NCT02357069

A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Enbrel	Etanercept
DRUG	LBEC0101	Etanercept

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-01
• First posted: 2015-02-06
• Last updated: 2016-01-06

Locations

2 sites across 2 countries: Japan, South Korea