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

January 5, 2016 updated by: LG Life Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Mochida Investigational site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • LGLS Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LBEC0101
Etanercept
Drug: LBEC0101
Etanercept
ACTIVE_COMPARATOR: Enbrel
Etanercept
Drug: Enbrel
Etanercept

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Collaborators

Mochida Pharmaceutical Company, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (ESTIMATE)

February 6, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-ECCL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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