Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00552058
First received: October 18, 2007
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.


Condition Intervention Phase
Crohn Disease
Biological: certolizumab pegol (CDP870, CZP)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects in Clinical Remission at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.


Secondary Outcome Measures:
  • Percentage of Subjects Achieving a Clinical Response at Week 6 [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

  • Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 [ Time Frame: Week 0 to Week 6 ] [ Designated as safety issue: No ]
    The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 [ Time Frame: Week 0 to Week 6 ] [ Designated as safety issue: No ]
    The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.

  • Percentage of Subjects in Clinical Remission at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Clinical Remission at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects Achieving a Clinical Response at Week 2 [ Time Frame: Week 0, Week 2 ] [ Designated as safety issue: No ]
    The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects Achieving a Clinical Response at Week 4 [ Time Frame: Week 0, Week 4 ] [ Designated as safety issue: No ]
    The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 [ Time Frame: Week 0 to Week 2 ] [ Designated as safety issue: No ]
    The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4 [ Time Frame: Week 0, Week 4 ] [ Designated as safety issue: No ]
    The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

  • Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

  • Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.

  • Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6 [ Time Frame: Week 0, Week 6 ] [ Designated as safety issue: No ]
    The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.


Enrollment: 439
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Biological: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Other Names:
  • CIMZIA ®
  • CDP870
  • CZP
Placebo Comparator: Placebo
Placebo, saline solution for sc injection
Other: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male/female
  • 18 - 75 years inclusive
  • diagnosis of Crohn's disease confirmed
  • moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
  • no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

  • previous participation in a certolizumab pegol study
  • general exclusion criteria as common for studies in this indication
  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: NCT00552058

  Show 116 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00552058     History of Changes
Other Study ID Numbers: C87085, 2007-001913-41
Study First Received: October 18, 2007
Results First Received: October 8, 2010
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Israel: Ministry of Health
Latvia: State Agency of Medicines
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by UCB, Inc.:
CDP 870
Certolizumab Pegol
CIMZIA ®
Crohn's disease
Induction
Clinical remission
Clinical response

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014