NCT00552344

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 \[NCT00552058\].

Detailed 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)

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Cimzia	* Active substance: Certolizumab Pegol * Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe * Concentration: 200 mg/ml * Route of Administration: Subcutaneous use

Timeline

• Start date: 2008-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2007-11-01
• Last updated: 2018-08-09
• Results posted: 2016-01-21

Locations

100 sites across 18 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Czechia, Estonia, Germany, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Romania, Russia, Ukraine