A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT ID: NCT02746380
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
383 participants
INTERVENTIONAL
2016-04-13
2018-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LBAL
Adalimumab
LBAL
Adalimumab
Humira®
Adalimumab
Humira®
Adalimumab
Interventions
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LBAL
Adalimumab
Humira®
Adalimumab
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
75 Years
ALL
No
Sponsors
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Mochida Pharmaceutical Company, Ltd.
INDUSTRY
LG Life Sciences
INDUSTRY
Responsible Party
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Locations
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Mochida Investigational site
Tokyo, , Japan
LGLS Investigational site
Seoul, , South Korea
Countries
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Other Identifiers
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LG-ALCL002
Identifier Type: -
Identifier Source: org_study_id
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