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

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Certolizumab pegol

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
  • Ioannina, Greece
  • Piraeus, Greece
  • Thessaloniki, Greece
  • Crete
    • Heraclion, Crete, Greece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Certolizumab pegol; certolizumab pegol 400 mg	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 Names: Cimzia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at 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.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Weeks 1, and 14 or Withdrawal
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	The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Weeks 1, 6 and 14
Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal	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.	Weeks 1, 6 and 14 or Withdrawal
Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 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.	Weeks 1, 2, 4, 6, 8, 12 and 14
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 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.	Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14		Weeks 1, 2, 4, 6, 8, 12 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14	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.	Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14	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.	Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14	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.	Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14	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.	Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14	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.	Baseline, and Weeks 6 and 14

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 24, 2006
• First Submitted That Met QC Criteria: March 24, 2006
• First Posted (Estimate): March 28, 2006

Study Record Updates

• Last Update Posted (Estimate): August 31, 2011
• Last Update Submitted That Met QC Criteria: August 30, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Cimzia; Crohn's disease; Certolizumab pegol; Greek patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Certolizumab Pegol
• Other Study ID Numbers: C87055; Eudract n° - 2006-002027-16