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

• ClinicalTrials.gov Identifier: NCT00307931
• Recruitment Status: Terminated
• First Posted: March 28, 2006
• Results First Posted: October 19, 2009
• Last Update Posted: August 31, 2011
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: Certolizumab pegol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: April 2007
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: August 2008

Arms and Interventions

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 Name: Cimzia

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   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.
5. 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 ]
   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.
6. 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 ]
7. Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14 [ Time Frame: 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.
8. Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: 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.
9. Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: 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.
10. Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: 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.
11. Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14 [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Greece

Heraclion, Crete, Greece

Athens, Greece

Ioannina, Greece

Piraeus, Greece

Thessaloniki, Greece

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00307931
• Other Study ID Numbers: C87055; Eudract n° - 2006-002027-16
• First Posted: March 28, 2006
• Results First Posted: October 19, 2009
• Last Update Posted: August 31, 2011
• Last Verified: December 2009

Keywords provided by UCB Pharma:

Certolizumab pegol; Cimzia; Crohn's disease; Greek patients

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Certolizumab Pegol; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents