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

Phase 3

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Enbrel; Drug: LBEC0101

• Registration Number: NCT02357069
• Lead Sponsor: LG Life Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-29
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

• Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
• Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
• Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.

Exclusion Criteria

• patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
• patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
• patients with any seropositive result for hepatitis B or hepatitis C or HIV
• patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enbrel	Enbrel	Etanercept
LBEC0101	LBEC0101	Etanercept

Primary Outcome Measures

Name	Time	Method
Disease activity score based on a 28 joint count (DAS28)	Week 24

Trial Locations

Locations (2)

Mochida Investigational site; 🇯🇵 Tokyo, Japan

LGLS Investigational site; 🇰🇷 Seoul, Korea, Republic of