A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
1 other identifier
interventional
383
2 countries
2
Brief Summary
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2016
CompletedStudy Start
First participant enrolled
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2018
CompletedMarch 15, 2021
March 1, 2021
1.3 years
April 5, 2016
March 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
DAS28-ESR
DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA). DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR.
Week 24
Study Arms (2)
LBAL
EXPERIMENTALAdalimumab
Humira®
ACTIVE COMPARATORAdalimumab
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
- Mochida Pharmaceutical Company, Ltd.collaborator
Study Sites (2)
Mochida Investigational site
Tokyo, Japan
LGLS Investigational site
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 21, 2016
Study Start
April 13, 2016
Primary Completion
July 14, 2017
Study Completion
February 23, 2018
Last Updated
March 15, 2021
Record last verified: 2021-03