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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00308581
First received: March 28, 2006
Last updated: August 30, 2011
Last verified: April 2011
  Purpose
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

Condition Intervention Phase
Crohn's Disease
Biological: Certolizumab pegol
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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 [ Time Frame: 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:
  • Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase [ Time Frame: 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.

  • Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase [ Time Frame: 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 [ Time Frame: 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.

  • Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase [ Time Frame: 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.

  • Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase [ Time Frame: 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 [ Time Frame: 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 4 of the Induction Phase [ Time Frame: 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.

  • CDAI Score at Week 6 of the Induction Phase [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 24 in the Randomized Maintenance Phase [ Time Frame: 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.

  • CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: 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 2 of the Induction Phase [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 14 in the Randomized Maintenance Phase [ Time Frame: 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 [ Time Frame: 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.

  • Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 24 in the Randomized Maintenance Phase [ Time Frame: 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.

  • Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase [ Time Frame: 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 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: Week 10 ]
    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. [ Time Frame: Week 12 ]
    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. [ Time Frame: 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. [ Time Frame: Week 16 ]
    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. [ Time Frame: Week 18 ]
    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. [ Time Frame: Week 20 ]
    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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Week 26 ]
    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. [ Time Frame: 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 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: 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. [ Time Frame: 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 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Week 24 ]
    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. [ Time Frame: Week 26 ]
    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 [ Time Frame: 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 [ Time Frame: 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 4 of the Induction Phase [ Time Frame: 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 6 of the Induction Phase [ Time Frame: Week 6 ]
    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 [ Time Frame: 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 10 in the Randomized Maintenance Phase [ Time Frame: 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 12 in the Randomized Maintenance Phase [ Time Frame: 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 14 in the Randomized Maintenance Phase [ Time Frame: 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 16 in the Randomized Maintenance Phase [ Time Frame: 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 [ Time Frame: 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 20 in the Randomized Maintenance Phase [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 539
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 1

Q4W regimen

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

Biological: Certolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Other Names:
  • CDP870
  • Cimzia
Other: Placebo
placebo administered 4-weekly in Active 1
Experimental: Active 2

Q2W regimen

- every 2 weeks: 400 mg Certolizumab Pegol

Biological: Certolizumab pegol
400mg Certolizumab Pegol, Q2W, administered 2-weekly
Other Names:
  • CDP870
  • Cimzia

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308581

  Show 107 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00308581     History of Changes
Other Study ID Numbers: C87042
Eudract number: 2005-004104-37
Study First Received: March 28, 2006
Results First Received: July 7, 2009
Last Updated: August 30, 2011

Keywords provided by UCB Pharma:
Crohn's Disease
Certolizumab pegol

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Infliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 27, 2017