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

LG Life Sciences

Status and phase

Unknown

Phase 3

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Enbrel

Drug: LBEC0101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02357069

LG-ECCL002

Details and patient eligibility

About

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.

Enrollment

372 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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