Back to resultsA Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Primary Purpose
Arthritis, Rheumatoid
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enbrel
LBEC0101
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
- Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.
Exclusion Criteria:
- patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
- patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
- patients with any seropositive result for hepatitis B or hepatitis C or HIV
- patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
Sites / Locations
- Mochida Investigational site
- LGLS Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LBEC0101
Enbrel
Arm Description
Etanercept
Etanercept
Outcomes
Primary Outcome Measures
Disease activity score based on a 28 joint count (DAS28)
Secondary Outcome Measures
Full Information
NCT ID
NCT02357069
First Posted
January 29, 2015
Last Updated
January 5, 2016
Sponsor
LG Life Sciences
Collaborators
Mochida Pharmaceutical Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02357069
Brief Title
A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
Collaborators
Mochida Pharmaceutical Company, Ltd.
4. Oversight
5. Study Description
Brief Summary
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
372 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBEC0101
Arm Type
Experimental
Arm Description
Etanercept
Arm Title
Enbrel
Arm Type
Active Comparator
Arm Description
Etanercept
Intervention Type
Drug
Intervention Name(s)
Enbrel
Intervention Description
Etanercept
Intervention Type
Drug
Intervention Name(s)
LBEC0101
Intervention Description
Etanercept
Primary Outcome Measure Information:
Title
Disease activity score based on a 28 joint count (DAS28)
Time Frame
Week 24
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:
Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.
Exclusion Criteria:
patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
patients with any seropositive result for hepatitis B or hepatitis C or HIV
patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
Facility Information:
Facility Name
Mochida Investigational site
City
Tokyo
Country
Japan
Facility Name
LGLS Investigational site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29259050
Citation
Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis. 2018 Apr;77(4):488-494. doi: 10.1136/annrheumdis-2017-212172. Epub 2017 Dec 19.
Results Reference
derived
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A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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