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Completed

NCT Number: NCT02715908

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

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

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBEC0101

Drug

Etanercept 50mg

Primary outcomes

  1. 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

  1. DAS28-CRP

    Time frame: 48 weeks

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

  2. 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)

  3. Remission rate

    Time frame: 48 weeks

    Remission rate (i.e., DAS28-ESR <2.6) at Weeks 52, 76, and 100

  4. EULAR response

    Time frame: 48 weeks

    Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 22, 2016
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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