MedTrace Logo

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

NCT00308581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2018-08-07

Study results available
· View outcomes & findings →

Summary

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

Conditions

Interventions

BIOLOGICAL

Certolizumab pegol

400mg Certolizumab Pegol, Q4W, administered 4-weekly

BIOLOGICAL

Certolizumab pegol

400mg Certolizumab Pegol, Q2W, administered 2-weekly

OTHER

Placebo

placebo administered 4-weekly in Active 1

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00308581 on ClinicalTrials.gov