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 Pharma
ClinicalTrials.gov Identifier:
NCT00307931
First received: March 24, 2006
Last updated: August 30, 2011
Last verified: December 2009
  Purpose

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 Intervention Phase
Crohn's Disease
Biological: Certolizumab pegol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00307931

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:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00307931     History of Changes
Other Study ID Numbers: C87055, Eudract n° - 2006-002027-16
Study First Received: March 24, 2006
Results First Received: September 8, 2009
Last Updated: August 30, 2011
Health Authority: Greece: National Organization of Medicines

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
Infliximab
Certolizumab pegol
Immunoglobulin Fab Fragments
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 22, 2014