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A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

Crohn Disease Clinical Trial

Official title:
A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

Clinical Trial Summary

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].

Clinical Trial Description

This study consisted of:

- Induction Period (dosing at Weeks 0, 2, and 4)

- Maintenance Dosing (dosing every 4 weeks up to Week 260)

- End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00552344
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 3
Start date May 2008
Completion date December 2014
View Details
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