Back to resultsA Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LBAL
Humira®
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 (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.
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
LBAL
Humira®
Arm Description
Adalimumab
Adalimumab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02746380
First Posted
April 5, 2016
Last Updated
March 12, 2021
Sponsor
LG Life Sciences
Collaborators
Mochida Pharmaceutical Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02746380
Brief Title
A Study Comparing LBAL to Humira® 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 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2016 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
February 23, 2018 (Actual)
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 LBAL compared to Humira® 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
383 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBAL
Arm Type
Experimental
Arm Description
Adalimumab
Arm Title
Humira®
Arm Type
Active Comparator
Arm Description
Adalimumab
Intervention Type
Drug
Intervention Name(s)
LBAL
Intervention Description
Adalimumab
Intervention Type
Drug
Intervention Name(s)
Humira®
Intervention Description
Adalimumab
Primary Outcome Measure Information:
Title
DAS28-ESR
Description
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.
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 (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.
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
Learn more about this trial
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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