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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Biological: Certolizumab pegol; Other: Placebo

• Registration Number: NCT00308581
• Lead Sponsor: UCB Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-29
• Study Start: 2006-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-07-07
• Results First Submitted QC: 2009-10-09
• Results First Posted: 2009-11-17
• Status Verified: 2011-04
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 539

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active 2	Certolizumab pegol	Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol
Active 1	Certolizumab pegol	Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Active 1	Placebo	Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol

Primary Outcome Measures

Name	Time	Method
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	Baseline to Week 6	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.

Secondary Outcome Measures

Name	Time	Method
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase	Baseline to Week 26	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.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase	Week 6	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.
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase	Baseline to Week 6	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.
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase	Baseline to Week 26	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.
CDAI Score at Week 4 of the Induction Phase	Week 4	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.
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase	Week 26	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.
CDAI Score at Week 2 of the Induction Phase	Week 2	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.
CDAI Score at Week 6 of the Induction Phase	Week 6	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.
CDAI Score at Week 8 in the Randomized Maintenance Phase	Week 8	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.
CDAI Score at Week 10 in the Randomized Maintenance Phase	Week 10	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.
CDAI Score at Week 12 in the Randomized Maintenance Phase	Week 12	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.
CDAI Score at Week 14 in the Randomized Maintenance Phase	Week 14	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.
CDAI Score at Week 16 in the Randomized Maintenance Phase	Week 16	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.
CDAI Score at Week 18 in the Randomized Maintenance Phase	Week 18	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.
CDAI Score at Week 20 in the Randomized Maintenance Phase	Week 20	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.
CDAI Score at Week 22 in the Randomized Maintenance Phase	Week 22	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.
CDAI Score at Week 26 in the Randomized Maintenance Phase	Week 26	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.
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase	Baseline to Week 14	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.
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase	Baseline to Week 16	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.
CDAI Score at Week 24 in the Randomized Maintenance Phase	Week 24	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.
Change From Baseline in CDAI Score at Week 2 of the Induction Phase	Baseline to Week 2	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.
Change From Baseline in CDAI Score at Week 4 of the Induction Phase	Baseline to Week 4	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.
Change From Baseline in CDAI Score at Week 6 of the Induction Phase	Baseline to Week 6	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.
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase	Baseline to Week 8	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.
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase	Baseline to Week 10	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.
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase	Baseline to Week 12	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.
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase	Baseline to Week 18	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.
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase	Baseline to Week 20	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.
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase	Baseline to Week 22	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.
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase	Baseline to Week 26	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.
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.	Week 20	Remission is defined as CDAI score ≤ 150.
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase	Baseline to Week 24	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.
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.	Week 10	Remission is defined as CDAI score ≤ 150.
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.	Week 14	Remission is defined as CDAI score ≤ 150.
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.	Week 16	Remission is defined as CDAI score ≤ 150.
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.	Week 12	Remission is defined as CDAI score ≤ 150.
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.	Week 18	Remission is defined as CDAI score ≤ 150.
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.	Week 22	Remission is defined as CDAI score ≤ 150.
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.	Week 24	Remission is defined as CDAI score ≤ 150.
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.	Week 26	Remission is defined as CDAI score ≤ 150.
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.	Week 12	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 14	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 10	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 16	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 18	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 20	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 22	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
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.	Week 24	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase	Week 0	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 2 of the Induction Phase	Week 2	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 6 of the Induction Phase	Week 6	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
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.	Week 26	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
CRP Level at Week 4 of the Induction Phase	Week 4	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 8 in the Randomized Maintenance Phase	Week 8	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 16 in the Randomized Maintenance Phase	Week 16	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 18 in the Randomized Maintenance Phase	Week 18 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 12 in the Randomized Maintenance Phase	Week 12	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 10 in the Randomized Maintenance Phase	Week 10 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 14 in the Randomized Maintenance Phase	Week 14 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 20 in the Randomized Maintenance Phase	Week 20	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 22 in the Randomized Maintenance Phase	Week 22 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 24 in the Randomized Maintenance Phase	Week 24	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Week 26 in the Randomized Maintenance Phase	Week 26	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase	Last visit on or before Week 26	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.