NCT01873443

Long-Term Efficacy and Safety of CT-P10 in Patients With RA

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Rituximab, MTX, folic acid	Rituximab IV 1000mg MTX 10\~25mg/week Folic acid at least 5mg/week

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-06-10
• Last updated: 2015-11-26

Locations

1 site across 1 country: South Korea