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Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease

NCT00356408 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2018-08-09

Study results available
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Summary

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Conditions

Interventions

BIOLOGICAL

Certolizumab pegol

Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356408 on ClinicalTrials.gov