Back to resultsA Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LBEC0101
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBEC0101
Arm Description
Etanercept 50mg
Outcomes
Primary Outcome Measures
DAS28-ESR
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Secondary Outcome Measures
DAS28-CRP
Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
ACR 20, 50, 70
Response rate on ACR20, 50, 70 at Weeks 52, 76, and 100 based on baseline (Week 0)
Remission rate
Remission rate (i.e., DAS28-ESR <2.6) at Weeks 52, 76, and 100
EULAR response
Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02715908
Brief Title
A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBEC0101
Arm Type
Experimental
Arm Description
Etanercept 50mg
Intervention Type
Drug
Intervention Name(s)
LBEC0101
Intervention Description
Etanercept 50mg
Primary Outcome Measure Information:
Title
DAS28-ESR
Description
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
DAS28-CRP
Description
Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Time Frame
48 weeks
Title
ACR 20, 50, 70
Description
Response rate on ACR20, 50, 70 at Weeks 52, 76, and 100 based on baseline (Week 0)
Time Frame
48 weeks
Title
Remission rate
Description
Remission rate (i.e., DAS28-ESR <2.6) at Weeks 52, 76, and 100
Time Frame
48 weeks
Title
EULAR response
Description
Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31113455
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
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