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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715908
• Other study ID #: LG-ECCL004
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LBEC0101
Etanercept 50mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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