Skip to main content
Clinical Trials/NCT02715908
NCT02715908CompletedPhase 3

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

LG Life Sciences1 site in 1 country148 target enrollmentStarted: April 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
148
Locations
1
Primary Endpoint
DAS28-ESR

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

LBEC0101

Experimental

Etanercept 50mg

Intervention: LBEC0101 (Drug)

Outcomes

Primary Outcomes

DAS28-ESR

Time Frame: 48 weeks

Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100

Secondary Outcomes

  • DAS28-CRP(48 weeks)
  • ACR 20, 50, 70(48 weeks)
  • Remission rate(48 weeks)
  • EULAR response(48 weeks)

Investigators

Sponsor
LG Life Sciences
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials