Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308581
• Other study ID #: C87042
• Secondary ID: Eudract number:
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
• Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly

Other:
• Placebo
placebo administered 4-weekly in Active 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (3)

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 Pha — View 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 Gastroe — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6	Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.	Week 6 to Week 26
Primary	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	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.; The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6
Secondary	Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase	Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Secondary	Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase	Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6
Secondary	Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase	Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Secondary	Remission Status With Remission Defined as CDAI Score = 150 in the Induction Phase	Remission is defined as CDAI score = 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 6
Secondary	Remission Status With Remission Defined as CDAI Score = 150 in the Randomized Maintenance Phase	Remission is defined as CDAI score = 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 26
Secondary	CDAI Score at Week 2 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 2
Secondary	CDAI Score at Week 4 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 4
Secondary	CDAI Score at Week 6 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 6
Secondary	CDAI Score at Week 8 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 8
Secondary	CDAI Score at Week 10 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 10
Secondary	CDAI Score at Week 12 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 12
Secondary	CDAI Score at Week 14 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 14
Secondary	CDAI Score at Week 16 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 16
Secondary	CDAI Score at Week 18 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 18
Secondary	CDAI Score at Week 20 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 20
Secondary	CDAI Score at Week 22 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 22
Secondary	CDAI Score at Week 24 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 24
Secondary	CDAI Score at Week 26 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 26
Secondary	Change From Baseline in CDAI Score at Week 2 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 2
Secondary	Change From Baseline in CDAI Score at Week 4 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 4
Secondary	Change From Baseline in CDAI Score at Week 6 of the Induction Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6
Secondary	Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 8
Secondary	Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 10
Secondary	Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 12
Secondary	Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 14
Secondary	Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 16
Secondary	Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 18
Secondary	Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 20
Secondary	Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 22
Secondary	Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 24
Secondary	Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Secondary	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.	Remission is defined as CDAI score = 150.	Week 10
Secondary	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.	Remission is defined as CDAI score = 150.	Week 12
Secondary	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.	Remission is defined as CDAI score = 150.	Week 14
Secondary	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.	Remission is defined as CDAI score = 150.	Week 16
Secondary	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.	Remission is defined as CDAI score = 150.	Week 18
Secondary	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.	Remission is defined as CDAI score = 150.	Week 20
Secondary	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.	Remission is defined as CDAI score = 150.	Week 22
Secondary	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.	Remission is defined as CDAI score = 150.	Week 24
Secondary	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.	Remission is defined as CDAI score = 150.	Week 26
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 10
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 12
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 14
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 16
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 18
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 20
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 22
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 24
Secondary	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.	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 26
Secondary	C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 0
Secondary	CRP Level at Week 2 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 2
Secondary	CRP Level at Week 4 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 4
Secondary	CRP Level at Week 6 of the Induction Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 6
Secondary	CRP Level at Week 8 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 8
Secondary	CRP Level at Week 10 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 10 (optional measurement)
Secondary	CRP Level at Week 12 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 12
Secondary	CRP Level at Week 14 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 14 (optional measurement)
Secondary	CRP Level at Week 16 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 16
Secondary	CRP Level at Week 18 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 18 (optional measurement)
Secondary	CRP Level at Week 20 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 20
Secondary	CRP Level at Week 22 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 22 (optional measurement)
Secondary	CRP Level at Week 24 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 24
Secondary	CRP Level at Week 26 in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 26
Secondary	CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.	Last visit on or before Week 26

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