CompletedNCT02715908Updated Jul 6, 2018

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

A Phase 3 interventional study of LBEC0101 in Rheumatoid Arthritis, sponsored by LG Life Sciences. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-06.

Sponsored by LG Life Sciences · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 148
Allocation: Not applicable
Ages: 20 Years to 75 Years
Sex: All

Study summary

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

Read the 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).

Conditions studied

Rheumatoid Arthritis

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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 148 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

LG Life Sciences is the lead sponsor of 75 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: 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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 148 participants (actual)

Study arms

Experimental
LBEC0101
Etanercept 50mg
Drug: LBEC0101

Interventions

DrugLBEC0101
Etanercept 50mg

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Seoul National University Hospital
Seoul, Korea, Republic of

References and documents

Publications

Park MC, Matsuno H, Kim J, Park SH, Lee SH, Park YB, Lee YJ, Lee SI, Park W, Sheen DH, Choe JY, Choi CB, Hong SJ, Suh CH, Lee SS, Cha HS, Yoo B, Hur JW, Kim GT, Yoo WH, Baek HJ, Shin K, Shim SC, Yang HI, Kim HA, Park KS, Choi IA, Lee J, Tomomitsu M, Shin S, Lee J, Song YW. Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study. Arthritis Res Ther. 2019 May 21;21(1):122. doi: 10.1186/s13075-019-1910-2. PubMed 31113455 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02715908
Lead sponsor: LG Life Sciences
Responsible party: Sponsor
First posted: Mar 22, 2016
Start date: Apr 2016
Primary completion: Dec 2017
Completion: Apr 2018
Last update: Jul 6, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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