano
country: Italy
facility: 27001
city: Palermo
country: Italy
facility: 27004
city: Roma
country: Italy
facility: 27007
city: Auckland
country: New Zealand
facility: 31002
city: Christchurch
country: New Zealand
facility: 31001
city: Hamilton
country: New Zealand
facility: 31005
city: Milford
country: New Zealand
facility: 31004
city: Tauranga
country: New Zealand
facility: 31003
city: Oslo
country: Norway
facility: 32005
city: Oslo
country: Norway
facility: 32008
city: Tromso
country: Norway
facility: 32004
city: Bydgoszcz
country: Poland
facility: 33008
city: Gdansk
country: Poland
facility: 33003
city: Lublin
country: Poland
facility: 33018
city: Szczecin
country: Poland
facility: 33013
city: Warsaw
country: Poland
facility: 33007
city: Warszawa
country: Poland
facility: 33009
city: Lipetsk
country: Russian Federation
facility: 34017
city: Moscow
country: Russian Federation
facility: 34006
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: Belgrade
country: Serbia
facility: 35001
city: Belgrade
country: Serbia
facility: 35002
city: Belgrade
country: Serbia
facility: 35004
city: Singapore
country: Singapore
facility: 36002
city: Celje
country: Slovenia
facility: 38001
city: Ljubljana
country: Slovenia
facility: 38003
city: Johannesburg
country: South Africa
facility: 39013
state: Gauteng
city: Cape Town
country: South Africa
facility: 39003
state: Somerset West
city: Cape Town
country: South Africa
facility: 39016
city: Cape Town
country: South Africa
facility: 39018
city: Goodwood
country: South Africa
facility: 39012
city: Johannesburg
country: South Africa
facility: 39010
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: 39009
city: Pretoria
country: South Africa
facility: 39014
city: Pretoria
country: South Africa
facility: 39019
city: Barcelona
country: Spain
facility: 40009
city: Dniepropetrovsk
country: Ukraine
facility: 43008
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: Sandborn WJ, Schreiber S, Hanauer SB, Colombel JF, Bloomfield R, Lichtenstein GR; PRECiSE 4 Study Investigators. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol. 2010 Aug;8(8):696-702.e1. doi: 10.1016/j.cgh.2010.03.024. Epub 2010 Apr 2.