Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LBEC0101 Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LBEC0101
Etanercept 50mg
Drug: LBEC0101
Etanercept 50mg




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715908


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02715908    
Other Study ID Numbers: LG-ECCL004
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases