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A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

NCT00160524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2018-08-01

Study results available
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Summary

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).

Conditions

Interventions

BIOLOGICAL

Certolizumab Pegol (CDP870)

Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.

Sponsors & Collaborators

  • UCB Pharma SA

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Georgia
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • New Zealand
  • Norway
  • Poland
  • Russia
  • Serbia
  • Singapore
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Ukraine

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 NCT00160524 on ClinicalTrials.gov