Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

This study has been terminated.
(Study was terminated early because of slow recruitment)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00307931
First received: March 24, 2006
Last updated: August 30, 2011
Last verified: December 2009

March 24, 2006
August 30, 2011
April 2007
August 2008   (final data collection date for primary outcome measure)
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
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.
Clinical efficacy evaluated on CDAI score at week 6
Complete list of historical versions of study NCT00307931 on ClinicalTrials.gov Archive Site
  • Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal [ Time Frame: Baseline to Weeks 1, and 14 or Withdrawal ] [ Designated as safety issue: No ]
    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 With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14 [ Time Frame: Baseline to Weeks 1, 6 and 14 ] [ Designated as safety issue: No ]
    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 With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal [ Time Frame: Weeks 1, 6 and 14 or Withdrawal ] [ Designated as safety issue: No ]
    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.
  • Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]
    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 Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]
    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.
  • C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 14 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]
    The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]
    The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]
    The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]
    The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: Baseline, and Weeks 6 and 14 ] [ Designated as safety issue: No ]
    The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
  • Assessment of clinical efficacy over 14 weeks;
  • Safety
Not Provided
Not Provided
 
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Biological: Certolizumab pegol

certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.

Treatment duration: 12 weeks.

Other Name: Cimzia
Experimental: Certolizumab pegol
certolizumab pegol 400 mg
Intervention: Biological: Certolizumab pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Exclusion Criteria:

  • Symptomatic obstructive intestinal strictures
  • Bowel resection within 4 weeks
  • Current total parenteral nutrition
  • Short bowel syndrome
  • Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00307931
C87055, Eudract n° - 2006-002027-16
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP