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

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ClinicalTrials.gov Identifier: NCT02715908
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2018)
DAS28-ESR [ Time Frame: 48 weeks ]
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
Disease activity score based on a 28 joint count (DAS28) [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2018)
  • DAS28-CRP [ Time Frame: 48 weeks ]
    Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
  • 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)
  • Remission rate [ Time Frame: 48 weeks ]
    Remission rate (i.e., DAS28-ESR <2.6) at Weeks 52, 76, and 100
  • EULAR response [ Time Frame: 48 weeks ]
    Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: LBEC0101
Etanercept 50mg
Study Arms  ICMJE Experimental: LBEC0101
Etanercept 50mg
Intervention: Drug: LBEC0101
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
148
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2016)
165
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715908
Other Study ID Numbers  ICMJE LG-ECCL004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party LG Life Sciences
Study Sponsor  ICMJE LG Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account LG Life Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP