Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00291668

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by UCB:

Primary Outcome Measures:

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 ]

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

Eligibility

Criteria

Inclusion Criteria:

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 inaoppropriate for enrollment by the principal investigator or subinvestigators

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291668

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	C87037
Study First Received:	February 10, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00291668
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB:

Crohn's Disease
CDP870, Certolizumab pegol

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009