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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02357069
• Other study ID #: LG-ECCL002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 29, 2015
• Last updated: January 5, 2016
• Start date: February 2015

Study information

• Verified date: January 2016
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug SafetyJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 372
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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-? 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Enbrel
Etanercept
• LBEC0101
Etanercept

Locations

Country	Name	City	State
Japan	Mochida Investigational site	Tokyo
Korea, Republic of	LGLS Investigational site	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
LG Life Sciences	Mochida Pharmaceutical Company, Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity score based on a 28 joint count (DAS28)		Week 24	No