Clinical trial NCT00552058: Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
Official title: Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: CDP 870
Certolizumab Pegol
CIMZIA ®
Crohn's disease
Induction
Clinical remission
Clinical response
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-11-01
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.


Eligibility criteria: Inclusion Criteria:

* male/female
* 18 - 75 years inclusive
* diagnosis of Crohn's disease confirmed
* moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
* no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

* previous participation in a certolizumab pegol study
* general exclusion criteria as common for studies in this indication

Primary outcomes:
measure: Percentage of Subjects in Clinical Remission at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Subjects Achieving a Clinical Response at Week 6
timeFrame: Week 0, Week 6
measure: Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
timeFrame: Week 6
measure: Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
timeFrame: Week 0 to Week 6
measure: Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
timeFrame: Week 0 to Week 6
measure: Percentage of Subjects in Clinical Remission at Week 2
timeFrame: Week 2
measure: Percentage of Subjects in Clinical Remission at Week 4
timeFrame: Week 4
measure: Percentage of Subjects Achieving a Clinical Response at Week 2
timeFrame: Week 0, Week 2
measure: Percentage of Subjects Achieving a Clinical Response at Week 4
timeFrame: Week 0, Week 4
measure: Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
timeFrame: Week 0 to Week 2
measure: Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
timeFrame: Week 0, Week 4
measure: Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
timeFrame: Week 2
measure: Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
timeFrame: Week 4
measure: Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
timeFrame: Week 6
measure: Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
timeFrame: Week 6
measure: Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
timeFrame: Week 0, Week 6
measure: Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
timeFrame: Week 0, Week 6
Other outcomes:
Locations:
city: Pell City
country: United States
state: Alabama
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Michigan
city: West Bloomfield
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Concord
country: Australia
state: New South Wales
city: Box Hill
country: Australia
state: Victoria
city: Footscray
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Adelaide
country: Australia
city: Bankstown
country: Australia
city: Clayton
country: Australia
city: Fitzroy
country: Australia
city: Fremantle
country: Australia
city: Garran
country: Australia
city: Wien
country: Austria
city: Bonheiden
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Belo-Horizonte
country: Brazil
state: MG
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Santo-Andre
country: Brazil
city: Santos
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Calgary
country: Canada
city: Santiago
country: Chile
city: Vina del Mar
country: Chile
city: Hradec Kralove
country: Czechia
city: Hradek Kralove
country: Czechia
city: Praha 7
country: Czechia
city: Usti Nad Orlici
country: Czechia
city: Zlin
country: Czechia
city: Tallin
country: Estonia
city: Tartu
country: Estonia
city: Mikkeli
country: Finland
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Homburg
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Munchen
country: Germany
city: Ulm
country: Germany
city: Wilhelmshaven
country: Germany
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Nagykanizsa
country: Hungary
city: Szeged
country: Hungary
city: Szombathely
country: Hungary
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petha Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Bologna
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Milford
country: New Zealand
state: Auckland
city: Newton
country: New Zealand
state: Wellington
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Czestochowa
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Constanta
country: Romania
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Dniepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13.
citation: Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1.
citation: Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22.