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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00291668
First received: February 10, 2006
Last updated: September 6, 2013
Last verified: March 2011
  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, Inc.:

Primary Outcome Measures:
  • The efficacy of CDP870, estimating the dose response [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • The safety and tolerability of CDP870 in patients with active Crohn's disease. [ Time Frame: 8 weeks or 16 weeks ]
  • The plasma CDP870 concentrations and anti-CDP870 antibody levels up to Week 16 after dosing at Weeks, 0, 2, and 4. [ Time Frame: 8 weeks or 16 weeks ]

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: 1
Certolizumab pegol 200mg
Biological: Certolizumab pegol
200mg subcutaneously on Weeks 0 (first dose), 2 and 4.
Other Name: CDP870
Experimental: 2
Certolizumab pegol 400mg
Biological: Certolizumab pegol
400 mg subcutaneously on Weeks 0 (first dose), 2 and 4.
Other Name: CDP870
Placebo Comparator: 3 Other: Placebo
Placebo is administered subcutaneously at Weeks 0 (first dose), 2 and 4.

  Eligibility

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

Inclusion Criteria:

  1. Patients who are diagnosed as Crohn's disease
  2. Patients with CDAI score ranging from 220 to 450
  3. CRP of 1 mg/dL or higher in the laboratory test

Exclusion Criteria:

  1. Stoma patient
  2. Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
  3. Patients who participated in a clinical study with CDP870
  4. Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
  5. Patients who are judged inaoppropriate 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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00291668     History of Changes
Other Study ID Numbers: C87037
Study First Received: February 10, 2006
Last Updated: September 6, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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 01, 2014