Clinical trial NCT00308581: Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Official title: Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Certolizumab pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 539
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: To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab


Eligibility criteria: Inclusion Criteria:

* Subjects with Crohn's Disease
* Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

* Obstructive intestinal strictures
* Recent bowel resection
* Proctocolectomy or total colectomy
* Current total parenteral nutrition
* Short bowel syndrome
* All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Primary outcomes:
measure: Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
timeFrame: Baseline to Week 26
measure: Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
timeFrame: Baseline to Week 6
measure: Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
timeFrame: Baseline to Week 26
measure: Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
timeFrame: Week 6
measure: Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
timeFrame: Week 26
measure: CDAI Score at Week 2 of the Induction Phase
timeFrame: Week 2
measure: CDAI Score at Week 4 of the Induction Phase
timeFrame: Week 4
measure: CDAI Score at Week 6 of the Induction Phase
timeFrame: Week 6
measure: CDAI Score at Week 8 in the Randomized Maintenance Phase
timeFrame: Week 8
measure: CDAI Score at Week 10 in the Randomized Maintenance Phase
timeFrame: Week 10
measure: CDAI Score at Week 12 in the Randomized Maintenance Phase
timeFrame: Week 12
measure: CDAI Score at Week 14 in the Randomized Maintenance Phase
timeFrame: Week 14
measure: CDAI Score at Week 16 in the Randomized Maintenance Phase
timeFrame: Week 16
measure: CDAI Score at Week 18 in the Randomized Maintenance Phase
timeFrame: Week 18
measure: CDAI Score at Week 20 in the Randomized Maintenance Phase
timeFrame: Week 20
measure: CDAI Score at Week 22 in the Randomized Maintenance Phase
timeFrame: Week 22
measure: CDAI Score at Week 24 in the Randomized Maintenance Phase
timeFrame: Week 24
measure: CDAI Score at Week 26 in the Randomized Maintenance Phase
timeFrame: Week 26
measure: Change From Baseline in CDAI Score at Week 2 of the Induction Phase
timeFrame: Baseline to Week 2
measure: Change From Baseline in CDAI Score at Week 4 of the Induction Phase
timeFrame: Baseline to Week 4
measure: Change From Baseline in CDAI Score at Week 6 of the Induction Phase
timeFrame: Baseline to Week 6
measure: Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 8
measure: Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 10
measure: Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 12
measure: Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 14
measure: Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 16
measure: Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 18
measure: Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 20
measure: Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 22
measure: Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 24
measure: Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
timeFrame: Baseline to Week 26
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 10
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 12
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 14
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 16
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 18
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 20
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 22
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 24
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 26
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 10
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 12
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 14
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 16
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 18
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 20
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 22
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 24
measure: Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
timeFrame: Week 26
measure: C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
timeFrame: Week 0
measure: CRP Level at Week 2 of the Induction Phase
timeFrame: Week 2
measure: CRP Level at Week 4 of the Induction Phase
timeFrame: Week 4
measure: CRP Level at Week 6 of the Induction Phase
timeFrame: Week 6
measure: CRP Level at Week 8 in the Randomized Maintenance Phase
timeFrame: Week 8
measure: CRP Level at Week 10 in the Randomized Maintenance Phase
timeFrame: Week 10 (optional measurement)
measure: CRP Level at Week 12 in the Randomized Maintenance Phase
timeFrame: Week 12
measure: CRP Level at Week 14 in the Randomized Maintenance Phase
timeFrame: Week 14 (optional measurement)
measure: CRP Level at Week 16 in the Randomized Maintenance Phase
timeFrame: Week 16
measure: CRP Level at Week 18 in the Randomized Maintenance Phase
timeFrame: Week 18 (optional measurement)
measure: CRP Level at Week 20 in the Randomized Maintenance Phase
timeFrame: Week 20
measure: CRP Level at Week 22 in the Randomized Maintenance Phase
timeFrame: Week 22 (optional measurement)
measure: CRP Level at Week 24 in the Randomized Maintenance Phase
timeFrame: Week 24
measure: CRP Level at Week 26 in the Randomized Maintenance Phase
timeFrame: Week 26
measure: CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
timeFrame: Last visit on or before Week 26
Other outcomes:
measure: Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
timeFrame: Week 6 to Week 26
Locations:
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Innsbruck
country: Austria
city: Oberpullendorf
country: Austria
city: Wien
country: Austria
city: Bonheiden
country: Belgium
city: Brussels
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Richmond
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Calgary
country: Canada
city: Aalborg
country: Denmark
city: Arhus
country: Denmark
city: Copenhagen
country: Denmark
city: Herlev
country: Denmark
city: Amiens
country: France
city: Clichy
country: France
city: Grenoble, Cedex 9
country: France
city: Lille
country: France
city: Montpellier, Cédex 5
country: France
city: Nice
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rouen
country: France
city: Toulouse, Cedex 9
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Herne
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Minden
country: Germany
city: Munchen
country: Germany
city: Munich
country: Germany
city: Bari
country: Italy
city: Bologna
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Amsterdam
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Heerlen
country: Netherlands
city: Leiden
country: Netherlands
city: Terneuven
country: Netherlands
city: Zwolle
country: Netherlands
city: Oslo
country: Norway
city: Tromso
country: Norway
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Santiago De Compostela
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Goteborg
country: Sweden
city: Malmo
country: Sweden
city: Orebro
country: Sweden
city: Stockholm
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Lausanne
country: Switzerland
city: Bristol
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Oxford
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
citation: Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
citation: Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.