A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)

July 4, 2018 updated by: LG Life Sciences

A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002

To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study is to evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX for additional 48 weeks (a total of 100 weeks including 52 weeks of the treatment period in Study LG-ECCL002) in the subjects who have completed the treatment period of phase III clinical study for LBEC0101 (Study No. LG-ECCL002).

Study Type

Interventional

Enrollment (Actual)

148

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

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:

  • Patients who completed the treatment period of Study LG-ECCL002
  • Patients requiring continuous treatment for rheumatoid arthritis upon the investigator's discretion
  • For childbearing female patients or surgically non-sterile male patients, those who agreed to avoid pregnancy using proper contraceptive methods during the study.
  • Patients who made a voluntary decision to participate in this clinical study and gave a voluntary written consent to comply with all the instructions with full understanding after being informed of the study

Exclusion Criteria:

  • Patients deemed difficult to participate in this extension study due to the adverse events which occurred in Study LG-ECCL002, upon the investigator's discretion at screening
  • Patients with at least 10 swollen joints (out of the total 66 assessing joints) or at least 12 tender joints (out of the total 68 assessing joints) at screening
  • Women in pregnancy or lactation, or patients planning to be pregnant during the study period
  • Patients ineligible for this clinical study upon the investigator's discretion

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBEC0101
Etanercept 50mg
Drug: LBEC0101
Etanercept 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS28-ESR
Time Frame: 48 weeks
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS28-CRP
Time Frame: 48 weeks
Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
48 weeks
ACR 20, 50, 70
Time Frame: 48 weeks
Response rate on ACR20, 50, 70 at Weeks 52, 76, and 100 based on baseline (Week 0)
48 weeks
Remission rate
Time Frame: 48 weeks
Remission rate (i.e., DAS28-ESR <2.6) at Weeks 52, 76, and 100
48 weeks
EULAR response
Time Frame: 48 weeks
Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100
48 weeks

Collaborators and Investigators

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

Sponsor

LG Life Sciences

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 (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-ECCL004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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