NCT01571219

An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	CT-P13(3mg/kg) administered as a 2-hour IV infusion per dose co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose (dose and route must be maintained from Study CT-P13 3.1 and be maintained from the beginning to the end of the extension study) and folic acid(≥5mg/week, oral dose)

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-04-05
• Last updated: 2017-08-01

Locations

1 site across 1 country: South Korea