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

NCT02715908 | Completed Phase 3

• 1 other identifier: LG-ECCL004
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• DAS28-ESR

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

  48 weeks

Secondary Outcomes (4)

• DAS28-CRP

  48 weeks

• ACR 20, 50, 70

  48 weeks

• Remission rate

  48 weeks

• EULAR response

  48 weeks

Study Arms (1)

LBEC0101

EXPERIMENTAL

Etanercept 50mg

Drug: LBEC0101

Interventions

LBEC0101 DRUG

Etanercept 50mg

LBEC0101

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31113455 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

LBEC0101

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

KR (1)