A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02746380
• Date of registration: 05/04/2016
• Prospective Registration: Yes
• Primary sponsor: LG Life Sciences
• Public title: A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
• Scientific 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
• Date of first enrolment: April 13, 2016
• Target sample size: 383
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02746380
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Japan, Korea, Republic of

Key inclusion & exclusion 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-? 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



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Humira®

Drug: LBAL

Primary Outcome(s)

DAS28-ESR [Time Frame: Week 24]

Secondary ID(s)

LG-ALCL002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mochida Pharmaceutical Company, Ltd.