Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT00291668
First received: February 10, 2006
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Biological: Certolizumab Pegol
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Crohn's Disease Activity Index (CDAI) response (clinical response or remission) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Crohn's Disease Activity Index (CDAI) score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index (CDAI) score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Crohn's Disease Activity Index (CDAI) score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve CDAI response at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve CDAI response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve remission (CDAI <= 150) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve remission (CDAI <= 150) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve remission (CDAI <= 150) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) value at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) value at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) value at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) Ratio to Baseline at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) Ratio to Baseline at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) Ratio to Baseline at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: March 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol 200 mg
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Biological: Certolizumab Pegol
  • Active Substance: Certolizumab Pegol
  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Concentration: 200 mg/mL
  • Route of Administration: Subcutaneous use
Other Name: CDP870
Other: Placebo
  • Active Substance: isotonic sodium chloride solution
  • Pharmaceutical Form: Solution for injection
  • Concentration: 1 mL
  • Route of Administration: Subcutaneous use
Experimental: Certolizumab pegol 400 mg
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Biological: Certolizumab Pegol
  • Active Substance: Certolizumab Pegol
  • Pharmaceutical Form: Solution for injection in pre-filled syringe
  • Concentration: 200 mg/mL
  • Route of Administration: Subcutaneous use
Other Name: CDP870
Placebo Comparator: Placebo
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
Other: Placebo
  • Active Substance: isotonic sodium chloride solution
  • Pharmaceutical Form: Solution for injection
  • Concentration: 1 mL
  • Route of Administration: Subcutaneous use

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
  • Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
  • C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Exclusion Criteria:

  • Stoma patient
  • Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
  • Patients who participated in a clinical study with CDP870
  • Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
  • Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators
  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: NCT00291668

Locations
Japan
Aichi-Gun, Aichi, Japan
Nagoya, Aichi, Japan
Toyoake, Aichi, Japan
Toyohashi, Aichi, Japan
Kashiwa, Chiba, Japan
Sakura, Chiba, Japan
Chikusino, Fukuoka, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyogo, Japan
Yokohama, Kanagawa, Japan
Miyazaki-gun, Miyazaki, Japan
Kurashiki, Okayama, Japan
Tyuto-gun, Okinawa, Japan
Suita, Osaka, Japan
Otsu, Shiga, Japan
Shinjyuku, Tokyo, Japan
Fukuoka, Japan
Kagoshima, Japan
Nagasaki, Japan
Niigata, Japan
Osaka, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT00291668     History of Changes
Other Study ID Numbers: C87037, 2014-004399-42
Study First Received: February 10, 2006
Last Updated: March 5, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Crohn's Disease
CDP870, Certolizumab pegol

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

ClinicalTrials.gov processed this record on August 02, 2015