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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02357069
• Date of registration: 29/01/2015
• Prospective Registration: Yes
• Primary sponsor: LG Life Sciences
• Public title: A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 372
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02357069
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan, Korea, Republic of

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Enbrel

Drug: LBEC0101

Primary Outcome(s)

Disease activity score based on a 28 joint count (DAS28) [Time Frame: Week 24]

Secondary ID(s)

LG-ECCL002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mochida Pharmaceutical Company, Ltd.