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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab pegol
Certolizumab pegol
Placebo
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Certolizumab pegol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active 1

Active 2

Arm Description

Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol

Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 28, 2006
Last Updated
July 10, 2018
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00308581
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, Certolizumab pegol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
539 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active 1
Arm Type
Experimental
Arm Description
Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol
Arm Title
Active 2
Arm Type
Experimental
Arm Description
Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol
Intervention Type
Biological
Intervention Name(s)
Certolizumab pegol
Other Intervention Name(s)
CDP870, Cimzia
Intervention Description
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Intervention Type
Biological
Intervention Name(s)
Certolizumab pegol
Other Intervention Name(s)
CDP870, Cimzia
Intervention Description
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo administered 4-weekly in Active 1
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 26
Title
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Description
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.
Time Frame
Baseline to Week 6
Title
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 26
Title
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Description
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.
Time Frame
Week 6
Title
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 26
Title
CDAI Score at Week 2 of the Induction Phase
Description
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.
Time Frame
Week 2
Title
CDAI Score at Week 4 of the Induction Phase
Description
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.
Time Frame
Week 4
Title
CDAI Score at Week 6 of the Induction Phase
Description
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.
Time Frame
Week 6
Title
CDAI Score at Week 8 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 8
Title
CDAI Score at Week 10 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 10
Title
CDAI Score at Week 12 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 12
Title
CDAI Score at Week 14 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 14
Title
CDAI Score at Week 16 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 16
Title
CDAI Score at Week 18 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 18
Title
CDAI Score at Week 20 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 20
Title
CDAI Score at Week 22 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 22
Title
CDAI Score at Week 24 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 24
Title
CDAI Score at Week 26 in the Randomized Maintenance Phase
Description
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.
Time Frame
Week 26
Title
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
Description
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.
Time Frame
Baseline to Week 2
Title
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
Description
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.
Time Frame
Baseline to Week 6
Title
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 8
Title
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 10
Title
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 12
Title
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 14
Title
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 16
Title
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 18
Title
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 20
Title
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 22
Title
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
Description
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.
Time Frame
Baseline to Week 26
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 10
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 12
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 14
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 16
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 18
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 20
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 22
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 24
Title
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.
Description
Remission is defined as CDAI score ≤ 150.
Time Frame
Week 26
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 10
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 12
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 14
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 16
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 18
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 20
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 22
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 24
Title
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.
Description
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time Frame
Week 26
Title
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 0
Title
CRP Level at Week 2 of the Induction Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 2
Title
CRP Level at Week 4 of the Induction Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 4
Title
CRP Level at Week 6 of the Induction Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 6
Title
CRP Level at Week 8 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 8
Title
CRP Level at Week 10 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 10 (optional measurement)
Title
CRP Level at Week 12 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 12
Title
CRP Level at Week 14 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 14 (optional measurement)
Title
CRP Level at Week 16 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 16
Title
CRP Level at Week 18 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 18 (optional measurement)
Title
CRP Level at Week 20 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 20
Title
CRP Level at Week 22 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 22 (optional measurement)
Title
CRP Level at Week 24 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 24
Title
CRP Level at Week 26 in the Randomized Maintenance Phase
Description
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time Frame
Week 26
Title
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
Description
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.
Time Frame
Last visit on or before Week 26
Other Pre-specified Outcome Measures:
Title
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Description
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.
Time Frame
Week 6 to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
San Francisco
State/Province
California
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Great Neck
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Galveston
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
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
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Richmond
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
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
ZIP/Postal Code
Cedex 3
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
20925993
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.
Results Reference
background
PubMed Identifier
20451663
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.
Results Reference
result
PubMed Identifier
21223344
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

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

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