An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).

UCB Pharma0 sites106 target enrollmentJanuary 2007

ConditionsCrohn's Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: UCB Pharma
Enrollment: 106
Primary Endpoint: Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

February 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion Criteria

•Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
•Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
•Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment

Outcomes

Primary Outcomes

Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)

Time Frame: During this study (maximum 122 weeks)

Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.

Secondary Outcomes

Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.(Week 34 in this study)