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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Biological: Certolizumab pegol

• Registration Number: NCT00356408
• Lead Sponsor: UCB Pharma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-25
• Study First Posted: 2006-07-26
• Study Start: 2007-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-02-23
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-21
• Results First Posted: 2011-05-25
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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• Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDP870 400 mg	Certolizumab pegol	Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) 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

Primary Outcome Measures

Name	Time	Method
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)	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 Outcome Measures

Name	Time	Method
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	Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.