Arthritis, Rheumatoid Clinical Trial
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
Verified date | March 2021 |
Source | LG Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 383 |
Est. completion date | February 23, 2018 |
Est. primary completion date | July 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | 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-? 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Mochida Investigational site | Tokyo | |
Korea, Republic of | LGLS Investigational site | Seoul |
Lead Sponsor | Collaborator |
---|---|
LG Life Sciences | Mochida Pharmaceutical Company, Ltd. |
Japan, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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