NCT01571206

An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-04-05
• Last updated: 2013-07-31

Locations

1 site across 1 country: South Korea